Bypass surgery is better for patients with severe heart failure than standard medical therapy, but not by a lot, and many patients who don't want to undergo surgery may do just as well without it, researchers said Monday.
In the first new trial in three decades to compare bypass surgery and conventional treatment, researchers found that improvements in medical therapy — particularly the use of drugs such as beta blockers to lower blood pressure and statins to reduce cholesterol — have sharply narrowed the effectiveness gap between the two approaches, doctors reported at a New Orleans meeting of the American College of Cardiology.
Bypass surgery made patients in the trial slightly less likely to die from heart disease compared with patients treated with drugs alone. But at the end of five years, surgery provided no significant improvement in overall survival compared with medical therapy alone.
"Medical therapy is getting so much better than it used to be," said Dr. Nicole Weinberg, a cardiologist at St. John's Health Center in Santa Monica who was not involved in the study. "Patients can potentially avoid surgeries that would cause them a lot of complications."
The new results have the potential to change practice, said Dr. Edward J. McNulty of UC San Francisco, who was also not involved in the study.
"For over 20 years, the standard wisdom has been that patients with a weak heart and blocked arteries do better with bypass surgery," said McNulty, who is co-chairman of the New Orleans meeting. "But medical therapy has improved dramatically, and this is the first comparison in the modern era."
An estimated 5.8 million Americans suffer from heart failure, in which the heart muscle is weakened and not able to pump blood effectively. In about two-thirds of those cases, the cause is a blockage in the arteries that supply blood to the heart. Coronary artery bypass surgery and balloon angioplasty are the primary methods of treating such blockages.
Dr. Eric J. Velazquez of the Duke University Medical Center in Durham, N.C., and his colleagues studied 1,212 patients with severe heart failure at 99 medical centers in 22 countries. The study, funded by the National Institutes of Health, was originally designed to enroll 2,000 patients, but physicians had difficulty reaching that goal because many patients did not want to risk being randomized to the no-surgery arm of the trial, Velazquez said.
All patients received the best medical therapy available, and half were scheduled to receive a bypass procedure as well. But 55 patients in the bypass group never underwent the procedure, and 100 in the medical therapy group eventually required it, complicating interpretation of the results.
Over the average follow-up period of more than 41/2 years, 244 patients who received medical therapy alone had died (41%), compared with 218 in the bypass surgery group (36%), a difference that was statistically insignificant.
But 33% of those in the medical therapy group died from cardiovascular-related causes, compared with 28% in the surgery group, and that difference was statistically significant. About 68% of those in the medical therapy group died from any cause or were hospitalized for cardiovascular causes, compared with 58% in the bypass surgery group, another statistically significant difference.
The results were published online Monday in the New England Journal of Medicine. In an editorial accompanying the report, Dr. James C. Fang of the University Hospitals Case Medical Center in Cleveland noted that many of the patients with the severe form of disease studied in the trial would not have been evaluated for surgery in the past. Now they should be, he said.
But the study also provides comfort in that physicians and patients do not need to make a decision about surgery right away if aggressive medical treatment is begun immediately, Fang said.
Or, as Velazquez put it, patients do not need to be on an "express train to surgery," but can instead "take the local train."