Patients with peripheral artery disease (PAD), a circulatory condition in which narrowed arteries reduce blood flow to limbs, have another treatment option that is gaining popularity across the United States. Massachusetts General Hospital’s Kenneth Rosenfield, MD, section head for Vascular Medicine and Intervention, and Michael R. Jaff, DO, medical director of the Fireman Vascular Center, have spearheaded the use of a drug-coated balloon, which was approved as the first of its kind by the U.S. Food and Drug Administration (FDA) in January 2015. This device is inflated within the artery and delivers a drug directly to the inner artery wall. The balloon is then deflated and removed, but the drug actively remains in the wall for about one month to prevent the formation of scar tissue and renarrowing, or restenosis, of the blood vessel.
Other treatment options for PAD include drug-eluting stents, bypass surgery, uncoated balloon procedures, exercise and medical therapy. Although the procedure may be more expensive, Dr. Rosenfield asserts the benefits greatly outweigh the costs. Not only have the effects of the procedure proved lasting in regards to reducing restenosis, but risk is marginalized because the balloon is removed, leaving no foreign body inside the artery.
The drug-coated balloon is not a novel idea in the world of PAD. It has been used in European countries for years, but information regarding outcomes had only been derived from smaller scale, less rigorous studies. As a result, Dr. Rosenfield designed a double-blind study consisting of 476 patients. These patients were either treated with a drug-coated balloon or a standard uncoated angioplasty catheter. After 12 months, unbiased evaluators examined the patients to see if their conditions had improved. They found that the rate of arterial patency, a completely open artery, for a patient treated with a drug-coated balloon versus the conventional angioplasty was 65.2% to 52.6%, respectively. This means that the drug-coated balloon had a significantly greater success rate than the standard uncoated angioplasty balloon. Upon reviewing the efficacy of the study, an independent FDA panel unanimously approved the use of drug-coated balloons within the U.S. This study was published in The New England Journal of Medicine on June 25, 2015.
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Currently, the drug-coated balloon is only being used within the leg arteries. Due to the longer length of the arteries in this region of the body, uncoated metallic stents are subjected to bending and may actually break, potentially resulting in more aggressive narrowing. Additionally, because there is a likelihood of greater plaque buildup in leg arteries, the drug-coated balloon is very effective at improving arterial patency. More advanced drug-coated balloons are in the developmental stages, and Dr. Rosenfield and colleagues are actively working on trials that will further support their approval so that patients may benefit from more durable angioplasty outcomes.
PAD affects between 12-18 million Americans, and is a major cause of disability and limb loss. The Mass General Fireman Vascular Center provides specialized diagnosis, treatment options, and continuing care for patients with PAD. Learn more about the PAD Treatment Program