By Michelle Fay Cortez and Robert Langreth – Nov 16, 2011 1:00 PM GMT+0000
Patients with clogged leg arteries are better off exercising with the help of a therapist than having a doctor place a stent in their legs to improve blood flow, a study found.
The research, presented at the American Heart Association’s meeting in Orlando, Florida, is the first to compare recommended treatments for patients with pain from blocked leg arteries. It found that both stents and supervised exercise helped more than being told to walk more and taking the blood thinner cilostazol, which all patients got. Those with supervised exercise did best.
More than 200,000 stent procedures are done each year to restore blood flow through the leg arteries and ease pain caused by the blockages, said Michael Conte, chief of the division of vascular and endovascular surgery at the University of California, San Francisco, in a telephone interview. The procedures are increasingly overused, he said.
“There are a huge number of these procedures being done around the country at really skyrocketing costs,” said Conte, who wasn’t involved in the research. “We cannot afford to keep treating all of these patients without knowing how efficacious the therapies are.”
The results show health insurers should start paying for exercise programs, which have been recommended since 2005 and are rarely covered, said Alan T. Hirsch, senior author and director of the vascular medicine program at the University of Minnesota in Minneapolis. Patients embraced the approach, with most attending at least 70 percent of their exercise sessions.
“We often blame the patients and say they are not willing to undergo lifestyle intervention, when in fact they are,” Hirsch said in an interview. “This should further encourage the dissemination of supervised exercise into real world practice.”
On the Treadmill
The supervised exercise program in the study consisted of hour-long treadmill sessions with a therapist three times a week, gradually escalating in intensity, Hirsch said.
Doctors and patients should try supervised exercise before moving on to the more invasive stenting treatment, said Vincent Bufalino, a cardiologist and president of Midwest Heart Specialists in Naperville, Illinois.
“We need to make sure we’re doing procedures in patients who benefit,” Bufalino said in an interview. “A lot of people do well with exercise. If you can get a less invasive approach to work, there’s nothing wrong with that.”
In the study of 111 patients, those getting supervised workouts improved their walking time by 5.8 minutes, compared with 3.7 minutes for those getting stents and 1.2 minutes for patients told to exercise at home. Stent patients reported less pain and higher quality of life.
Stents Still Important
Companies should continue to develop stents for use in the leg arteries, Hirsch said. The study is also one of the first to show the devices benefit patients with the condition known as peripheral artery disease, a narrowing of the leg arteries that causes pain and can lead to amputation.
Between 8 million and 12 million American are affected by the condition, according to the Peripheral Arterial Disease Coalition in Lakewood, Colorado.
Stents are sold by companies including Boston Scientific Corp. (BSX), Johnson & Johnson, Covidien Plc (COV), Cook Medical Inc., Abbott Laboratories (ABT) and C.R. Bard Inc. Peripheral vascular devices, including stents, angioplasty balloons and synthetic grafts, generated $4.3 billion in global revenue last year and may earn $5.6 billion in 2014, according to Technavio, a market research firm in Elmhurst, Illinois.
The study looked at stents versus exercise for patients with blockages in the aortoiliac artery, the main highway to the legs. It did not examine a common situation where smaller arteries in the thighs are blocked, Conte said.
The research, dubbed Clever, was published in the journal Circulation. It was funded by the National Heart, Lung and Blood Institute, with additional assistance from New Brunswick, New Jersey-based Johnson & Johnson (JNJ), Dublin-based Covidien and Boston Scientific, based in Natick, Massachusetts.