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XIENCE 28 Global Study

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ClinicalTrials.gov Identifier: NCT03355742
Recruitment Status : Completed
First Posted : November 28, 2017
Results First Posted : February 8, 2021
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Bleeding Disorder
Stroke, Ischemic
Stroke Hemorrhagic
Hematological Disease
Thrombocytopenia
Coagulation Disorder
Anemia
Renal Insufficiency
Coronary Artery Disease
Interventions Device: XIENCE
Drug: DAPT
Enrollment 963
Recruitment Details A total of 963 subjects were enrolled across 52 sites globally, between 09 February, 2018 and 30 April, 2020. The last subject last visit was on 30 April, 2020 and the final data was extracted from the database on 01 July, 2020.
Pre-assignment Details  
Arm/Group Title XIENCE
Hide Arm/Group Description

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Period Title: Overall Study
Started 963
Completed 864
Not Completed 99
Reason Not Completed
Lost to Follow-up             4
Withdrawal by Subject             29
Physician Decision             6
Death             55
Administrative Closure of the Study, Other Status Change Reason, Missed Visit, Protocol Violation             5
Arm/Group Title XIENCE
Hide Arm/Group Description

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Baseline Participants 963
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 963 participants
76.84  (7.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 963 participants
Female
320
  33.2%
Male
643
  66.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 963 participants
Hispanic or Latino
145
  15.1%
Not Hispanic or Latino
360
  37.4%
Unknown or Not Reported
458
  47.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 963 participants
American Indian or Alaska Native
0
   0.0%
Asian
124
  12.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
381
  39.6%
More than one race
0
   0.0%
Unknown or Not Reported
458
  47.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Singapore Number Analyzed 963 participants
22
Hong Kong Number Analyzed 963 participants
48
United Kingdom Number Analyzed 963 participants
30
Portugal Number Analyzed 963 participants
8
Switzerland Number Analyzed 963 participants
37
Spain Number Analyzed 963 participants
89
Austria Number Analyzed 963 participants
3
Netherlands Number Analyzed 963 participants
49
Belgium Number Analyzed 963 participants
64
China Number Analyzed 963 participants
7
Taiwan Number Analyzed 963 participants
48
Italy Number Analyzed 963 participants
231
Germany Number Analyzed 963 participants
327
Prior Percutaneous Coronary Intervention (PCI)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 963 participants
276
History of Major Bleeding   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 961 participants
26
[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 Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles
Hide Description

Net Adverse Clinical Endpoint (NACE):

A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)

Time Frame From 1 to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 828
Measure Type: Count of Participants
Unit of Measure: Participants
Q1 Number Analyzed 15 participants
2
  13.3%
Q2 Number Analyzed 55 participants
5
   9.1%
Q3 Number Analyzed 124 participants
10
   8.1%
Q4 Number Analyzed 245 participants
15
   6.1%
Q5 Number Analyzed 389 participants
40
  10.3%
2.Secondary Outcome
Title Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
Hide Description

Net Adverse Clinical Endpoint (NACE):

A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)

Time Frame From 6 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 811
Measure Type: Count of Participants
Unit of Measure: Participants
55
   6.8%
3.Secondary Outcome
Title Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
Hide Description

Net Adverse Clinical Endpoint (NACE):

A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)

Time Frame From 1 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 825
Measure Type: Count of Participants
Unit of Measure: Participants
121
  14.7%
4.Secondary Outcome
Title Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Hide Description

Definite stent thrombosis:

Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

Probable stent thrombosis:

Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

  • Any unexplained death within the first 30 days
  • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time Frame From 1 to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up, or withdrew consent, or died before time point analyzed, without any Stent Thrombosis event, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 816
Measure Type: Count of Participants
Unit of Measure: Participants
4
   0.5%
5.Secondary Outcome
Title Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Hide Description

Definite stent thrombosis:

Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

Probable stent thrombosis:

Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

  • Any unexplained death within the first 30 days
  • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time Frame From 6 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up, or withdrew consent, or died before time point analyzed, without any Stent Thrombosis event, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 791
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
6.Secondary Outcome
Title Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Hide Description

Definite stent thrombosis:

Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

Probable stent thrombosis:

Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

  • Any unexplained death within the first 30 days
  • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time Frame From 1 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up, or withdrew consent, or died before time point analyzed, without any Stent Thrombosis event, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 793
Measure Type: Count of Participants
Unit of Measure: Participants
4
   0.5%
7.Secondary Outcome
Title Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Hide Description

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

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.

Time Frame From 1 to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 828
Measure Type: Count of Participants
Unit of Measure: Participants
13
   1.6%
8.Secondary Outcome
Title Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Hide Description

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

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.

Time Frame From 6 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 811
Measure Type: Count of Participants
Unit of Measure: Participants
30
   3.7%
9.Secondary Outcome
Title Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Hide Description

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

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.

Time Frame From 1 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 825
Measure Type: Count of Participants
Unit of Measure: Participants
43
   5.2%
10.Secondary Outcome
Title Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Hide Description

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI:

    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame From 1 to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 828
Measure Type: Count of Participants
Unit of Measure: Participants
16
   1.9%
11.Secondary Outcome
Title Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Hide Description

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI:

    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame From 6 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 811
Measure Type: Count of Participants
Unit of Measure: Participants
11
   1.4%
12.Secondary Outcome
Title Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Hide Description

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI:

    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame From 1 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 825
Measure Type: Count of Participants
Unit of Measure: Participants
27
   3.3%
13.Secondary Outcome
Title Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
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.

