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DCB shows promise in femoropopliteal arterial disease, diabetes

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A drug-coated balloon was safe and effective at 12 months in patients with femoropopliteal arterial disease and diabetes, according to findings presented at VIVA 14.

Peter A. Schneider, MD, presented results from a subgroup analysis of patients with diabetes in the IN.PACT SFA I/II trial comparing a paclitaxel-coated balloon (IN.PACT Admiral, Medtronic) with standard balloon angioplasty for the treatment of superficial femoral and proximal popliteal arterial disease causing claudication or rest pain. The drug-coated balloon (DCB) studied is not yet approved for sale in the United States.

The primary efficacy endpoint was primary patency, defined as freedom from clinically driven target lesion revascularization and duplex ultrasound-derived restenosis at 12 months. The primary safety endpoint was freedom from device- and procedure-related death at 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization at 12 months.

In a prespecified subgroup analysis, the patients with diabetes assigned DCB (n=89) had a higher rate of primary patency (77.3% vs. 49%; P=.005) and a lower rate of clinically driven TLR (3.7% vs. 23.1%; P<.001) compared with the patients with diabetes assigned balloon angioplasty (n=54), Schneider, chief of vascular therapy at Kaiser Foundation Hospital, Honolulu, said at a press conference.

Results for the patients with diabetes were similar to the results for the overall patient population, in which those assigned the DCB had a higher rate of primary patency (89.8% vs. 66.8%; P<.001) and a lower rate of TLR (2.4% vs. 20.6%; P<.001) compared with those assigned balloon angioplasty, Schneider said.

“That’s what we need to know as we struggle to look for answers for our diabetic patients,” he said.

There were no device- or procedure-related deaths at 30 days, no major amputations at 12 months and a low rate of vessel thrombosis at 12 months (DCB group, 2.4%; balloon angioplasty group, 5.8%; P=.161) in both groups, Schneider said.

“The IN.PACT SFA trial presents robust level 1 evidence,” he said. “It has consistent primary outcomes in the entire group, but also this extends to diabetics, which is important. There is the potential that DCBs could influence the standard of care in that population.” – by Erik Swain

For more information:

Schneider PA. Late-Breaking Clinical Trials. Presented at: VIVA 14; Nov. 4-7, 2014; Las Vegas.

Disclosure: Schneider reports no relevant financial disclosures.