Trial Outcomes & Findings for XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort) (NCT NCT01120379)

NCT ID: NCT01120379

Last Updated: 2015-06-22

Results Overview

Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation), or very late (\>1 year post stent implantation).

• Recruitment status: COMPLETED
• Target enrollment: 5034 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2015-06-22

Participant Flow

Subjects are derived from the USA interventional cardiology population.

8000 patients (5034 patients in initial enrollment phase and 2998 patients in second enrollment phase) were enrolled in XIENCE V USA trial. Out of these 5034 patients, 14 patients were transferred to the HCRI DAPT cohort, leaving 5020 in the XIENCE V USA LTF cohort.

Participant milestones

Measure	XV-LTF Cohort XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
One Year Timepoint STARTED	5020
One Year Timepoint COMPLETED	4742
One Year Timepoint NOT COMPLETED	278
Two Year Timepoint STARTED	4742
Two Year Timepoint COMPLETED	4505
Two Year Timepoint NOT COMPLETED	237
Three Year Timepoint STARTED	4505
Three Year Timepoint COMPLETED	4291
Three Year Timepoint NOT COMPLETED	214
Four Year Timepoint STARTED	4291
Four Year Timepoint COMPLETED	3923
Four Year Timepoint NOT COMPLETED	368

Reasons for withdrawal

Measure	XV-LTF Cohort XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
One Year Timepoint Withdrawal by Subject	41
One Year Timepoint Lost to Follow-up	115
One Year Timepoint Death	108
One Year Timepoint Physician Decision	9
One Year Timepoint Any other reason for early termination	5
Two Year Timepoint Withdrawal by Subject	11
Two Year Timepoint Lost to Follow-up	87
Two Year Timepoint Death	123
Two Year Timepoint Physician Decision	12
Two Year Timepoint Any other reason for early termination	4
Three Year Timepoint Withdrawal by Subject	25
Three Year Timepoint Lost to Follow-up	43
Three Year Timepoint Death	120
Three Year Timepoint Physician Decision	9
Three Year Timepoint Any other reason for early termination	17
Four Year Timepoint Withdrawal by Subject	5
Four Year Timepoint Lost to Follow-up	10
Four Year Timepoint Death	131
Four Year Timepoint Physician Decision	5
Four Year Timepoint Any other reason for early termination	217

Baseline Characteristics

XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)

Baseline characteristics by cohort

Measure	XV-LTF Cohort n=5020 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2525 Participants n=5 Participants
Age, Categorical >=65 years	2495 Participants n=5 Participants
Age, Continuous	64.75 years STANDARD_DEVIATION 11.07 • n=5 Participants
Sex: Female, Male Female	1564 Participants n=5 Participants
Sex: Female, Male Male	3456 Participants n=5 Participants
Region of Enrollment United States	5020 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).

Outcome measures

Measure	XV-LTF Cohort n=4587 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)	1.05 percentage of participants Interval 0.77 to 1.39

PRIMARY outcome

Timeframe: 3 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).

Outcome measures

Measure	XV-LTF Cohort n=4475 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)	1.18 percentage of participants Interval 0.89 to 1.55

PRIMARY outcome

Timeframe: 4 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).

Outcome measures

Measure	XV-LTF Cohort n=4093 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Stent Thrombosis (Definite and Probable) as Defined by ARC	1.56 percentage of participants Interval 1.21 to 1.99

PRIMARY outcome

Timeframe: 2 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4769 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined).	9.5 percentage of participants Interval 8.64 to 10.32

PRIMARY outcome

Timeframe: 3 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4741 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).	11.7 percentage of participants Interval 10.78 to 12.63

PRIMARY outcome

Timeframe: 4 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4530 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).	14.9 percentage of participants Interval 13.9 to 15.99

SECONDARY outcome

Timeframe: 2 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4769 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)	11.8 percentage of participants Interval 10.9 to 12.76

SECONDARY outcome

Timeframe: 3 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4741 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)	15.0 percentage of participants Interval 14.03 to 16.09

SECONDARY outcome

Timeframe: 4 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4530 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)	19.8 percentage of participants Interval 18.65 to 20.99

SECONDARY outcome

Timeframe: 2 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4769 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]	22.4 percentage of participants Interval 21.2 to 23.58

SECONDARY outcome

Timeframe: 3 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4741 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]	27.5 percentage of participants Interval 26.2 to 28.76

SECONDARY outcome

Timeframe: 4 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4530 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]	34.5 percentage of participants Interval 33.14 to 35.93

