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

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01120379
• Collaborator: (none)
• Enrollment: 5,034
• Location: 1
• Duration (Months): 65
• Patients Per Site Per Month: 77.4

Study Details

Study Description

Brief Summary

XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are

• To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and

• To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.

Condition or Disease	Intervention/Treatment	Phase
Chronic Coronary Occlusion; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis	Device: XIENCE V® EECSS

Detailed Description

Among patients enrolled in the XIENCE V USA who have completed Study Phase I, some will be eligible to participate in the XIENCE V USA Long Term Follow-up (LTF) Cohort. This LTF cohort is a prospective, open-label, multi-center, observational, single-arm study is designed to evaluate XIENCE V EECSS continued safety and effectiveness in real world settings from 1 year after the index procedure up to 5 years. The XIENCE V USA LTF cohort will consist of the following from the initial 5,000 patients:

• The first 1,500 on-label patients who are treated in accordance with the XIENCE V EECSS Instruction for Use (IFU), and consecutively enrolled in the XIENCE V USA study

• The remaining patients who do not participate in the HCRI-DAPT cohort

• Data monitoring committee up to two years

Study Design

• Study Type: Observational
• Actual Enrollment: 5034 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
XV-LTF cohort	Device: XIENCE V® EECSS; Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.

Outcome Measures

Primary Outcome Measures

1. Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium) [2 years]

   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).

2. Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium) [3 years]

   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).

3. Stent Thrombosis (Definite and Probable) as Defined by ARC [4 years]

   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).

4. Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined). [2 years]

5. Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined). [3 years]

6. Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined). [4 years]

Secondary Outcome Measures

1. Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) [2 years]

2. Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) [3 years]

3. Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) [4 years]

4. 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] [2 years]

5. 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] [3 years]

6. 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] [4 years]

7. 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) [2 years]

8. 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) [3 years]

9. 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) [4 years]

10. 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) [2 years]

11. 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) [3 years]

12. 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) [4 years]

13. Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) [2 years]

14. Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) [3 years]

15. Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) [4 years]

16. Any MI (Q-wave and Non Q-wave) [2 years]

17. Any MI (Q-wave and Non Q-wave) [3 years]

18. Any MI (Q-wave and Non Q-wave) [4 years]

19. Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) [2 years]

20. Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) [3 years]

21. Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) [4 years]

22. Major Bleeding Complications [2 years]

    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.

23. Major Bleeding Complications (Site Reported) [3 years]

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

24. Major Bleeding Complications [4 years]

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

25. Dual Antiplatelet Medication Usage [2 years]

    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.

26. Dual Antiplatelet Medication Usage [3 years]

    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.

27. Dual Antiplatelet Medication Usage [4 years]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The patient agrees to participate in this study by signing the Institutional Review Board approved informed consent form.

Exclusion Criteria:

• The inability to obtain an informed consent.

• Age limit is determined by investigator.

• There are no angiographic inclusion or exclusion criteria for this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abbott Vascular	Santa Clara	California	United States	95054

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: James Hermiller, MD, Heart Center of Indianapolis
• Principal Investigator: Mitch Krucoff, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• NCT00676520
• NCT01106534

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01120379
• Other Study ID Numbers: 06-374B
• First Posted: May 10, 2010
• Last Update Posted: Jun 22, 2015
• Last Verified: May 1, 2015

• Keywords provided by Abbott Medical Devices: drug eluting stents; Stents; Angioplasty; Stent thrombosis
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Vascular Diseases; Coronary Stenosis; Coronary Occlusion; Coronary Restenosis; Ischemia

Study Results

Participant Flow

Recruitment Details	Subjects are derived from the USA interventional cardiology population.
Pre-assignment Detail	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.

