Ken Kozuma1, Masaya Otsuka2, Yuji Ikari3, Yoshiki Uehara4, Hiroyoshi Yokoi5, Koichi Sano6, Kengo Tanabe7, Kiyoshi Hibi8, Masahisa Yamane9, Sugao Ishiwata10, Hiroshi Ohta11, Yasutaka Yamauchi12, Nobuhiro Suematsu13, Mio Nakayama14, Naoto Inoue15, Hiroyuki Kyono16, Nobuaki Suzuki16, Takaaki Isshiki16. 1. Teikyo University Hospital, Tokyo, Japan. Electronic address: PXE00364@nifty.com. 2. Akane Foundation Tsuchiya General Hospital, Hiroshima, Japan. 3. Tokai University School of Medicine, Isehara, Japan. 4. The Jikei University School of Medicine, Kashiwa Hospital, Kashiwa, Japan. 5. Kokura Memorial Hospital, Kitakyushu, Japan. 6. Iwatsuki Minami Hospital, Saitama, Japan. 7. Mitsui Memorial Hospital, Tokyo, Japan. 8. Yokohama City University Medical Center, Yokohama, Japan. 9. Sekishinkai Sayama Hospital, Sayama, Japan. 10. Toranomon Hospital, Tokyo, Japan. 11. Itabashi Chuo Medical Center, Tokyo, Japan. 12. Kikuna Memorial Hospital, Yokohama, Japan. 13. Japanese Red Cross Fukuoka Hospital, Fukuoka, Japan. 14. Jichi Medical University Hospital, Shimotsuke, Japan. 15. Sendai Kousei Hospital, Sendai, Japan. 16. Teikyo University Hospital, Tokyo, Japan.
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.
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 HDpatients 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.