Three-Year Results Published From IN.PACT SFA Trial

January 16, 2018—Online in Circulation: Cardiovascular Interventions, Peter A. Schneider, MD, et al published the long-term results of the IN.PACT SFA randomized trial, which is evaluating the In.Pact Admiral paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter (Medtronic) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA). The IN.PACT SFA trial enrolled in two phases: IN.PACT SFA phase I in the European Union and IN.PACT SFA phase II in the United States.

As summarized in Circulation: Cardiovascular Interventions, the single-blind randomized IN.PACT SFA trial enrolled 331 patients with symptomatic (Rutherford class 2–4) femoropopliteal lesions up to 18 cm in length. Patients were randomized 2:1 to undergo treatment with the In.Pact Admiral drug-coated balloon (DCB) or standard PTA. The 36-month assessments included primary patency, freedom from clinically driven target lesion revascularization (TLR), major adverse events, and functional outcomes.

The investigators reported that at 36 months, primary patency remained significantly higher among patients treated via DCB compared with PTA (69.5% vs 45.1%; log rank P < .001). The rate of clinically driven TLR was 15.2% for DCB versus 31.1% for PTA (P = .002).

Functional outcomes were similarly improved between treatment groups, even though patients in the DCB group required significantly fewer reinterventions versus those in the PTA group (P < .001 for TLR; P = .001 for target vessel revascularization). There were no device- or procedure-related deaths as adjudicated by an independent Clinical Events Committee, noted the investigators.

The 3-year results demonstrate a durable and superior treatment effect among patients treated with DCB versus standard PTA, with significantly higher primary patency and lower clinically driven TLR, resulting in similar functional improvements with a reduced need for repeat interventions, concluded the IN.PACT SFA trial investigators in Circulation: Cardiovascular Interventions.