Clinical and angiographic outcomes of paclitaxel-eluting coronary stent implantation in hemodialysis patients: A prospective multicenter registry: The OUCH-TL study (outcome in hemodialysis of TAXUS Liberte).

ABSTRACT

BACKGROUND: The outcome of percutaneous coronary intervention (PCI) has been reported to be poor in hemodialysis (HD) patients even in the drug-eluting stent era. We have reported relatively poor outcomes after sirolimus-eluting stent implantation in the OUCH study. METHODS: The OUCH-TL study is a prospective, non-randomized, single-arm registry designed to assess the results of paclitaxel-eluting stent (PES) in HD patients with follow-up quantitative coronary angiography analysis. The primary endpoint was the occurrence of target-vessel failure (TVF) defined as cardiac death, myocardial infarction (MI), and target-vessel revascularization (TVR) at 12 months. RESULTS: A total of 119 patients with 154 lesions were enrolled (one withdrawal). Mean age was 65±10 years, male gender was 79%, 89% of cases had stable coronary disease. Diabetic nephropathy was diagnosed in 61% of the patients. American College of Cardiology/American Heart Association type B2/C accounted for 96% of lesions and 22.7% of lesions were treated with Rotablator (Boston Scientific Corporation, Natick, MA, USA). Rates of TVF, death, MI, stent thrombosis and TVR at 12 months were 20.2%, 5.9%, 5.0%, 1.4%, and 12.6%, respectively. TVR was performed in 8.4% of the patients up to 12 months. Late loss in-stent was 0.48±0.61mm, and late loss in-segment was 0.37±0.61mm at 9 months. Binary restenosis in-stent was 10.3% and in-segment was 14.5%. CONCLUSIONS: Outcomes of PES implantation in hemodialysis patients appears comparable to those of non-hemodialysis patients.