Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry

Purpose After promising small randomized trials, the aim of BIOLUX P-III was to further investigate the safety and performance of the Passeo-18 lx drug-coated balloon in infrainguinal arteries under real-world conditions. Methods BIOLUX P-III is a global prospective single-arm study with follow-up at 6, 12 and 24 months. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months. The primary performance endpoint was freedom from clinically driven target lesion revascularization (TLR) within 12 months. Results 877 patients/1084 lesions were enrolled. Diabetes mellitus was present in 47.7%, and 42.1% had critical limb ischemia (CLI). The mean lesion length was 89.0 mm with 76.1% of calcified lesions, and 24.9% occluded. At 24 months, freedom from MAE was 83.1% in the full cohort; 84.9% in the femoropopliteal population (592 patients, 691 lesions); 77.7% for long lesions (187 subjects/192 lesions); and 72.5% in the in-stent restenosis (ISR) subgroup (103 subjects/116 lesions). Twenty-four-month freedom from clinically driven TLR was 88.1% in the full cohort; 88.9% in the femoropopliteal population; 80.3% for the long lesions; and 78.4% for ISR. Twenty-four-month all-cause mortality was 12.0% in the full cohort, 10.2% in the femoropopliteal population, 14.8% for the long lesions and 12.0% for ISR. There was no device- or procedure-related death up to 24-month follow-up. Conclusion The BIOLUX P-III 24-month outcomes confirm the safety and performance of Passeo-18 lx in infrainguinal arteries in a large population treated under real-world conditions with low complication rates and good clinical outcomes (NCT02276313).

Rotational Atherectomy Plus Drug-Coated Balloon Angioplasty for the Treatment of Total In-Stent Occlusions in Iliac and Infrainguinal Arteries

Purpose: To analyze the long-term outcomes of a hybrid treatment method combining rotational atherectomy with drug-coated balloon (DCB) angioplasty in patients with total in-stent occlusion in the iliac and/or infrainguinal arteries. Materials and Methods: Between April 2014 and June 2017, 74 consecutive patients (mean age 66.7±9.7 years; 49 men) with total occlusion of a previously implanted stent underwent endovascular recanalization using the Rotarex system and DCB angioplasty. Half (37, 50%) of the patients had critical limb ischemia (CLI), and 30 (41%) of the procedures were performed in emergency. Mean lesion length was 22±15 cm. Results: Overall procedure success was achieved in 73 (98.6%) patients. Six (8.1%) CLI patients developed distal embolism that responded to thrombolysis. Three (4.1%) dissections did not require treatment, while 1 (1.4%) perforation necessitated stent-graft implantation. In all, 33 (44.6%) patients had an additional stent implanted, mainly due to a suboptimal outcome (n=28) or complications (n=5 including the stent-graft). The restenosis rate assessed by duplex ultrasound at 12 months was 20.5% (15/73); 4 (5.5%) patients underwent target lesion revascularization. Recurrent restenosis was more frequent in patients with Rutherford category 5 ischemia (p=0.005), in emergency procedures (p=0.021), after extensive procedures involving 3 independent vessel segments (p=0.016), and if a complication arose during the procedure (p<0.001). In multivariate analysis, only occurrence of a procedural complication was an independent predictor of recurrent restenosis at 1 year (OR 63.3, 95% CI 5.7 to 701.5). Conclusion: These findings imply that rotational atherectomy and DCB angioplasty may provide satisfactory outcomes in the treatment of total in-stent occlusion, with a satisfactory recurrent restenosis rate at 12 months.

Real-world experience with a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries: 12-month interim results of the BIOLUX P-III registry first year of enrolment

Background Endovascular management of atherosclerotic infrainguinal arteries recently shifted towards drug eluting devices, designed to locally prevent the restenosis process. Numerous clinical studies report an advantage of drug coated balloons over uncoated balloon angioplasty in treating lower extremity peripheral artery disease. However, as coating and balloon platforms are different, each device requires dedicated clinical evaluations. Objective The aim of the study is to further investigate the safety and effectiveness of a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries in a real-world setting. Methods 203 patients out of a final sample of 882 were enrolled in this prospective multicenter, observational, all-comers registry during the first 12 months. The primary endpoints were major adverse events (defined as procedure or device related death within 30 days post index procedure, clinically-driven target lesion revascularization or major target limb amputation) at 6 months and freedom from clinically-driven target lesion revascularization at 12 months. Both endpoints were adjudicated by a Clinical Events Committee. Results Mean patient age was 70.2±10.4 years (60.1% male). 47.3% of the patients were diabetic and 67.5% had a history of smoking. Severe claudication was reported in 37.4% and 40% had critical limb ischemia. 257 lesions, including 13.2% in the infrapopliteal territory, were treated with Passeo-18 Lux (mean lesion length 75.1 mm±69.4, 20% occlusions, 76.3% calcified). At 6 months, the rate of major adverse events was 5.5% (95%CI 3.1-9.7). Freedom from clinically-driven target lesion revascularization at 12 months was 93.2% (95%CI 89.1-95.8). All causes mortality was 6.5% (95%CI 3.8-11.0) and overall amputation rate was 4.2% (95%CI 2.1-8.3) at 12 months. Conclusion In a real-world environment, the BIOLUX P-III registry preliminary results confirm the safety and efficacy of the Paclitaxel-Coated Passeo-18 Lux balloon as a stand-alone treatment option for atherosclerotic infrainguinal arteries.