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Absorb IV Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02173379
Recruitment Status : Active, not recruiting
First Posted : June 25, 2014
Results First Posted : July 24, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Coronary Artery Disease
Coronary Artery Stenosis
Coronary Disease
Coronary Stenosis
Interventions Device: Absorb BVS
Device: XIENCE
Enrollment 2610
Recruitment Details A total of 2610 subjects were originally randomized at 147 sites between August 15, 2014 and March 31, 2017. The last 30-day follow-up visit occurred on April 27, 2017. The database was then cleaned and locked, and data extraction for the 30-day analysis occurred on August 21, 2017.
Pre-assignment Details In preparation for database lock for the primary endpoint analysis, a review of the database was conducted that identified 6 patients that were randomized in error. None of these patients received a study device, and they were all withdrawn by physician.Therefore, the analyzable population is 2604.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Period Title: Overall Study
Started 1296 1308
Completed 1287 1301
Not Completed 9 7
Reason Not Completed
Lost to Follow-up             3             0
Withdrawal by Subject             1             4
Physician Decision             4             1
Death             1             1
Withdrawn by the physician             0             1
Arm/Group Title Absorb BVS XIENCE Total
Hide Arm/Group Description Subjects receiving public) Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) Total of all reporting groups
Overall Number of Baseline Participants 1296 1308 2604
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1296 participants 1308 participants 2604 participants
63.1  (10.1) 62.2  (10.3) 62.65  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1296 participants 1308 participants 2604 participants
Female
369
  28.5%
361
  27.6%
730
  28.0%
Male
927
  71.5%
947
  72.4%
1874
  72.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1296 participants 1308 participants 2604 participants
Hispanic or Latino
40
   3.1%
29
   2.2%
69
   2.6%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1256
  96.9%
1279
  97.8%
2535
  97.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1296 participants 1308 participants 2604 participants
American Indian or Alaska Native
4
   0.3%
8
   0.6%
12
   0.5%
Asian
30
   2.3%
36
   2.8%
66
   2.5%
Native Hawaiian or Other Pacific Islander
11
   0.8%
4
   0.3%
15
   0.6%
Black or African American
71
   5.5%
61
   4.7%
132
   5.1%
White
1135
  87.6%
1160
  88.7%
2295
  88.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
45
   3.5%
39
   3.0%
84
   3.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1296 participants 1308 participants 2604 participants
Canada 28 26 54
United States 1021 1041 2062
Australia 80 68 148
Germany 164 171 335
Singapore 3 2 5
1.Primary Outcome
Title Number of Participants With Target Lesion Failure (TLF)
Hide Description Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1288 1303
Measure Type: Count of Participants
Unit of Measure: Participants
64
   5.0%
48
   3.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Absorb BVS, XIENCE
Comments

The hypothesis test is designed to show non-inferiority of Absorb BVS to XIENCE for the primary endpoint with a one-sided alpha of 0.025. The null (H0) and alternative (HA) hypotheses are:

H0: TLFAbsorb - TLFXIENCE ≥ ∆TLF HA: TLFAbsorb - TLFXIENCE < ∆TLF.

Type of Statistical Test Non-Inferiority
Comments One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 2.9%, to be compared with a one-sided significance level of 0.025.
Statistical Test of Hypothesis P-Value 0.0244
Comments [Not Specified]
Method Farrington-Manning
Comments [Not Specified]
2.Secondary Outcome
Title Powered TLF, Tested for Non-inferiority of Absorb BVS to XIENCE
Hide Description This analysis will consist of ~2610 subjects in ABSORB IV.
Time Frame 1 year
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Number of Participants With Powered Angina
Hide Description
  • Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC).
  • This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1287 1301
Measure Type: Count of Participants
Unit of Measure: Participants
117
   9.1%
117
   9.0%
4.Secondary Outcome
Title Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis)
Hide Description Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.
Time Frame In-hospital (≤ 7days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1282 1303
Overall Number of Units Analyzed
Type of Units Analyzed: Target lesions
1424 1450
Measure Type: Number
Unit of Measure: Percentage of target lesions
94.6 99.0
5.Secondary Outcome
Title Number of Participants With Acute Success- Procedural Success (Subject Level Analysis)
Hide Description Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).
Time Frame In-hospital (≤ 7days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1282 1303
Measure Type: Count of Participants
Unit of Measure: Participants
1203
  93.8%
1250
  95.9%
6.Secondary Outcome
Title Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)
Hide Description

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time Frame In-hospital (≤ 7 days post index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1291 1304
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.1%
0
   0.0%
7.Secondary Outcome
Title Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)
Hide Description

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1288 1303
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.1%
1
   0.1%
8.Secondary Outcome
Title Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)
Hide Description

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time Frame 90 days
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)
Hide Description

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time Frame 180 days
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)
Hide Description

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time Frame 270 days
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)
Hide Description

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time Frame 1 year
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)
Hide Description

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time Frame 2 years
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)
Hide Description

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time Frame 3 years
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)
Hide Description