MI (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI:

    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame From 1 to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 828
Measure Type: Count of Participants
Unit of Measure: Participants
22
   2.7%
14.Secondary Outcome
Title Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
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.

MI (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI:

    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame From 6 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 811
Measure Type: Count of Participants
Unit of Measure: Participants
23
   2.8%
15.Secondary Outcome
Title Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
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.

MI (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI:

    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame From 1 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 825
Measure Type: Count of Participants
Unit of Measure: Participants
45
   5.5%
16.Secondary Outcome
Title Number of Participants With Composite of All Death or All MI (Modified ARC)
Hide Description

All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

MI (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame From 1 to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 828
Measure Type: Count of Participants
Unit of Measure: Participants
29
   3.5%
17.Secondary Outcome
Title Number of Participants With Composite of All Death or All MI (Modified ARC)
Hide Description

All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

MI (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame From 6 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 811
Measure Type: Count of Participants
Unit of Measure: Participants
41
   5.1%
18.Secondary Outcome
Title Number of Participants With Composite of All Death or All MI (Modified ARC)
Hide Description

All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

MI (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame From 1 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 825
Measure Type: Count of Participants
Unit of Measure: Participants
70
   8.5%
19.Secondary Outcome
Title Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Hide Description

An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.

  • Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
  • Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
  • Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
  • Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time Frame From 1 to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 815
Measure Type: Count of Participants
Unit of Measure: Participants
3
   0.4%
20.Secondary Outcome
Title Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Hide Description

An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.

  • Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
  • Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
  • Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
  • Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time Frame From 6 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 784
Measure Type: Count of Participants
Unit of Measure: Participants
3
   0.4%
21.Secondary Outcome
Title Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Hide Description

An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.

  • Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
  • Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
  • Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
  • Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time Frame From 1 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 785
Measure Type: Count of Participants
Unit of Measure: Participants
6
   0.8%
22.Secondary Outcome
Title Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Hide Description

TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography.

A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs:

  • A positive history of recurrent angina pectoris, presumably related to the target vessel;
  • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
  • Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve);
  • A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame From 1 to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 828
Measure Type: Count of Participants
Unit of Measure: Participants
7
   0.8%
23.Secondary Outcome
Title Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Hide Description

TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography.

A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs:

  • A positive history of recurrent angina pectoris, presumably related to the target vessel;
  • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
  • Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve);
  • A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame From 6 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 811
Measure Type: Count of Participants
Unit of Measure: Participants
3
   0.4%
24.Secondary Outcome
Title Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Hide Description

TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography.

A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs:

  • A positive history of recurrent angina pectoris, presumably related to the target vessel;
  • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
  • Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve);
  • A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame From 1 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 825
Measure Type: Count of Participants
Unit of Measure: Participants
10
   1.2%
25.Secondary Outcome
Title Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-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

A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

  • A positive history of recurrent angina pectoris, presumably related to the target vessel;
  • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
  • Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);
  • A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame From 1 to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 828
Measure Type: Count of Participants
Unit of Measure: Participants
5
   0.6%
26.Secondary Outcome
Title Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-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

A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

  • A positive history of recurrent angina pectoris, presumably related to the target vessel;
  • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
  • Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);
  • A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame From 6 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 811
Measure Type: Count of Participants
Unit of Measure: Participants
4
   0.5%
27.Secondary Outcome
Title Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-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

A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

  • A positive history of recurrent angina pectoris, presumably related to the target vessel;
  • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
  • Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);
  • A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame From 1 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 825
Measure Type: Count of Participants
Unit of Measure: Participants
9
   1.1%
28.Secondary Outcome
Title Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Hide Description TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time Frame From 1 to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 828
Measure Type: Count of Participants
Unit of Measure: Participants
21
   2.5%
29.Secondary Outcome
Title Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Hide Description TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time Frame From 6 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 811
Measure Type: Count of Participants
Unit of Measure: Participants
21
   2.6%
30.Secondary Outcome
Title Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Hide Description TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time Frame From 1 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 825
Measure Type: Count of Participants
Unit of Measure: Participants
42
   5.1%
31.Secondary Outcome
Title Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
Hide Description TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time Frame From 1 to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 828
Measure Type: Count of Participants
Unit of Measure: Participants
22
   2.7%
32.Secondary Outcome
Title Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
Hide Description TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time Frame From 6 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 811
Measure Type: Count of Participants
Unit of Measure: Participants
22
   2.7%
33.Secondary Outcome
Title Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
Hide Description TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time Frame From 1 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 825
Measure Type: Count of Participants
Unit of Measure: Participants
44
   5.3%
34.Secondary Outcome
Title Number of Participants With Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 2-5 and Type 3-5
Hide Description

Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows:

Type 0

Type 1

Type 2

Type 3

Type 4

Type 5

Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.

