Five-year outcomes of Cypher™ coronary stent: report from J-PMS Study.

The long-term outcome and compliance of dual-antiplatelet therapy after implantation of drug-eluting stent in the "real world" setting in Japan has not been well investigated. The purpose of this study was to provide information on the introduction and outcomes including status and compliance of dual-antiplatelet therapy of sirolimus-eluting stent (SES). Five-year follow-up was achieved in 1937 of 2050 patients (94.5%). Off-label use was 87.3% in this study. The incidence of MACE was 23.2%, including death (13.4%), MI (3.4%), and target lesion revascularization (TLR, 9.6%). Multivariate analysis for TLR predicted dialysis [hazard ratio (HR) 3.5, 95% confidence interval (CI) 2.13-5.93], lesion length >30 mm (HR 1.89, 95% CI 1.24-2.84), vessel diameter <2.5 mm (HR 1.55, 95% CI 1.10-2.18), ostial lesion (HR 1.59, 95% CI 1.10-2.31), and previous PCI (HR 1.42, 95% CI 1.00-2.00). There were 25 events of definite/probable thrombosis. Very late thrombosis was identified in 17 cases, and the slope of the linear portion of the cumulative incidence curve of stent thrombosis was 0.28% per year. Seven of the 17 events (41.2%) occurred under dual anti-platelet therapy. Five-year outcomes after SES implantation in the "real world" in Japanese showed that dialysis, previous PCI, small vessel <2.5 mm, long lesion >30 mm, and ostial lesions were the predictors of TLR at 5-years. Stent thrombosis rate was lower than previous reports.