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

Baseline Characteristics

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Overall Participants	5020
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2525 50.3%
>=65 years	2495 49.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.75 (11.07)
Sex: Female, Male (Count of Participants)
Female	1564 31.2%
Male	3456 68.8%
Region of Enrollment (participants) [Number]
United States	5020 100%

Outcome Measures

1. Primary Outcome

Title	Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)
Description	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).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4587
Number (95% Confidence Interval) [percentage of participants]	1.05 0%

2. Primary Outcome

Title	Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)
Description	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).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4475
Number (95% Confidence Interval) [percentage of participants]	1.18 0%

3. Primary Outcome

Title	Stent Thrombosis (Definite and Probable) as Defined by ARC
Description	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).
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4093
Number (95% Confidence Interval) [percentage of participants]	1.56 0%

4. Primary Outcome

Title	Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4769
Number (95% Confidence Interval) [percentage of participants]	9.5 0.2%

5. Primary Outcome

Title	Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4741
Number (95% Confidence Interval) [percentage of participants]	11.7 0.2%

6. Primary Outcome

Title	Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4530
Number (95% Confidence Interval) [percentage of participants]	14.9 0.3%

7. Secondary Outcome

Title	Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4769
Number (95% Confidence Interval) [percentage of participants]	11.8 0.2%

8. Secondary Outcome

Title	Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4741
Number (95% Confidence Interval) [percentage of participants]	15.0 0.3%

9. Secondary Outcome

Title	Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4530
Number (95% Confidence Interval) [percentage of participants]	19.8 0.4%

10. Secondary Outcome

Title	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]
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4769
Number (95% Confidence Interval) [percentage of participants]	22.4 0.4%

11. Secondary Outcome

Title	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]
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4741
Number (95% Confidence Interval) [percentage of participants]	27.5 0.5%

12. Secondary Outcome

Title	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]
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4530
Number (95% Confidence Interval) [percentage of participants]	34.5 0.7%

13. Secondary Outcome

Title	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)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4769
Number (95% Confidence Interval) [percentage of participants]	13.3 0.3%

14. Secondary Outcome

Title	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)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4741
Number (95% Confidence Interval) [percentage of participants]	16.0 0.3%

15. Secondary Outcome

Title	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)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4530
Number (95% Confidence Interval) [percentage of participants]	19.7 0.4%

16. Secondary Outcome

Title	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)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4769
Number (95% Confidence Interval) [percentage of participants]	13.0 0.3%

17. Secondary Outcome

Title	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)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4741
Number (95% Confidence Interval) [percentage of participants]	15.7 0.3%

18. Secondary Outcome

Title	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)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4530
Number (95% Confidence Interval) [percentage of participants]	19.3 0.4%

19. Secondary Outcome

Title	Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4769
Number (95% Confidence Interval) [percentage of participants]	5.4 0.1%

20. Secondary Outcome

Title	Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4741
Number (95% Confidence Interval) [percentage of participants]	7.6 0.2%

21. Secondary Outcome

Title	Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4530
Number (95% Confidence Interval) [percentage of participants]	10.9 0.2%

22. Secondary Outcome

Title	Any MI (Q-wave and Non Q-wave)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4769
Number (95% Confidence Interval) [percentage of participants]	7.6 0.2%

23. Secondary Outcome

Title	Any MI (Q-wave and Non Q-wave)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4741
Number (95% Confidence Interval) [percentage of participants]	9.1 0.2%

24. Secondary Outcome

Title	Any MI (Q-wave and Non Q-wave)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4530
Number (95% Confidence Interval) [percentage of participants]	11.3 0.2%

25. Secondary Outcome

Title	Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4769
Number (95% Confidence Interval) [percentage of participants]	14.7 0.3%

26. Secondary Outcome

Title	Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4741
Number (95% Confidence Interval) [percentage of participants]	18.2 0.4%

27. Secondary Outcome

Title	Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4530
Number (95% Confidence Interval) [percentage of participants]	22.5 0.4%

28. Secondary Outcome

Title	Major Bleeding Complications
Description	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.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4541
Number (95% Confidence Interval) [percentage of participants]	4.3 0.1%

29. Secondary Outcome

Title	Major Bleeding Complications (Site Reported)
Description	Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4435
Number (95% Confidence Interval) [percentage of participants]	7.3 0.1%

30. Secondary Outcome

Title	Major Bleeding Complications
Description	Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	4050
Number (95% Confidence Interval) [percentage of participants]	8.4 0.2%

31. Secondary Outcome

Title	Dual Antiplatelet Medication Usage
Description	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.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	5020
Number [percentage of participants]	61.9 1.2%

32. Secondary Outcome

Title	Dual Antiplatelet Medication Usage
Description	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.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	5020
Number [percentage of participants]	53.1 1.1%

33. Secondary Outcome

Title	Dual Antiplatelet Medication Usage
Description	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.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Measure Participants	5020
Number [percentage of participants]	42.5 0.8%