Time Frame From 1 to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 817
Measure Type: Count of Participants
Unit of Measure: Participants
BARC Type 2-5
44
   5.4%
BARC Type 3-5
20
   2.4%
35.Secondary Outcome
Title Number of Participants With Bleeding Defined by the BARC, Type 2-5 and Type 3-5
Hide Description

Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows:

Type 0

Type 1

Type 2

Type 3

Type 4

Type 5

Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.

Time Frame From 6 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 789
Measure Type: Count of Participants
Unit of Measure: Participants
BARC Type 2-5
19
   2.4%
BARC Type 3-5
7
   0.9%
36.Secondary Outcome
Title Number of Participants With Bleeding Defined by BARC, Type 2-5 and Type 3-5
Hide Description

Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows:

Type 0

Type 1

Type 2

Type 3

Type 4

Type 5

Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.

Time Frame From 1 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Overall Number of Participants Analyzed 792
Measure Type: Count of Participants
Unit of Measure: Participants
BARC Type 2-5
61
   7.7%
BARC Type 3-5
27
   3.4%
Time Frame 1 Year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title XIENCE
Hide Arm/Group Description

XIENCE + Short duration (1 month) of DAPT

XIENCE: Subjects who received XIENCE family stent systems will be included.

DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

All-Cause Mortality
XIENCE
Affected / at Risk (%)
Total   55/963 (5.71%) 
Hide Serious Adverse Events
XIENCE
Affected / at Risk (%)
Total   374/963 (38.84%) 
Blood and lymphatic system disorders   
Anaemia  1  11/963 (1.14%) 
Bicytopenia  1  1/963 (0.10%) 
Hypochromic Anaemia  1  1/963 (0.10%) 
Nephrogenic Anaemia  1  1/963 (0.10%) 
Normochromic Normocytic Anaemia  1  1/963 (0.10%) 
Cardiac disorders   
Angina Pectoris  1  55/963 (5.71%) 
Angina Unstable  1  1/963 (0.10%) 
Aortic Valve Incompetence  1  2/963 (0.21%) 
Aortic Valve Stenosis  1  3/963 (0.31%) 
Arrhythmia  1  2/963 (0.21%) 
Atrial Fibrillation  1  27/963 (2.80%) 
Atrial Flutter  1  3/963 (0.31%) 
Atrial Tachycardia  1  1/963 (0.10%) 
Atrioventricular Block  1  2/963 (0.21%) 
Atrioventricular Block Complete  1  3/963 (0.31%) 
Atrioventricular Block Second Degree  1  1/963 (0.10%) 
Bifascicular Block  1  1/963 (0.10%) 
Bradycardia  1  3/963 (0.31%) 
Cardiac Failure  1  30/963 (3.12%) 
Cardiac Failure Acute  1  6/963 (0.62%) 
Cardiac Failure Congestive  1  4/963 (0.42%) 
Cardiac Tamponade  1  1/963 (0.10%) 
Cardiomyopathy  1  1/963 (0.10%) 
Congestive Cardiomyopathy  1  1/963 (0.10%) 
Coronary Artery Disease  1  7/963 (0.73%) 
Dressler's Syndrome  1  1/963 (0.10%) 
Mitral Valve Incompetence  1  5/963 (0.52%) 
Myocardial Infarction  1  18/963 (1.87%) 
Myocardial Ischaemia  1  1/963 (0.10%) 
Myopericarditis  1  1/963 (0.10%) 
Palpitations  1  1/963 (0.10%) 
Pericarditis  1  1/963 (0.10%) 
Pleuropericarditis  1  1/963 (0.10%) 
Right Ventricular Failure  1  1/963 (0.10%) 
Sick Sinus Syndrome  1  3/963 (0.31%) 
Sinoatrial Block  1  1/963 (0.10%) 
Sinus Bradycardia  1  2/963 (0.21%) 
Supraventricular Tachycardia  1  2/963 (0.21%) 
Tachyarrhythmia  1  4/963 (0.42%) 
Tricuspid Valve Incompetence  1  2/963 (0.21%) 
Ventricular Extrasystoles  1  3/963 (0.31%) 
Ventricular Fibrillation  1  1/963 (0.10%) 
Ventricular Tachycardia  1  5/963 (0.52%) 
Ear and labyrinth disorders   
Vertigo  1  3/963 (0.31%) 
Vertigo Positional  1  2/963 (0.21%) 
