Prospective Evaluation of Outcomes of Everolimus-Eluting Stent (XIENCE V) Implantation for Unprotected Left Main Coronary Artery Stenosis: Multicenter Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Seung-Jung Park
- Enrollment
- 397
- Locations
- 21
- Primary Endpoint
- MACCE free survival
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study is a multicenter, open label, prospective, single arm trial
Single arm group; following angiography, eligible patients with unprotected LMCA stenosis >50% by visual estimation, which is equally treatable by the both treatment strategy (EES stenting or CABG), will be treated with EES
Detailed Description
The primary objective of the PRECOMBAT-2 trial is to establish the safety and effectiveness of coronary stenting with the everolimus-eluting Xience V stent (EES) compared with the historical control (PRE-COMBAT-1) of bypass surgery and sirolimus-eluting stent (SES) for the treatment of an unprotected LMCA stenosis. The primary alternative hypothesis is that the experimental starategy (coronary stenting with the everolimus-eluting stents) is not inferior to the standard strategy (CABG) or SES. All consecutive patients with unprotected LMCA diseases at participating centers, who are treated with Xience V stent, will be evaluated for the entry into the study.
Investigators
Seung-Jung Park
M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine
CardioVascular Research Foundation, Korea
Eligibility Criteria
Inclusion Criteria
- •The patient must be at least 18 years of age.
- •Significant de novo left main stenosis (\>50% by visual estimation) with or without any additional target lesions (\>70% by visual estimation)
- •Left main lesion and lesions outside LMCA (if present) potentially equally treatable with coronary stenting and CABG
- •Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia
- •The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion Criteria
- •The patient has a known hypersensitivity or contraindication to any of the following medications:
- •Both Clopidogrel and TIclopidine
- •Everolimus, paclitaxel, ABT 578
- •Stainless steel and/or
- •Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
- •Systemic (intravenous) Everolimus, paclitaxel or ABT-578 use within 12 months.
- •Any previous PCI within 1 year
- •Previous bypass surgery
- •Any previous PCI of a LMCA or ostial left circumflex artery or ostial left anterior descending artery lesion within 1 year
- •Intention to treat more than one totally occluded major epicardial vessel
Outcomes
Primary Outcomes
MACCE free survival
Time Frame: at 2 year
Death (all-cause mortality) Cerebrovascular accident Non-fatal myocardial infarction (Q wave and non-Q wave) Ischemia-driven target vessel revascularization either percutaneous or surgical treatment
Secondary Outcomes
- Angina status(5 years)
- Death(all cause and cardiac)(5 years)
- Target lesion revascularization(5 years)
- Myocardial Infarction(5 years)
- Binary restenosis in both in-stent and in-segment(9 months)
- Late luminal loss in both in-stent and in-segment(9 months)
- Stent thrombosis(5 years)
- Cerebrovascular accident(5 years)
- Target vessel revascularization(5 years)
- pattern of restenosis(9 months)
- Re-hospitalization with a cardiac cause(5 years)