Premium
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
Author(s) -
Iida Osamu,
Soga Yoshimitsu,
Urasawa Kazushi,
Saito Shigeru,
Jaff Michael R.,
Wang Hong,
Ookubo Hiroko,
Yokoi Hiroyoshi
Publication year - 2019
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.28048
Subject(s) - medicine , percutaneous , surgery , popliteal artery , angioplasty , critical limb ischemia , femoral artery , randomized controlled trial , revascularization , target lesion , clinical endpoint , balloon , lesion , randomization , restenosis , superficial femoral artery , prospective cohort study , vascular disease , stent , radiology , arterial disease , myocardial infarction , percutaneous coronary intervention
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.