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Randomized Controlled Trial
. 2022 Sep;37(9):1596-1603.
doi: 10.1007/s00380-022-02060-9. Epub 2022 Apr 9.

Intensive exercise therapy for restenosis after superficial femoral artery stenting: the REASON randomized clinical trial

Tamon Kato  1 , Takashi Miura  2   3 , Shuhei Yamamoto  4 , Yusuke Miyashita  2   5 , Naoto Hashizume  6 , Kyoko Shoin  7 , Shinya Sasaki  8 , Yusuke Kanzaki  2 , Hisanori Yui  2 , Shusaku Maruyama  2 , Ayumu Nagae  2 , Takahiro Sakai  2 , Tatsuya Saigusa  2 , Soichiro Ebisawa  2 , Ayako Okada  2 , Hirohiko Motoki  2 , Uichi Ikeda  2   3 , Koichiro Kuwahara  2 ; REASON Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Intensive exercise therapy for restenosis after superficial femoral artery stenting: the REASON randomized clinical trial

Tamon Kato et al. Heart Vessels. 2022 Sep.

Abstract

Endovascular treatment (EVT) is the main treatment for peripheral artery disease (PAD). Despite advances in device development, the restenosis rate remains high in patients with femoropopliteal lesions (FP). This study aimed to evaluate the effectiveness of exercise training in reducing the 1-year in-stent restenosis rate of bare metal nitinol stents for FPs. This prospective, randomized, open-label, multicenter study was conducted from January 2017 to March 2019. We randomized 44 patients who had claudication with de novo stenosis or occlusion of the FP into an intensive exercise group (n = 22) and non-intensive exercise group (n = 22). Non-intensive exercise was defined as walking for less than 30 min per session, fewer than three times a week. We assessed exercise tolerance using an activity meter at 1, 3, 6, and 12 months, and physiotherapists ensured maintenance of exercise quality every month. The primary endpoint was instant restenosis defined as a peak systolic velocity ratio > 2.5 on duplex ultrasound imaging. Kaplan-Meier analysis was used to evaluate the data. There were no significant differences in background characteristics between the groups. Six patients dropped out of the study within 1 year. In terms of the primary endpoint, intensive exercise significantly improved the patency rate of bare nitinol stents at 12 months. The 1-year freedom from in-stent restenosis rates were 81.3% in the intensive exercise group and 47.6% in the non-intensive exercise group (p = 0.043). No cases of stent fracture were observed in the intensive exercise group. Intensive exercise is safe and reduces in-stent restenosis in FP lesions after endovascular therapy for PAD. Clinical trial registration: University Hospital Medical Information Network Clinical Trials Registry (No. UMIN 000025259).

Keywords: Endovascular therapy; Exercise; Femoropopliteal lesions; In-stent restenosis; Peripheral artery disease.

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Conflict of interest statement

All the authors declare no conflicts of interest.

Figures

Fig. 1
Fig. 1
Patient flow chart. Eligible patients were assigned in a 1:1 ratio to either a combination of supervised and home-based exercise or an attention control condition. In the EVT with intensive exercise group, one patient withdrew from the study, and four patients were lost before follow-up. One patient in the EVT with no exercise group died. Finally, we analyzed data for 16 patients in the intensive exercise group and 21 patients in the non-intensive exercise group. EVT endovascular therapy
Fig. 2
Fig. 2
Kaplan–Meier graph of freedom from TLR at 1 year. Kaplan–Meier analysis indicated that the rate of freedom from ISR in the EVT with intensive exercise group was higher than that in the EVT without intensive exercise group. EVT endovascular therapy, TLR target lesion revascularization, ISR in-stent restenosis
Fig. 3
Fig. 3
Kaplan–Meier graph of freedom from MALEs at 1 year. There was no significant difference in MALEs between the intensive exercise and non-intensive exercise groups. MALE major adverse limb event (limb-related death, target lesion revascularization, major amputation, major bleeding, and definite or probable stent thrombosis), EVT endovascular therapy, ISR in-stent restenosis
See this image and copyright information in PMC

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