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A new heart tack

Though on the decline, the use of angioplasty and stents in non-acute coronary patients remains a cause of concern

By Deborah Kotz
Globe Staff / August 8, 2011

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Using minimally invasive angioplasty to reopen clogged arteries and insert stents in patients with stable heart disease doesn’t extend life or prevent future heart attacks any better than medications such as baby aspirin or cholesterol-lowering statins. Yet 173,000 such patients have angioplasties with stents every year in the United States, according to a recent study.

The research, published last month in the Journal of the American Medical Association, found that 12 percent of elective stent procedures performed in heart disease patients were clearly inappropriate and that an additional 38 percent were of “uncertain’’ benefit.

“We know that in people having an acute heart attack, finding a blockage and opening it with angioplasty can save the heart muscle and save lives,’’ said study author Dr. Paul Chan, a cardiologist at Saint Luke’s Mid America Heart and Vascular Institute. But that’s not the case, he said, for “ordinary vanilla-brand elective angioplasty’’ used for narrowed coronary arteries that aren’t completely blocked by a clot or ruptured plaque.

Without a doubt, a significant percentage of stable heart disease patients who receive stents - tiny mesh cylinders inserted in arteries to prop them open - do enjoy more short-term relief from the chest pain and breathlessness caused by angina than those who rely on medications alone.

But many stent patients expect the benefits will be far greater. Studies suggest the vast majority of them believe that if they check in for an overnight stay to have the $12,000 to $15,000 procedure, they will check out with extra protection against a heart attack or death from heart disease. The lesson, doctors say, is that patients should not rush into the procedure before asking questions and understanding precisely what they stand to gain.

“I see stable heart disease patients all the time unnecessarily referred to me by internists,’’ said Dr. Patrick O’Gara, medical director of the cardiovascular center at Brigham and Women’s Hospital. These patients may have an abnormal exercise stress test or chronic chest pain that convinces them, or their doctors, that a heart attack is just around the corner.

“I reassure these patients that the use of medication constitutes very active treatment of their problems, but it’s sometimes very hard to convince them,’’ O’Gara said.

Hailed as a safer, less invasive alternative to coronary bypass surgery, angioplasty became more popular than bypass procedures nearly two decades ago when studies found that the procedure was just as effective and far safer than the chest-cracking surgery. Angioplasty involves threading a balloon through a tiny incision into a narrowed artery of the heart, where it is inflated to crush fatty deposits - opening the vessel for improved blood flow - before it is withdrawn.

The results looked even better once stents were added to keep arteries from closing up again after the procedure. But then stents were found to cause their own problems: scar tissue formed around bare metal stents, and blood clots occurred in stents that release medications intended to prevent scar tissue from forming.

And sometimes the stents simply failed to work properly: Natick-based Boston Scientific, which gets a major portion of its revenues from stents, recalled thousands of them in 2004 because of design flaws in two popular stent models.

While stents were falling out of favor, newer drugs such as statins, ACE inhibitors, and platelet inhibitors were shown to enhance the life-extending and heart attack-preventing benefits of baby aspirin. A landmark 2007 trial, called COURAGE, that tested the medical regimen against stents found no difference in outcomes among nearly 2,300 patients with stable heart disease who were randomly assigned to get the procedure along with medication or to just take medication alone. Both groups had the same rate of heart attacks and heart disease deaths after nearly five years, and while the stent group had more significant relief from angina symptoms for a year or two, by the third year of the study, there was no difference between the two groups.

This and other studies led the American College of Cardiology to issue guidelines in 2009 outlining when stents were appropriate, when not, and when somewhat questionable. And it led to a slow, steady decline of elective interventions in many hospitals.

In Massachusetts, the total number of angioplasties with stents fell from 17,110 in 2004 to 13,493 in 2009, the last year for which data are available. Over the same period, the percentage of stent patients who had been admitted to the hospital with a recent heart attack or in shock from a serious heart problem - both appropriate reasons for undergoing the procedure - increased from 15 percent to 19 percent. (The state doesn’t track patients who had the intervention for other appropriate, high-risk circumstances such as unstable angina.)

But the JAMA study indicates a wide variation among hospitals in the appropriate use of stents. In one-quarter of hospitals, fewer than 6 percent of procedures were inappropriate, while in another quarter of hospitals, more than 16 percent were unnecessary. A few institutions performed inappropriate stent insertions more than half the time. (The study researchers didn’t have access to the hospital names in the data they collected.)

Part of the problem could be a refusal among some doctors to shed the mindset that stents save lives even when they are not inserted within a few hours after a heart attack.

“There was a lot of push back from doctors after COURAGE came out,’’ said Dr. William Boden, a cardiologist at Buffalo General Hospital who was an author of that study. “Many couldn’t understand how a procedure that works in acute heart attack patients wouldn’t work the same way in those with chronic angina. They made a leap of faith that opening the artery improves outcomes,’’ when most of the time a clogged artery never becomes completely blocked and causes a heart attack.

A few doctors were clearly driven by profits. One Maryland cardiologist recently lost his medical license for performing too many inappropriate angioplasties; another, from Baltimore, was convicted of health fraud last month for writing false diagnoses and inserting stents into more than 100 unwitting patients.

Some don’t have patients try medical therapy first. A Cornell University study published in May found that more than half of heart disease patients who elected to have stents didn’t first try the full range of medications, as the cardiology guidelines recommend.

But other heart specialists point out that the picture is far more complicated than the broad strokes painted by the COURAGE trial and that the guidelines leave wiggle room for cardiologists to practice the art of medicine, considering a patient’s individual set of circumstances before determining the best course of action.

“Some patients have mild symptoms and there’s room to maneuver with medications, while others are on high doses of medications and still can’t play a full match of tennis because of the heaviness in their chest,’’ said Dr. Kenneth Rosenfield, head of vascular medicine and intervention at Massachusetts General Hospital. Ultimately, he added, it is left up to patients to decide how they want to manage their symptoms.

Elizabeth G., 85, who preferred not to use her last name, said she decided to have a stent procedure at Brigham and Women’s Hospital in July because she couldn’t take the extreme fatigue that she attributed to metropolol, a beta blocker prescribed to her in May to ease her shortness of breath and chest pain. “I could lay down at any time and take a nap,’’ she said. “I’m normally a very active person, not a sitter. I do line dancing, swim laps, play golf, but this slowed me down.’’

While she is still on her other heart medications, she has already cut back on the metropolol and is hoping to get off it altogether. That alone, she said, would make the procedure worthwhile, even if it will not prevent a future heart attack. “It was my decision and I felt very comfortable with it.’’

Deborah Kotz can be reached at dkotz@globe.com.

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