Sirolimus eluting coronary stent implantation in patients on maintenance hemodialysis: the OUCH study (outcome of cypher stent inhemodialysis patients).

BACKGROUND: Pivotal studies on drug-eluting stents have excluded hemodialysis (HD) patients. No quantitative coronary angiography (QCA) analysis has been reported. METHODS AND RESULTS: The OUtcome of Cypher stent in Hemodialysis patients (OUCH) Study is a prospective non-randomized single-arm registry designed to assess the results of sirolimus-eluting stents in HD patients, with follow-up QCA in an independent core laboratory. The primary endpoint was the occurrence of target-vessel failure (TVF) defined as cardiac death, myocardial infarction (MI), and target-vessel revascularization (TVR) at 1 year. A total of 117 patients were enrolled. The TVF rate was 24.9% (2.6% cardiac death, 1.4% MI, 23.9% TVR), and stent thrombosis was documented in 1 patient (0.9%). Coronary calcification was a predictor of TVF. Late lumen loss (LLL) averaged 0.69±0.93mm. The histogram of LLL showed that a total of 76% of lesions were distributed the same normally as that in normal renal function (average LLL 0.20±0.29mm), but 24% of lesions were outliers (average LLL 2.07±0.62mm). CONCLUSIONS: This report describes different clinical and QCA results in HD patients as higher TVF rate, different predictive factors, and different histogram of LLL compared with normal renal function. The different histogram of LLL was the existence of many outliers with the same average and the same deviation, suggesting the loss of sirolimus had an effect on a significant number of HD patients.