The Mount Sinai Hospital became the first institution in the United States to use a U.S. Food and Drug Adminstration-approved drug-coated balloon to reopen arteries in a patient’s leg. The new device was approved last October to treat arteries above the knee that have been narrowed or blocked by peripheral arterial disease (PAD), a potentially life-threatening condition that may cause leg pain, skin ulcers, and gangrene, and can result in amputation if left untreated.
“This drug-coated balloon may be a game changer in the management of patients with peripheral arterial disease,” says Prakash Krishnan, MD, Director of Endovascular Services at Mount Sinai Heart, who performed the first procedure with Jose Wiley, MD, and Bhaskar Purushottam, MD. “It can effectively reduce the recurrence of blockages in patients.” Dr. Wiley is Assistant Professor of Medicine (Cardiology), and Radiology, at Icahn School of Medicine at Mount Sinai. Dr. Purushottam is an endovascular fellow.
In conventional artery procedures, physicians use a balloon to reopen an artery to help restore blood to the limb. In the new procedure, physicians use the traditional balloon to partially open the artery, but also a second balloon coated on its outer surface with the drug paclitaxel to fully open the artery. The drug, which works to prevent inflammation and scar tissue from building up in the area where the balloon was inserted, is applied to the artery wall, where it remains for about a month, and is believed to help prevent new blockages. The new device, the Lutonix® 035 Drug-Coated Balloon (DCB) Catheter, is made by C. R. Bard, Inc.
“Preventing future artery blockages is as important as opening the initial blockage,” says Dr. Krishnan, who is also Assistant Professor of Medicine (Cardiology), and Radiology, at Icahn School of Medicine at Mount Sinai.
PAD is believed to affect 8 million Americans. At-risk patients include those with high blood pressure; a family history of an amputation; a history of atherosclerosis, stroke, or heart attack; or individuals who have renal failure and are on dialysis. Treatment varies widely and may include minimal approaches, such as reducing risk through lowering an individual’s cholesterol and blood pressure measures; surgical bypass; or other endovascular interventions—such as stents or traditional balloon therapy.
Angioplasty procedure data show that using nondrug-coated balloons could result in restenosis—the renarrowing of blood vessels—following a procedure in nearly 50 percent of patients. By comparison, clinical trial studies show that restenosis occurs in only approximately 28 percent of patients with drug-coated balloons.
Mount Sinai was one of 54 sites in the world participating in the LEVANT-2 pivotal study, a global randomized clinical trial that compared the new drug-coated balloon to the standard therapy of using a nondrug-coated balloon. The study results, which helped lead to the device’s Food and Drug Administration approval, demonstrated the technology improved blood flow in arteries, increased patient mobility for walking longer distances, and reduced the rates of blood clots. Dr. Krishnan served as principal investigator at Mount Sinai for the study. He also is a consultant for C. R. Bard, Inc. the maker of the drug-coated balloon.