Evaluation of Outcomes of EES Implantation for Unprotected Left Main Coronary Artery Stenosis (PRE-COMBAT 2)
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01348022
- Lead Sponsor
- Seung-Jung Park
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 397
- 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.
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The patient has a known hypersensitivity or contraindication to any of the following medications:
- Heparin
- Aspirin
- 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).
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Systemic (intravenous) Everolimus, paclitaxel or ABT-578 use within 12 months.
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Any previous PCI within 1 year
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Previous bypass surgery
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Any previous PCI of a LMCA or ostial left circumflex artery or ostial left anterior descending artery lesion within 1 year
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Intention to treat more than one totally occluded major epicardial vessel
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Acute MI patients within 1 week
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Patients with EF<30%.
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Patients with cardiogenic shock
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Any disabled stroke with neurological deficit or any cerebrovascular accident within 6 months
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Creatinine level 2.0mg/dL or dependence on dialysis.
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Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).
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Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
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History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
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Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
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An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 1 year post enrollment.
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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).
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Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
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Subject unable or unwilling to follow-up with visits required by protocol
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Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MACCE free survival 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 Outcome Measures
Name Time Method 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 angiographic follow-up
Late luminal loss in both in-stent and in-segment 9 months angiographic follow-up
Stent thrombosis 5 years Cerebrovascular accident 5 years Target vessel revascularization 5 years pattern of restenosis 9 months angiographic follow-up
Re-hospitalization with a cardiac cause 5 years
Trial Locations
- Locations (21)
The Catholic University of Korea, Daejeon ST. Mary's Hospital
🇰🇷Daejeon, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
Kangwon National University Hospital
🇰🇷Chuncheon, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Kwangju Christian Hospital
🇰🇷Kwangju, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Seoul National University hospital
🇰🇷Seoul, Korea, Republic of
Veterans Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of