Medtronic's In.Pact Admiral Paclitaxel-Coated Balloon Evaluated at 2 Years in DEB SFA-LONG Study

September 20, 2016—Antonio Micari, MD, presented results from the DEB SFA­-LONG study during the second Late-Breaking Trials session at VIVA 16, the 14th annual Vascular InterVentional Advances meeting, which is sponsored by VIVA Physicians, Inc. and held September 18–22, 2016 at the Wynn Las Vegas in Las Vegas, Nevada.

Dr. Micari explained that the DEB SFA­-LONG study is an independent, prospective, multicenter, single-­arm study designed to evaluate outcomes with the In.Pact Admiral paclitaxel­-coated balloon (Medtronic plc) in the treatment of long (TASC C and D) femoropopliteal artery disease. In the study, consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions > 15 cm long and with 4­- to 7­-mm reference vessel diameter were prospectively enrolled in a multicenter study. 

The primary study endpoint was primary patency at 12 months. Secondary endpoints included major adverse events (composite of death, amputation, or clinically driven target lesion revascularization [CD­-TLR]), changes in Rutherford class, ankle­-brachial index, and quality of life 12 months after the procedure.

As summarized at VIVA 16 by Dr. Micari, a total of 105 patients (mean age, 68 ± 9 years; 81.9% men) were enrolled and treated with the In.Pact Admiral device. The mean lesion length treated was 251.71 ± 78.9 mm, including 50.4% moderate-to-severely calcified lesions and 49.5% total occlusions. The bailout stent rate was 10.9%. Follow­-up after 24 months was completed in 93 (88.5%) patients. 

The primary patency rate at 24 months was 70.4%. By Kaplan­-Meier estimate, patency in patients with stenotic versus occlusive lesions was 74% versus 68% (P = .42), respectively. No significant differences were observed in patency between long lesions (< 25 cm) and very long lesions (> 25 cm) at 24 months (75% vs 66%; P = .25). Freedom from CD-­TLR was 84.7%. Significant clinical benefits in Rutherford class and functional measures by WIQ score were seen through 24 months.

Two­-year results demonstrate durable safety and efficacy outcomes with the In.Pact Admiral paclitaxel­-coated balloon in patients with long femoropopliteal artery disease, concluded Dr. Micari at VIVA 16.