Bypass Surgery Is Shown to Extend Survival in Heart Failure
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FOR IMMEDIATE RELEASE on Sunday, April 3, 2016
DURHAM, N.C. – After nearly 10 years of follow-up, a large international study led by the Duke Clinical Research Institute (DCRI) provides definitive evidence that coronary bypass surgery plus drug therapy saves and extends the lives of patients with severe heart disease when compared to medications alone.
The study found that patients with coronary artery disease, heart failure and severe left ventricular dysfunction who underwent coronary-artery bypass grafting surgery, or CABG, lived a median 16 months or longer than similarly afflicted patients who only took medications to manage their conditions. The bypass patients also had significantly fewer cardiac-related deaths, hospitalizations or episodes of heart failure, heart attacks and strokes.
“These results definitely show that there really are long-term benefits to CABG even among patient who are considered high risk for surgery,” said Eric J. Velazquez, M.D., professor of medicine and heart failure specialist at DCRI. Velazquez led the study, called Surgical Treatment for Ischemic Heart Failure Extension Study, and reported the 10-year results at the annual meeting of the American College of Cardiology in Chicago and online April 3 in the New England Journal of Medicine.
“We reported mid-term analysis of the data five years ago, but immediately sought to extend the follow-up period to establish whether the benefits of CABG were lasting,” Velazquez said. “This now demonstrates that the advantages of CABG are robust and durable and the procedure saves and extends lives.”
Velazquez and colleagues launched the study in 2002, enrolling 1,212 patients with severe heart diseases at 99 sites in 22 countries. The purpose of the study was to determine whether bypass surgery with drug therapy offered any extra benefit or excessive risk compared to drug therapy alone, which had become increasingly available in the decades after CABG was first performed to treat clogged coronary arteries.
All study participants were taking standard prescribed drug therapies as warranted for their heart conditions, including beta blockers, ACE inhibitors, nitrates, anticoagulants, and/or medications to control high cholesterol, high blood pressure, atrial fibrillation and other conditions.
Roughly half the patients were then randomly assigned to receive a bypass procedure, while the other half remained on their recommended medication regimens.
Over the follow-up period that spanned a median 9.8 years:
• Significantly fewer of the bypass patients died compared to those on medication alone - 359 vs. 398.
• The median survival time for those in the bypass group was 7.73 years, compared to 6.29 years for those in the medication group.
• Death or hospitalization from a cardiovascular event occurred in 467 CABG patients, vs. 524 medication patients.
• For every 14 patients treated with bypass, one patient’s life was saved – a significant reduction in absolute risk.
Velazquez said the benefits of bypass surgery might be even greater in real-world applications, because patients undergo the procedure when warranted, rather than by a random assignment as in this clinical study. In this study, 20 percent of patients assigned to drug therapy alone had undergone bypass surgery by the end of the study.
Study co-author George Sopko, M.D., a program director within the Division of Cardiovascular Sciences at the National Heart, Lung, and Blood Institute (NHLBI), said the long-term analysis of CABG among patients with severe heart disease is important for clinical practice.
“There are risks associated with all surgical procedures, so the benefits need to be followed for a long time,” Sopko said. “If surgery can be done with reasonable risk and extends life, it becomes the recommended approach.”
The clinical trial was sponsored by the NHLBI, which is part of the National Institutes of Health.
In addition to Velazquez and Sopko, study co-authors include Kerry L. Lee, Robert H. Jones, Hussein R. Al-Khalidi, James A. Hill, Julio A. Panza, Robert E. Michler, Robert O. Bonow, Torsten Doenst, Mark C. Petrie, Jae K. Oh, Lilin She, Vanessa L. Moore, Patrice Desvigne-Nickens and Jean L. Rouleau on behalf of the Surgical Treatment for Ischemic Heart Failure Extension Study investigators.