At 1 year, a drug-coated balloon was superior to percutaneous transluminal angioplasty for treating atherosclerotic lesions in the superficial femoral and proximal popliteal arteries, researchers reported.
For the MDT-2113 SFA Japan trial, researchers randomly assigned on a 2:1 basis 100 patients (mean age, 74 years; 76% men) from 11 centers in Japan to the DCB (IN.PACT Admiral, Medtronic) or percutaneous transluminal angioplasty (PTA). All patients had de novo or native artery restenotic lesions in the superficial femoral or proximal popliteal arteries. Mean lesion length was 9.15 cm in the DCB group and 8.89 cm in the PTA group.
Although the DCB had been shown to be superior to PTA in other trials, those patient populations were predominantly white, and little was known about performance in Japanese patients, the researchers wrote.
The primary effectiveness outcome was primary patency, defined as freedom from clinically driven target lesion revascularization and from restenosis, at 1 year. The primary safety outcome was a composite of 30-day device- and procedure-related death, 1-year target limb major amputation and 1-year clinically driven target vessel revascularization.
Primary patency at 1 year was 89% in the DCB group vs. 48% in the PTA group (P < .001), Osamu Iida, MD, from the Cardiovascular Center at Kansai Rosai Hospital in Hyogo, Japan, and colleagues wrote.
Clinically driven TLR at 1 year occurred in 3% of the DCB group and 19% of the PTA group (P = .012), according to the researchers.
The primary safety outcome did not occur in any patients in either group, and quality-of-life improved in both groups at 12 months.
“These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and efficacy of this DCB for the treatment of complex femoropopliteal lesions,” Iida and colleagues wrote. – by Erik Swain
Two authors report they are employees of Medtronic. Another author reports he is a noncompensated adviser for Medtronic, an equity investor in PQ Bypass and a compensated board member of VIVA Physicians, a not-for-profit education and research organization.