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Long-term clinical outcomes and thrombosis rates of sirolimus-eluting versus bare-metal stents in patients with end-stage renal disease; Results of Korean Multicenter Angioplasty Team (KOMATE) Registry
국민건강보험공단 일산병원 심장혈관센터 순환기 내과¹, 연세대 의대 신촌 세브란스 심장혈관병원², 영동 세브란스 심장혈관병원³, 원주 기독병원⁴, 인제대 의대 상계 백병원5, 이화여대 목동 병원6, 을지대 의대 노원 병원7
김병극¹, 오성진¹, 김중선², 최동훈², 전동운¹, 장양수², 홍범기³, 권혁문³, 이승환⁴, 고충원5, 권기환6, 유승기7, 양주영¹
Background and Objectives: Although sirolimus-eluting stents (SES), as compared with bare-metal stents (BMS), have been shown to markedly reduce the restenosis in the complex lesions and patients with high risks such as end-stage renal disease (ESRD), there are still controversies about the safety issues and the actually survival benefits of SES implantation in patients with ESRD. The aim of this study is to compare long-term clinical outcomes and stent thrombosis (ST) rates in patients with ESRD following SES versus BMS implantation. Subjects and Methods: Between March 2003 and July 2005, a total 58 patient with ESRD undergoing SES implantation [SES-ESRD group; 58 patients (80 lesions)] were enrolled and compared with those with ESRD receiving BMS previously [BMS-ESRD group; 50 patients (54 lesions)] in a Korean Multicenter Angioplasty Team (KOMATE) Registry. We assessed the cumulative incidence of major adverse cardiac events [MACE; death, acute myocardial infarction (AMI), and target-vessel revascularization (TVR)] and ST rate, by Academic Research Consortium definition, in the both groups. Results: Despite the improvement of short-term clinical outcomes in the SES-ESRD group (1-year MACE rate; SES-ESRD vs. BMS-ESRD group = 12.5% vs. 30.0%, p=0.031), there were no statistical differences in the overall rates of MACE during the long-term follow-up (mean follow-up duration; 30.1±9.9 months) between the 2 groups (SES-ESRD vs. BMS-ESRD group = 31.0% vs. 40.0%, p=0.419). In addition, the analysis of the overall mortality in both groups did not show a significant survival benefit (SES-ESRD vs. BMS-ESRD group; 17.2% vs. 20.1%, p=0.792). The incidences of definite or probable ST rates were not different between the 2 groups (8.6% in SES-ESRD vs. 6.0% in the BMS-ESRD group, p=0.722). Using Kaplan-Meier methods, the cumulative MACE-free rates at 3 years were found to be 62.0% in SES-ESRD and 55.5% in the BMS-ESRD group, not showing statistical significance (Log Rank test, p=0.768). Conclusions: Compared with BMS, SES implantation has not caused an improvement in long-term clinical outcomes in patients with ESRD. However, SES did not increase the risk of ST as compared with BMS.


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