Reewarm™ PTX drug-coated balloon in the treatment of femoropopliteal artery disease: A multi-center, randomized controlled trial in China. (1st March 2021)

• Record Type: Journal Article
• Authors: Ye, Wei; Zhang, Xiaoming; Dai, Xiangchen; Huang, Xiaojin; Liu, Zhaoyu; Jiang, Mi'er; Liu, Changwei
• Is Part Of: International journal of cardiology. Volume 326(2021)
• Page Start: 164
• Page End: 169
• Publication Date: 2021-03-01
• Subjects: Peripheral artery disease -- Stenosis -- Angioplasty -- Drug-coated balloon; DCB Drug-coated balloons -- LLL Late lumen loss -- TLR Target lesion revascularization -- PAD Peripheral artery disease -- ABI Ankle-brachial index -- DSA Digital subtraction angiography -- ITT Intent-to-treat -- SS Safety set; Cardiology -- Periodicals; Electronic journals; 616.12
• DOI: 10.1016/j.ijcard.2020.10.060
• Languages: English
• ISSNs: 0167-5273

Abstract

Abstract: Background: Drug-coated balloons (DCB) have demonstrated satisfactory clinical results in the treatment of femoropopliteal artery diseases. Objective: To evaluate the efficacy and safety of the Reewarm™ PTX DCB in the treatment of femoropopliteal artery lesions compared with plain balloon. Methods: This was a multi-center, parallel-group, randomized controlled trial in patients with femoropopliteal artery lesions in China, . The participants were randomized 1:1 to percutaneous transluminal angioplasty with Reewarm™ PTX DCB or with standard plain balloon (PTA group) after pre-dilatation with a residual stenosis less than 70%. The primary endpoint was late lumen loss (LLL) at 6 months in the intent-to-treat set. The secondary endpoints included the target lesion revascularization (TLR) and major advance events( MAE )rate at 12 months. Results: Between July 2014 and April 2017, a total of 200 patients were enrolled. The mean age of the subjects was 67.8 ± 9.2 years in the DCB group ( n = 100) and 69.4 ± 10.3 years in the PTA group (n = 100). The LLL at 6 months in the DCB group was significantly lower than in the PTA group (0.5 ± 0.8 mm vs. 1.5 ± 1.2 mm, P < 0.001). The TLR rate in the DCB group was lower than in the PTA group at 12 months (15.0% vs. 29.0%, P < 0.05). The occurrence of MAE 4 in the DCB group by 12 months was lower than in the PTA group (23.0% vs. 38.0%, P < 0.05). Conclusion: Reewarm-PTX drug-coated balloon is associated with better efficacy and safety than the plain balloon for femoropopliteal lesion. Highlights: The LLL at 6 months in the DCB group was lower than in the PTA group. The TLR rate in the DCB group was lower than in the PTA group at 12 months. The occurrence of major adverse events in the DCB group by 12 months was lower than in the PTA group.