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time Frame 4 years
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)
Hide Description

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time Frame 5 years
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)
Hide Description

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time Frame 6 years
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)
Hide Description

Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time Frame 7 years
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 8 years
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 9 years
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 10 years
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Hide Description
  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
Time Frame In-hospital (≤ 7 days post index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1291 1304
Measure Type: Count of Participants
Unit of Measure: Participants
50
   3.9%
43
   3.3%
22.Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Hide Description
  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1288 1303
Measure Type: Count of Participants
Unit of Measure: Participants
58
   4.5%
47
   3.6%
23.Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Hide Description
  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
Time Frame 90 days
Outcome Measure Data Not Reported
24.Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Hide Description
  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
Time Frame 180 days
Outcome Measure Data Not Reported
25.Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Hide Description
  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
Time Frame 270 days
Outcome Measure Data Not Reported
26.Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Hide Description
  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
Time Frame 1 year
Outcome Measure Data Not Reported
27.Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Hide Description
  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
Time Frame 2 years
Outcome Measure Data Not Reported
28.Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Hide Description
  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
Time Frame 3 years
Outcome Measure Data Not Reported
29.Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Hide Description
  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
Time Frame 4 years
Outcome Measure Data Not Reported
30.Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Hide Description
  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
Time Frame 5 years
Outcome Measure Data Not Reported
31.Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Hide Description
  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
Time Frame 6 years
Outcome Measure Data Not Reported
32.Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Hide Description
  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
Time Frame 7 years
Outcome Measure Data Not Reported
33.Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 8 years
Outcome Measure Data Not Reported
34.Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 9 years
Outcome Measure Data Not Reported
35.Secondary Outcome
Title Number of Participants With Myocardial Infarction (MI)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 10 years
Outcome Measure Data Not Reported
36.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame In-hospital (≤ 7 days post index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1291 1304
Measure Type: Count of Participants
Unit of Measure: Participants
8
   0.6%
1
   0.1%
37.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1288 1303
Measure Type: Count of Participants
Unit of Measure: Participants
14
   1.1%
3
   0.2%
38.Secondary Outcome
Title Number of Participants withTarget Lesion Revascularization (TLR)
Hide Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 90 days
Outcome Measure Data Not Reported
39.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 180 days
Outcome Measure Data Not Reported
40.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 270 days
Outcome Measure Data Not Reported
41.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 1 year
Outcome Measure Data Not Reported
42.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 2 years
Outcome Measure Data Not Reported
43.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 3 years
Outcome Measure Data Not Reported
44.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 4 years
Outcome Measure Data Not Reported
45.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 5 years
Outcome Measure Data Not Reported
46.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 6 years
Outcome Measure Data Not Reported
47.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time Frame 7 years
Outcome Measure Data Not Reported
48.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 8 years
Outcome Measure Data Not Reported
49.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 9 years
Outcome Measure Data Not Reported
50.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 10 years
Outcome Measure Data Not Reported
51.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
  • TVR includes all TVR, excluding TLR
Time Frame In-hospital (≤ 7 days post index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1291 1304
Measure Type: Count of Participants
Unit of Measure: Participants
3
   0.2%
0
   0.0%
52.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
  • TVR includes all TVR, excluding TLR
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1288 1303
Measure Type: Count of Participants
Unit of Measure: Participants
5
   0.4%
1
   0.1%
53.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
  • TVR includes all TVR, excluding TLR
Time Frame 90 days
Outcome Measure Data Not Reported
54.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. classified as: Ischemic driven TVR and Non-ischemic driven TVR.

-TVR includes all TVR, excluding TLR

Time Frame 180 days
Outcome Measure Data Not Reported
55.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
  • TVR includes all TVR, excluding TLR
Time Frame 270 days
Outcome Measure Data Not Reported
56.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
  • TVR includes all TVR, excluding TLR
Time Frame 1 year
Outcome Measure Data Not Reported
57.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
  • TVR includes all TVR, excluding TLR
Time Frame 2 years
Outcome Measure Data Not Reported
58.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
  • TVR includes all TVR, excluding TLR
Time Frame 3 years
Outcome Measure Data Not Reported
59.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
  • TVR includes all TVR, excluding TLR
Time Frame 4 years
Outcome Measure Data Not Reported
60.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
  • TVR includes all TVR, excluding TLR
Time Frame 5 years
Outcome Measure Data Not Reported
61.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
  • TVR includes all TVR, excluding TLR
Time Frame 6 years
Outcome Measure Data Not Reported
62.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
  • TVR includes all TVR, excluding TLR
Time Frame 7 years
Outcome Measure Data Not Reported
63.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 8 years
Outcome Measure Data Not Reported
64.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 9 years
Outcome Measure Data Not Reported
65.Secondary Outcome
Title Number of Participants With Target Vessel Revascularization (TVR)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 10 years
Outcome Measure Data Not Reported
66.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame In-hospital (≤ 7 days post index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1291 1304
Measure Type: Count of Participants
Unit of Measure: Participants
10
   0.8%
4
   0.3%
67.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1288 1303
Measure Type: Count of Participants
Unit of Measure: Participants
19
   1.5%
8
   0.6%
68.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 90 days
Outcome Measure Data Not Reported
69.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 180 days
Outcome Measure Data Not Reported
70.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 270 days
Outcome Measure Data Not Reported
71.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 1 year
Outcome Measure Data Not Reported
72.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 2 years
Outcome Measure Data Not Reported
73.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 3 years
Outcome Measure Data Not Reported
74.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 4 years
Outcome Measure Data Not Reported
75.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 5 years
Outcome Measure Data Not Reported
76.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 6 years
Outcome Measure Data Not Reported
77.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time Frame 7 years
Outcome Measure Data Not Reported
78.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 8 years
Outcome Measure Data Not Reported
79.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 9 years
Outcome Measure Data Not Reported
80.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 10 years
Outcome Measure Data Not Reported
81.Secondary Outcome
Title Number of Participants Experienced All Death/All MI
Hide Description

