Drug-coated balloons (DCB) proved superior to percutaneous transluminal angioplasty (PTA) in patients with symptomatic femoropopliteal lesions at two-year follow-up, according to the IN.PACT SFA trial, presented Oct. 14 at TCT 2015 and simultaneously published in the Journal of the American College of Cardiology.

John R. Laird, MD, FACC, et al., evaluated the safety and efficacy of the DCB in patients with superficial femoral artery disease and/or proximal popliteal artery disease, compared to conventional PTA in this multi-center, randomized, single-blinded trial. The primary endpoint at two-year follow-up was primary patency, defined as freedom from clinically driven target lesion revascularization or freedom from restenosis.

The results of the study showed the high primary patency rate (78.9 percent) of the DCB treatment, with a low clinically driven target lesion revascularization rate of 9.1 percent, compared to PTA after two years (50.1 and 28.3 percent, respectively). According to Laird, et al., “these data continue to support an excellent safety profile with no major amputations in the DCB group and no new thrombosis events reported between one and two years.”

In an accompanying editorial comment, Mehdi H. Shishehbor, DO, MPH, FACC, questions the generalizability of the study results and whether DCB should become the default treatment for all femoropopliteal lesions. He states that “the decision [of treatment] will undoubtedly rest with the treating physician, taking a personalized approach to each patient, his or her clinical presentation and lesion characteristics.”

Keywords: Transcatheter Cardiovascular Therapeutics, Femoral Artery, Popliteal Artery, Angioplasty, Thrombosis, Vascular Diseases

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