Endocrine disorders   
Hypothyroidism  1  1/963 (0.10%) 
Eye disorders   
Retinal Artery Occlusion  1  1/963 (0.10%) 
Gastrointestinal disorders   
Abdominal Pain  1  4/963 (0.42%) 
Abdominal Pain Upper  1  1/963 (0.10%) 
Colonic Polyp  1  2/963 (0.21%) 
Constipation  1  1/963 (0.10%) 
Diarrhoea  1  1/963 (0.10%) 
Duodenal Ulcer  1  1/963 (0.10%) 
Enteritis  1  2/963 (0.21%) 
Faeces Discoloured  1  1/963 (0.10%) 
Gastric Ulcer  1  1/963 (0.10%) 
Gastritis  1  1/963 (0.10%) 
Gastritis Erosive  1  2/963 (0.21%) 
Gastrointestinal Haemorrhage  1  1/963 (0.10%) 
Inguinal Hernia  1  2/963 (0.21%) 
Intestinal Ischaemia  1  1/963 (0.10%) 
Nausea  1  1/963 (0.10%) 
Peritoneal Haemorrhage  1  1/963 (0.10%) 
Small Intestinal Obstruction  1  1/963 (0.10%) 
Vomiting  1  1/963 (0.10%) 
General disorders   
Chest Pain  1  5/963 (0.52%) 
Death  1  15/963 (1.56%) 
General Physical Health Deterioration  1  1/963 (0.10%) 
Hernia Obstructive  1  1/963 (0.10%) 
Impaired Healing  1  1/963 (0.10%) 
Multi-Organ Failure  1  2/963 (0.21%) 
Pain  1  2/963 (0.21%) 
Pyrexia  1  3/963 (0.31%) 
Hepatobiliary disorders   
Cholangitis  1  4/963 (0.42%) 
Cholecystitis  1  2/963 (0.21%) 
Hepatic Cirrhosis  1  1/963 (0.10%) 
Jaundice Cholestatic  1  1/963 (0.10%) 
Infections and infestations   
Abscess Limb  1  2/963 (0.21%) 
Arthritis Infective  1  1/963 (0.10%) 
Bronchitis  1  4/963 (0.42%) 
Bronchopneumonia  1  1/963 (0.10%) 
Cellulitis  1  3/963 (0.31%) 
Cholecystitis Infective  1  1/963 (0.10%) 
Diverticulitis  1  1/963 (0.10%) 
Endocarditis  1  1/963 (0.10%) 
Erysipelas  1  2/963 (0.21%) 
Gangrene  1  1/963 (0.10%) 
Gastroenteritis  1  5/963 (0.52%) 
Haematoma Infection  1  1/963 (0.10%) 
Herpes Zoster  1  1/963 (0.10%) 
Infection  1  4/963 (0.42%) 
Infectious Pleural Effusion  1  1/963 (0.10%) 
Influenza  1  1/963 (0.10%) 
Lobar Pneumonia  1  1/963 (0.10%) 
Localised Infection  1  1/963 (0.10%) 
Lower Respiratory Tract Infection  1  1/963 (0.10%) 
Lung Abscess  1  1/963 (0.10%) 
Muscle Abscess  1  1/963 (0.10%) 
Osteomyelitis  1  1/963 (0.10%) 
Otitis Externa  1  1/963 (0.10%) 
Peritonitis  1  1/963 (0.10%) 
Pneumonia  1  22/963 (2.28%) 
Pyelonephritis Acute  1  1/963 (0.10%) 
Respiratory Tract Infection  1  6/963 (0.62%) 
Sepsis  1  6/963 (0.62%) 
Septic Shock  1  4/963 (0.42%) 
Sinusitis  1  1/963 (0.10%) 
Soft Tissue Infection  1  1/963 (0.10%) 
Upper Respiratory Tract Infection  1  2/963 (0.21%) 
Urinary Tract Infection  1  10/963 (1.04%) 
Vulval Abscess  1  1/963 (0.10%) 
Wound Infection  1  2/963 (0.21%) 
Injury, poisoning and procedural complications   
Clavicle Fracture  1  1/963 (0.10%) 
Compression Fracture  1  1/963 (0.10%) 
Cranial Nerve Injury  1  1/963 (0.10%) 
Fall  1  5/963 (0.52%) 
Femoral Neck Fracture  1  1/963 (0.10%) 
Femur Fracture  1  5/963 (0.52%) 
Hip Fracture  1  1/963 (0.10%) 
Lumbar Vertebral Fracture  1  1/963 (0.10%) 
Patella Fracture  1  2/963 (0.21%) 
Pelvic Fracture  1  2/963 (0.21%) 
Pubis Fracture  1  1/963 (0.10%) 
Rib Fracture  1  1/963 (0.10%) 
Subdural Haematoma  1  1/963 (0.10%) 
Vascular Pseudoaneurysm  1  1/963 (0.10%) 
Investigations   
Arteriogram Coronary  1  1/963 (0.10%) 
Blood Pressure Abnormal  1  1/963 (0.10%) 
Ejection Fraction Decreased  1  1/963 (0.10%) 
Electrocardiogram Abnormal  1  1/963 (0.10%) 
Metabolism and nutrition disorders   
Dehydration  1  1/963 (0.10%) 
Diabetes Mellitus  1  3/963 (0.31%) 
Diabetic Ketoacidosis  1  1/963 (0.10%) 
Fluid Overload  1  4/963 (0.42%) 
Hyperglycaemia  1  1/963 (0.10%) 
