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J Am Coll Cardiol, 2008; 52:727-733, doi:10.1016/j.jacc.2008.04.056
© 2008 by the American College of Cardiology Foundation
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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

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

Seung-Whan Lee, MD, PhD*, Seong-Wook Park, MD, PhD, FACC*,*, Young-Hak Kim, MD, PhD*, Sung-Cheol Yun, PhD*, Duk-Woo Park, MD, PhD*, Cheol Whan Lee, MD, PhD*, Myeong-Ki Hong, MD, PhD*, Kyoung-Suk Rhee, MD, PhD{dagger}, Jei Keon Chae, MD, PhD{dagger}, Jae-Ki Ko, MD, PhD{dagger}, Jae-Hyeong Park, MD, PhD{ddagger}, Jae-Hwan Lee, MD, PhD{ddagger}, Si Wan Choi, MD{ddagger}, Jin-Ok Jeong, MD, PhD{ddagger}, In-Whan Seong, MD, PhD{ddagger}, Yoon Haeng Cho, MD, PhD§, Nae-Hee Lee, MD, PhD§, June Hong Kim, MD, PhD||, Kook-Jin Chun, MD||, Hyun-Sook Kim, MD, PhD and Seung-Jung Park, MD, PhD, FACC*

* Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
{dagger} Chonbuk National University Hospital, Jeonju, Korea
{ddagger} Cardiology Division of Internal Medicine, Chungnam National University Hospital, Chungnam National University, Deajeon, Korea
§ Soonchunhyang University Bucheon Hospital, Bucheon, Korea
|| Busan National University Hospital, Busan, Korea
Hallym University Sacred Heart Hospital, Anyang, Korea.

Manuscript received December 3, 2007; revised manuscript received April 14, 2008, accepted April 15, 2008.

* Reprint requests and correspondence: Dr. Seong-Wook Park, Department of Medicine, University of Ulsan College of Medicine, Asan Medical Center, 388-1 Poongnap-dong, Songpa-gu, Seoul, 138-736, Korea. (Email: swpark{at}amc.seoul.kr).

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.

Key Words: coronary artery disease • diabetes mellitus • paclitaxel-eluting stent • sirolimus-eluting stent

Abbreviations and Acronyms
  AMI = acute myocardial infarction
  BMS = bare-metal stent(s)
  CI = confidence interval
  DES = drug-eluting stent(s)
  DM = diabetes mellitus
  IQR = interquartile range
  MACE = major adverse cardiac events
  MI = myocardial infarction
  MLD = minimal lumen diameter
  PES = paclitaxel-eluting stent(s)
  QCA = quantitative coronary angiography
  RR = relative risk
  SES = sirolimus-eluting stent(s)
  TLR = target lesion revascularization
  TVR = target vessel revascularization


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J. Am. Coll. Cardiol. 2008 52: A27-A28. [Full Text] [PDF]



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