Clinical Outcomes Following Sirolimus-Eluting Stent Implantation in Patients with End-Stage Renal Disease: Korean Multicenter Angioplasty Team (KOMATE) Registry

ABSTRACT

BACKGROUND AND OBJECTIVES: Sirolimus-eluting stents (SES), as opposed to bare metal stents (BMS), have been shown to markedly reduce restenosis. However, many clinical trials have excluded the subset of patients (pts) with end-stage renal disease (ESRD). The aim of this study was to evaluate the clinical outcomes following SES implantation in ESRD pts. SUBJECTS AND METHODS: We analyzed the clinical outcomes in 50 pts from our registry following SES implantation, and compared the outcomes between those with ESRD receiving SES (SES-ESRD) and BMS (BMS-ESRD), and with non-ESRD pts following SES implantation (SES-non ESRD). RESULTS: A comparison of the SES-ESRD (50 pts, 72 lesions) with BMS-ESRD groups (42 pts, 45 lesions); those in the SES-ESRD group included; diabetes 78%, hypertension 94% and age 62+/-10 years. Those in the SES-ESRD group were more likely to have diabetes (diabetes of BMS-ESRD, 57%; p=0.04). The reference vessel diameters (RVD) of the SES-ESRD group were smaller (2.76+/-0.50 mm vs. 3.05+/-0.46 mm, p<0.001), but the lesion length was longer (25.6+/-7.0 mm vs. 19.1+/-8.8 mm, p<0.001) than those of the BMS-ESRD group. The SES-ESRD group had a lower 1-year major adverse cardiac events (MACE) rate than the BMS-ESRD group (6.0% vs. 33.3%; p<0.001). There were no differences in mortality and incidence of myocardial infarction between the two groups. The incidence of target vessel revascularization decreased significantly in the SES-ESRD group (2.0% vs. 19.0%, p=0.01). From a multivariate regression analysis, the use of SES was the only significant independent predictor of MACE (OR=0.054, 95% confidence interval 0.01 to 0.26, p<0.001). A comparison with SES-non ESRD group in our total registry (644 pts, 758 lesions); MACE in the SES-ESRD group (6.0%) was higher than in the SES-non ESRD group (3.1%), but there was no statistical significance (p=0.23). CONCLUSION: Compared with BMS, SES caused an improvement in the clinical outcomes in pts with ESRD.