After two years of follow up, patients with peripheral artery disease who received a drug-coated balloon had significantly higher primary patency and a significantly lower rate of clinically driven target lesion revascularization compared with patients who received conventional percutaneous transluminal angioplasty (PTA).

The updated results of the IN.PACT SFA trial also found that the all-cause mortality rate was 8.1 percent in the drug-coated balloon group and 0.9 percent in the PTA group. However, there were no device- or procedure-related deaths and no major amputations at 24 months.

The primary patency rate was 78.9 percent in the drug-coated balloon group and 50.1 percent in the PTA group, while the clinically driven target lesion revascularization rate was 9.1 percent and 28.3 percent, respectively. The researchers defined primary patency as freedom for clinically driven target lesion revascularization or freedom from restenosis.

Lead author John R. Laird, Jr., MD, medical director of the Vascular Center and professor of medicine at UC Davis Medical Center in California, presented the findings on Oct. 14 in a first report investigations session at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco.

The study results were simultaneously published online in The Journal of the American College of Cardiology.

Medtronic, the manufacturer of the IN.PACT Admiral drug-coated balloon used in the study, funded the trial. In January, the FDA approved the IN.PACT Admiral to treat patients with peripheral artery disease in the upper leg.

Laird said there is no evidence-based standard treatment for the superficial femoral artery (SFA). He added that previous studies showed stents had a better patency rate than balloon angioplasty, although there were concerns about in-stent restenosis and the potential for stents to fracture when placed in leg arteries.

“I think the strategy of not having a permanent implant like a stent in the leg artery is very attractive to a lot of endovascular specialists around the world,” Laird said. “The patterns of practice are definitely shifting in the U.S. towards drug-coated balloons, and they’ve been used for many years outside the U.S. with great frequency. Some of it is driven by reimbursement, particularly in Europe. In some countries, they’re not used as much because they’re not reimbursed yet.”

In the IN.PACT SFA trial, researchers randomized 331 patients with symptomatic SFA and/or popliteal artery disease in a 2:1 ratio to receive a drug-coated balloon or standard PTA.

They found that 87.4 percent of patients in the drug-coated balloon group and 69.8 percent of patients in the PTA group had achieved the primary safety end point of freedom from 30-day device and procedure-related death and target limb major amputation and clinically driven target vessel revascularization within 24 months.

Most of the deaths occurred late in the study. The median time to death was 564.5 days in the drug-coated balloon group and 397 days in the PTA group. None of the deaths were limb-related.

Laird said the blinded and independent clinical events committee adjudicated the deaths and found none of the deaths were device- or procedure-related.

“The differences are probably driven by the extremely low mortality rate in the standard angioplasty arm of the trial, which was 0.9 percent,” Laird said. “If you look through the literature, the usual mortality rates that you would expect in a trial like this are generally in the 3 to 11 percent range.”

As assessed by the EQ-5D Index, patients in the drug-coated balloon group had a better quality-of-life. The groups had a similar improvement in walking distance at 24 months:

The patients will be followed up to 5 years, according to Laird.

“The [24-month] results were consistent and durable across all important subgroups,” Laird said. “We think the excellent and durable results from this trial will drive a paradigm shift with regards to SFA interventions.”