N/A
Completed N=5,020
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)
Chronic Coronary Occlusion · Vascular Disease · myocardial ischemia · Coronary Artery Stenosis
Source: ClinicalTrials.gov NCT01120379 ↗
Enrolled (actual)
5,020
Serious AEs
56.3%
Results posted
Oct 2013
Primary outcomePrimary: Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium) — 1.05 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium) |
1.18 | — |
| PRIMARY Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium) |
1.18 | — |
| PRIMARY Stent Thrombosis (Definite and Probable) as Defined by ARC |
1.56 | — |
| PRIMARY Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined). |
9.5 | — |
| PRIMARY Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined). |
14.9 | — |
| PRIMARY Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined). |
14.9 | — |
| SECONDARY Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) |
19.8 | — |
| SECONDARY Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) |
19.8 | — |
| SECONDARY Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) |
19.8 | — |
| 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] |
34.5 | — |
| 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] |
34.5 | — |
| 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] |
34.5 | — |
| 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) |
19.7 | — |
| 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) |
19.7 | — |
| 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) |
19.7 | — |
| 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) |
19.3 | — |
| 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) |
19.3 | — |
| 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) |
19.3 | — |
| SECONDARY Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) |
10.9 | — |
| SECONDARY Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) |
10.9 | — |
| SECONDARY Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) |
10.9 | — |
| SECONDARY Any MI (Q-wave and Non Q-wave) |
11.3 | — |
| SECONDARY Any MI (Q-wave and Non Q-wave) |
11.3 | — |
| SECONDARY Any MI (Q-wave and Non Q-wave) |
11.3 | — |
| SECONDARY Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) |
22.5 | — |
| SECONDARY Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) |
22.5 | — |
| SECONDARY Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) |
22.5 | — |
| SECONDARY Major Bleeding Complications |
8.4 | — |
| SECONDARY Major Bleeding Complications (Site Reported) |
7.3 | — |
| SECONDARY Major Bleeding Complications |
8.4 | — |
| SECONDARY Dual Antiplatelet Medication Usage |
42.5 | — |
| SECONDARY Dual Antiplatelet Medication Usage |
42.5 | — |
| SECONDARY Dual Antiplatelet Medication Usage |
42.5 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01120379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.