Adverse Events

Time Frame	Four year endpoint (up to 1502 days)
Adverse Event Reporting Description	The number of participants at risk excludes subjects who were early terminated up to 1460 days and had no events through given timepoint.
Arm/Group Title	XV-LTF Cohort
Arm/Group Description	XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
All Cause Mortality
	XV-LTF Cohort
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	XV-LTF Cohort
	Affected / at Risk (%)	# Events
Total	2730/4852 (56.3%)
Blood and lymphatic system disorders
Others/Miscellaneous	89/4852 (1.8%)	116
Cardiac disorders
Acute coronary syndrome	23/4852 (0.5%)	24
Acute myocardial infarction	229/4852 (4.7%)	251
Angina pectoris	784/4852 (16.2%)	1131
Angina unstable	218/4852 (4.5%)	277
Aortic valve disease	1/4852 (0%)	1
Aortic valve stenosis	22/4852 (0.5%)	22
Arrhythmia	11/4852 (0.2%)	11
Arteriosclerosis coronary artery	4/4852 (0.1%)	4
Arteriospasm coronary	3/4852 (0.1%)	3
Atrial fibrillation	110/4852 (2.3%)	141
Atrial flutter	37/4852 (0.8%)	47
Atrial tachycardia	1/4852 (0%)	1
Atrial thrombosis	2/4852 (0%)	2
Atrioventricular block	4/4852 (0.1%)	4
Atrioventricular block complete	6/4852 (0.1%)	6
Atrioventricular block second degree	3/4852 (0.1%)	4
Bradycardia	34/4852 (0.7%)	35
Bundle branch block left	1/4852 (0%)	1
Cardiac arrest	38/4852 (0.8%)	38
Cardiac disorder	2/4852 (0%)	2
Cardiac failure	28/4852 (0.6%)	30
Cardiac failure acute	19/4852 (0.4%)	21
Cardiac failure chronic	4/4852 (0.1%)	4
Cardiac failure congestive	183/4852 (3.8%)	295
Cardiac perforation	1/4852 (0%)	1
Cardiac tamponade	4/4852 (0.1%)	4
Cardiac valve disease	3/4852 (0.1%)	3
Cardio-respiratory arrest	20/4852 (0.4%)	20
Cardiogenic shock	12/4852 (0.2%)	12
Cardiomyopathy	18/4852 (0.4%)	19
Cardiopulmonary failure	1/4852 (0%)	1
Congestive cardiomyopathy	5/4852 (0.1%)	5
Cor pulmonale chronic	1/4852 (0%)	1
Coronary artery aneurysm	1/4852 (0%)	1
Coronary artery disease	120/4852 (2.5%)	127
Coronary artery dissection	15/4852 (0.3%)	15
Coronary artery occlusion	32/4852 (0.7%)	32
Coronary artery perforation	1/4852 (0%)	1
Coronary artery stenosis	74/4852 (1.5%)	76
Coronary artery thrombosis	9/4852 (0.2%)	9
Coronary ostial stenosis	4/4852 (0.1%)	4
Electromechanical dissociation	3/4852 (0.1%)	3
Extrasystoles	1/4852 (0%)	1
Hypertensive cardiomyopathy	1/4852 (0%)	1
Intracardiac thrombus	2/4852 (0%)	2
Ischaemic cardiomyopathy	16/4852 (0.3%)	16
Left ventricular dysfunction	5/4852 (0.1%)	5
Left ventricular hypertrophy	1/4852 (0%)	1
Low cardiac output syndrome	1/4852 (0%)	1
Mitral valve calcification	1/4852 (0%)	1
Mitral valve incompetence	8/4852 (0.2%)	9
Mitral valve prolapse	1/4852 (0%)	1
Mitral valve stenosis	1/4852 (0%)	1
Myocardial infarction	57/4852 (1.2%)	59
Myocardial ischaemia	43/4852 (0.9%)	44
Palpitations	11/4852 (0.2%)	11
Pericardial effusion	5/4852 (0.1%)	6
Pericardial haemorrhage	1/4852 (0%)	1
Pericarditis	4/4852 (0.1%)	4
