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).

[Endovascular exclusion of peripheral aneurysms with polytetrafluoroethene stent graft].

OBJECTIVE: To evaluate the value and clinical effect of peripheral aneurysms with polytetrafluoroethene (PTFE) stent graft after peripheral endovascular procedures. METHODS: From May 2012 to November 2013, 13 patients of peripheral aneurysms were treated with PTFE stent graft. There were 9 male and 4 female patients, aged from 24 to 74 years with a mean of 52 years. There were 7 aneurysms and 6 pseudoaneurysms. This stent graft was a self-expanding nitinol stent, internally covered by an ultra-thin polytetrafluoroethene (PTFE) graft. All peripheral aneurysms were repaired with the PTFE stent graft, using an entirely percutaneous approach. All patients were given clopidogrel and (or) aspirin postoperatively. Complications and reintervention rates were also examined. RESULTS: PTFE stent graft placement was successfully performed in all the 13 cases, and the instant isolation effect was quite satisfactory. During the follow-up period of 3 to 18 months, no stent graft related complications occurred in all patients except one patient with iliac arterial pseudoaneurysm, who developed pseudoaneurysms presented as a complication at puncture site. There were no other symptomatic complications with graft patience. CONCLUSION: Endovascular repair can be considered as an effective treatment strategy for peripheral aneurysms by PTFE stent graft.