Early trial results suggest that drug-coated angioplasty balloons reduce restenosis in leg arteries affected by peripheral arterial disease, according to a presentation at the 18th Annual International Symposium on Endovascular Therapy.

The drug-coated balloon concept has proven effective in opening previously stented coronary arteries. The balloon is coated with paclitaxel; when the balloon is inflated, the drug is transferred from the balloon to the atherosclerotic plaque.

Previously, drug-coated stents have not worked well in leg arteries because they are larger than heart arteries and the areas of stenosis are longer, requiring excessive amounts of drug. Also, depending on the location of the blockage, stents can become twisted and bent due to leg movement, leading to breakage and clotting. However, non-drug-coated stents have been shown to be useful in certain cases in the treatment of PAD, including: the repair of arteries that are torn during treatment, opening of completely blocked vessels, managing heavily calcified arteries, and treating vessels for prevention of early restenosis.

The current, German study included 150 patients. Patients were evenly divided among three groups: treatment with drug-coated balloon angioplasty, treatment with conventional angioplasty with a non-coated balloon, and conventional angioplasty with drug in the contrast medium.

The meeting presentation involved early results for the first patients in the two balloon groups: 20 who received angioplasty with the drug-coated balloon and 25 who received conventional angioplasty with non-coated balloons. Preliminary research shows that after six months, drug-coated balloons were significantly more effective than non-coated balloons at preventing restenosis.

“The drug prevents the growth of scar tissue that can cause the vessels to renarrow,” said Gunnar Tepe, MD, an assistant professor of radiology at the University of Tuebingen, Germany, who presented the data. “We’re employing the same drug concept used in drug-coated stents, except the drug is delivered in a much shorter period of time and we don’t leave behind a foreign object, a coated stent, which itself can cause problems down the road. Also, the drug is embedded in a coating material on the stent, which remains after the drug has been completely delivered to the vessel wall. This coating material may cause undesired effects later, as well.”

Studies have shown that, within a year, about 4 in 10 conventional angioplasty procedures in the legs need to be repeated because of restenosis. To improve results, physicians in recent years have tested other minimally invasive methods, including balloon angioplasty followed by placement of a stent, and more recently, coating stents with drugs to prevent restenosis.

Researchers will continue to follow the patients for two years to determine if the incidence of restenosis remains reduced.

“Our early results suggest the effects of drug-coated balloons are by far superior to uncoated balloons. Careful analysis of data and more research are required to confirm the findings and explore additional applications,” said Tepe. “If research bears out, drug-coated balloons could be a very useful option for treating blocked arteries. In particular, they could play a major role in the peripheral arteries, because the incidence of restenosis is higher than in all other parts of the body. In addition, all other successful methods used to gain a better long-term benefit in the coronary arteries failed in the peripheral arteries.”