Hyperkalaemia  1  2/963 (0.21%) 
Hypoglycaemia  1  1/963 (0.10%) 
Type 2 Diabetes Mellitus  1  1/963 (0.10%) 
Musculoskeletal and connective tissue disorders   
Arthritis  1  1/963 (0.10%) 
Back Pain  1  2/963 (0.21%) 
Fistula  1  1/963 (0.10%) 
Intervertebral Disc Protrusion  1  1/963 (0.10%) 
Joint Effusion  1  1/963 (0.10%) 
Lumbar Spinal Stenosis  1  1/963 (0.10%) 
Muscular Weakness  1  1/963 (0.10%) 
Musculoskeletal Disorder  1  1/963 (0.10%) 
Osteoarthritis  1  10/963 (1.04%) 
Osteochondrosis  1  1/963 (0.10%) 
Polyarthritis  1  1/963 (0.10%) 
Spondylitis  1  1/963 (0.10%) 
Systemic Lupus Erythematosus  1  1/963 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute Lymphocytic Leukaemia Re  1  1/963 (0.10%) 
Biliary Neoplasm  1  2/963 (0.21%) 
Bladder Cancer  1  2/963 (0.21%) 
Bladder Transitional Cell Carc  1  1/963 (0.10%) 
Colon Cancer  1  1/963 (0.10%) 
Endometrial Cancer  1  1/963 (0.10%) 
Gastric Cancer  1  1/963 (0.10%) 
Gastrointestinal Tract Adenoma  1  1/963 (0.10%) 
Hepatic Neoplasm Malignant  1  1/963 (0.10%) 
Lipoma  1  1/963 (0.10%) 
Lung Cancer Metastatic  1  1/963 (0.10%) 
Lung Neoplasm  1  2/963 (0.21%) 
Lung Neoplasm Malignant  1  2/963 (0.21%) 
Multiple Myeloma  1  1/963 (0.10%) 
Myelodysplastic Syndrome  1  1/963 (0.10%) 
Myelofibrosis  1  1/963 (0.10%) 
Neoplasm Malignant  1  1/963 (0.10%) 
Oesophageal Adenocarcinoma  1  1/963 (0.10%) 
Pancreatic Carcinoma  1  1/963 (0.10%) 
Pancreatic Neoplasm  1  1/963 (0.10%) 
Pleural Mesothelioma  1  1/963 (0.10%) 
Prostate Cancer  1  2/963 (0.21%) 
Prostate Cancer Metastatic  1  1/963 (0.10%) 
Renal Cancer  1  1/963 (0.10%) 
Squamous Cell Carcinoma  1  2/963 (0.21%) 
Transitional Cell Carcinoma  1  1/963 (0.10%) 
Urethral Cancer  1  1/963 (0.10%) 
Nervous system disorders   
Carotid Artery Stenosis  1  1/963 (0.10%) 
Cauda Equina Syndrome  1  1/963 (0.10%) 
Cerebrovascular Accident  1  7/963 (0.73%) 
Cognitive Disorder  1  1/963 (0.10%) 
Complex Regional Pain Syndrome  1  1/963 (0.10%) 
Dementia  1  2/963 (0.21%) 
Dizziness Postural  1  1/963 (0.10%) 
Epilepsy  1  1/963 (0.10%) 
Headache  1  2/963 (0.21%) 
Hepatic Encephalopathy  1  1/963 (0.10%) 
Loss Of Consciousness  1  1/963 (0.10%) 
Neurodegenerative Disorder  1  1/963 (0.10%) 
Syncope  1  5/963 (0.52%) 
Transient Ischaemic Attack  1  2/963 (0.21%) 
Viith Nerve Paralysis  1  1/963 (0.10%) 
Psychiatric disorders   
Confusional State  1  1/963 (0.10%) 
Delirium  1  1/963 (0.10%) 
Mental Disorder  1  1/963 (0.10%) 
Renal and urinary disorders   
Diabetic Nephropathy  1  1/963 (0.10%) 
Nephrolithiasis  1  1/963 (0.10%) 
Prerenal Failure  1  1/963 (0.10%) 
Renal Failure  1  6/963 (0.62%) 
Renal Failure Acute  1  13/963 (1.35%) 
Renal Failure Chronic  1  3/963 (0.31%) 
Urinary Retention  1  2/963 (0.21%) 
Reproductive system and breast disorders   
Benign Prostatic Hyperplasia  1  2/963 (0.21%) 
Prostatomegaly  1  1/963 (0.10%) 
Respiratory, thoracic and mediastinal disorders   
Acute Pulmonary Oedema  1  2/963 (0.21%) 
Acute Respiratory Failure  1  1/963 (0.10%) 
Asthma  1  1/963 (0.10%) 
Bronchial Hyperreactivity  1  1/963 (0.10%) 
Chronic Obstructive Pulmonary Disease  1  9/963 (0.93%) 
Cough  1  1/963 (0.10%) 
Dyspnoea  1  10/963 (1.04%) 
Haemoptysis  1  1/963 (0.10%) 
Idiopathic Pulmonary Fibrosis  1  1/963 (0.10%) 
Pleural Effusion  1  4/963 (0.42%) 
Pneumonia Aspiration  1  3/963 (0.31%) 
Pneumothorax  1  2/963 (0.21%) 
Pulmonary Embolism  1  2/963 (0.21%) 
Pulmonary Fibrosis  1  1/963 (0.10%) 
Pulmonary Oedema  1  1/963 (0.10%) 