All deaths includes

  • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
  • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
  • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Those MIs which are not Q-wave MI

Time Frame In-hospital (≤ 7 days post index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1291 1304
Measure Type: Count of Participants
Unit of Measure: Participants
51
   4.0%
43
   3.3%
82.Secondary Outcome
Title Number of Participants Experienced All Death/All MI
Hide Description

All deaths includes

  • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
  • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
  • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Those MIs which are not Q-wave MI

Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1288 1303
Measure Type: Count of Participants
Unit of Measure: Participants
59
   4.6%
48
   3.7%
83.Secondary Outcome
Title Number of Participants Experienced Death/All MI
Hide Description

All deaths includes

  • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
  • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
  • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Those MIs which are not Q-wave MI

Time Frame 90 days
Outcome Measure Data Not Reported
84.Secondary Outcome
Title Number of Participants Experienced Death/All MI
Hide Description

All deaths includes

  • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
  • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
  • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Those MIs which are not Q-wave MI

Time Frame 180 days
Outcome Measure Data Not Reported
85.Secondary Outcome
Title Number of Participants Experienced Death/All MI
Hide Description

All deaths includes

  • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
  • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
  • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Those MIs which are not Q-wave MI

Time Frame 270 days
Outcome Measure Data Not Reported
86.Secondary Outcome
Title Number of Participants Experienced Death/All MI
Hide Description

All deaths includes

  • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
  • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
  • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Those MIs which are not Q-wave MI

Time Frame 1 year
Outcome Measure Data Not Reported
87.Secondary Outcome
Title Number of Participants Experienced Death/All MI
Hide Description

All deaths includes

  • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
  • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
  • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Those MIs which are not Q-wave MI

Time Frame 2 years
Outcome Measure Data Not Reported
88.Secondary Outcome
Title Number of Participants Experienced Death/All MI
Hide Description

All deaths includes

  • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
  • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
  • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Those MIs which are not Q-wave MI

Time Frame 3 years
Outcome Measure Data Not Reported
89.Secondary Outcome
Title Number of Participants Experienced Death/All MI
Hide Description

All deaths includes

  • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
  • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
  • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Those MIs which are not Q-wave MI

Time Frame 4 years
Outcome Measure Data Not Reported
90.Secondary Outcome
Title Number of Participants Experienced Death/All MI
Hide Description

All deaths includes

  • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
  • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
  • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Those MIs which are not Q-wave MI

Time Frame 5 years
Outcome Measure Data Not Reported
91.Secondary Outcome
Title Number of Participants Experienced Death/All MI
Hide Description

All deaths includes

  • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
  • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
  • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Those MIs which are not Q-wave MI

Time Frame 6 years
Outcome Measure Data Not Reported
92.Secondary Outcome
Title Number of Participants Experienced Death/All MI
Hide Description

All deaths includes

  • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
  • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
  • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Those MIs which are not Q-wave MI

