Evaluation of Effectiveness and Safety of Everolimus-Eluting Stents in Routine Clinical Practice
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Seung-Jung Park
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- Composite of death, nonfatal myocardial infarction (MI), and Target Vessel Revascularization (TVR)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The objective of this study is to evaluate effectiveness and safety of everolimus-eluting stents (XIENCE, Abbott) in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus-eluting stents).
Detailed Description
This study is a non-randomized, open-label registry to compare the efficacy and safety of everolimus-eluting stents versus sirolimus-eluting stents in patients with coronary artery disease.
Investigators
Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
CardioVascular Research Foundation, Korea
Eligibility Criteria
Inclusion Criteria
- •Patients received XIENCE stents
- •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
Exclusion Criteria
- •Patients with a mixture of other DESs
- •Terminal illness with life expectancy \<1 year.
- •Patients with cardiogenic shock
Outcomes
Primary Outcomes
Composite of death, nonfatal myocardial infarction (MI), and Target Vessel Revascularization (TVR)
Time Frame: at 12 months after PCI
composite of death, nonfatal myocardial infarction (MI), or ischemic driven Target Vessel Revascularization (TVR). Individual events are to be assessed as secondary.
Secondary Outcomes
- All Death(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- Cardiac death(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- MI(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- Composite of death or MI(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- Composite of cardiac death or MI(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- TVR(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- Target-lesion revascularization (TLR)(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- Stent thrombosis (ARC criteria)(1month ,6 month and 12 months,2year,3year,4 year and 5year)
- Procedural success(at discharge)