Safety and Efficacy of the Passeo-18 Lux Drug-Coated Balloon Catheter in Atherosclerotic Femoropopliteal Lesions: The Multicenter BIOLUX P-IV China Study.

BACKGROUND: The purpose of this trial was to assess the safety and effectiveness of a paclitaxel-coated balloon catheter in Chinese patients with de novo or nonstented restenotic femoropopliteal atherosclerotic lesions. METHODS: BIOLUX P-IV China is a prospective, independently adjudicated, multicenter, single-arm trial conducted in China. Patients with Rutherford class 2-4 were eligible, excluded were patients in which predilation resulted in severe (≥ grade D) flow-limiting dissection or residual stenosis > 70%. Follow-up assessments were conducted at 1, 6, and 12 months. The primary safety end point was 30-day major adverse event rate and the primary effectiveness end point was primary patency at 12 months. RESULTS: We enrolled 158 patients with 158 lesions. Mean age was 67.6 ± 9.6 years, diabetes was present in 53.8% (n = 85), and previous peripheral intervention/surgeries in 17.1% (n = 27). Lesions were 4.1 ± 0.9 mm in diameter and 74 ± 50 mm long with a mean diameter stenosis of 91 ± 13%; 58.2% (n = 92) were occluded (core laboratory analysis). Device success was achieved in all patients. The rate of major adverse events was 0.6% (95% confidence interval: 0.0; 3.5) at 30 days, consisting of 1 target lesion revascularization. At 12 months, binary restenosis was present in 18.7% (n = 26) and target lesion revascularization was performed in 1.4% (n = 2, all clinically driven), resulting in a primary patency of 80.0% (95% confidence interval: 72.4, 85.8); no major target limb amputation occurred. Clinical improvement at 12 months, defined as improvement of at least 1 Rutherford class, was 95.3% (n = 130). The median walking distance per 6-minute walk test was 279 m at baseline and improved by 50 m at 30 days and by 60 m at 12 months; the visual analogue scale changed from 76.6 ± 15.6 at baseline to 80.0 ± 15.0 at 30 days and 78.6 ± 14.6 at 12 months. CONCLUSIONS: Our results confirmed the clinical effectiveness and safety of a paclitaxel-coated peripheral balloon dilatation catheter for the treatment of de novo and nonstented restenotic lesion of the superficial femoral and proximal popliteal artery in Chinese patients (NCT02912715).

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

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 MAE4 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.