Drug-coated balloon keeps leg arteries open

By Gene Emery

BOSTON (Reuters) - Balloons coated with a common cancer drug can help keep blood flowing in clogged leg arteries better than plain angioplasty balloons, German researchers reported on Wednesday.

These so-called drug eluting balloons have been seen as an alternative to drug-coated stents -- little mesh tubes often used to hold an artery open after angioplasty.

"I am sure that this technology will have a great impact on the future treatment," Dr. Gunnar Tepe of Eberhard-Karls University in Tubingen said by e-mail.

About 8 million people have blood flow problems to their legs and hips, known as peripheral artery disease, according to the American Heart Association. In the leg, it can cause pain and muscle cramps, sometimes just from mild exercise.

The balloon technique is usually effective at restoring blood flow to the leg, but about half the arteries close again within a year, often as muscle cells grow into the area.

Drug-coated stents have been widely used, but recent reports of complications have doctors worried. The U.S. Food and Drug Administration has formed a special advisory board to investigate.

Tepe's team wanted to see if paclitaxel, commonly known by its brand name Taxol, might work on a balloon instead, and help keep the arteries open longer.

Doctors used balloons sprayed with the drug to press the medicine directly against the artery walls of 48 patients as the device was expanded.

In another 52 volunteers, doctors mixed a high dose of the drug into the contrast medium that is injected into the site so X-rays can track the progress of the procedure.

Another 54 people did not receive paclitaxel in any form.

Six months surgery, 37 percent of the people who did not get Taxol and 29 percent of those who got their paclitaxel in the contrast medium needed to have their arteries reopened compared to only 4 percent of those who got the drug via the coated balloon.

By the two-year mark, 15 percent treated with the coated balloon needed further surgery, far fewer than the 40 percent who got the paclitaxel contrast medium and 52 percent who received no paclitaxel at all.

"The paclitaxel-coated balloons used in this trial were standard angioplasty balloons. Paclitaxel adheres to the balloon until it is expanded. During inflation of the balloon, it is almost completely released," the researchers wrote in their report, published in the New England Journal of Medicine.

Tepe said the coated balloon is not commercially available but should be in the near future. Bayer Schering Pharma holds a patent on the process.

(Editing by Maggie Fox and Alan Elsner)