Comparison of the Efficacy of Everolimus-Eluting Versus Sirolimus-Eluting Stent for Coronary Lesions

Detailed Summary

Objectives 1. To evaluate the safety and long-term effectiveness of coronary stenting with the Everolimus-eluting coronary stent system(EECSS) (XIENCETM V, Abbott Vascular, Santa Clara, CA, PromusTM, Boston Scientific, Natick, MA), compared with the sirolimus-eluting coronary stent system(SECSS) (CypherTM, Cordis Johnson \& Johnson, Warren, NJ) in the treatment of coronary stenosis. 2. To evaluate the safety and efficacy of 6-month clopidogrel therapy compared with 12-month clopidogrel therapy. Study Design: Prospective, open label, two-arm, randomized multi-center trial to test the non-inferiority of EECSS compared with the SECSS, and to test the non-inferiority of 6 months duration compared with 12 months duration of clopidogrel therapy. Patients will be randomized in a two by two factorial manner according to the type of drug eluting stent (EECSS vs. SECSS) and the duration of dual anti-platelet therapy (6 months vs. 12 months). Randomization will also be stratified per hospital for the presence of DM and the presence of long lesions (lesion length ≥ 28mm) Patient Enrollment: 1,372 patients enrolled at 17 centers in Korea. Patient Follow-Up: Clinical follow-up will occur at 1, 3, and 9 months, and at 1, 2, 3, 4, and 5 years. Investigator or designee may conduct follow-up as telephone contacts or office visits. Primary Endpoint * In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS. * Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months of clopidogrel therapy Secondary Endpoint * All Death * Cardiac death * Myocardial infarction * Target vessel revascularization (TVR) (all and ischemia-driven) * Target lesion revascularization (TLR) (all and ischemia-driven) * Stent thrombosis * Acute success (device, lesion, and procedure) * Bleeding * Cerebrovascular accident * In-stent LL at 9 months * Angiographic pattern of restenosis at 9-month angiographic follow-up * In-stent and in-segment % diameter stenosis (%DS) at 9 months * In-stent % volume obstruction (%VO) at 9 months * Incomplete stent apposition post index procedure * Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months

Study Details

Timeline

Interventions