Researchers Questioning Angioplasties

Mar 28, 04:49 AM

Current Headlines: By Thomas H. Maugh II and Daniel Costello

For patients with clogged arteries who have not yet had a heart attack, the widely used surgical treatment of balloon angioplasty with the insertion of a stent is no better than conventional drug treatment, researchers said Monday

In a study of more than 2,000 patients, those receiving only drug therapy had the same number of heart attacks, strokes and deaths as those who received the drugs and underwent artery-opening angioplasty, researchers from the Department of Veterans Affairs told a meeting of the American College of Cardiology.

The only difference was a slight improvement in quality of life for those receiving angioplasty because of fewer chest pains, known as angina.

The findings deal a blow to the stent industry, which sells an estimated $3.2 billion worth of stents each year in the United States. As many as 65 percent of the estimated 1 million stenting procedures performed each year occur in such patients at a cost of about $40,000 per surgery.

"This is good news for patients and physicians," said Dr. William E. Boden of the University of Buffalo School of Medicine, who led the study.

In the rush to perform angioplasty, the effectiveness of drug treatment "was lost in the shuffle. It was considered old- fashioned, ho-hum. Now we can say to physicians ... you are not putting patients in harm's way. That is something we didn't know before."

Experts cautioned that the results do not apply to patients who have suffered a heart attack because of a blockage in the coronary artery. Numerous studies have shown that angioplasty is the gold standard for such patients, and physicians urge that it be implemented as soon as possible to re-open the artery and restore blood flow to the heart.

But in nonemergency situations, the drugs act fast enough to forestall the need for angioplasty.

Stent makers said the study provided little new information, did not include the newest generation of drug-eluting stents and did not address the key issue of whether stents prevent the need for further angioplasties.

They also argued that the device's greatest benefit is improving quality of life.

The study, also published online Monday by the New England Journal of Medicine, is the first large analysis examining its value for those with what is known as stable disease.

The study, called the Courage Trial, enrolled 2,287 patients at 15 Veterans Administration medical centers and another 35 hospitals in the United States and Canada. It was sponsored primarily by the VA and the Canadian Institutes of Health Research. Many of the researchers involved have received consulting and lecture fees from major drug companies.

All the patients had at least a 70 percent blockage of their coronary artery and chest pains several times per week. Most also had high cholesterol and high blood pressure, and many had diabetes.

"This is a moderate- to high-risk group of patients," Boden said. "We wanted to give angioplasty the best possible chance to show a benefit."

All of the patients were placed on multiple medications, including beta-blockers, ACE inhibitors and diuretics to lower blood pressure, statins to decrease cholesterol and blood thinners to prevent clots. The drug treatments typically costs about $1,500 a year, according to the American Heart Association.

The patients were also counseled about lifestyle programs for smoking cessation, increased exercise and a better diet.

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