Results Encouraging for New PAD Treatment

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September 29, 2015


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A new “drug-coated balloon” used to open blocked arteries in people suffering from peripheral arterial disease (PAD) yields better results than standard angioplasty treatment, according to the findings of a new trial published in the New England Journal of Medicine.

One of the authors of the article is James Benenati, M.D., medical director of the Peripheral Vascular Laboratory at Miami Cardiac & Vascular Institute, which became one of the first entities nationwide to use the device in a procedure on a PAD patient last October, days after it was approved by the U.S. Food and Drug Administration.

“The results are encouraging and this new technology will be studied further throughout longer patient recovery periods,” says Dr. Benenati. “But the outcomes so far are very positive. The drug is being delivered precisely and effectively to the targeted areas of the arteries.”

The FDA approved the first drug-coated “balloon catheter” to advance the treatment of PAD on Oct. 10, 2014. Millions of Americans suffer from PAD in the femoropopliteal artery in the thigh. If untreated, PAD can lead to loss of blood flow to the legs or feet, and eventually amputation.

The drug-coated device (see illustration above) helps a blocked artery heal properly by preventing inflammation and scar tissue, all without the need for a stent to hold the artery open. It essentially inflates to coat a therapeutic dose of a drug directly onto arterial walls in the thigh (superficial femoral arteries), or knee (popliteal arteries), when these arteries are narrowed or blocked as a result of PAD.

Since the FDA’s approval, dozens of procedures have been performed on PAD patients at the Institute by interventional radiologists using the drug-coated device.

Researchers involved in the study co-authored by Dr. Benenati found the rate of artery widening at 12 months “superior among patients who had undergone angioplasty with the drug-coated balloon vs. conventional angioplasty (65.2 percent vs. 52.6 percent). The study was funded by Lutonix-Bard, manufacturer of the paclitaxel-coated balloon used in the study. The balloon is coated on its outer surface with the drug paclitaxel, which helps prevent recurrent narrowing of arteries after the procedure.

The drug-coated balloon catheter could prove to be a better option for many patients who don’t react well to a stent, a tiny metal cylinder. Angioplasty with stenting can lead to bleeding, clotting, and other problems. With the newly approved device, therapeutic drug levels through the balloon catheter are sustained for several days, and its effects can be evident for months

The results of the trial are very encouraging, but “long-term follow-up will be useful in determining whether the benefit of this intervention is sustained, increased, or attenuated over time,” the article published in the New England Journal of Medicine says.

In addition, further studies will compare the drug-coated balloon with other therapeutic options, such as atherectomy (a minimally invasive to alternative to angioplasty), or stenting with bare-metal stents or drug-eluting stents, the article says.

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