Pericarditis constrictive	1/4852 (0%)	1
Post procedural myocardial infarction	6/4852 (0.1%)	6
Right ventricular dysfunction	1/4852 (0%)	1
Right ventricular failure	1/4852 (0%)	1
Sick sinus syndrome	23/4852 (0.5%)	23
Sinus arrest	2/4852 (0%)	2
Sinus arrhythmia	4/4852 (0.1%)	4
Sinus bradycardia	6/4852 (0.1%)	6
Sinus tachycardia	2/4852 (0%)	2
Sudden cardiac death	2/4852 (0%)	2
Supraventricular extrasystoles	1/4852 (0%)	1
Supraventricular tachycardia	11/4852 (0.2%)	11
Tachycardia	2/4852 (0%)	2
Torsade de pointes	1/4852 (0%)	1
Tricuspid valve incompetence	2/4852 (0%)	2
Ventricular arrhythmia	3/4852 (0.1%)	3
Ventricular asystole	1/4852 (0%)	1
Ventricular dysfunction	2/4852 (0%)	2
Ventricular extrasystoles	2/4852 (0%)	2
Ventricular fibrillation	18/4852 (0.4%)	18
Ventricular flutter	1/4852 (0%)	1
Ventricular tachycardia	40/4852 (0.8%)	45
Congenital, familial and genetic disorders
Others/Miscellaneous	10/4852 (0.2%)	11
Ear and labyrinth disorders
Others/Miscellaneous	3/4852 (0.1%)	3
Endocrine disorders
Others/Miscellaneous	5/4852 (0.1%)	5
Eye disorders
Others/Miscellaneous	10/4852 (0.2%)	10
Gastrointestinal disorders
Others/Miscellaneous	218/4852 (4.5%)	277
General disorders
Accidental death	1/4852 (0%)	1
Adverse drug reaction	4/4852 (0.1%)	4
Asthenia	15/4852 (0.3%)	15
Catheter site haematoma	21/4852 (0.4%)	21
Catheter site haemorrhage	9/4852 (0.2%)	9
Chest pain	1/4852 (0%)	1
Drug withdrawal syndrome	1/4852 (0%)	1
Exercise tolerance decreased	1/4852 (0%)	1
Fatigue	6/4852 (0.1%)	6
Gait disturbance	3/4852 (0.1%)	3
Generalised oedema	2/4852 (0%)	2
Hernia	1/4852 (0%)	1
Hernia obstructive	1/4852 (0%)	1
Hypothermia	1/4852 (0%)	1
Impaired healing	1/4852 (0%)	1
Implant site discharge	1/4852 (0%)	1
Infusion site phlebitis	1/4852 (0%)	1
Malaise	1/4852 (0%)	1
Multi-organ failure	10/4852 (0.2%)	10
Non-cardiac chest pain	231/4852 (4.8%)	311
Oedema peripheral	9/4852 (0.2%)	9
Organ failure	1/4852 (0%)	1
Pain	1/4852 (0%)	1
Pyrexia	11/4852 (0.2%)	13
Sudden death	3/4852 (0.1%)	3
Surgical failure	1/4852 (0%)	1
Systemic inflammatory response syndrome	2/4852 (0%)	2
Unevaluable event	1/4852 (0%)	1
Hepatobiliary disorders
Others/Miscellaneous	55/4852 (1.1%)	58
Immune system disorders
Allergy to metals	1/4852 (0%)	1
Amyloidosis	1/4852 (0%)	1
Contrast media reaction	1/4852 (0%)	1
Dermatitis allergic	1/4852 (0%)	1
Drug hypersensitivity	3/4852 (0.1%)	3
Hypersensitivity	1/4852 (0%)	1
Infections and infestations
Others/Miscellaneous	414/4852 (8.5%)	585
Injury, poisoning and procedural complications
Anaemia postoperative	10/4852 (0.2%)	10
Arteriovenous fistula site complication	1/4852 (0%)	1
Arteriovenous fistula thrombosis	1/4852 (0%)	1
Arteriovenous graft thrombosis	2/4852 (0%)	2
Cardiac pacemaker malfunction	2/4852 (0%)	2
Coronary artery reocclusion	1/4852 (0%)	1
Coronary artery restenosis	12/4852 (0.2%)	12
Coronary bypass thrombosis	1/4852 (0%)	1
Device dislocation	1/4852 (0%)	1
Device electrical finding	3/4852 (0.1%)	3
