Impact of hemodialysis on clinical and angiographic outcomes in in-stent restenotic lesions following optical coherence tomography-guided drug-coated balloon treatment

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 mm(2)versus 0.68 +/- 1.07 mm(2),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: