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

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.

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