NEW ORLEANS – Common heart drugs work just as well as the more invasive and expensive procedure known as stenting, according to a landmark study, suggesting that as many as hundreds of thousands of the procedures done each year may be unnecessary.
The study found in non-emergency situations that drugs performed equally in preventing heart attacks and deaths, and nearly as well in providing relief for chest pain, as did propping open a blocked artery with a stent, known as angioplasty.
The study shows that hundreds of thousands of elective angioplasty procedures, which cost an average of $38,000 each, are not needed, said Raymond Gibbons, president of the American Heart Association and a cardiologist at the Mayo Clinic.
The research should lead to fewer angioplasties in patients with stable coronary artery disease, he said.
The research is the latest in a recent series of revelations calling into question the value and safety of elective angioplasty, which is done more than 1 million times a year in the U.S.
It also highlights what has become a misnomer among many patients and some doctors, cardiologists said.
“Americans think that just because you have a blockage it has to be opened,” said James Stein, a cardiologist at the University of Wisconsin Hospital and Clinics in Madison. “It’s just not the case.”
The study was released Monday in the New England Journal of Medicine and at the American College of Cardiology meeting here.
It looked at 2,287 patients in the U.S. and Canada with angina, or chest pain, and stable coronary artery disease who had at least a 70 percent blockage of an artery.
Each group got optimal medical therapy, which included aggressive treatment with drugs to lower cholesterol and blood pressure, blood thinners such as aspirin and angina relief drugs such as nitroglycerin. In addition, about half the patients also underwent angioplasty with the use of bare-metal stents.
In nearly five years of follow up, stenting did not reduce the risk of death, heart attack, stroke or hospitalization for certain heart problems, compared with drug therapy alone.
Cardiologists said there still is a large number of patients with unstable angina and a condition known as acute coronary syndrome who will benefit from angioplasty.
At the same time, keeping the other patients on the kind of vigorous drug and lifestyle therapy used in the study can be hard to do, said Thomas Ryan, a cardiologist with Boston University School of Medicine.
Even when it came to relieving angina symptoms, angioplasty had only a modest benefit. After three years, 72 percent of the angioplasty patients were angina free, compared with 67 percent who got just drug therapy.
Cardiologists say there never has been strong evidence that doing angioplasties on stable patients was preferable to the best drug treatment, however there have been strong economic incentives to do the procedures.
“Doctors and hospitals work in a system that rewards and pays for procedures,” said Heart Association president Gibbons. “The doctor who does the right thing and doesn’t do as many angioplasties is penalized.”
The study, officially called Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation, is dubbed COURAGE.
“I wonder if cardiologists are going to have the courage to face the fact,” said UW’s Stein.
He said some doctors still might be reluctant not to recommend angioplasty for fear of being sued if the patient has a heart attack.
The study comes after a string of bad news for elective angioplasty.
Last November, a separate group of researchers said that as many as 50,000 angioplasties performed each year on heart attack patients days after they get to the hospital are unnecessary and actually may be harmful, though angioplasty performed as far out as 24 hours after heart attack symptoms begin is a proven lifesaver.
In addition, in the last year the drug-coated stents used in most angioplasties have been associated with potentially deadly clots.
The study was funded by the U.S. Department of Veterans Affairs, the Canadian Institutes of Health Research and grants from several drug companies.