Abstract
PurposeAfter 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.MethodsBIOLUX 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.Results877 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.ConclusionThe 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).
Highlights
Lower extremity artery disease is present in approximately 202 million people worldwide [1]
We report the 12and 24-month outcomes of the full cohort and 3 selected predefined subgroups: femoropopliteal lesions, long lesions, in-stent restenosis (ISR)
Mean age was 70.1 ± 10.2 years, and 64.0% of patients were male. 57.5% of the full cohort had a history of peripheral artery disease (PAD) with previous peripheral procedure or surgery performed in 49.9%
Summary
Lower extremity artery disease is present in approximately 202 million people worldwide (approximately 40 million in Europe) [1]. While standard balloon angioplasty alone is limited by low longterm patency, stents can improve patency. The long-term durability of stent is challenged, in particular, in very mobile arterial segment such as in the femoropopliteal artery. Treatment of in-stent restenosis (ISR) is more challenging than revascularization after balloon angioplasty [1]. None of these techniques is sufficient enough from a biological point of view to prevent recurrent stenosis due to smooth muscle cells proliferation and migration, extracellular matrix production and neointimal hyperplasia
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