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

Abstract

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. 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 12months. The primary safety end point was 30-day major adverse event rate and the primary effectiveness end point was primary patency at 12months. We enrolled 158 patients with 158 lesions. Mean age was 67.6±9.6years, diabetes was present in 53.8% (n=85), and previous peripheral intervention/surgeries in 17.1% (n=27). Lesions were 4.1±0.9mm in diameter and 74±50mm 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 30days, consisting of 1 target lesion revascularization. At 12months, 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 12months, defined as improvement of at least 1 Rutherford class, was 95.3% (n=130). The median walking distance per 6-minute walk test was 279m at baseline and improved by 50m at 30days and by 60m at 12months; the visual analogue scale changed from 76.6±15.6 at baseline to 80.0±15.0 at 30days and 78.6±14.6 at 12months. 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).