Drug-coated balloon for in-stent restenosis in femoropopliteal segment: 1-year clinical outcomes from a multicenter study in China
10.3760/cma.j.cn113855-20210826-00516
- VernacularTitle:药物涂层球囊治疗股腘动脉段支架内再狭窄的多中心研究
- Author:
Bo MA
1
;
Kun XU
;
Hao ZHAO
;
Xueqiang FAN
;
Xia ZHENG
;
Jie CHEN
;
Zhichao LAI
;
Jiang SHAO
;
Xin ZHANG
;
Bihui ZHANG
;
Guochen NIU
;
Ziguang YAN
;
Bao LIU
;
Min YANG
;
Zhidong YE
Author Information
1. 中日友好医院心脏血管外科，北京 100029
- Keywords:
Angioplasty,balloon;
Peripheral artery disease;
In-stent restenosis;
Multicenter study
- From:
Chinese Journal of General Surgery
2022;37(8):588-591
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the safety and efficacy at 1-year follow-up of the use of drug-coated balloon (DCB) for the treatment of femoropopliteal in-stent restenosis (ISR).Methods:This study enrolled 252 patients undergoing Orchid DCB angioplasty for peripheral arterial disease in the femoral-popliteal segment. The clinical data were retrospectively analyzed.Results:Forty-nine patients were eligible, including 29 (59.2%) chronic total occlusions belonging to TransAtlantic Inter-Society Consensus-Ⅱ(TASC Ⅱ) D, 7 (14.3%) thrombosis, and 14 (28.6%) moderate to severe calcifications. The mean lesion length was (215.9±97.1) mm. 69.4% were of occlusive lesions (Tosaka Ⅲ category). Only 1 provisional stent was implanted. 98% patients had severe claudication or even worse. Of these cases, 34 (73.9%) showed improvements in Rutherford category, while 11 (23.9%) did not change and 1 (2.2%) case deteriorated. The average value of ABI was 0.478±0.264 before surgery and 0.907±0.207 at the end of follow-up. The improvement in Rutherford category ( P<0.01) and ABI ( P<0.005) were both significant. The primary patency (PP) was 80.4%, and the freedom from clinically driven TLR was 84.8% at 1 year. During the follow-up period, there was no all-cause death and major limb amputation. Conclusion:This multicenter study demonstrated the effectiveness of DCB as a treatment for complicated and extensive ISR lesions within 12 months.
