NEW ORLEANS (Reuters) - A popular procedure using stents to prop open unclogged arteries provided no extra safety benefit compared with prescription drugs alone in treating patients with stable heart disease, according to a large study released on Monday.
The highly-anticipated findings cast more doubt on the utility of stents, mesh devices used to prop open arteries. Use of a drug-emitting type of stent has been under scrutiny after recent data revealed a small but serious risk of blood clots long after implantation.
The study, presented at the American College of Cardiology’s annual meeting in New Orleans, followed about 2,300 patients over an average of five years. It found similar rates of death, heart attack, stroke and hospitalization among those treated with drugs and those getting an artery-clearing angioplasty, a stent, and medication.
“The results demonstrate that two treatments are not always better than one,” said Bill Boden, chief of cardiology at Buffalo (New York) General Hospital, who led the Department of Veterans’ Affairs-sponsored study, which is also being published in the New England Journal of Medicine.
The one benefit of stenting was an improvement in patients’ chest pain, the study found.
Patients enrolled in the study had chronic chest pain and at least a 70 percent blockage of one of more of their heart arteries. They all took a combination of drugs for heart disease, including aspirin and cholesterol-lowering statin drugs.
The data were released a day ahead of schedule after a doctor who is also an adviser to Boston Scientific Corp., which makes stents, revealed the results at a meeting with doctors and analysts on Sunday night. The Wall Street Journal reported the doctor’s comments on its Web site.
The artery-opening surgery is performed more than 1 million times a year, according to the cardiology association. Patients in the study received the bare-metal version of stents, not the more controversial drug-eluting type.
Stents have never been proven to help this group of patients, but the population makes up at least 40 percent of those getting stents today.
“As so often happens, people start using these things for indications other than for what they were approved.” Boden said. “Clinical practice got out in front of clinical evidence.”
The drug-coated variety of stent quickly supplanted the bare-metal type when introduced three years ago, generating about 90 percent of all stent sales and creating a nearly $6 billion market for the devices, made largely by Johnson & Johnson and Boston Scientific.
The recent controversy over blood clot risks, though, has shrunken the drug-coated stent’s share of the total stent market, now at about 70 percent.
WAR OF WORDS
The study has spurred a war of words between doctors who treat heart disease patients with medications, like Boden, and those who perform the angioplasty-stenting procedure, called interventional cardiologists.
Boston Scientific shares were down 7 percent on Monday. Positive data on a potential rival stent from Abbott Laboratories Inc. were released over the weekend, which likely contributed to the decline.
Several interventional cardiologists were on the defensive about the study and said the results were not surprising because stents were never sold to extend life, only to improve quality of life.
“Most people use stents for quality of life, not quantity of life,” said William Knopf, an interventional cardiologist at St. Joseph’s Hospital in Atlanta.
Knopf said the recent furor about the potential overuse of stents is directly related to the device’s economics.
Drug-eluting stents often cost at least three times as much as bare-metal versions, and doctors often implant more than one per patient.
“You have to put it in the context of the health-care economy. There have been a number of articles about overuse of stenting. But if it improves a patient’s quality of life, is that overuse?”
The study was funded primarily by the Department of Veterans’ Affairs, but also with grants from drugmakers including Merck & Co., Pfizer Inc. and Sanofi-Aventis.
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