Time Frame 7 years
Outcome Measure Data Not Reported
93.Secondary Outcome
Title Number of Participants Experienced Death/All MI
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 8 years
Outcome Measure Data Not Reported
94.Secondary Outcome
Title Number of Participants Experienced Death/All MI
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 9 years
Outcome Measure Data Not Reported
95.Secondary Outcome
Title Number of Participants Experienced Death/All MI
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 10 years
Outcome Measure Data Not Reported
96.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Hide Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame In-hospital (≤ 7 days post index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1291 1304
Measure Type: Count of Participants
Unit of Measure: Participants
51
   4.0%
43
   3.3%
97.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Hide Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1288 1303
Measure Type: Count of Participants
Unit of Measure: Participants
59
   4.6%
47
   3.6%
98.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Hide Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 90 days
Outcome Measure Data Not Reported
99.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Hide Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 180 days
Outcome Measure Data Not Reported
100.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Hide Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 270 days
Outcome Measure Data Not Reported
101.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Hide Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 1 year
Outcome Measure Data Not Reported
102.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Hide Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 2 years
Outcome Measure Data Not Reported
103.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Hide Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 3 years
Outcome Measure Data Not Reported
104.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Hide Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 4 years
Outcome Measure Data Not Reported
105.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Hide Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 5 years
Outcome Measure Data Not Reported
106.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Hide Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 6 years
Outcome Measure Data Not Reported
107.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Hide Description Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 7 years
Outcome Measure Data Not Reported
108.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 8 years
Outcome Measure Data Not Reported
109.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 9 years
Outcome Measure Data Not Reported
110.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 10 years
Outcome Measure Data Not Reported
111.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame In-hospital (≤ 7 days post index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1291 1304
Measure Type: Count of Participants
Unit of Measure: Participants
57
   4.4%
44
   3.4%
112.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 90 days
Outcome Measure Data Not Reported
113.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 180 days
Outcome Measure Data Not Reported
114.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 270 days
Outcome Measure Data Not Reported
115.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 1 year
Outcome Measure Data Not Reported
116.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 2 years
Outcome Measure Data Not Reported
117.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 3 years
Outcome Measure Data Not Reported
118.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 4 years
Outcome Measure Data Not Reported
119.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 5 years
Outcome Measure Data Not Reported
120.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 6 years
Outcome Measure Data Not Reported
121.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 7 years
Outcome Measure Data Not Reported
122.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 8 years
Outcome Measure Data Not Reported
123.Secondary Outcome
Title Number of Participants Expereienced Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 9 years
Outcome Measure Data Not Reported
124.Secondary Outcome
Title Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 10 years
Outcome Measure Data Not Reported
125.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
Hide Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame In-hospital (≤ 7 days post index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1291 1304
Measure Type: Count of Participants
Unit of Measure: Participants
57
   4.4%
44
   3.4%
126.Secondary Outcome
Title Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE)
Hide Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1288 1303
Measure Type: Count of Participants
Unit of Measure: Participants
65
   5.0%
48
   3.7%
127.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Hide Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 90 days
Outcome Measure Data Not Reported
128.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Hide Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 180 days
Outcome Measure Data Not Reported
129.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Hide Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 270 days
Outcome Measure Data Not Reported
130.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Hide Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 1 year
Outcome Measure Data Not Reported
131.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Hide Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 2 years
Outcome Measure Data Not Reported
132.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Hide Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 3 years
Outcome Measure Data Not Reported
133.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Hide Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 4 years
Outcome Measure Data Not Reported
134.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Hide Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 5 years
Outcome Measure Data Not Reported
135.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Hide Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 6 years
Outcome Measure Data Not Reported
136.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Hide Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 7 years
Outcome Measure Data Not Reported
137.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 8 years
Outcome Measure Data Not Reported
138.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 9 years
Outcome Measure Data Not Reported
139.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 10 years
Outcome Measure Data Not Reported
140.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF)
Hide Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame In-hospital (≤ 7 days post index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1291 1304
Measure Type: Count of Participants
Unit of Measure: Participants
57
   4.4%
44
   3.4%
141.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Hide Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1288 1303
Measure Type: Count of Participants
Unit of Measure: Participants
66
   5.1%
48
   3.7%
142.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Hide Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 90 days
Outcome Measure Data Not Reported
143.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Hide Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 180 days
Outcome Measure Data Not Reported
144.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Hide Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 270 days
Outcome Measure Data Not Reported
145.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Hide Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 1 year
Outcome Measure Data Not Reported
146.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Hide Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 2 years
Outcome Measure Data Not Reported
147.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Hide Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 3 years
Outcome Measure Data Not Reported
148.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Hide Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 4 years
Outcome Measure Data Not Reported
149.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Hide Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 5 years
Outcome Measure Data Not Reported
150.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Hide Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 6 years
Outcome Measure Data Not Reported
151.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Hide Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 7 years
Outcome Measure Data Not Reported
152.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 8 years
Outcome Measure Data Not Reported
153.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 9 years
Outcome Measure Data Not Reported
154.Secondary Outcome
Title Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 10 years
Outcome Measure Data Not Reported
155.Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Hide Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame In-hospital (≤ 7 days post index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1291 1304
Measure Type: Count of Participants
Unit of Measure: Participants
57
   4.4%
46
   3.5%
156.Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization
Hide Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1288 1303
Measure Type: Count of Participants
Unit of Measure: Participants
67
   5.2%
53
   4.1%
157.Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization
Hide Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 90 days
Outcome Measure Data Not Reported
158.Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization
Hide Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 180 days
Outcome Measure Data Not Reported
159.Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization
Hide Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 270 days
Outcome Measure Data Not Reported
160.Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization
Hide Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 1 year
Outcome Measure Data Not Reported
161.Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization
Hide Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 2 years
Outcome Measure Data Not Reported
162.Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization
Hide Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 3 years
Outcome Measure Data Not Reported
163.Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization
Hide Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 4 years
