Impact of hemodialysis on clinical and angiographic outcomes in in-stent restenotic lesions following optical coherence
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ORIGINAL ARTICLE
Impact of hemodialysis on clinical and angiographic outcomes in in‑stent restenotic lesions following optical coherence tomography‑guided drug‑coated balloon treatment Jiro Aoki1 · Gaku Nakazawa2 · Kenji Ando3 · Shigeru Nakamura4 · Tetsuya Tobaru5 · Masami Sakurada6 · Hisayuki Okada7 · Kiyoshi Hibi8 · Kan Zen9 · Akihiro Ikuta10 · Kenshi Fujii11 · Maoto Habara12 · Junya Ako13 · Taku Asano14 · Shunsuke Ozaki15 · Tetsuya Fusazaki16 · Ken Kozuma17 on behalf of The ELEGANT investigators Received: 24 July 2020 / Accepted: 1 October 2020 © Japanese Association of Cardiovascular Intervention and Therapeutics 2020
Abstract Hemodialysis (HD) is associated with a high in-stent restenosis (ISR) rate even in the second-generation era. Drug-coated balloons (DCB) generally provide excellent clinical outcomes in patients with ISR lesions. Nonetheless, safety and efficacy of DCB for ISR lesions in HD patients are largely unknown. A total of 17 centers across Japan participated in this study. Patients were eligible for the study if ISR lesions were treated with DCB. Enrolled patients were divided into 2 groups (HD and non-HD groups). Angiographic, OCT, and clinical outcomes were compared between the HD and the non-HD groups. A total of 210 patients were enrolled (36 patients in the HD group, and 174 patients in the non-HD group). At 8 months, the binary restenosis rate was significantly higher (26.3% versus 11.3%, p = 0.02) and in-segment late loss was significantly higher (0.49 ± 0.61 mm versus 0.23 ± 0.33 mm, p = 0.02) in the HD group than the non-HD group. In the OCT analyses, change of minimum stent area between post- and pre-procedure was significantly smaller in the HD group compared to the non-HD group (0.08 ± 0.95 mm2 versus 0.68 ± 1.07 mm2, p = 0.004). Target vessel failure (TVF) rate at 2 years was significantly different between the 2 groups (25.0% in the HD group and 12.1% in the non-HD group, p = 0.04). In the multivariate analysis, HD was a significant predictor for TVF (Hazard ratio 5.81, 95% CI 1.28–26.4, p = 0.02). Clinical and angiographic outcomes following OCT-guided DCB treatment in ISR lesions were significantly worse in HD patients compared to non-HD patients. Clinical Trial Registration Information: https://clinicaltrials.gov/ct2/show/NCT02300454 Keywords Hemodialysis · Restenosis · Stent · Drug-coated balloon
Introduction The association between chronic kidney disease and cardiovascular events following coronary intervention has been the focus of many studies over the past decade [1]. Several studies showed worsened clinical outcomes in a severitydependent manner with renal dysfunction [2, 3]. Hemodialysis (HD) on end-stage renal disease is the worst category of renal dysfunction; thus, clinical outcomes were worse when compared to other categories of renal dysfunction. Even in the second-generation DES era, HD is still a significant predictor of major cardiovascular events [4]. Although a high
in-stent restenosis (ISR) rate is observed in HD patients, the best strategy of treatmen
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