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

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.
Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Kenji Suzuki had a payment for lectures from Boston Scientific Japan, Japan GORE, Kaneka, Cook Medical, Cordis, and Bayer. Mitsuyoshi Takahara had a payment for lectures from Japan GORE, Boston Scientific Japan, and TERUMO. Kazuki Tobita had a payment for lectures from Medtronic, TERUMO, BD, and Kaneka, and had a consulting fees from Japan GORE. Naoki Hayakawa had a payment for lectures from Boston Scientific Japan, TERUMO, Kaneka, Medtronic, and Medicos Hirata. Yo Iwata had a payment for lectures from Boston Scientific Japan, Cook, and Philips Japan. Tatsuya Nakama had a payment for lectures from Boston Scientific Japan, Medtronic, Cook, TERUMO, Abbott Vascular, and Becton Dickinson and Company, had a consulting fee from Boston Scientific Japan, Medtronic, Cook, Century Medical, Cordis, OrbusNeichi, and Becton Dickinson and Company, had a payment for expert testimony from NIPRO, Kaneka, and Asahi Intecc.