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

Vascular and endovascular surgery Pub Date : 2024-10-01 Epub Date: 2024-05-13 DOI:10.1177/15385744241253170

Kenji Suzuki, Mitsuyoshi Takahara, Kazuki Tobita, Naoki Hayakawa, Shinsuke Mori, Yo Iwata, Kazunori Horie, Tatsuya Nakama

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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.

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股动脉支架内再狭窄/闭塞的当代疗法，36 个月随访研究。

背景：药物洗脱装置改善了股骨头病变血管内治疗（EVT）的疗效，但主要是针对新发病变。支架内再狭窄/闭塞（ISR/O）的血管内治疗具有挑战性，大型试验和长期数据尚未得到充分报道：本研究由医生发起，采用多中心和回顾性设计。来自日本 7 家医疗机构的 3635 例股骨头病例被纳入研究。其中研究了 346 例首次 ISR/O 病例。我们将药物涂层球囊、药物洗脱支架和覆盖支架定义为新设备。对照组包括球囊血管成形术和裸镍钛诺支架：倾向评分匹配提取了 112 对患者。12 个月时，新装置组的主要通畅率为 80.3%，对照组为 52.7%，组间差异显著（P = .004）。但在 36 个月时，新装置组和对照组的初次通畅率分别为 43.3% 和 39.2%，无明显差异（P = 090）。所有基线特征都没有明显的交互影响（P > .05）：结论：与对照组相比，新设备在 1 年内对 ISR/O 的治疗效果更好，但在 3 年内则迎头赶上。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Vascular and endovascular surgery

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