Respiratory Failure  1  1/963 (0.10%) 
Skin and subcutaneous tissue disorders   
Diabetic Foot  1  2/963 (0.21%) 
Skin Ulcer  1  2/963 (0.21%) 
Subcutaneous Emphysema  1  1/963 (0.10%) 
Telangiectasia  1  1/963 (0.10%) 
Surgical and medical procedures   
Arteriovenous Fistula Operation  1  1/963 (0.10%) 
Cardiac Pacemaker Insertion  1  1/963 (0.10%) 
Cataract Operation  1  1/963 (0.10%) 
Colon Polypectomy  1  1/963 (0.10%) 
Hip Arthroplasty  1  1/963 (0.10%) 
Hospitalisation  1  1/963 (0.10%) 
Limb Immobilisation  1  1/963 (0.10%) 
Vascular disorders   
Aortic Stenosis  1  6/963 (0.62%) 
Arteriovenous Fistula  1  2/963 (0.21%) 
Deep Vein Thrombosis  1  1/963 (0.10%) 
Femoral Arterial Stenosis  1  1/963 (0.10%) 
Haemorrhage  1  54/963 (5.61%) 
Hypertension  1  2/963 (0.21%) 
Hypertensive Crisis  1  6/963 (0.62%) 
Hypotension  1  1/963 (0.10%) 
Orthostatic Hypotension  1  1/963 (0.10%) 
Peripheral Arterial Occlusive Disease  1  2/963 (0.21%) 
Peripheral Ischaemia  1  2/963 (0.21%) 
Thrombosis  1  1/963 (0.10%) 
Vascular Stenosis  1  1/963 (0.10%) 
1
Term from vocabulary, MedDRA 11.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
XIENCE
Affected / at Risk (%)
Total   357/963 (37.07%) 
Blood and lymphatic system disorders   
Anaemia  1  6/963 (0.62%) 
Hypochromic Anaemia  1  1/963 (0.10%) 
Iron Deficiency Anaemia  1  2/963 (0.21%) 
Microcytic Anaemia  1  1/963 (0.10%) 
Normochromic Normocytic Anaemia  1  1/963 (0.10%) 
Splenomegaly  1  1/963 (0.10%) 
Spontaneous Haematoma  1  1/963 (0.10%) 
Thrombocytopenia  1  1/963 (0.10%) 
Cardiac disorders   
Acute Coronary Syndrome  1  1/963 (0.10%) 
Angina Pectoris  1  54/963 (5.61%) 
Atrial Fibrillation  1  15/963 (1.56%) 
Atrial Flutter  1  1/963 (0.10%) 
Atrial Thrombosis  1  1/963 (0.10%) 
Atrioventricular Block Complete  1  1/963 (0.10%) 
Atrioventricular Block First Degree  1  3/963 (0.31%) 
Atrioventricular Block Second Degree  1  1/963 (0.10%) 
Bradyarrhythmia  1  1/963 (0.10%) 
Bradycardia  1  4/963 (0.42%) 
Bundle Branch Block Left  1  2/963 (0.21%) 
Bundle Branch Block Right  1  1/963 (0.10%) 
Cardiac Arrest  1  1/963 (0.10%) 
Cardiac Failure  1  7/963 (0.73%) 
Cardiac Failure Congestive  1  1/963 (0.10%) 
Coronary Artery Dissection  1  1/963 (0.10%) 
Myocardial Infarction  1  2/963 (0.21%) 
Palpitations  1  8/963 (0.83%) 
Pericardial Effusion  1  1/963 (0.10%) 
Pericarditis  1  1/963 (0.10%) 
Tachyarrhythmia  1  1/963 (0.10%) 
Tachycardia  1  2/963 (0.21%) 
Ventricular Tachycardia  1  1/963 (0.10%) 
Congenital, familial and genetic disorders   
Phimosis  1  1/963 (0.10%) 
Ear and labyrinth disorders   
Otorrhoea  1  1/963 (0.10%) 
Vertigo  1  8/963 (0.83%) 
Eye disorders   
Cataract  1  1/963 (0.10%) 
Conjunctivitis  1  1/963 (0.10%) 
Visual Impairment  1  1/963 (0.10%) 
Gastrointestinal disorders   
Abdominal Discomfort  1  1/963 (0.10%) 
Abdominal Pain  1  3/963 (0.31%) 
Abdominal Pain Upper  1  4/963 (0.42%) 
Aphthous Stomatitis  1  1/963 (0.10%) 
Constipation  1  1/963 (0.10%) 
Diarrhoea  1  6/963 (0.62%) 
Diverticulum  1  2/963 (0.21%) 
Dry Mouth  1  1/963 (0.10%) 
Dyspepsia  1  2/963 (0.21%) 
Epigastric Discomfort  1  1/963 (0.10%) 
Gastric Disorder  1  1/963 (0.10%) 
Gastric Ulcer  1  1/963 (0.10%) 
Gastritis  1  8/963 (0.83%) 
Gastritis Erosive  1  1/963 (0.10%) 
Gingival Bleeding  1  1/963 (0.10%) 
Haematochezia  1  1/963 (0.10%) 
Hiatus Hernia  1  1/963 (0.10%) 
Inguinal Hernia  1  1/963 (0.10%) 
Nausea  1  1/963 (0.10%) 
Peptic Ulcer  1  1/963 (0.10%) 