SECONDARY outcome

Timeframe: 2 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4769 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)	13.3 percentage of participants Interval 12.34 to 14.29

SECONDARY outcome

Timeframe: 3 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4741 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)	16.0 percentage of participants Interval 14.96 to 17.06

SECONDARY outcome

Timeframe: 4 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4530 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)	19.7 percentage of participants Interval 18.56 to 20.9

SECONDARY outcome

Timeframe: 2 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4769 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)	13.0 percentage of participants Interval 12.06 to 13.99

SECONDARY outcome

Timeframe: 3 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4741 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)	15.7 percentage of participants Interval 14.65 to 16.74

SECONDARY outcome

Timeframe: 4 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4530 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)	19.3 percentage of participants Interval 18.18 to 20.5

SECONDARY outcome

Timeframe: 2 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4769 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)	5.4 percentage of participants Interval 4.78 to 6.09

SECONDARY outcome

Timeframe: 3 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4741 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)	7.6 percentage of participants Interval 6.86 to 8.38

SECONDARY outcome

Timeframe: 4 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4530 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)	10.9 percentage of participants Interval 10.01 to 11.85

SECONDARY outcome

Timeframe: 2 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4769 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Any MI (Q-wave and Non Q-wave)	7.6 percentage of participants Interval 6.85 to 8.38

SECONDARY outcome

Timeframe: 3 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4741 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Any MI (Q-wave and Non Q-wave)	9.1 percentage of participants Interval 8.29 to 9.95

SECONDARY outcome

Timeframe: 4 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4530 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Any MI (Q-wave and Non Q-wave)	11.3 percentage of participants Interval 10.37 to 12.24

SECONDARY outcome

Timeframe: 2 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4769 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)	14.7 percentage of participants Interval 13.69 to 15.71

SECONDARY outcome

Timeframe: 3 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4741 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)	18.2 percentage of participants Interval 17.11 to 19.33

SECONDARY outcome

Timeframe: 4 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Outcome measures

Measure	XV-LTF Cohort n=4530 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)	22.5 percentage of participants Interval 21.33 to 23.78

SECONDARY outcome

Timeframe: 2 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Major bleeding complications consisted of Clinical Events Committee (CEC)-adjudicated Thrombolysis In Myocardial Infarction (TIMI) major bleeding through 2-year follow-up and site reported major bleeding after 2 years.

Outcome measures

Measure	XV-LTF Cohort n=4541 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Major Bleeding Complications	4.3 percentage of participants Interval 3.68 to 4.88

SECONDARY outcome

Timeframe: 3 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.

Outcome measures

Measure	XV-LTF Cohort n=4435 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Major Bleeding Complications (Site Reported)	7.3 percentage of participants Interval 6.56 to 8.11

SECONDARY outcome

Timeframe: 4 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.

Outcome measures

Measure	XV-LTF Cohort n=4050 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Major Bleeding Complications	8.4 percentage of participants Interval 7.54 to 9.27

SECONDARY outcome

Timeframe: 2 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 2-year visit is 688-772 days.

Outcome measures

Measure	XV-LTF Cohort n=5020 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Dual Antiplatelet Medication Usage	61.9 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 3-year visit is 1053-1137 days.

Outcome measures

Measure	XV-LTF Cohort n=5020 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Dual Antiplatelet Medication Usage	53.1 percentage of participants

SECONDARY outcome

Timeframe: 4 years

Population: Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.

Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 4-year visit is 1502 days.

Outcome measures

Measure	XV-LTF Cohort n=5020 Participants XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Dual Antiplatelet Medication Usage	42.5 percentage of participants

