Retrospective Comparison of Midterm Clinical and Angiographic Outcomes after the Implantation of Paclitaxel- and Sirolimus-Eluting Stents for de novo Coronary Complex Lesions in Nonrandomized Japanese Patients

OBJECTIVE: We retrospectively analyzed the midterm clinical and angiographic outcomes after the implantation of paclitaxel- (PES, TAXUS Express) and sirolimus- (SES, Cypher Bx Velocity) eluting stents in Japanese patients with complex coronary lesions. METHODS: From August 2004 to May 2009, 1,335 nonrandomized de novo native complex coronary lesions treated with either a PES (357 cases) or SES were included. The inclusion criteria for patients with complex lesions were those with diabetes, those undergoing hemodialysis, and those with a low ejection fraction, as well as subjects who had lesions with severe calcification, ostiums of the right coronary and left circumflex arteries, and who underwent the side-branch bifurcation 2-stent technique. The subjects were evaluated for consistent predictors of cardiac events, binary restenosis and target lesion vascularization of the SES. The composite primary endpoint percentage (900-day cardiac death, nonfatal recurrent myocardial infarction, and definite stent thrombosis) after PES placement was 0.6%, which was not significantly different from that after SES placement (0.12%; p=0.290). The incidence of the secondary endpoint (binary restenosis; stenosis >50% of the diameter at the secondary angiographic examination performed within 550 days after the procedure) after PES placement (15.0%) was also not significantly different than that after SES placement (13.3%; p=0.498). There was no relationship between PES placement and binary restenosis upon angiographic follow-up of 989 lesions (odds ratio of 1.14; 95% confidence interval, 0.73-1.77; p=0.57). CONCLUSION: For de novo native complex coronary stenosis, the midterm safety and efficacy of PES placement was statistically equivalent to that of SES placement in a clinical setting in Japan.