FROM VIVA 17
The 2-year results of the largest real-world study of the use of drug-coated balloons (DCB) in patients with symptomatic femoropopliteal peripheral arterial disease showed a durable treatment effect with a 16.9% rate of reintervention, according to a presentation by Thomas Zeller, MD.
Dr. Zeller, who is director of the department of angiology at University Heart Center, Freiburg-Bad Krozingen, Germany, presented the 2-year results from the full clinical cohort of the IN.PACT Admiral Global Clinical Study as a late-breaking clinical trial presentation at the 2017 Vascular Interventional Advances meeting in Las Vegas.
The IN.PACT Global study is a real-world, prospective, multicenter, single-arm, independently adjudicated femoropopliteal study of the safety and effectiveness of a 150-mm drug-coated balloon treatment. The primary efficacy endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) within 12 months. The primary safety endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and CD-TLR within 12 months.
The study examined patients with symptomatic femoropopliteal disease at 64 non-U.S. sites. Mean lesion length in these patients was 12.1 cm: 18.0% were in-stent restenosis lesions, 35.5% were occluded lesions. In terms of comorbidities, 40% of the patients had diabetes, 40% had coronary heart disease, and 32% were current smokers. More than half (52%) of the patients had a previous peripheral revascularization. The mean patient age was 69 years and 68% were men.
Kaplan-Meier survival analysis showed a freedom from CD-TLR rate of 83% in the patient cohort through 2-year outcomes. The researchers’ safety and effectiveness outcomes included thrombosis rate (4.5%), occurrences of major target limb amputation (0.7%), and CD-TLR (16.9%) within 2 years, according to Dr. Zeller.
“These data continue to confirm the safety and strong performance of the IN.PACT DCB in this cohort of real-world patients,” he concluded.
The IN.PACT Admiral DCB was approved by the Food and Drug Administration in 2014 to treat superficial femoral and popliteal arteries and it received an expanded indication for treating in-stent restenosis in 2016.
The IN.PACT Global Clinical Study is sponsored by Medtronic Endovascular. Dr. Zeller reported receiving honoraria and research funding from and acting as a consultant to a number of device companies, including Medtronic.