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).

IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population.

Purpose: To confirm the safety and effectiveness of the IN.PACT Admiral drug-coated balloon (DCB) as a treatment for de novo and native artery restenotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery in Chinese subjects. Materials and Methods: IN.PACT SFA China (ClinicalTrials.gov identifier NCT02118532) was a single-arm, independently adjudicated, prospective, premarket study that enrolled 143 subjects (mean age 66.8±7.7 years; 107 men) at 15 centers. The predominant risk factors were hypertension (104, 72.7%) and diabetes mellitus (66, 46.2%). The majority of subjects were classified as Rutherford category 2 or 3 [69 (48.3%) and 55 (38.5%), respectively]; 19 (13.3%) subjects had critical limb ischemia (Rutherford category 4). The mean lesion length was 10.4±6.51 cm; more than half of the lesions (75, 52.4%) were chronic total occlusions. Calcification was found in 66 (46.2%) lesions. Outcomes at 12 months were compared with DCB safety and effectiveness performance goals derived from the literature. The 30-day primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion revascularization (CD-TLR). Results: The primary safety outcome was 99.3% at 30 days. Follow-up compliance at 12 months was 92.6%. Estimated 1-year primary patency using Kaplan-Meier analysis was 90.9% and freedom from CD-TLR was 97.1%. The rate of CD-TLR at 12 months was 2.9%. The Rutherford category status improved significantly (p<0.001) between baseline and 12 months. Conclusion: Results from IN.PACT SFA China demonstrated high rates of patency and low rates of CD-TLR in Chinese subjects through 12 months despite patient and lesion complexity. These data are consistent with the results of other IN.PACT DCB trials.