OBJECTIVES: We compared 4-year efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM). BACKGROUND: Four-year comparison of SES with PES in diabetic patients has not been evaluated in a randomized manner. METHODS: This prospective, multicenter, randomized study compared SES (n = 200) and PES (n = 200) implantation in diabetic patients. We evaluated 4-year major adverse cardiac events (MACE) including death, myocardial infarction (MI), and target lesion revascularization (TLR). RESULTS: The 2 groups had similar baseline characteristics. At 2 years, TLR (3.5% vs. 11.0%, log-rank, p < 0.01) and MACE (3.5% vs. 12.5%, log-rank, p < 0.01) were significantly lower in SES versus PES group with no difference of death or MI. At 4 years there were no differences in death (3.0% vs. 5.0%, p = 0.45) or MI (1.5% vs. 1.0%, p = 0.99) between SES and PES group. The TLR (7.5% vs. 12.0%, log-rank, p = 0.10) and MACE (11.0% vs. 16.0%, log-rank, p = 0.10) were statistically not different between SES and PES group. At multivariate Cox regression, post-procedural minimal lumen diameter (hazard ratio [HR]: 0.44, 95% confidence interval [CI]: 0.24 to 0.81, p < 0.01), hypercholesterolemia (HR: 2.21, 95% CI: 1.29 to 3.79, p < 0.01), and use of intravascular ultrasound (HR: 0.51, 95% CI: 0.26 to 0.99, p = 0.049) were independent predictors of 4-year MACE. CONCLUSIONS: Superiority of SES over PES during 2 years was attenuated between 2 years and 4 years in diabetic patients. Use of intravascular ultrasound and larger post-procedural minimal lumen diameter were independent predictors of the improved long-term clinical outcomes.
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OBJECTIVES: We compared 4-year efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM). BACKGROUND: Four-year comparison of SES with PES in diabeticpatients has not been evaluated in a randomized manner. METHODS: This prospective, multicenter, randomized study compared SES (n = 200) and PES (n = 200) implantation in diabeticpatients. We evaluated 4-year major adverse cardiac events (MACE) including death, myocardial infarction (MI), and target lesion revascularization (TLR). RESULTS: The 2 groups had similar baseline characteristics. At 2 years, TLR (3.5% vs. 11.0%, log-rank, p < 0.01) and MACE (3.5% vs. 12.5%, log-rank, p < 0.01) were significantly lower in SES versus PES group with no difference of death or MI. At 4 years there were no differences in death (3.0% vs. 5.0%, p = 0.45) or MI (1.5% vs. 1.0%, p = 0.99) between SES and PES group. The TLR (7.5% vs. 12.0%, log-rank, p = 0.10) and MACE (11.0% vs. 16.0%, log-rank, p = 0.10) were statistically not different between SES and PES group. At multivariate Cox regression, post-procedural minimal lumen diameter (hazard ratio [HR]: 0.44, 95% confidence interval [CI]: 0.24 to 0.81, p < 0.01), hypercholesterolemia (HR: 2.21, 95% CI: 1.29 to 3.79, p < 0.01), and use of intravascular ultrasound (HR: 0.51, 95% CI: 0.26 to 0.99, p = 0.049) were independent predictors of 4-year MACE. CONCLUSIONS: Superiority of SES over PES during 2 years was attenuated between 2 years and 4 years in diabeticpatients. Use of intravascular ultrasound and larger post-procedural minimal lumen diameter were independent predictors of the improved long-term clinical outcomes.
Authors: Arun Samidurai; Sean K Roh; Meeta Prakash; David Durrant; Fadi N Salloum; Rakesh C Kukreja; Anindita Das Journal: Cardiovasc Res Date: 2020-11-01 Impact factor: 13.081
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
Authors: Eliano P Navarese; Kenneth Tandjung; Bimmer Claessen; Felicita Andreotti; Mariusz Kowalewski; David E Kandzari; Dean J Kereiakes; Ron Waksman; Laura Mauri; Ian T Meredith; Aloke V Finn; Hyo-Soo Kim; Jacek Kubica; Harry Suryapranata; Toni Mustahsani Aprami; Giuseppe Di Pasquale; Clemens von Birgelen; Elvin Kedhi Journal: BMJ Date: 2013-11-06