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 ,
Jei Keon Chae, MD, PhD,
Jae-Ki Ko, MD, PhD,
Jae-Hyeong Park, MD, PhD ,
Jae-Hwan Lee, MD, PhD,
Si Wan Choi, MD,
Jin-Ok Jeong, MD, PhD,
In-Whan Seong, MD, PhD,
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
Chonbuk National University Hospital, Jeonju, Korea
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
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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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