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Drug-coated balloons (DCBs) have emerged as an effective treatment for patients with symptomatic peripheral arterial disease in the femero-popliteal arteries. They have been shown to be superior to balloon angioplasty (PTA) in large, multi-center randomized trials. These data come from carefully selected patients at high volume global centers. DCBs are also a potential therapy for more challenging patients, and as a possible alternative to permanent implanted devices (stents). Long term data in challenging patients in a “real world setting” treated with DCBs is needed. Objective of the study is to demonstrate safety and assess the clinical use and outcomes of the LUTONIX® Drug Coated PTA Dilatation Catheter in a heterogeneous patient population in real world clinical practice.
The Lutonix Global SFA Registry is a prospective, global multi-center, single arm real-world registry investigating the clinical use and safety of the Lutonix® 035 Drug Coated PTA Dilatation Catheter. The primary end points were efficacy defined as freedom from TLR at 12 months and safety defined as freedom at 30 days from TVR, major index limb amputation, and device or procedure-related death. All SAEs and TLRs were adjudicated. Subjects were followed for 24 months post-DCB. Patients with complex treatment lengths of >150 mm were enrolled. Between December 2012 and July 2014, 691 patients were enrolled at 38 centers in 10 European countries. Patients were followed at pre-specified visits for a follow-up of 24 months, with the primary endpoint at 12 months.
Six hundred ninety one (691) patients were enrolled and will complete the 24 month follow up in August 2016. Mean lesion length was 101 mm, mean treatment length was 137 mm and 13% with ISR confirming a high risk cohort. Forty percent (40%) were diabetic and 72% are current or were previous smokers. There were no procedure or device-related deaths.
Complete 24 month results and an ISR subset analysis of this large patient group will be reported at TCT.
ENDOVASCULAR: Peripheral Vascular Disease and Intervention.