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.
RCT Entities:
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 diabeticpatients. However, comparison of SES with PES in diabeticpatients has not been sufficiently evaluated. METHODS: This prospective, multicenter, randomized study compared SES (n = 200) and PES implantation (n = 200) for diabeticpatients (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.
Authors: William M Wolf; Helen A Vlachos; Oscar C Marroquin; Joon S Lee; Conrad Smith; William D Anderson; John T Schindler; Elizabeth M Holper; J Dawn Abbott; David O Williams; Warren K Laskey; Kevin E Kip; Sheryl F Kelsey; Suresh R Mulukutla Journal: Circ Cardiovasc Interv Date: 2010-01-26 Impact factor: 6.546
Authors: Sripal Bangalore; Sunil Kumar; Mario Fusaro; Nicholas Amoroso; Ajay J Kirtane; Robert A Byrne; David O Williams; James Slater; Donald E Cutlip; Frederick Feit Journal: BMJ Date: 2012-08-10