J Vasc Interv Radiol
October 2023
Purpose: To investigate the clinical performance and safety of the Passeo-18 Lux drug-coated balloon (DCB) in complex femoropopliteal Trans-Atlantic Inter-Society Consensus (TASC) C and D lesions in an all-comers patient population.
Material And Methods: Data from BIOLUX P-III SPAIN, a prospective, national, multicenter, postmarket all-comers registry conducted from 2017 to 2019, and a matching long lesion subgroup from the BIOLUX P-III All-Comers global registry conducted from 2014 to 2018 were pooled for analysis. The primary safety end point was freedom from major adverse events (MAEs) at 6 months, and the primary performance end point was freedom from clinically driven target lesion revascularization (fCD-TLR) at 12 months, both adjudicated by an independent clinical events committee.
Background: Anticoagulation is the treatment of choice in the management of venous thromboembolic disease. This approach is applied to reduce mortality and the risk of recurrences and associated complications. Standard therapy for non-oncologic patients has traditionally been based on parenteral anticoagulation followed by vitamin K antagonists.
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