Adverse Events

XV-LTF Cohort

Serious events: 2730 serious events

Other events: 883 other events

Deaths: 0 deaths

Serious adverse events

Measure	XV-LTF Cohort n=4852 participants at risk XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Injury, poisoning and procedural complications Device malfunction	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Endotracheal intubation complication	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Implantable defibrillator malfunction	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Device lead damage	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Acute coronary syndrome	0.47% 23/4852 • Number of events 24 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Acute myocardial infarction	4.7% 229/4852 • Number of events 251 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Angina pectoris	16.2% 784/4852 • Number of events 1131 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Angina unstable	4.5% 218/4852 • Number of events 277 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Aortic valve disease	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Aortic valve stenosis	0.45% 22/4852 • Number of events 22 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Arrhythmia	0.23% 11/4852 • Number of events 11 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Arteriosclerosis coronary artery	0.08% 4/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Arteriospasm coronary	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Atrial fibrillation	2.3% 110/4852 • Number of events 141 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Atrial flutter	0.76% 37/4852 • Number of events 47 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Atrial tachycardia	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Atrial thrombosis	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Atrioventricular block	0.08% 4/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Atrioventricular block complete	0.12% 6/4852 • Number of events 6 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Atrioventricular block second degree	0.06% 3/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Bradycardia	0.70% 34/4852 • Number of events 35 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Bundle branch block left	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Cardiac arrest	0.78% 38/4852 • Number of events 38 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Cardiac disorder	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Cardiac failure	0.58% 28/4852 • Number of events 30 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Cardiac failure acute	0.39% 19/4852 • Number of events 21 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Cardiac failure chronic	0.08% 4/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Cardiac failure congestive	3.8% 183/4852 • Number of events 295 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Cardiac perforation	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Cardiac tamponade	0.08% 4/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Cardiac valve disease	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Cardio-respiratory arrest	0.41% 20/4852 • Number of events 20 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Cardiogenic shock	0.25% 12/4852 • Number of events 12 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Cardiomyopathy	0.37% 18/4852 • Number of events 19 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Cardiopulmonary failure	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Congestive cardiomyopathy	0.10% 5/4852 • Number of events 5 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Cor pulmonale chronic	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Coronary artery aneurysm	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Coronary artery disease	2.5% 120/4852 • Number of events 127 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Coronary artery dissection	0.31% 15/4852 • Number of events 15 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Coronary artery occlusion	0.66% 32/4852 • Number of events 32 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Coronary artery perforation	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Coronary artery stenosis	1.5% 74/4852 • Number of events 76 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Coronary artery thrombosis	0.19% 9/4852 • Number of events 9 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Coronary ostial stenosis	0.08% 4/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Electromechanical dissociation	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Extrasystoles	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Hypertensive cardiomyopathy	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Intracardiac thrombus	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Ischaemic cardiomyopathy	0.33% 16/4852 • Number of events 16 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Left ventricular dysfunction	0.10% 5/4852 • Number of events 5 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Left ventricular hypertrophy	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Low cardiac output syndrome	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Mitral valve calcification	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Mitral valve incompetence	0.16% 8/4852 • Number of events 9 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Mitral valve prolapse	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Mitral valve stenosis	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Myocardial infarction	1.2% 57/4852 • Number of events 59 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Myocardial ischaemia	0.89% 43/4852 • Number of events 44 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Palpitations	0.23% 11/4852 • Number of events 11 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Pericardial effusion	0.10% 5/4852 • Number of events 6 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Pericardial haemorrhage	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Pericarditis	0.08% 4/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Pericarditis constrictive	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Post procedural myocardial infarction	0.12% 6/4852 • Number of events 6 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Right ventricular dysfunction	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Right ventricular failure	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Sick sinus syndrome	0.47% 23/4852 • Number of events 23 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Sinus arrest	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Sinus arrhythmia	0.08% 4/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Sinus bradycardia	0.12% 6/4852 • Number of events 6 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Sinus tachycardia	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Sudden cardiac death	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Supraventricular extrasystoles	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Supraventricular tachycardia	0.23% 11/4852 • Number of events 11 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Tachycardia	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Torsade de pointes	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Tricuspid valve incompetence	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Ventricular arrhythmia	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Ventricular asystole	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Ventricular dysfunction	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Ventricular extrasystoles	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Ventricular fibrillation	0.37% 18/4852 • Number of events 18 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Ventricular flutter	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Cardiac disorders Ventricular tachycardia	0.82% 40/4852 • Number of events 45 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Accidental death	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Adverse drug reaction	0.08% 4/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Asthenia	0.31% 15/4852 • Number of events 15 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Catheter site haematoma	0.43% 21/4852 • Number of events 21 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Catheter site haemorrhage	0.19% 9/4852 • Number of events 9 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Chest pain	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Drug withdrawal syndrome	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Exercise tolerance decreased	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Fatigue	0.12% 6/4852 • Number of events 6 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Gait disturbance	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Generalised oedema	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Hernia	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Hernia obstructive	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Hypothermia	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Impaired healing	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Implant site discharge	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Infusion site phlebitis	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Malaise	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Multi-organ failure	0.21% 10/4852 • Number of events 10 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Non-cardiac chest pain	4.8% 231/4852 • Number of events 311 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Oedema peripheral	0.19% 9/4852 • Number of events 9 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Organ failure	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Pain	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Pyrexia	0.23% 11/4852 • Number of events 13 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Sudden death	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Surgical failure	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Systemic inflammatory response syndrome	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Unevaluable event	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Immune system disorders Allergy to metals	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Immune system disorders Amyloidosis	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Immune system disorders Contrast media reaction	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Immune system disorders Dermatitis allergic	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Immune system disorders Drug hypersensitivity	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Immune system disorders Hypersensitivity	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Anaemia postoperative	0.21% 10/4852 • Number of events 10 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Arteriovenous graft thrombosis	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Cardiac pacemaker malfunction	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Coronary artery reocclusion	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Coronary artery restenosis	0.25% 12/4852 • Number of events 12 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Coronary bypass thrombosis	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Device dislocation	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Device electrical finding	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications In-stent arterial restenosis	0.19% 9/4852 • Number of events 10 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications In-stent coronary artery restenosis	3.3% 160/4852 • Number of events 195 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Incision site haemorrhage	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Incisional hernia	0.06% 3/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Joint dislocation postoperative	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Lead dislodgement	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Mechanical complication of implant	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Operative haemorrhage	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Other injuries	2.4% 118/4852 • Number of events 139 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Post procedural complication	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.12% 6/4852 • Number of events 6 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Postoperative renal failure	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Procedural headache	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Procedural hypotension	0.21% 10/4852 • Number of events 10 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Procedural nausea	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Procedural vomiting	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Reperfusion injury	0.14% 7/4852 • Number of events 7 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Seroma	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Stent occlusion	0.12% 6/4852 • Number of events 6 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Stent-graft endoleak	0.02% 1/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Thrombosis in device	0.16% 8/4852 • Number of events 9 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Urinary retention postoperative	0.04% 2/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Vascular graft complication	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Vascular graft occlusion	0.31% 15/4852 • Number of events 15 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Weaning failure	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Injury, poisoning and procedural complications Wound dehiscence	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Blood and lymphatic system disorders Others/Miscellaneous	1.8% 89/4852 • Number of events 116 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Congenital, familial and genetic disorders Others/Miscellaneous	0.21% 10/4852 • Number of events 11 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Ear and labyrinth disorders Others/Miscellaneous	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Endocrine disorders Others/Miscellaneous	0.10% 5/4852 • Number of events 5 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Eye disorders Others/Miscellaneous	0.21% 10/4852 • Number of events 10 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Gastrointestinal disorders Others/Miscellaneous	4.5% 218/4852 • Number of events 277 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Hepatobiliary disorders Others/Miscellaneous	1.1% 55/4852 • Number of events 58 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Infections and infestations Others/Miscellaneous	8.5% 414/4852 • Number of events 585 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Investigations Others/Miscellaneous	1.6% 76/4852 • Number of events 83 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Metabolism and nutrition disorders Others/Miscellaneous	2.2% 106/4852 • Number of events 141 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Musculoskeletal and connective tissue disorders Others/Miscellaneous	3.7% 181/4852 • Number of events 194 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Others/Miscellaneous	3.3% 161/4852 • Number of events 184 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Nervous system disorders Others/Miscellaneous	6.8% 332/4852 • Number of events 386 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Psychiatric disorders Others/Miscellaneous	0.87% 42/4852 • Number of events 49 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Reproductive system and breast disorders Others/Miscellaneous	0.25% 12/4852 • Number of events 13 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Respiratory, thoracic and mediastinal disorders Others/Miscellaneous	7.0% 340/4852 • Number of events 485 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Skin and subcutaneous tissue disorders Others/Miscellaneous	0.31% 15/4852 • Number of events 15 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Surgical and medical procedures Others/Miscellaneous	0.62% 30/4852 • Number of events 30 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Renal and urinary disorders Other renal and urinary disorders	2.0% 95/4852 • Number of events 106 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Renal and urinary disorders Renal failure acute	1.4% 68/4852 • Number of events 72 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Accelerated hypertension	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Aortic aneurysm	0.37% 18/4852 • Number of events 19 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Aortic aneurysm rupture	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Aortic