A Randomized Comparison of Sirolimus- Versus Paclitaxel-Eluting Stent Implantation in Patients With Diabetes Mellitus 4-Year Clinical Outcomes of DES-DIABETES (Drug-Eluting Stent in patients with DIABETES mellitus) Trial
- Authors
- Lee, Seung-Whan; Park, Seong-Wook; Kim, Young-Hak; Yun, Sung-Cheol; Park, Duk-Woo; Lee, Cheol Whan; Kang, Soo-Jin; Rhee, Kyoung-Suk; Chae, Jei-Keon; Ko, Jae-Ki; Park, Jae-Hyeong; Lee, Jae-Hwan; Choi, Si-Wan; Jeong, Jin-Ok; Seong, In-Whan; Cho, Yoon-Haeng; Lee, Nae-Hee; Kim, June-Hong; Chun, Kook-Jin; Kim, Hyun-Sook; Park, Seung-Jung
- Issue Date
- Mar-2011
- Publisher
- Elsevier BV
- Keywords
- coronary artery disease; diabetes mellitus; paclitaxel-eluting stent(s); sirolimus-eluting stent(s)
- Citation
- JACC: Cardiovascular Interventions, v.4, no.3, pp 310 - 316
- Pages
- 7
- Journal Title
- JACC: Cardiovascular Interventions
- Volume
- 4
- Number
- 3
- Start Page
- 310
- End Page
- 316
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/16697
- DOI
- 10.1016/j.jcin.2010.12.006
- ISSN
- 1936-8798
1876-7605
- Abstract
- 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 [Cl]: 0.24 to 0.81, p < 0.01), hypercholesterolemia (HR: 2.21, 95% Cl: 1.29 to 3.79, p < 0.01), and use of intravascular ultrasound (HR: 0.51, 95% Cl: 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. (J Am Coll Cardiol Intv 2011;4:310-6) (C) 2011 by the American College of Cardiology Foundation
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