NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial

Brief Summary

Detailed Description

Everolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Biolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in 2011 by the Japanese Ministry of Health, Labor and Welfare. It has been reported that biolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 9 months as compared with paclitaxel-eluting stent. However, trial results comparing biolimus-eluting stent with everolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice. The design of this study is all-comer design enrolling patients scheduled for percutaneous coronary intervention using drug-eluting stents without any exclusion criteria.

Primary Outcomes

Secondary Outcomes

• cardiac death(3-year)
• acute myocardial infarction(3-year)
• stent thrombosis(3-year)
• all-cause death(3-year)
• stroke(3-year)
• bleeding complications(3-year)
• success rate for stent deployment(3-year)
• procedure time(3-year)
• clinically-driven target-lesion revascularization(3-year)
• non-target-lesion revascularization(3-year)
• coronary artery bypass grafting(3-year)
• target-vessel revascularization(3-year)
• any repeat coronary revascularization(3-year)
• composite of cardiac death, acute myocardial infarction in the territory of the target vessel or target-lesion revascularization(3-year)
• composite of all-cause death, acute myocardial infarction or any repeat coronary revascularization(3-year)