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

Completed

Conditions: Chronic Coronary Occlusion
Coronary Artery Stenosis
Coronary Disease
Coronary Restenosis
Myocardial Ischemia
Coronary Artery Disease
Vascular Disease

Interventions: Device: XIENCE V® EECSS

Registration Number: NCT01120379

Lead Sponsor: Abbott Medical Devices

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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 5034

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
XV-LTF cohort	XIENCE V® EECSS	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Any MI (Q-wave and Non Q-wave)	4 years
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
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)	4 years
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)	4 years
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.
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.
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)	4 years
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
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
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.