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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 : Completed
First Posted : June 25, 2014
Results First Posted : July 24, 2018
Last Update Posted : August 2, 2022
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 2604
Recruitment Details A total of 2604 subjects were randomized at 147 sites between August 15, 2014 and March 31, 2017. The last 1-year follow-up visit occurred on March 31, 2018. The database was then cleaned and locked, and data extraction for the 2-year analysis occurred on June 04, 2019.
Pre-assignment Details The last 2-year follow-up visit occurred on 16 April, 2019.
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 1205 1231
Not Completed 91 77
Reason Not Completed
Lost to Follow-up             48             34
Withdrawal by Subject             14             17
Physician Decision             7             4
Death             22             22
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
Canada Number Analyzed 1296 participants 1308 participants 2604 participants
28 26 54
United States Number Analyzed 1296 participants 1308 participants 2604 participants
1021 1041 2062
Australia Number Analyzed 1296 participants 1308 participants 2604 participants
80 68 148
Germany Number Analyzed 1296 participants 1308 participants 2604 participants
164 171 335
Singapore Number Analyzed 1296 participants 1308 participants 2604 participants
3 2 5
Prior Coronary Intervention   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1294 participants 1307 participants 2601 participants
390
  30.1%
435
  33.3%
825
  31.7%
[1]
Measure Analysis Population Description: The number of participants analyzed includes subjects who were available at that time of analysis
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%
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 TLF at 1-year, Non-inferiority Against the Control
Hide Description One-sided p-value by using Farrington-Manning non-inferiority test will be used with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.
Time Frame 1 year
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 1254 1272
Measure Type: Count of Participants
Unit of Measure: Participants
98
   7.8%
82
   6.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Absorb BVS, XIENCE
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Farrington-Manning
Comments [Not Specified]
3.Secondary Outcome
Title Angina at 1-year, Non-inferiority Against the Control
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 1 year
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 1249 1261
Measure Type: Count of Participants
Unit of Measure: Participants
253
  20.3%
259
  20.5%
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 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 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 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
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 1286 1300
Measure Type: Count of Participants
Unit of Measure: Participants
5
   0.4%
5
   0.4%
9.Secondary Outcome
Title Number of 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
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 1291
Measure Type: Count of Participants
Unit of Measure: Participants
7
   0.5%
8
   0.6%
10.Secondary Outcome
Title Number of 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
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 1264 1279
Measure Type: Count of Participants
Unit of Measure: Participants
10
   0.8%
11
   0.9%
11.Secondary Outcome
Title Number of 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
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 1254 1272
Measure Type: Count of Participants
Unit of Measure: Participants
16
   1.3%
14
   1.1%
12.Secondary Outcome
Title Number of 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
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 1232 1255
Measure Type: Count of Participants
Unit of Measure: Participants
22
   1.8%
22
   1.8%
13.Secondary Outcome
Title Number of 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
14.Secondary Outcome
Title Number of 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
15.Secondary Outcome
Title Number of 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 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%
17.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%
18.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
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 1286 1300
Measure Type: Count of Participants
Unit of Measure: Participants
66
   5.1%
50
   3.8%
19.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
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 1291
Measure Type: Count of Participants
Unit of Measure: Participants
70
   5.5%
56
   4.3%
20.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
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 1264 1279
Measure Type: Count of Participants
Unit of Measure: Participants
75
   5.9%
62
   4.8%
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 1 year
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 1254 1272
Measure Type: Count of Participants
Unit of Measure: Participants
80
   6.4%
65
   5.1%
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 2 years
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 1232 1255
Measure Type: Count of Participants
Unit of Measure: Participants
104
   8.4%
86
   6.9%
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 3 years
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 4 years
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 5 years
Outcome Measure Data Not Reported
26.Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Hide Description Myocardial infarction attributed to target vessel myocardial infarction (TV-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), 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%
27.Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Hide Description Myocardial infarction attributed to target vessel myocardial infarction (TV-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), 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
57
   4.4%
47
   3.6%
28.Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Hide Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 90 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 1286 1300
Measure Type: Count of Participants
Unit of Measure: Participants
63
   4.9%
48
   3.7%
29.Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Hide Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 180 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 1282 1291
Measure Type: Count of Participants
Unit of Measure: Participants
67
   5.2%
53
   4.1%
30.Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Hide Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 270 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 1264 1279
Measure Type: Count of Participants
Unit of Measure: Participants
71
   5.6%
56
   4.4%
31.Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Hide Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 1 year
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 1254 1272
Measure Type: Count of Participants
Unit of Measure: Participants
75
   6.0%
58
   4.6%
32.Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Hide Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 2 year
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 1232 1255
Measure Type: Count of Participants
Unit of Measure: Participants
94
   7.6%
72
   5.7%