Device lead damage	1/4852 (0%)	1
Device malfunction	2/4852 (0%)	2
Endotracheal intubation complication	1/4852 (0%)	1
Implantable defibrillator malfunction	1/4852 (0%)	1
In-stent arterial restenosis	9/4852 (0.2%)	10
In-stent coronary artery restenosis	160/4852 (3.3%)	195
Incision site haemorrhage	1/4852 (0%)	1
Incisional hernia	3/4852 (0.1%)	4
Joint dislocation postoperative	1/4852 (0%)	1
Lead dislodgement	1/4852 (0%)	1
Mechanical complication of implant	2/4852 (0%)	2
Operative haemorrhage	1/4852 (0%)	1
Other injuries	118/4852 (2.4%)	139
Post procedural complication	2/4852 (0%)	2
Post procedural haemorrhage	6/4852 (0.1%)	6
Postoperative renal failure	3/4852 (0.1%)	3
Procedural headache	2/4852 (0%)	2
Procedural hypotension	10/4852 (0.2%)	10
Procedural nausea	1/4852 (0%)	1
Procedural vomiting	2/4852 (0%)	2
Reperfusion injury	7/4852 (0.1%)	7
Seroma	1/4852 (0%)	1
Stent occlusion	6/4852 (0.1%)	6
Stent-graft endoleak	1/4852 (0%)	2
Thrombosis in device	8/4852 (0.2%)	9
Urinary retention postoperative	2/4852 (0%)	3
Vascular graft complication	1/4852 (0%)	1
Vascular graft occlusion	15/4852 (0.3%)	15
Weaning failure	1/4852 (0%)	1
Wound dehiscence	2/4852 (0%)	2
Investigations
Others/Miscellaneous	76/4852 (1.6%)	83
Metabolism and nutrition disorders
Others/Miscellaneous	106/4852 (2.2%)	141
Musculoskeletal and connective tissue disorders
Others/Miscellaneous	181/4852 (3.7%)	194
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Others/Miscellaneous	161/4852 (3.3%)	184
Nervous system disorders
Others/Miscellaneous	332/4852 (6.8%)	386
Psychiatric disorders
Others/Miscellaneous	42/4852 (0.9%)	49
Renal and urinary disorders
Other renal and urinary disorders	95/4852 (2%)	106
Renal failure acute	68/4852 (1.4%)	72
Reproductive system and breast disorders
Others/Miscellaneous	12/4852 (0.2%)	13
Respiratory, thoracic and mediastinal disorders
Others/Miscellaneous	340/4852 (7%)	485
Skin and subcutaneous tissue disorders
Others/Miscellaneous	15/4852 (0.3%)	15
Surgical and medical procedures
Others/Miscellaneous	30/4852 (0.6%)	30
Vascular disorders
Accelerated hypertension	3/4852 (0.1%)	3
Aortic aneurysm	18/4852 (0.4%)	19
Aortic aneurysm rupture	3/4852 (0.1%)	3
Aortic dissection	2/4852 (0%)	2
Aortic intramural haematoma	1/4852 (0%)	1
Aortic stenosis	4/4852 (0.1%)	4
Aorto-duodenal fistula	1/4852 (0%)	1
Arterial occlusive disease	1/4852 (0%)	1
Arterial restenosis	1/4852 (0%)	1
Arterial stenosis	2/4852 (0%)	2
Arterial thrombosis limb	2/4852 (0%)	2
Arteriosclerosis	19/4852 (0.4%)	22
Arteriovenous fistula	4/4852 (0.1%)	5
Arteriovenous malformation	1/4852 (0%)	1
Carotid arteriosclerosis	1/4852 (0%)	1
Carotid artery disease	7/4852 (0.1%)	7
Carotid artery occlusion	3/4852 (0.1%)	3
Carotid artery stenosis	46/4852 (0.9%)	52
Cerebral haemorrhage	4/4852 (0.1%)	4
Deep vein thrombosis	24/4852 (0.5%)	26
Diverticulitis intestinal haemorrhagic	1/4852 (0%)	1
Diverticulum intestinal haemorrhagic	4/4852 (0.1%)	4
