Reewarm™ PTX drug-coated balloon in the treatment of femoropopliteal artery disease: A multi-center, randomized controlled trial in China

Drug-coated balloons (DCB) have demonstrated satisfactory clinical results in the treatment of femoropopliteal artery diseases.To evaluate the efficacy and safety of the Reewarm™ PTX DCB in the treatment of femoropopliteal artery lesions compared with plain balloon.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.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 MAE4 in the DCB group by 12 months was lower than in the PTA group (23.0% vs. 38.0%, P < 0.05).Reewarm-PTX drug-coated balloon is associated with better efficacy and safety than the plain balloon for femoropopliteal lesion.