33.Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Hide Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 3 years
Outcome Measure Data Not Reported
34.Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Hide Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 4 years
Outcome Measure Data Not Reported
35.Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Hide Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 5 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
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 1286 1300
Measure Type: Count of Participants
Unit of Measure: Participants
16
   1.2%
4
   0.3%
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
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 1291
Measure Type: Count of Participants
Unit of Measure: Participants
23
   1.8%
11
   0.9%
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
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 1264 1279
Measure Type: Count of Participants
Unit of Measure: Participants
33
   2.6%
15
   1.2%
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
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 1254 1272
Measure Type: Count of Participants
Unit of Measure: Participants
38
   3.0%
24
   1.9%
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
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 1232 1255
Measure Type: Count of Participants
Unit of Measure: Participants
69
   5.6%
36
   2.9%
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 Ischemia Driven TLR (ID-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), 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%
47.Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-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), 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
13
   1.0%
3
   0.2%
48.Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-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
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 1286 1300
Measure Type: Count of Participants
Unit of Measure: Participants
15
   1.2%
4
   0.3%
49.Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-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
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 1291
Measure Type: Count of Participants
Unit of Measure: Participants
22
   1.7%
11
   0.9%
50.Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-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
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 1264 1279
Measure Type: Count of Participants
Unit of Measure: Participants
32
   2.5%
15
   1.2%
51.Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-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
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 1254 1272
Measure Type: Count of Participants
Unit of Measure: Participants
37
   3.0%
24
   1.9%
52.Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-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
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 1232 1255
Measure Type: Count of Participants
Unit of Measure: Participants
66
   5.4%
36
   2.9%
53.Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-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
54.Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-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
55.Secondary Outcome
Title Number of Participants With Ischemia Driven TLR (ID-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
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 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%
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 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%
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 90 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 1286 1300
Measure Type: Count of Participants
Unit of Measure: Participants
10
   0.8%
6
   0.5%
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. classified as: Ischemic driven TVR and Non-ischemic driven TVR.

-TVR includes all TVR, excluding TLR

Time Frame 180 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 1282 1291
Measure Type: Count of Participants
Unit of Measure: Participants
14
   1.1%
14
   1.1%
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 270 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 1264 1279
Measure Type: Count of Participants
Unit of Measure: Participants
19
   1.5%
16
   1.3%
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 1 year
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 1254 1272
Measure Type: Count of Participants
Unit of Measure: Participants
22
   1.8%
18
   1.4%
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 2 years
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 1232 1255
Measure Type: Count of Participants
Unit of Measure: Participants
42
   3.4%
36
   2.9%
63.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
64.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
65.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
66.Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
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), 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%
67.Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
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), 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%
68.Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
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
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 1286 1300
Measure Type: Count of Participants
Unit of Measure: Participants
10
   0.8%
6
   0.5%
69.Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
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 180 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 1282 1291
Measure Type: Count of Participants
Unit of Measure: Participants
14
   1.1%
14
   1.1%
70.Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
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
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 1264 1279
Measure Type: Count of Participants
Unit of Measure: Participants
19
   1.5%
16
   1.3%
71.Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
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
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 1254 1272
Measure Type: Count of Participants
Unit of Measure: Participants
22
   1.8%
18
   1.4%
72.Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
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
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 1232 1255
Measure Type: Count of Participants
Unit of Measure: Participants
40
   3.2%
35
   2.8%
73.Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
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
74.Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
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
75.Secondary Outcome
Title Number of Participants With ID-TVR Excluding TLR
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
76.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%
77.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%
78.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
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 1286 1300
Measure Type: Count of Participants
Unit of Measure: Participants
28
   2.2%
15
   1.2%
79.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
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 1291
Measure Type: Count of Participants
Unit of Measure: Participants
41
   3.2%
30
   2.3%
80.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
