Efficacy and safety of Rotarex mechanical thrombectomy combined with DCB versus PTA combined with DCB in the treatment of femoropopliteal artery in-stent restenosis
10.3760/cma.j.cn115396-20250702-00174
- VernacularTitle:Rotarex机械血栓切除＋DCB与PTA＋DCB治疗股腘动脉支架内再狭窄的疗效与安全性
- Author:
Wei WANG
1
;
Chunmin LI
;
Xuan TIAN
;
Xixiang GAO
;
Tong ZHANG
;
Bin LIU
;
Zhe ZHANG
;
Lishan LIAN
;
Mingyuan LIU
;
Zhao LIU
;
Heping GAO
;
Hai FENG
Author Information
1. 首都医科大学附属北京友谊医院血管外科，北京 100050
- Keywords:
Femoral artery;
Popliteal artery;
In-stent restenosis;
Mechanical thrombectomy;
Drug-coated balloon;
Randomized controlled trial
- From:
International Journal of Surgery
2025;52(10):706-712
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the efficacy and safety of Rotarex mechanical thrombectomy (Rotarex) combined with drug-coated balloon (DCB) versus percutaneous transluminal angioplasty (PTA) combined with DCB in the treatment of femoropopliteal artery in-stent restenosis (ISR).Methods:A multicenter, prospective, randomized controlled trial was conducted. 46 patients with femoropopliteal artery ISR admitted to five hospitals (Beijing Friendship Hospital, Capital Medical University; Beijing Chaoyang Hospital, Capital Medical University; Beijing Jishuitan Hospital, Capital Medical University; Xuanwu Hospital, Capital Medical University; Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University) from July 2020 to June 2024 were enrolled. Patients were randomly divided into the Rotarex+ DCB group ( n=24) and the PTA+ DCB group ( n=22) using a random number table. The clinical data of the two groups were collected, including clinical characteristics, Fontaine classification, stent placement location, stent duration, and lesion length. The primary endpoint was the target blood vessel patency rate at 6 and 12 months postoperatively; the secondary endpoints included improvement in clinical symptoms (Fontaine classification), rate of reintervention, and safety indicators. Measurement data were expressed as mean±standard deviation ( ± s), and the t-test was used for comparison between groups; count data were expressed as the number of cases and percentages, and intergroup comparisons were performed using the Chi-test or Fisher exact probability method. Results:At 12 months postoperatively, the target blood vessel patency rate in the Rotarex+ DCB group was significantly higher than that in the PTA+ DCB group (81.8% vs 45.5%, P=0.012), and the proportion of patients in Fontaine classification stage I was also higher (86.4% vs 45.5%, P=0.004). The results at the 6-month follow-up were consistent (target blood vessel patency rate: 87.0% vs 59.1%, P=0.035). In terms of safety, no severe complications such as arterial rupture, amputation, or procedure-related death occurred during the perioperative period in either group. During the postoperative follow-up, no amputation or procedure-related deaths occurred in either group. Conclusion:For the treatment of femoropopliteal artery ISR, Rotarex mechanical thrombectomy combined with DCB is significantly superior to PTA+ DCB in terms of 12-month target blood vessel patency rate and improvement of clinical symptoms, with comparable safety.