Duodenal ulcer haemorrhage	5/4852 (0.1%)	5
Embolism	1/4852 (0%)	1
Epistaxis	9/4852 (0.2%)	9
Femoral arterial stenosis	8/4852 (0.2%)	9
Femoral artery occlusion	7/4852 (0.1%)	8
Gastric haemorrhage	2/4852 (0%)	2
Gastric ulcer haemorrhage	7/4852 (0.1%)	7
Gastrointestinal haemorrhage	70/4852 (1.4%)	77
Gastrointestinal ulcer haemorrhage	3/4852 (0.1%)	3
Haemarthrosis	1/4852 (0%)	1
Haematemesis	3/4852 (0.1%)	3
Haematoma	4/4852 (0.1%)	4
Haemoptysis	5/4852 (0.1%)	5
Haemorrhage	1/4852 (0%)	1
Haemorrhage intracranial	8/4852 (0.2%)	8
Haemorrhagic erosive gastritis	2/4852 (0%)	2
Haemorrhagic stroke	2/4852 (0%)	2
Hepatic haemorrhage	1/4852 (0%)	1
Hypertension	24/4852 (0.5%)	27
Hypertensive crisis	7/4852 (0.1%)	7
Hypertensive emergency	2/4852 (0%)	2
Hypotension	33/4852 (0.7%)	39
Hypovolaemic shock	1/4852 (0%)	1
Iliac artery occlusion	3/4852 (0.1%)	3
Iliac artery stenosis	3/4852 (0.1%)	3
Intermittent claudication	23/4852 (0.5%)	29
Ischaemic limb pain	1/4852 (0%)	1
Labile blood pressure	1/4852 (0%)	1
Lower gastrointestinal haemorrhage	15/4852 (0.3%)	15
Mallory-Weiss syndrome	1/4852 (0%)	1
Mesenteric artery stenosis	2/4852 (0%)	2
Mesenteric occlusion	1/4852 (0%)	1
Oesophageal haemorrhage	1/4852 (0%)	1
Oesophageal varices haemorrhage	3/4852 (0.1%)	3
Operative haemorrhage	2/4852 (0%)	2
Orthostatic hypotension	12/4852 (0.2%)	14
Pelvic haematoma	1/4852 (0%)	1
Peptic ulcer haemorrhage	1/4852 (0%)	1
Peripheral arterial occlusive disease	10/4852 (0.2%)	11
Peripheral artery aneurysm	2/4852 (0%)	2
Peripheral ischaemia	10/4852 (0.2%)	12
Peripheral vascular disorder	16/4852 (0.3%)	19
Petechiae	1/4852 (0%)	1
Pharyngeal haematoma	1/4852 (0%)	1
Portal vein thrombosis	1/4852 (0%)	1
Post procedural haematoma	1/4852 (0%)	1
Pulmonary artery thrombosis	1/4852 (0%)	1
Pulmonary embolism	15/4852 (0.3%)	17
Pulmonary hypertension	2/4852 (0%)	2
Renal artery occlusion	1/4852 (0%)	1
Renal artery stenosis	11/4852 (0.2%)	11
Renal hypertension	1/4852 (0%)	1
Retinal vascular occlusion	1/4852 (0%)	1
Retroperitoneal haematoma	2/4852 (0%)	2
Retroperitoneal haemorrhage	15/4852 (0.3%)	15
Skin ulcer	3/4852 (0.1%)	3
Subarachnoid haemorrhage	4/4852 (0.1%)	4
Subclavian artery stenosis	3/4852 (0.1%)	3
Subclavian steal syndrome	1/4852 (0%)	1
Subdural haematoma	13/4852 (0.3%)	13
Subdural haemorrhage	1/4852 (0%)	1
Superior vena caval occlusion	1/4852 (0%)	1
Thrombosis	4/4852 (0.1%)	4
Ulcer haemorrhage	2/4852 (0%)	2
Upper gastrointestinal haemorrhage	15/4852 (0.3%)	15
Vascular insufficiency	1/4852 (0%)	1
Vascular occlusion	1/4852 (0%)	1
Vascular pseudoaneurysm	21/4852 (0.4%)	21
Vessel perforation	1/4852 (0%)	1
Wound haemorrhage	1/4852 (0%)	1
Other (Not Including Serious) Adverse Events
	XV-LTF Cohort
	Affected / at Risk (%)	# Events
Total	883/4852 (18.2%)
Cardiac disorders
Angina pectoris	644/4852 (13.3%)	805
General disorders
Non-cardiac chest pain	308/4852 (6.3%)	366

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.