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 1264 1279
Measure Type: Count of Participants
Unit of Measure: Participants
54
   4.3%
39
   3.0%
81.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
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 1254 1272
Measure Type: Count of Participants
Unit of Measure: Participants
63
   5.0%
50
   3.9%
82.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
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 1232 1255
Measure Type: Count of Participants
Unit of Measure: Participants
114
   9.3%
86
   6.9%
83.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
84.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
85.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
86.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%
87.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%
88.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 90 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 1286 1300
Measure Type: Count of Participants
Unit of Measure: Participants
69
   5.4%
55
   4.2%
89.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 180 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 1282 1291
Measure Type: Count of Participants
Unit of Measure: Participants
74
   5.8%
64
   5.0%
90.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 270 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 1264 1279
Measure Type: Count of Participants
Unit of Measure: Participants
80
   6.3%
72
   5.6%
91.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 1 year
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 1254 1272
Measure Type: Count of Participants
Unit of Measure: Participants
89
   7.1%
78
   6.1%
92.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 2 years
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 1232 1255
Measure Type: Count of Participants
Unit of Measure: Participants
116
   9.4%
106
   8.4%
93.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 3 years
Outcome Measure Data Not Reported
94.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 4 years
Outcome Measure Data Not Reported
95.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 5 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
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 1286 1300
Measure Type: Count of Participants
Unit of Measure: Participants
67
   5.2%
53
   4.1%
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
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 1291
Measure Type: Count of Participants
Unit of Measure: Participants
71
   5.5%
61
   4.7%
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
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 1264 1279
Measure Type: Count of Participants
Unit of Measure: Participants
77
   6.1%
68
   5.3%
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
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 1254 1272
Measure Type: Count of Participants
Unit of Measure: Participants
83
   6.6%
72
   5.7%
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
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 1232 1255
Measure Type: Count of Participants
Unit of Measure: Participants
107
   8.7%
96
   7.6%
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/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%
107.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 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%
108.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
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 1286 1300
Measure Type: Count of Participants
Unit of Measure: Participants
71
   5.5%
53
   4.1%
109.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
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 1291
Measure Type: Count of Participants
Unit of Measure: Participants
77
   6.0%
64
   5.0%
110.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
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 1264 1279
Measure Type: Count of Participants
Unit of Measure: Participants
90
   7.1%
71
   5.6%
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 1 year
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 1254 1272
Measure Type: Count of Participants
Unit of Measure: Participants
98
   7.8%
82
   6.4%
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 2 years
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 1232 1255
Measure Type: Count of Participants
Unit of Measure: Participants
137
  11.1%
105
   8.4%
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 3 years
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 4 years
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 5 years
Outcome Measure Data Not Reported
116.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%
117.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%
118.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
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 1286 1300
Measure Type: Count of Participants
Unit of Measure: Participants
74
   5.8%
55
   4.2%
119.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
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 1291
Measure Type: Count of Participants
Unit of Measure: Participants
80
   6.2%
67
   5.2%
120.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
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 1264 1279
Measure Type: Count of Participants
Unit of Measure: Participants
93
   7.4%
77
   6.0%
121.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
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 1254 1272
Measure Type: Count of Participants
Unit of Measure: Participants
102
   8.1%
88
   6.9%
122.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
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 1232 1255
Measure Type: Count of Participants
Unit of Measure: Participants
145
  11.8%
119
   9.5%
123.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
124.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
125.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
126.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%
127.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%
128.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
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 1286 1300
Measure Type: Count of Participants
Unit of Measure: Participants
77
   6.0%
59
   4.5%
129.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
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 1291
Measure Type: Count of Participants
Unit of Measure: Participants
86
   6.7%
75
   5.8%
130.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
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 1264 1279
Measure Type: Count of Participants
Unit of Measure: Participants
101
   8.0%
86
   6.7%
131.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
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 1254 1272
Measure Type: Count of Participants
Unit of Measure: Participants
111
   8.9%
99
   7.8%
132.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
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 1232 1255
Measure Type: Count of Participants
Unit of Measure: Participants
160
  13.0%
136
  10.8%
133.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
134.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
135.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
136.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%
137.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 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%
138.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.