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Analysis: Stent Fallout After Big Study

MARILYNN MARCHIONE

Heart patients around the country are calling their doctors to question plans to treat clogged arteries with stents. It is the early fallout from a big study that showed drugs work just as well in non-emergency cases to prevent heart attacks, deaths, and over the long run, chest pain.

But Americans love a quick fix, and some doctors make a lot of money providing it. Many experts predict the study will not drastically cut the number of angioplasties that are done unless insurers balk at the $40,000 cost and force patients to try drugs first.

"People want their chest pain to go away right away. They don't care about three years, they want it gone tomorrow," said Dr. Christopher Kramer, a University of Virginia heart specialist.

At issue is angioplasty, in which a tiny balloon is snaked through an artery and inflated to flatten a blockage. Mesh tubes called stents are usually placed to keep the vessel open. It is the gold standard for treating heart attacks and worsening symptoms that land people in the hospital. Doctors say no one who has chest pains should delay seeing a doctor.

But in recent years, angioplasty also has become popular for treating patients with chest pain who aren't in imminent danger - despite the fact that no big studies ever proved it better than medications alone.

This week at a cardiology conference in New Orleans, doctors presented results of the first big study to test this. It found that drugs were just as good for preventing heart attacks and death in these elective cases. Angioplasty was better for chest pain early on, but that waned over time.

At the start of the study, 80 percent had chest pain. Three years into it, 72 percent of the angioplasty group was free of it as was 67 percent of the drug group. By five years, there was no difference.

Critics immediately attacked. A doctor who consults for stent makers called the study "rigged to fail." Others shifted their rationale to quick symptom relief rather than preventing heart attacks.

Some quibbled over how widely the results apply. Others said patients will not give drugs a chance. A stent maker said results would have been better if more people in the study had received newer drug-coated stents.

"And if we had more women with blond hair and blue eyes, we would have had a different outcome as well," scoffed the study's leader, Dr. William Boden of Buffalo General Hospital.

Word spread through the meeting that from Texas to New York, patients were calling to cancel or question procedures.

Tom Elghanayan, a 61-year-old real estate developer, read about the study on Tuesday as he waited for a heart test, and became alarmed. A week earlier, his doctor had referred him to a specialist, warning that he might need angioplasty on the spot. The test showed the clog to be less severe, so he left with prescriptions for aspirin and cholesterol-lowering statin drugs.

Had it been worse, "A week ago, I might have offered a stent," said the specialist, Dr. Kirk Garratt of Lenox Hill Hospital in New York.

So many people are unwilling to accept results that go against their beliefs and business interests that the study seems destined to have less impact than many believe it should.

"There are huge vested interests that are going to push back on these results, and they have already begun to do so," Dr. Salim Yusuf of McMaster University in Hamilton, Ontario, said at the meeting.

For years, smaller studies have shown angioplasty has little to offer over other treatments, he said. "Medicine here has gone wrong," he declared to big applause. "We're going to have a helluva tough time putting the genie back in the bottle."

Some argued that patients themselves may thwart the new advice. Drugs work "if you can get patients to take their medicines," said Dr. Gregory Dehmer, a Texas A&M cardiologist who heads the Society for Cardiovascular Angiography and Interventions, the doctors who specialize in angioplasty.

Even doctors who believe the study's results predict patients will still demand angioplasty, just as many choose obesity surgery rather than diet and exercise to shed weight, said Dr. Deepak Bhatt of the Cleveland Clinic.

"We all like a quick fix," he said. "They don't want chest pain because it keeps them from enjoying life. That's especially true of baby boomers."

It seemed to surprise everyone that modern heart drugs worked as well as they did.

Dr. Roger Blumenthal, chief of preventive cardiology at Johns Hopkins University, cited combo pills like Caduet, which lower cholesterol and improve heart functions. "For a lot of people, two pills might be all they really need," he said.

Still, many patients believe they are being denied the best care if doctors don't open the artery, said Dr. Martin O'Riordan, a cardiologist in private practice in Philadelphia.

"Even when you try to talk them into conservative medical therapy, many of them want to have the vessel opened. They say, 'I want it fixed.' They think it's a cure," he said.

Insurers may decide whether that happens in the future.

Dr. Alan Rosenberg, a vice president at WellPoint Inc., said it will take months to fully review the study, but predicted that the company eventually would review more claims to make sure angioplasties were medically necessary before paying for them.

"I think we'll see less of the procedures being done," he said.

Cigna Corp. said its coverage will not change, "as this is a decision that should be made between a physician and his patient" based on individual circumstances. UnitedHealth Group Inc. said it was too soon to know the study's impact.

"It isn't going to kill angioplasty, but it is going to cut into it, probably appropriately," said one of its leading practitioners, Dr. Spencer King of Piedmont Hospital in Atlanta.

He predicted a 10 percent drop in procedures, "not huge."

Boden, the study's leader, said too many doctors "pay lip service to evidence-based medicine" but don't practice what they preach.

"I hope that people will look at this ... and give us a fair shake, rather than say, I don't believe the results, I don't like the results, and I'm going to reject them."

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AP Business Writer Theresa Agovino contributed to this story from New York.

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On the Net:

Heart study: https://www.nejm.org

Heart meeting: https://www.acc.org


Copyright 2005 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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