Outcome Measure Data Not Reported
164.Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization
Hide Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 5 years
Outcome Measure Data Not Reported
165.Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization
Hide Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 6 years
Outcome Measure Data Not Reported
166.Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization
Hide Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 7 years
Outcome Measure Data Not Reported
167.Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 8 years
Outcome Measure Data Not Reported
168.Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 9 years
Outcome Measure Data Not Reported
169.Secondary Outcome
Title Number of Participants Experienced Death/All MI/All Revascularization
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 10 years
Outcome Measure Data Not Reported
170.Secondary Outcome
Title Number of Participants With Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition)
Hide Description Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
Time Frame Acute (0 - 24 hours post stent implantation)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1291 1305
Measure Type: Count of Participants
Unit of Measure: Participants
Definite
3
   0.2%
0
   0.0%
Definite/Probable
4
   0.3%
0
   0.0%
171.Secondary Outcome
Title Number of Participants With Scaffold/Stent Thrombosis (Per ARC Definition)
Hide Description Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
Time Frame Subacute (>24 hours - 30 days post stent implantation)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1287 1301
Measure Type: Count of Participants
Unit of Measure: Participants
Definite
4
   0.3%
2
   0.2%
Definite/Probable
4
   0.3%
2
   0.2%
172.Secondary Outcome
Title Number of Participants With Scaffold/Stent Thrombosis (Per ARC Definition)
Hide Description Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
Time Frame Late (30 days - 1 year post stent implantation)
Outcome Measure Data Not Reported
173.Secondary Outcome
Title Number of Participants With Scaffold/Stent Thrombosis (Per ARC Definition)
Hide Description Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained
Time Frame Very late (>1 year post stent implantation)
Outcome Measure Data Not Reported
174.Secondary Outcome
Title Number of Participants With Rehospitalization
Hide Description
  • Coronary artery disease (CAD) related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1288 1302
Measure Type: Count of Participants
Unit of Measure: Participants
65
   5.0%
59
   4.5%
175.Secondary Outcome
Title Number of Participants With Rehospitalization
Hide Description
  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
Time Frame 90 days
Outcome Measure Data Not Reported
176.Secondary Outcome
Title Number of Participants With Rehospitalization
Hide Description
  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
Time Frame 180 days
Outcome Measure Data Not Reported
177.Secondary Outcome
Title Number of Participants With Rehospitalization
Hide Description
  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
Time Frame 270 days
Outcome Measure Data Not Reported
178.Secondary Outcome
Title Number of Participants With Rehospitalization
Hide Description
  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
Time Frame 1 year
Outcome Measure Data Not Reported
179.Secondary Outcome
Title Number of Participants With Rehospitalization
Hide Description
  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
Time Frame 2 years
Outcome Measure Data Not Reported
180.Secondary Outcome
Title Number of Participants With Rehospitalization
Hide Description
  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
Time Frame 3 years
Outcome Measure Data Not Reported
181.Secondary Outcome
Title Number of Participants With Rehospitalization
Hide Description
  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
Time Frame 4 years
Outcome Measure Data Not Reported
182.Secondary Outcome
Title Number of Participants With Rehospitalization
Hide Description
  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
Time Frame 5 years
Outcome Measure Data Not Reported
183.Secondary Outcome
Title Number of Participants With Rehospitalization
Hide Description
  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
Time Frame 6 years
Outcome Measure Data Not Reported
184.Secondary Outcome
Title Number of Participants With Rehospitalization
Hide Description
  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
Time Frame 7 years
Outcome Measure Data Not Reported
185.Secondary Outcome
Title Number of Participants With Rehospitalization
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 8 years
Outcome Measure Data Not Reported
186.Secondary Outcome
Title Number of Participants With Rehospitalization
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 9 years
Outcome Measure Data Not Reported
187.Secondary Outcome
Title Number of Participants With Rehospitalization
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 10 years
Outcome Measure Data Not Reported
188.Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Hide Description [Not Specified]
Time Frame In-hospital (≤ 7 days post index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1290 1304
Measure Type: Count of Participants
Unit of Measure: Participants
4
   0.3%
6
   0.5%
189.Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1288 1301
Measure Type: Count of Participants
Unit of Measure: Participants
18
   1.4%
20
   1.5%
190.Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Hide Description [Not Specified]
Time Frame 90 days
Outcome Measure Data Not Reported
191.Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Hide Description [Not Specified]
Time Frame 180 days
Outcome Measure Data Not Reported
192.Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Hide Description [Not Specified]
Time Frame 270 days
Outcome Measure Data Not Reported
193.Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
194.Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Hide Description [Not Specified]
Time Frame 2 years
Outcome Measure Data Not Reported
195.Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Hide Description [Not Specified]
Time Frame 3 years
Outcome Measure Data Not Reported
196.Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
197.Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
198.Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Hide Description [Not Specified]
Time Frame 6 years
Outcome Measure Data Not Reported
199.Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Hide Description [Not Specified]
Time Frame 7 years
Outcome Measure Data Not Reported
200.Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 8 years
Outcome Measure Data Not Reported
201.Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 9 years
Outcome Measure Data Not Reported
202.Secondary Outcome
Title Number of Participants With Repeat Coronary Arteriography
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 10 years
Outcome Measure Data Not Reported
203.Secondary Outcome
Title Landmark Analysis on MACE and TVF and Their Components
Hide Description [Not Specified]
Time Frame 3-4 years
Outcome Measure Data Not Reported
204.Secondary Outcome
Title Landmark Analysis on MACE and TVF and Their Components
Hide Description [Not Specified]
Time Frame 3-5 years
Outcome Measure Data Not Reported
205.Secondary Outcome
Title Landmark Analysis on MACE and TVF and Their Components
Hide Description [Not Specified]
Time Frame 3-6 years
Outcome Measure Data Not Reported
206.Secondary Outcome
Title Landmark Analysis on MACE and TVF and Their Components
Hide Description [Not Specified]
Time Frame 3-7 years
Outcome Measure Data Not Reported
207.Secondary Outcome
Title Landmark Analysis on MACE and TVF and Their Components
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 3-8 years
Outcome Measure Data Not Reported
208.Secondary Outcome
Title Landmark Analysis on MACE and TVF and Their Components
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 3-9 years
Outcome Measure Data Not Reported
209.Secondary Outcome
Title Landmark Analysis on MACE and TVF and Their Components
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 3-10 years
Outcome Measure Data Not Reported
210.Secondary Outcome
Title Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Hide Description [Not Specified]
Time Frame 3-4 years
Outcome Measure Data Not Reported
211.Secondary Outcome
Title Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Hide Description [Not Specified]
Time Frame 3-5 years
Outcome Measure Data Not Reported
212.Secondary Outcome
Title Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Hide Description [Not Specified]
Time Frame 3-6 years
Outcome Measure Data Not Reported
213.Secondary Outcome
Title Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Hide Description [Not Specified]
Time Frame 3-7 years
Outcome Measure Data Not Reported
214.Secondary Outcome
Title Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 3-8 years
Outcome Measure Data Not Reported
215.Secondary Outcome
Title Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 3-9 years
Outcome Measure Data Not Reported
216.Secondary Outcome
Title Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 3-10 years
Outcome Measure Data Not Reported
217.Secondary Outcome
Title Number of Participants With Target Lesion Failure (TLF)
Hide Description The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)
Time Frame 1 year
Outcome Measure Data Not Reported
218.Secondary Outcome
Title Number of Participants With Target Lesion Failure (TLF)
Hide Description The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)
Time Frame 7 years
Outcome Measure Data Not Reported
219.Secondary Outcome
Title Number of Participants With Target Lesion Failure (TLF)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 8 years
Outcome Measure Data Not Reported
220.Secondary Outcome
Title Number of Participants With Target Lesion Failure (TLF)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 9 years
Outcome Measure Data Not Reported
221.Secondary Outcome
Title Number of Participants With Target Lesion Failure (TLF)
Hide Description Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.
Time Frame 10 years
Outcome Measure Data Not Reported
222.Secondary Outcome
Title Number of Participants With Cumulative Stent/Scaffold Thrombosis
Hide Description Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
Time Frame 0 to 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description:
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System
Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only)
Overall Number of Participants Analyzed 1288 1301
Measure Type: Count of Participants
Unit of Measure: Participants
Definite
7
   0.5%
2
   0.2%
Definite/Probable
8
   0.6%
2
   0.2%
223.Other Pre-specified Outcome
Title Patient Reported Outcomes
Hide Description

Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

The following questionnaires will be used in this study:

  • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
  • EuroQoL 5D (EQ-5D) survey to assess overall health status

(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.

Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.

Time Frame Baseline
Outcome Measure Data Not Reported
224.Other Pre-specified Outcome
Title Patient Reported Outcomes
Hide Description

Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

The following questionnaires will be used in this study:

  • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
  • EuroQoL 5D (EQ-5D) survey to assess overall health status

(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.

Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.

Time Frame 1 month
Outcome Measure Data Not Reported
225.Other Pre-specified Outcome
Title Patient Reported Outcomes
Hide Description

Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

The following questionnaires will be used in this study:

  • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
  • EuroQoL 5D (EQ-5D) survey to assess overall health status

(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.

Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.

Time Frame 6 months
Outcome Measure Data Not Reported
226.Other Pre-specified Outcome
Title Patient Reported Outcomes
Hide Description

Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

The following questionnaires will be used in this study:

  • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
  • EuroQoL 5D (EQ-5D) survey to assess overall health status

(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.

Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.

Time Frame 1 year
Outcome Measure Data Not Reported
227.Other Pre-specified Outcome
Title Patient Reported Outcomes
Hide Description

Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

The following questionnaires will be used in this study:

  • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
  • EuroQoL 5D (EQ-5D) survey to assess overall health status

(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.

Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.

Time Frame 3 years
Outcome Measure Data Not Reported
228.Other Pre-specified Outcome
Title Patient Reported Outcomes (PRO)
Hide Description

Patient-reported outcomes (PRO) are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

The following questionnaires will be used in this study:

  • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
  • EuroQoL 5D (EQ-5D) survey to assess overall health status

(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.

Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.

Time Frame 5 years
Outcome Measure Data Not Reported
229.Other Pre-specified Outcome
Title Landmark Analysis on TLF and Components
Hide Description TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).
Time Frame 3-4 years
Outcome Measure Data Not Reported
230.Other Pre-specified Outcome
Title Landmark Analysis on TLF and Components
Hide Description TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).
Time Frame 3-5 years
Outcome Measure Data Not Reported
231.Other Pre-specified Outcome
Title Landmark Analysis on TLF and Components
Hide Description TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).
Time Frame 3-6 years
Outcome Measure Data Not Reported
232.Other Pre-specified Outcome
Title Landmark Analysis on TLF
Hide Description TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).
Time Frame 3-7 years
Outcome Measure Data Not Reported
233.Other Pre-specified Outcome
Title Landmark Analysis on TLF and Components
Hide Description TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).
Time Frame 3-8 years
Outcome Measure Data Not Reported
234.Other Pre-specified Outcome
Title Landmark Analysis on TLF and Components
Hide Description TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).
Time Frame 3-9 years
Outcome Measure Data Not Reported
235.Other Pre-specified Outcome
Title Landmark Analysis on TLF and Components
Hide Description TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).
Time Frame 3-10 years
Outcome Measure Data Not Reported
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Absorb BVS XIENCE
Hide Arm/Group Description Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
All-Cause Mortality
Absorb BVS XIENCE
Affected / at Risk (%) Affected / at Risk (%)
Total   59/1296 (4.55%)   48/1308 (3.67%) 
Show Serious Adverse Events Hide Serious Adverse Events
Absorb BVS XIENCE
Affected / at Risk (%) Affected / at Risk (%)
Total   154/1296 (11.88%)   120/1308 (9.17%) 
Cardiac disorders     
ACUTE MYOCARDIAL INFARCTION  1  5/1296 (0.39%)  4/1308 (0.31%) 
ANGINA PECTORIS  1  21/1296 (1.62%)  17/1308 (1.30%) 
ANGINA UNSTABLE  1  3/1296 (0.23%)  1/1308 (0.08%) 
ARTERIOSCLEROSIS CORONARY ARTERY  1  1/1296 (0.08%)  1/1308 (0.08%) 
ARTERIOSPASM CORONARY  1  0/1296 (0.00%)  1/1308 (0.08%) 
ATRIOVENTRICULAR BLOCK COMPLETE  1  1/1296 (0.08%)  0/1308 (0.00%) 
CARDIAC ARREST  1  2/1296 (0.15%)  0/1308 (0.00%) 
CARDIAC FAILURE  1  2/1296 (0.15%)  0/1308 (0.00%) 
CARDIAC FAILURE ACUTE  1  1/1296 (0.08%)  0/1308 (0.00%) 
CARDIAC FAILURE CHRONIC  1  0/1296 (0.00%)  1/1308 (0.08%) 
CARDIAC FAILURE CONGESTIVE  1  1/1296 (0.08%)  0/1308 (0.00%) 
CARDIOGENIC SHOCK  1  3/1296 (0.23%)  0/1308 (0.00%) 
CORONARY ARTERY DISEASE  1  2/1296 (0.15%)  2/1308 (0.15%) 
CORONARY ARTERY DISSECTION  1  40/1296 (3.09%)  16/1308 (1.22%) 
CORONARY ARTERY EMBOLISM  1  1/1296 (0.08%)  0/1308 (0.00%) 
CORONARY ARTERY OCCLUSION  1  0/1296 (0.00%)  1/1308 (0.08%) 
CORONARY ARTERY PERFORATION  1  1/1296 (0.08%)  0/1308 (0.00%) 
CORONARY ARTERY STENOSIS  1  0/1296 (0.00%)  1/1308 (0.08%) 
MITRAL VALVE INCOMPETENCE  1  1/1296 (0.08%)  0/1308 (0.00%) 
MYOCARDIAL INFARCTION  1  9/1296 (0.69%)  5/1308 (0.38%) 
MYOCARDIAL ISCHAEMIA  1  1/1296 (0.08%)  1/1308 (0.08%) 
