Prospective Evaluation of Outcomes of Everolimus-Eluting Stent (XIENCE V) Implantation for Unprotected Left Main Coronary Artery Stenosis: Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 397
- 试验地点
- 21
- 主要终点
- MACCE free survival
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Acute MI patients within 1 week
- •Patients with EF<30%.
- •Patients with cardiogenic shock
- •Any disabled stroke with neurological deficit or any cerebrovascular accident within 6 months
- •Creatinine level 2.0mg/dL or dependence on dialysis.
- •Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).
- •Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- •History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- •Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
- •An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 1 year post enrollment.
- •Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- •Subject unable or unwilling to follow-up with visits required by protocol
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
结局指标
主要结局
MACCE free survival
时间窗: 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
次要结局
- 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)
研究者
Seung-Jung Park
M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine
CardioVascular Research Foundation, Korea