Drug-coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2-year results of the MDT-2113 SFA Japan randomized trial.

OBJECTIVES: To assess the longer-term safety and efficacy of the IN.PACT Admiral (MDT-2113) drug-coated balloon (DCB) for the treatment of de novo and non-stented restenotic lesions in the superficial femoral and/or proximal popliteal arteries versus uncoated percutaneous transluminal angioplasty (PTA) in a Japanese cohort.

BACKGROUND: Although DCBs are the newest endovascular strategy for patients with peripheral artery disease presenting with femoropopliteal lesions, there remains a paucity of results in non-Caucasian populations.

METHODS: IN.PACT SFA Japan is an independently-adjudicated, prospective, multicenter, randomized, single-blinded trial. Endpoints through 2 years included primary patency and a composite safety endpoint of freedom from device- and procedure-related death through 30 days, freedom from target limb major amputation and freedom from clinically-driven target vessel revascularization at 24 months.

RESULTS: One hundred patients were assigned by 2:1 randomization to treatment with the IN.PACT Admiral DCB (n = 68) or PTA (n = 32). The groups were well-matched at baseline. Mean lesion length for the DCB and PTA groups were 9.15 ± 5.85 and 8.89 ± 6.01 cm (P = 0.838), respectively. Patients treated with DCB exhibited superior 24-month primary patency compared to PTA (79.8% vs. 46.9%; log rank P < 0.001). The 24-month clinically driven target lesion revascularization rate was 9.1% for DCB versus 20.7% for PTA (P = 0.177). There were no device- or procedure-related deaths, major amputations, or thromboses in either group.

CONCLUSIONS: Two-year results from IN.PACT SFA Japan demonstrated persistently superior patency and low CD-TLR rates through 2 years when compared to uncoated PTA in Japanese patients. These data are consistent with other IN.PACT DCB trials.