dissection	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Aortic intramural haematoma	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Aortic stenosis	0.08% 4/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Aorto-duodenal fistula	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Arterial occlusive disease	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Arterial restenosis	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Arterial stenosis	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Arterial thrombosis limb	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Arteriosclerosis	0.39% 19/4852 • Number of events 22 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Arteriovenous fistula	0.08% 4/4852 • Number of events 5 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Arteriovenous malformation	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Carotid arteriosclerosis	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Carotid artery disease	0.14% 7/4852 • Number of events 7 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Carotid artery occlusion	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Carotid artery stenosis	0.95% 46/4852 • Number of events 52 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Cerebral haemorrhage	0.08% 4/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Deep vein thrombosis	0.49% 24/4852 • Number of events 26 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Diverticulitis intestinal haemorrhagic	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Diverticulum intestinal haemorrhagic	0.08% 4/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Duodenal ulcer haemorrhage	0.10% 5/4852 • Number of events 5 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Embolism	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Epistaxis	0.19% 9/4852 • Number of events 9 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Femoral arterial stenosis	0.16% 8/4852 • Number of events 9 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Femoral artery occlusion	0.14% 7/4852 • Number of events 8 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Gastric haemorrhage	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Gastric ulcer haemorrhage	0.14% 7/4852 • Number of events 7 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Gastrointestinal haemorrhage	1.4% 70/4852 • Number of events 77 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Gastrointestinal ulcer haemorrhage	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Haemarthrosis	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Haematemesis	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Haematoma	0.08% 4/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Haemoptysis	0.10% 5/4852 • Number of events 5 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Haemorrhage	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Haemorrhage intracranial	0.16% 8/4852 • Number of events 8 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Haemorrhagic erosive gastritis	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Haemorrhagic stroke	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Hepatic haemorrhage	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Hypertension	0.49% 24/4852 • Number of events 27 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Hypertensive crisis	0.14% 7/4852 • Number of events 7 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Hypertensive emergency	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Hypotension	0.68% 33/4852 • Number of events 39 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Hypovolaemic shock	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Iliac artery occlusion	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Iliac artery stenosis	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Intermittent claudication	0.47% 23/4852 • Number of events 29 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Ischaemic limb pain	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Labile blood pressure	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Lower gastrointestinal haemorrhage	0.31% 15/4852 • Number of events 15 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Mallory-Weiss syndrome	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Mesenteric artery stenosis	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Mesenteric occlusion	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Oesophageal haemorrhage	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Oesophageal varices haemorrhage	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Operative haemorrhage	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Orthostatic hypotension	0.25% 12/4852 • Number of events 14 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Pelvic haematoma	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Peptic ulcer haemorrhage	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Peripheral arterial occlusive disease	0.21% 10/4852 • Number of events 11 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Peripheral artery aneurysm	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Peripheral ischaemia	0.21% 10/4852 • Number of events 12 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Peripheral vascular disorder	0.33% 16/4852 • Number of events 19 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Petechiae	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Pharyngeal haematoma	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Portal vein thrombosis	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Post procedural haematoma	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Pulmonary artery thrombosis	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Pulmonary embolism	0.31% 15/4852 • Number of events 17 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Pulmonary hypertension	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Renal artery occlusion	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Renal artery stenosis	0.23% 11/4852 • Number of events 11 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Renal hypertension	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Retinal vascular occlusion	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Retroperitoneal haematoma	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Retroperitoneal haemorrhage	0.31% 15/4852 • Number of events 15 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Skin ulcer	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Subarachnoid haemorrhage	0.08% 4/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Subclavian artery stenosis	0.06% 3/4852 • Number of events 3 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Subclavian steal syndrome	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Subdural haematoma	0.27% 13/4852 • Number of events 13 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Subdural haemorrhage	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Superior vena caval occlusion	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Thrombosis	0.08% 4/4852 • Number of events 4 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Ulcer haemorrhage	0.04% 2/4852 • Number of events 2 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Upper gastrointestinal haemorrhage	0.31% 15/4852 • Number of events 15 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Vascular insufficiency	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Vascular occlusion	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Vascular pseudoaneurysm	0.43% 21/4852 • Number of events 21 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Vessel perforation	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Vascular disorders Wound haemorrhage	0.02% 1/4852 • Number of events 1 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.

Other adverse events

Measure	XV-LTF Cohort n=4852 participants at risk XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Cardiac disorders Angina pectoris	13.3% 644/4852 • Number of events 805 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
General disorders Non-cardiac chest pain	6.3% 308/4852 • Number of events 366 • Four year endpoint (up to 1502 days) The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.

Additional Information

Robert Smith Jr, Ph.D., Sr Clinical Research Scientist

Abbott Vascular

Phone: 408-845-8265

Email: robert.smithjr@av.abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60