Stent Stocks To Come Under Pressure: Physicians Rethinking Bypass Surg

Surgeons at St. Michael’s Medical Center in Newark performed a coronary bypass operation last month.

http://www.nytimes.com/2007/02/25/health/25bypass.html

By BARNABY J. FEDER
THE NEW YORK TIMES
Published: February 25, 2007

After more than a decade-long decline, is heart bypass surgery poised for a comeback?

Bypass surgery is the recommended treatment for such patients, according to the guidelines of the American Heart Association and the American College of Cardiology. But some doctors say too many patients never hear about those recommendations from their cardiologists.

A joint committee of the heart association and cardiology society expects to release new guidelines within the next month that could clarify the proper boundary between stenting and surgery, according to Dr. Sydney C. Smith Jr., the head of the committee.

One controversial factor in such assessments is the accumulating data suggesting that surgery may help the sickest heart patients live longer.

Studies tracking long-term results among patients around the nation have prompted some surgeons to argue that thousands of people with blockages in multiple arteries may be dying months or even years prematurely because they receive stents instead of surgery.

Dr. Robert A. Guyton, the chief of cardiothoracic surgery at the Emory University School of Medicine in Atlanta, argues that as many as 200,000 such patients who get stents each year should be having bypass surgery instead. He bases that conclusion on studies using data from nearly 40,000 patient cases in New England and New York and at Duke University.

Stenting and bypass surgery are both meant to relieve symptoms like chest pain and shortness of breath, which are caused by a buildup of arterial plaque that may eventually lead to heart attacks and gradual heart failure.

Neither stents nor bypass surgery can halt the buildup of plaque. But surgery, by bypassing an entire section of diseased artery with a vessel taken from elsewhere in the body, can restore more blood flow and the benefits may last longer.

And while bypass surgery still typically involves the trauma of sawing through the breastbone to open the chest, the operation is getting gentler. Blood vessels for grafting can be harvested from arms and legs through much smaller incisions than in the past, for example.

And about 20 percent of the operations no longer require stopping the heart and attaching patients to an external pump, thus eliminating a step believed to increase the risk of strokes in the sickest patients. Some bypasses now can even be performed using a robotic tool through small incisions between the ribs.

Most of the debate over stents versus surgery focuses on complex patients like Edgardo Hilario, 59, a Kmart shelf stocker from Spotswood, N.J. After he was hospitalized last fall with severe chest pain, his doctors found that he had four severe blockages in three arteries.

Mr. Hilario was operated on last month at St. Michael’s Medical Center, a 337-bed teaching and referral hospital in Newark.

The chief of cardiac surgery there is Dr. Mark W. Connolly, a nationally known heart surgeon who was named physician of the year in 2006 by the American Heart Association. Well-regarded among stent specialists, he was invited to speak last fall at their national meeting.

 

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Dr. Connolly, who says he has performed more than 4,000 bypass surgeries, operated on Mr. Hilario and another patient, Francisco Tobio, that day. Both patients probably would have received stents in many other hospitals.

In fact, Mr. Tobio had arrived at St. Michael’s expecting to have a stent procedure performed by Dr. Fayez Shamoon, who had previously treated Mr. Tobio’s wife. But the X-rays of Mr. Tobio’s blockages led Dr. Shamoon to consult with Dr. Connolly, and the two doctors together advised him to have surgery instead.

“Dr. Shamoon put three stents in my wife, so I trusted him,” Mr. Tobio said.

All hospitals expect both cardiologists and surgeons to consult with heart patients when the form of treatment is in question. But with few patients demanding the chance to talk to a surgeon, it is usually up to a cardiologist like Dr. Shamoon to initiate such a meeting.

How often that happens may depend on the degree of respect and collaboration between a hospital’s cardiologists and surgeons, many doctors say.

Another factor, cardiologists say, is the unwillingness of some surgeons to take on complex cases, especially in states like New York and California that now report performance statistics for each doctor.

“They started sending cases back to us because of reporting,” said Dr. Robert Jesse, the top cardiologist for the Veterans Health Administration.

The data suggesting that patients may be suffering as a result of such trends is hardly ironclad. Little of it comes from randomized clinical trials, which are considered the highest level of evidence in medicine. Instead, the pro-bypass case rests mainly on data from registries that track long-term outcomes for every patient treated at a single major hospital or across large regions.

Such registries can offer a more accurate picture of how medicine is really practiced than clinical trials, which focus on preselected patients. But many researchers say that because registry data tends to be collected more haphazardly, it is better at identifying issues for further study than guiding medical practice.

Two major clinical trials now under way will try to directly compare stents and bypass surgery in patients with the most serious forms of artery disease. One trial, sponsored by Boston Scientific, randomly assigns 1,500 patients to either surgery or stenting. The other, sponsored by the National Heart, Lung and Blood Institute, compares stenting to bypass surgery in diabetic patients with multiple coronary blockages.

But the first results, which will come from the Boston Scientific trial, are not expected before the second half of next year. And those near-term results cannot be conclusive about the main stent safety issue now worrying doctors — the long-term risk of potentially fatal blood clots.

Moreover, by the time the trials’ longer-term results are available in 2012, they may have little applicability to medical practice at that time.

Despite the forces now favoring stents, Mr. Goodman, the consultant, says he expects the number of bypass surgeries to begin rising this year. Concerns about stent safety will play a role, he said, but another inducement will come from patients who received stents in recent years and now need follow-up care.

That is what happened to Joseph Gubernick, 72, the chief marketing officer for a division of the Estée Lauder Companies.

Mr. Gubernick had four bare-metal stents implanted in 2000 at Lenox Hill Hospital, after suffering a heart attack on a business trip to Japan. Last fall, when he began feeling symptoms he feared were signs of a new blockage, Mr. Gubernick called Dr. Connolly at St. Michael’s.

A St. Michael’s cardiologist, Dr. Jonathan Goldstein, took X-ray images of the arteries, and told Mr. Gubernick, “The time for stents is past.”

Dr. Connolly did the bypass operation on Dec. 20.

“I’m back at work and feeling terrific,” Mr. Gubernick said on Thursday.