A randomized comparison of sirolimus- versus Paclitaxel-eluting stent implantation in patients with diabetes mellitus.

Author(s): Lee SW, Park SW, Kim YH, Yun SC, Park DW, Lee CW, Hong MK, Rhee KS, Chae JK, Ko JK, Park JH, Lee JH, Choi SW, Jeong JO, Seong IW, Cho YH, Lee NH, Kim JH, Chun KJ, Kim HS, Park SJ

Affiliation(s): Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

Publication date & source: 2008-08-26, J Am Coll Cardiol., 52(9):727-33.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVES: The aim of this study was to compare the effectiveness of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM). BACKGROUND: Drug-eluting stent implantation significantly improved the angiographic and clinical outcomes compared with bare-metal stent implantation in diabetic patients. However, comparison of SES with PES in diabetic patients has not been sufficiently evaluated. METHODS: This prospective, multicenter, randomized study compared SES (n = 200) and PES implantation (n = 200) for diabetic patients (n = 400). The primary end point was in-segment restenosis at 6 months according to intention-to-treat principle. RESULTS: The 2 groups had similar baseline clinical and angiographic characteristics. Six-month in-stent (3.4% vs. 18.2%, p < 0.001) and in-segment restenosis (4.0% vs. 20.8%, p < 0.001) and 9-month target lesion revascularization (2.0% vs. 7.5%, p = 0.017) were significantly lower in the SES versus the PES group. The incidence of death (0% in SES vs. 0.5% in PES, p = 0.999) or myocardial infarction (0.5% in SES vs. 0.5% in PES, p = 0.999) at 9-month follow-up was not statistically different between the 2 groups. Major adverse cardiac events including death, myocardial infarction, and target lesion revascularization at 9 months (2.0% vs. 8.0%, p = 0.010) were lower in the SES versus the PES group. CONCLUSIONS: Sirolimus-eluting stent implantation is superior in reducing angiographic restenosis and improving 9-month clinical outcomes in patients with DM and coronary artery disease compared with PES implantation.