Evaluation of Outcomes of EES Implantation for Unprotected Left Main Coronary Artery Stenosis (PRE-COMBAT 2)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Evaluation of Outcomes of Everolimus-Eluting Stent (XIENCE V) Implantation for Unprotected Left Main Coronary Artery Stenosis: Multicenter Trial

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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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: 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). 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Xience V stent<br>unprotected Left Main Coronary Artery stenting treated with Xience V stent | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE free survival | 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 | at 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death(all cause and cardiac) |  | 5 years | 
| Myocardial Infarction |  | 5 years | 
| Cerebrovascular accident |  | 5 years | 
| Target vessel revascularization |  | 5 years | 
| Target lesion revascularization |  | 5 years | 
| Stent thrombosis |  | 5 years | 
| Binary restenosis in both in-stent and in-segment | angiographic follow-up | 9 months | 
| Late luminal loss in both in-stent and in-segment | angiographic follow-up | 9 months | 
| pattern of restenosis | angiographic follow-up | 9 months | 
| Angina status |  | 5 years | 
| Re-hospitalization with a cardiac cause |  | 5 years |