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Many Stent Procedures Unnecessary

Heart Drugs Just as Good at Preventing Heart Attacks, Death in Some People, Study Shows

Stent Patients as Likely to Die, Have Heart Attack continued...

Then, about half the participants also underwent angioplasty, usually with stents.

Over the next five years, 19% of those in both groups died or had a heart attack. Similar numbers of people in both groups -- about 12% -- were hospitalized for heart problems.

However, there were some benefits to angioplasty. People who had the procedure were 40% less likely to need another procedure to open up blocked heart arteries. And, particularly in the first two years, they reported better quality of life and less frequent episodes of chest pain.

But over time, some of the differences started to dissipate. By five years later, 74% of people who had angioplasty were angina-free vs. 72% of those who got drugs alone, a difference so small it could be due to chance.

Results Stun Medical Community

Boden notes that COURAGE is "the first properly-sized study to answer the question of whether angioplasty and stents reduce the risk of death and heart attacks in people with stable coronary artery disease."

The results came as a shock to many in the cardiology community -- even to the researchers themselves.

"The study was designed with the hypothesis that the combination of angioplasty and optimal medical therapy would be superior," Boden says. "But the results do not support its benefit in reducing heart attacks and death when used as an initial management strategy."

So why would so many doctors recommend a costly procedure without strong evidence it works?

The average cost of having an angioplasty was $38,000 in 2003, according to the American Heart Association.

Nissen thinks it’s because “it seems so intuitively obvious: If you open up a block artery, you’ll fix the problem.”

American Heart Association President Raymond J. Gibbons, MD, chief of cardiology at the Mayo Clinic, adds that there’s a financial incentive for doctors. "People get paid for how many procedures they do," he tells WebMD.

But this study "clearly shows there is no advantage to PCI [percutaneous coronary intervention, or angioplasty] as an initial strategy. It’s unnecessary," Gibbons says. "Angioplasty should be reserved for patients [who can’t be helped] by medical therapy."

Adds Nissen, "This study will change a lot of thinking. The benefits of angioplasty in people with stable chest pain is very modest, at most. It should be reserved for patients for intolerable symptoms."

Results Questioned

But many doctors who perform angioplasties say the procedure’s proven benefits in relieving angina, or chest pain, is getting lost in the shuffle.

Donald Baim, MD, chief medical officer of Boston Scientific, a manufacturer of drug-eluting stents, says, "COURAGE is not a catastrophic failure. [It shows that angioplasty plus stents] improves symptoms."

Marty Leon, MD, of Columbia University Medical Center, says, "There are so many deep flaws in the way this study was executed and planned. It was rigged to fail," and it did. "This study should not affect treatment patterns."

Boden says the criticism is unfounded, pointing out that the researchers purposely studied people at medium to high risk of having a heart attack or dying -- "the very people you would expect to benefit most from the procedure."

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