Chronic Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Restenosis, Myocardial Ischemia, Vascular Disease
Conditions
Keywords
drug eluting stents, Stents, Angioplasty, Stent thrombosis
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
Interventions
DEVICEXIENCE V® EECSS
Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). | 3 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) | 2 years | — |
| Any MI (Q-wave and Non Q-wave) | 2 years | — |
| Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) | 2 years | — |
| Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) | 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. |
| 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. |
| 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. |
| 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 | — |
| 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 | — |
| 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 | — |
Countries
United States
Participant flow
Recruitment details
Subjects are derived from the USA interventional cardiology population.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5,020 |
| Total | 5,020 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Four Year Timepoint | Any other reason for early termination | 217 |
| Four Year Timepoint | Death | 131 |
| Four Year Timepoint | Lost to Follow-up | 10 |
| Four Year Timepoint | Physician Decision | 5 |
| Four Year Timepoint | Withdrawal by Subject | 5 |
| One Year Timepoint | Any other reason for early termination | 5 |
| One Year Timepoint | Death | 108 |
| One Year Timepoint | Lost to Follow-up | 115 |
| One Year Timepoint | Physician Decision | 9 |
| One Year Timepoint | Withdrawal by Subject | 41 |
| Three Year Timepoint | Any other reason for early termination | 17 |
| Three Year Timepoint | Death | 120 |
| Three Year Timepoint | Lost to Follow-up | 43 |
| Three Year Timepoint | Physician Decision | 9 |
| Three Year Timepoint | Withdrawal by Subject | 25 |
| Two Year Timepoint | Any other reason for early termination | 4 |
| Two Year Timepoint | Death | 123 |
| Two Year Timepoint | Lost to Follow-up | 87 |
| Two Year Timepoint | Physician Decision | 12 |
| Two Year Timepoint | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | XV-LTF Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2495 Participants |
| Age, Categorical Between 18 and 65 years | 2525 Participants |
| Age, Continuous | 64.75 years STANDARD_DEVIATION 11.07 |
| Region of Enrollment United States | 5020 participants |
| Sex: Female, Male Female | 1564 Participants |
| Sex: Female, Male Male | 3456 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 883 / 4,852 |
| serious Total, serious adverse events | 2,730 / 4,852 |
Outcome results
Primary
Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined). | 14.9 percentage of participants |
Primary
Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined). | 11.7 percentage of participants |
Primary
Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined). | 9.5 percentage of participants |
Primary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Stent Thrombosis (Definite and Probable) as Defined by ARC | 1.56 percentage of participants |
Primary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium) | 1.05 percentage of participants |
Primary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium) | 1.18 percentage of participants |
Secondary
Any MI (Q-wave and Non Q-wave)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Any MI (Q-wave and Non Q-wave) | 7.6 percentage of participants |
Secondary
Any MI (Q-wave and Non Q-wave)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Any MI (Q-wave and Non Q-wave) | 9.1 percentage of participants |
Secondary
Any MI (Q-wave and Non Q-wave)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Any MI (Q-wave and Non Q-wave) | 11.3 percentage of participants |
Secondary
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) | 19.8 percentage of participants |
Secondary
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) | 15.0 percentage of participants |
Secondary
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) | 11.8 percentage of participants |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | 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 |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | 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 |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | 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 |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | 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 |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | 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 |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | 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 |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | 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 |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | 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 |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | 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 |
Secondary
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) | 5.4 percentage of participants |
Secondary
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) | 10.9 percentage of participants |
Secondary
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) | 7.6 percentage of participants |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Dual Antiplatelet Medication Usage | 42.5 percentage of participants |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Dual Antiplatelet Medication Usage | 53.1 percentage of participants |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Dual Antiplatelet Medication Usage | 61.9 percentage of participants |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Major Bleeding Complications | 4.3 percentage of participants |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Major Bleeding Complications | 8.4 percentage of participants |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Major Bleeding Complications (Site Reported) | 7.3 percentage of participants |
Secondary
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) | 18.2 percentage of participants |
Secondary
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) | 22.5 percentage of participants |
Secondary
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XV-LTF Cohort | Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) | 14.7 percentage of participants |