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

N/ACompletedNCT01120379

Abbott Medical Devices5,034 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

5,034

Conditions

Chronic Coronary Occlusion Vascular Disease Myocardial Ischemia

Interventions

XIENCE V® EECSSDEVICE

Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Abbott Vascular

Santa Clara, California, United States

Outcomes

Primary Outcomes

Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)

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

Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)

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

Stent Thrombosis (Definite and Probable) as Defined by ARC

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

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

Time frame: 2 years

Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).

Time frame: 3 years

Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).

Time frame: 4 years

Secondary Outcomes

Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)

Time frame: 2 years

Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)

Time frame: 3 years

Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)

Time frame: 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]

Time frame: 2 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]

Time frame: 3 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]

Time frame: 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)

Time frame: 2 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)

Time frame: 3 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)

Time frame: 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)

Data from ClinicalTrials.gov

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Time frame: 3 years

Time frame: 4 years

Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)

Time frame: 2 years

Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)

Time frame: 3 years

Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)

Time frame: 4 years

Any MI (Q-wave and Non Q-wave)

Time frame: 2 years

Any MI (Q-wave and Non Q-wave)

Time frame: 3 years

Any MI (Q-wave and Non Q-wave)

Time frame: 4 years

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

Time frame: 2 years

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

Time frame: 3 years

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

Time frame: 4 years

Major Bleeding Complications

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

Major Bleeding Complications (Site Reported)

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

Major Bleeding Complications

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

Dual Antiplatelet Medication Usage

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

Dual Antiplatelet Medication Usage

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

Dual Antiplatelet Medication Usage

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