MYOPERICARDITIS  1  0/1296 (0.00%)  1/1308 (0.08%) 
PERICARDITIS  1  1/1296 (0.08%)  1/1308 (0.08%) 
SICK SINUS SYNDROME  1  0/1296 (0.00%)  1/1308 (0.08%) 
SUPRAVENTRICULAR TACHYCARDIA  1  0/1296 (0.00%)  1/1308 (0.08%) 
TACHYCARDIA  1  0/1296 (0.00%)  1/1308 (0.08%) 
VENTRICULAR FIBRILLATION  1  3/1296 (0.23%)  0/1308 (0.00%) 
VENTRICULAR TACHYCARDIA  1  2/1296 (0.15%)  3/1308 (0.23%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  2/1296 (0.15%)  0/1308 (0.00%) 
CONSTIPATION  1  1/1296 (0.08%)  0/1308 (0.00%) 
DIVERTICULUM INTESTINAL  1  0/1296 (0.00%)  1/1308 (0.08%) 
GASTRITIS  1  0/1296 (0.00%)  1/1308 (0.08%) 
GASTRITIS EROSIVE  1  0/1296 (0.00%)  1/1308 (0.08%) 
GASTROINTESTINAL HAEMORRHAGE  1  2/1296 (0.15%)  0/1308 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  1/1296 (0.08%)  0/1308 (0.00%) 
GINGIVAL BLEEDING  1  1/1296 (0.08%)  0/1308 (0.00%) 
IMPAIRED GASTRIC EMPTYING  1  1/1296 (0.08%)  0/1308 (0.00%) 
OESOPHAGEAL STENOSIS  1  1/1296 (0.08%)  0/1308 (0.00%) 
PANCREATITIS ACUTE  1  0/1296 (0.00%)  1/1308 (0.08%) 
PANCREATITIS CHRONIC  1  0/1296 (0.00%)  1/1308 (0.08%) 
RETROPERITONEAL HAEMORRHAGE  1  0/1296 (0.00%)  1/1308 (0.08%) 
SMALL INTESTINAL OBSTRUCTION  1  1/1296 (0.08%)  0/1308 (0.00%) 
General disorders     
ADVERSE DRUG REACTION  1  2/1296 (0.15%)  2/1308 (0.15%) 
CARDIAC COMPLICATION ASSOCIATED WITH DEVICE  1  1/1296 (0.08%)  0/1308 (0.00%) 
CATHETER SITE HAEMATOMA  1  4/1296 (0.31%)  1/1308 (0.08%) 
CHEST DISCOMFORT  1  0/1296 (0.00%)  2/1308 (0.15%) 
CHEST PAIN  1  1/1296 (0.08%)  1/1308 (0.08%) 
COMPLICATION OF DEVICE REMOVAL  1  1/1296 (0.08%)  0/1308 (0.00%) 
NON-CARDIAC CHEST PAIN  1  7/1296 (0.54%)  8/1308 (0.61%) 
PAIN  1  0/1296 (0.00%)  1/1308 (0.08%) 
THROMBOSIS IN DEVICE  1  6/1296 (0.46%)  2/1308 (0.15%) 
Hepatobiliary disorders     
BILE DUCT STONE  1  0/1296 (0.00%)  1/1308 (0.08%) 
Immune system disorders     
DRUG HYPERSENSITIVITY  1  1/1296 (0.08%)  0/1308 (0.00%) 
Infections and infestations     
DIVERTICULITIS  1  0/1296 (0.00%)  1/1308 (0.08%) 
INFLUENZA  1  0/1296 (0.00%)  1/1308 (0.08%) 
LOBAR PNEUMONIA  1  1/1296 (0.08%)  1/1308 (0.08%) 
PNEUMONIA  1  1/1296 (0.08%)  2/1308 (0.15%) 
SEPSIS  1  1/1296 (0.08%)  0/1308 (0.00%) 
Injury, poisoning and procedural complications     
ACETABULUM FRACTURE  1  1/1296 (0.08%)  0/1308 (0.00%) 
ANASTOMOTIC ULCER HAEMORRHAGE  1  1/1296 (0.08%)  0/1308 (0.00%) 
CARDIAC PROCEDURE COMPLICATION  1  2/1296 (0.15%)  1/1308 (0.08%) 
CATHETER SITE HAEMATOMA  1  1/1296 (0.08%)  0/1308 (0.00%) 
CERVICAL VERTEBRAL FRACTURE  1  1/1296 (0.08%)  0/1308 (0.00%) 
CONFUSION POSTOPERATIVE  1  1/1296 (0.08%)  0/1308 (0.00%) 
CORONARY ARTERY RESTENOSIS  1  5/1296 (0.39%)  2/1308 (0.15%) 
FALL  1  0/1296 (0.00%)  1/1308 (0.08%) 
IN-STENT CORONARY ARTERY RESTENOSIS  1  1/1296 (0.08%)  0/1308 (0.00%) 
OVERDOSE  1  0/1296 (0.00%)  1/1308 (0.08%) 
PLAQUE SHIFT  1  0/1296 (0.00%)  1/1308 (0.08%) 
POST PROCEDURAL MYOCARDIAL INFARCTION  1  11/1296 (0.85%)  6/1308 (0.46%) 
PROCEDURAL HYPERTENSION  1  0/1296 (0.00%)  1/1308 (0.08%) 
PROCEDURAL PAIN  1  1/1296 (0.08%)  0/1308 (0.00%) 
PROCEDURAL VOMITING  1  1/1296 (0.08%)  0/1308 (0.00%) 
SUBDURAL HAEMATOMA  1  0/1296 (0.00%)  1/1308 (0.08%)