Medtronic's In.Pact Admiral DCB Compared to PTA in IN.PACT SFA Trial

September 19, 2016—Prakash Krishnan, MD, presented results from the IN.PACT SFA trial during the first 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.

IN.PACT SFA is evaluating the In.Pact Admiral drug-coated balloon (DCB) (Medtronic plc) versus percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic (Rutherford class 2–4) femoropopliteal lesions. 

The independently adjudicated, prospective, multicenter, randomized, single-blinded trial enrolled 331 patients who were randomly assigned in a 2:1 ratio to treatment with the In.Pact Admiral DCB or PTA. Study assessments included primary patency, defined as freedom from clinically driven target lesion revascularization (CD-TLR) and duplex-derived restenosis; major adverse events, including target vessel revascularization (TVR); and functional outcomes (EQ-5D questionnaire, walking impairment questionnaire, and 6-minute walk test) were evaluated through 3 years.

At VIVA 16, Dr. Krishnan reported that at 3 years, patients treated with the In.Pact Admiral DCB demonstrated significantly superior primary patency when compared to PTA (69.5% vs 45.1%; P < .001). The rates of CD-TLR were 15.2% for DCB and 31.1% for PTA (P = .002), with time to first event significantly longer for the DCB group (542.9 ± 278.2 days vs 302.9 ± 213 days; P < .001). 

Additionally, there were no device- or procedure-related deaths and no major amputations in either group through 3-year follow-up. The rate of thrombosis was low (2% for DCB vs 4.9% for PTA; P = .283). Both groups showed similar functional assessment results at 3 years, although DCB patients achieved this level of function with 48% fewer reinterventions.

The IN.PACT SFA investigators concluded that this multicenter randomized trial showed superior long-term patency and low reintervention rates with the In.Pact Admiral DCB compared to angioplasty. To date, this is the only DCB to show durable treatment effect through 3 years, supporting its continued use as a first-line treatment for symptomatic femoropopliteal disease, stated Dr. Krishnan at VIVA 16.