A Randomized Comparison of Sirolimus- Versus Paclitaxel-Eluting Stent Implantation in Patients With Diabetes Mellitus

Seung Whan Lee, Seong Wook Park, Young Hak Kim, Sung Cheol Yun, Duk Woo Park, Cheol Whan Lee, Myeong Ki Hong, Kyoung Suk Rhee, Jei Keon Chae, Jae Ki Ko, Jae Hyeong Park, Jae Hwan Lee, Si Wan Choi, Jin Ok Jeong, In Whan Seong, Yoon Haeng Cho, Nae Hee Lee, June Hong Kim, Kook Jin Chun, Hyun Sook KimSeung Jung Park

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Abstract

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.

Original languageEnglish
Pages (from-to)727-733
Number of pages7
JournalJournal of the American College of Cardiology
Volume52
Issue number9
DOIs
Publication statusPublished - 2008 Aug 26

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

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    Lee, S. W., Park, S. W., Kim, Y. H., Yun, S. C., Park, D. W., Lee, C. W., Hong, M. K., Rhee, K. S., Chae, J. K., Ko, J. K., Park, J. H., Lee, J. H., Choi, S. W., Jeong, J. O., Seong, I. W., Cho, Y. H., Lee, N. H., Kim, J. H., Chun, K. J., ... Park, S. J. (2008). A Randomized Comparison of Sirolimus- Versus Paclitaxel-Eluting Stent Implantation in Patients With Diabetes Mellitus. Journal of the American College of Cardiology, 52(9), 727-733. https://doi.org/10.1016/j.jacc.2008.04.056