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.

ABSTRACT: 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?

SUBMITTER: Iida O 

PROVIDER: S-EPMC6594002 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature