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 to 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, bringing medical therapy near par with surgery, doctors reported at a New Orleans meeting of the American College of Cardiology.
In a major trial of 1,212 patients with severe heart failure that did not include painful angina, researchers found that bypass surgery reduced the death rate from heart disease slightly compared with treatment with drugs alone. But at the end of five years, surgery provided no significant improvement in overall survival compared with medical therapy alone.
“For more than 20 years, the standard wisdom has been that patients with a weak heart and blocked arteries do better with bypass surgery,” said Dr. Edward J. McNulty of UC San Francisco, who was not involved in the study. “However, in the interim, medical therapy has improved dramatically.”
The new results have the potential to change practice, added McNulty, who is co-chair of the American College of Cardiology meeting.
“Medical therapy is getting so much better than it used to be,” added Dr. Nicole Weinberg, a cardiologist at Saint John’s Health Center in Santa Monica. “Patients can potentially avoid surgeries that would cause them a lot of complications.”
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 enrolling that many because many patients did not want to risk being randomized to the medical therapy arm of the trial, Velazquez said.
All patients received the best medical therapy available and half were scheduled to receive a bypass procedure in addition. 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 56 months, 244 patients who received medical therapy alone had died (41%), compared with 218 in the bypass surgery group (36%), a statistically insignificant difference.
But 33% of 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 to 58% in the bypass surgery group, also statistically significant.
The results were also published online in the New England Journal of Medicine. In an editorial accompanying the report, Dr. James C. Fang of the Case Medical Center in Cleveland noted that many of the patients with the severe form of the 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 physician and patient do not need to make an immediate decision about surgery if aggressive medical treatment is begun immediately. Decisions about surgery “can be safely deferred as treatment plans are individualized and modified over time” without significant risk to the patient.
Or, as Velazquez said, patients do not need to be on an “express train to surgery,” but can instead “take the local train.”