Contemporary Therapy of Femoropopliteal In-Stent Restenosis / Occlusion, 36-month Follow up Study

Abstract

Background Drug-eluting devices improved outcomes of endovascular therapy (EVT) for femoropopliteal lesions, but mainly for de novo lesions. Endovascular therapy for in-stent restenosis/occlusion (ISR/O) is challenging, and large trials and long-term data are not well reported. Materials and Methods This study is a physician initiated, multicenter, and retrospective design. From 7 Japanese institutes, 3635 femoropopliteal cases were enrolled in the study. Among these, 346 cases of first ISR/O were studied. We defined drug-coated-balloon, drug-eluting stent, and covered stent as New devices. Balloon angioplasty and bare nitinol stent were included in the control group. Results The propensity score matching extracted 112 pairs. At 12 months, the primary patency rate was 80.3% in the new device group and 52.7% in the control group, and there was a significant intergroup difference ( P = .004). However, at 36 months, the rate was 43.3% vs 39.2%, with no significant difference ( P = .090). No baseline characteristics had any significant interaction effect (all P > .05). Conclusions The New devices were more effective than the control group for ISR/O at 1 year, but caught up at 3 years.