Tooth Loss  1  1/963 (0.10%) 
Toothache  1  2/963 (0.21%) 
Upper Gastrointestinal Haemorrhage  1  1/963 (0.10%) 
Vomiting  1  4/963 (0.42%) 
General disorders   
Chest Discomfort  1  4/963 (0.42%) 
Chest Pain  1  5/963 (0.52%) 
Fatigue  1  3/963 (0.31%) 
Impaired Healing  1  1/963 (0.10%) 
Nodule  1  1/963 (0.10%) 
Non-Cardiac Chest Pain  1  4/963 (0.42%) 
Oedema  1  3/963 (0.31%) 
Oedema Peripheral  1  9/963 (0.93%) 
Pacemaker Generated Arrhythmia  1  1/963 (0.10%) 
Pain  1  2/963 (0.21%) 
Pyrexia  1  2/963 (0.21%) 
Spinal Pain  1  1/963 (0.10%) 
Ulcer  1  2/963 (0.21%) 
Hepatobiliary disorders   
Biliary Colic  1  1/963 (0.10%) 
Hepatic Cirrhosis  1  1/963 (0.10%) 
Hepatic Steatosis  1  3/963 (0.31%) 
Liver Disorder  1  1/963 (0.10%) 
Infections and infestations   
Asymptomatic Bacteriuria  1  1/963 (0.10%) 
Bronchitis  1  2/963 (0.21%) 
Bronchopneumonia  1  1/963 (0.10%) 
Cellulitis  1  1/963 (0.10%) 
Cystitis  1  2/963 (0.21%) 
Enterobiasis  1  1/963 (0.10%) 
Erysipelas  1  1/963 (0.10%) 
Gastroenteritis  1  1/963 (0.10%) 
Gastroenteritis Viral  1  1/963 (0.10%) 
Herpes Zoster  1  1/963 (0.10%) 
Influenza  1  2/963 (0.21%) 
Lower Respiratory Tract Infection  1  1/963 (0.10%) 
Lung Infection  1  1/963 (0.10%) 
Nasopharyngitis  1  5/963 (0.52%) 
Osteomyelitis  1  1/963 (0.10%) 
Paronychia  1  1/963 (0.10%) 
Pneumonia  1  7/963 (0.73%) 
Respiratory Tract Infection  1  1/963 (0.10%) 
Sinusitis  1  1/963 (0.10%) 
Tinea Cruris  1  1/963 (0.10%) 
Upper Respiratory Tract Infection  1  2/963 (0.21%) 
Urethritis  1  2/963 (0.21%) 
Urinary Tract Infection  1  15/963 (1.56%) 
Vaginal Infection  1  1/963 (0.10%) 
Viral Infection  1  1/963 (0.10%) 
Injury, poisoning and procedural complications   
Cardiac Procedure Complication  1  2/963 (0.21%) 
Contusion  1  3/963 (0.31%) 
Fall  1  6/963 (0.62%) 
Joint Injury  1  1/963 (0.10%) 
Lumbar Vertebral Fracture  1  1/963 (0.10%) 
Rib Fracture  1  1/963 (0.10%) 
Spinal Compression Fracture  1  1/963 (0.10%) 
Vascular Pseudoaneurysm  1  4/963 (0.42%) 
Wound  1  1/963 (0.10%) 
Wound Complication  1  1/963 (0.10%) 
Investigations   
Blood Calcium Increased  1  1/963 (0.10%) 
Blood Creatinine Increased  1  2/963 (0.21%) 
Blood Glucose Abnormal  1  1/963 (0.10%) 
Blood Thyroid Stimulating Hormone Increased  1  1/963 (0.10%) 
Cardiac Enzymes Increased  1  1/963 (0.10%) 
Ejection Fraction Decreased  1  2/963 (0.21%) 
Glycosylated Haemoglobin Increased  1  1/963 (0.10%) 
Haemoglobin Decreased  1  1/963 (0.10%) 
Prostatic Specific Antigen Increased  1  1/963 (0.10%) 
Troponin I Increased  1  1/963 (0.10%) 
Metabolism and nutrition disorders   
Decreased Appetite  1  1/963 (0.10%) 
Dehydration  1  1/963 (0.10%) 
Diabetes Mellitus  1  4/963 (0.42%) 
Diabetes Mellitus Inadequate Control  1  1/963 (0.10%) 
Gout  1  1/963 (0.10%) 
Hypercholesterolaemia  1  1/963 (0.10%) 
Hyperkalaemia  1  2/963 (0.21%) 
Hyperlipidaemia  1  1/963 (0.10%) 
Hypoglycaemia  1  1/963 (0.10%) 
Hypokalaemia  1  4/963 (0.42%) 
Hyponatraemia  1  3/963 (0.31%) 
Hypoproteinaemia  1  1/963 (0.10%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/963 (0.31%) 
Arthritis  1  1/963 (0.10%) 
Back Pain  1  3/963 (0.31%) 
Bursitis  1  1/963 (0.10%) 
Exostosis  1  1/963 (0.10%) 
Foot Deformity  1  1/963 (0.10%) 
Intervertebral Disc Protrusion  1  1/963 (0.10%) 
Joint Swelling  1  3/963 (0.31%) 
Muscle Fatigue  1  1/963 (0.10%) 
Muscle Spasms  1  1/963 (0.10%) 
Musculoskeletal Chest Pain  1  1/963 (0.10%) 
Musculoskeletal Pain  1  2/963 (0.21%) 
Myalgia  1  5/963 (0.52%) 
Neck Pain  1  2/963 (0.21%) 
Osteoarthritis  1  2/963 (0.21%) 
Pain In Extremity  1  6/963 (0.62%) 
Spondylolisthesis  1  1/963 (0.10%) 
Systemic Sclerosis  1  1/963 (0.10%) 
Tendonitis  1  1/963 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hepatic Neoplasm  1  1/963 (0.10%) 
Lung Neoplasm Malignant  1  1/963 (0.10%) 
Neoplasm Malignant  1  1/963 (0.10%) 
Oesophageal Papilloma  1  1/963 (0.10%) 
Prostate Cancer  1  1/963 (0.10%) 
Nervous system disorders   
Amnesia  1  1/963 (0.10%) 
Balance Disorder  1  1/963 (0.10%) 
Cerebrovascular Accident  1  3/963 (0.31%) 
Cervicogenic Headache  1  1/963 (0.10%) 
Dizziness  1  9/963 (0.93%) 
Dizziness Postural  1  1/963 (0.10%) 
Headache  1  4/963 (0.42%) 
Paraesthesia  1  1/963 (0.10%) 
Petit Mal Epilepsy  1  1/963 (0.10%) 
Polyneuropathy  1  2/963 (0.21%) 
Presyncope  1  2/963 (0.21%) 
Restless Legs Syndrome  1  1/963 (0.10%) 
Sciatica  1  1/963 (0.10%) 
Syncope  1  4/963 (0.42%) 
Transient Ischaemic Attack  1  2/963 (0.21%) 
Tunnel Vision  1  1/963 (0.10%) 
Psychiatric disorders   
Delirium  1  1/963 (0.10%) 
Depression  1  2/963 (0.21%) 
Listless  1  1/963 (0.10%) 
Sleep Disorder  1  1/963 (0.10%) 
Renal and urinary disorders   
Cystitis Haemorrhagic  1  1/963 (0.10%) 
Dysuria  1  1/963 (0.10%) 
Haematuria  1  3/963 (0.31%) 
Nephrolithiasis  1  1/963 (0.10%) 
Renal Failure  1  2/963 (0.21%) 
Renal Failure Acute  1  6/963 (0.62%) 
Renal Failure Chronic  1  3/963 (0.31%) 
Renal Impairment  1  1/963 (0.10%) 
Urinary Retention  1  2/963 (0.21%) 
Reproductive system and breast disorders   
Benign Prostatic Hyperplasia  1  1/963 (0.10%) 
Vaginismus  1  1/963 (0.10%) 
Respiratory, thoracic and mediastinal disorders   
Chronic Obstructive Pulmonary Disease  1  3/963 (0.31%) 
Cough  1  6/963 (0.62%) 
Dyspnoea  1  29/963 (3.01%) 
Dyspnoea Exertional  1  2/963 (0.21%) 
Epistaxis  1  2/963 (0.21%) 
Haemoptysis  1  1/963 (0.10%) 
Oropharyngeal Pain  1  1/963 (0.10%) 
Productive Cough  1  1/963 (0.10%) 
Pulmonary Oedema  1  2/963 (0.21%) 
Rhinitis Allergic  1  2/963 (0.21%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  1/963 (0.10%) 
Decubitus Ulcer  1  1/963 (0.10%) 
Dermatitis  1  2/963 (0.21%) 
Hyperhidrosis  1  3/963 (0.31%) 
Pruritus  1  5/963 (0.52%) 
Rash  1  5/963 (0.52%) 
Rash Generalised  1  1/963 (0.10%) 
Skin Ulcer  1  1/963 (0.10%) 
Urticaria  1  2/963 (0.21%) 
Surgical and medical procedures   
Cardiac Ablation  1  1/963 (0.10%) 
Vascular disorders   
Aortic Aneurysm  1  2/963 (0.21%) 
Arteriosclerosis  1  1/963 (0.10%) 
Femoral Arterial Stenosis  1  1/963 (0.10%) 
Haematoma  1  8/963 (0.83%) 
Haemorrhage  1  100/963 (10.38%) 
Hypertension  1  17/963 (1.77%) 
Hypertensive Crisis  1  4/963 (0.42%) 
Hypotension  1  5/963 (0.52%) 
Intermittent Claudication  1  1/963 (0.10%) 
Orthostatic Hypotension  1  1/963 (0.10%) 
Peripheral Arterial Occlusive Disease  1  2/963 (0.21%) 
Vascular Dissection  1  1/963 (0.10%) 
Vascular Stenosis  1  1/963 (0.10%) 
1
Term from vocabulary, MedDRA 11.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Siok Hwee Tan, PhD, Principal Clinical Research Scientist
Organization: Clinical Affairs, Abbott Vascular
Phone: +1 408-845-3581
EMail: siokhwee.tan@abbott.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03355742    
Other Study ID Numbers: ABT-CIP-10235
First Submitted: November 22, 2017
First Posted: November 28, 2017
Results First Submitted: October 28, 2020
Results First Posted: February 8, 2021
Last Update Posted: March 4, 2021