VIVA.14: Promising 1-year results for drug-coated balloons in diabetics

Patients with peripheral artery disease (PAD) and diabetes who underwent treatment with a drug-coated balloon fared better than counterparts who received standard care, according to a subanalysis of the IN.PACT SFA trial.

“When I first heard about drug-coated balloons and studied it, I was very skeptical,” said Peter Schneider, MD, chief of vascular surgery at Kaiser Permanente Moanalua Medical Center and Clinic in Honolulu, in an interview with Cardiovascular Business. A principal investigator in the IN.PACT SFA trial, he presented the one-year results from the subanalysis Nov. 4 at the 2014 Vascular Interventional Advances (VIVA) meeting in Las Vegas. “I thought, how could there be a lasting effect just from blowing up a balloon coated with paclitaxel for a few minutes at one time in one day and somehow that will last for years? At least in the one-year timeframe, I am wrong. The early signals we have look promising.”

The international IN.PACT SFA study randomized 331 patients with femoropopliteal artery disease to treatment with the Admiral drug-coated balloon (Medtronic) or standard percutaneous transluminal angioplasty. One-year results unveiled in April showed that the drug-coated balloon group had a higher primary patency rate (89.8 percent vs. 66.8 percent) and a lower target vessel revascularization rate (2.4 percent vs. 20.6 percent) than the standard care group.

They defined primary patency as freedom from restenosis and clinically driven target lesion revascularization. Primary safety was freedom from 30-day device- and procedure-related death and major amputation of the target limb and clinically driven target vessel revascularization within 12 months.

The subanalysis assessed outcomes in the 89 patients with diabetes in the drug-coated balloon arm and 54 patients with diabetes in the standard care arm. The subgroups had similar baseline characteristics.

At one year, the primary patency rate was 82.7 percent vs. 62.3 percent and the target lesion revascularization rate was 3.7 percent vs. 23.1 percent for the drug-coated balloon group vs. standard care. They reported no device- and procedure-related death or major amputations at 12 months. Both groups had low rates of vessel thrombosis.

Schneider pointed to the need for better cardiovascular treatments for diabetic patients, who more frequently are coming under the care of cardiologists. People with diabetes tend to be complicated patients and while advancements in overall diabetes care have extended longevity, the disease remains chronic. “The overall percentage of my practice and probably everyone’s practice is increasing with how many diabetics we need to take care of,” he said.

Unlike stents, which also are a potential option for treating patients with PAD, drug-coated balloons don’t require implanting a device permanently. “One advantage is we haven’t committed the patient to an irreversible type of therapy,” he said. “If there is a failure later, as long as they don’t have an implant, you still have every possible therapy available to treat a problem when it arises.”

Schneider said he remained “on the fence” until long-term results are in. The trial, which was funded by Medtronic, will follow patients for five years.

The Admiral drug-coated balloon received CE mark in Europe in 2009 but it remains an investigational device in the U.S.