April 3, 2016 – The STICH study followed more than 1,200 patients with severe heart diseases for 10 years.
After nearly 10 years of follow-up, a large international study led by the Duke Clinical Research Institute provides definitive evidence that coronary bypass surgery saves and extends the lives of patients with severe heart disease when compared to drug therapies alone.
The study found that patients with coronary artery disease, heart failure or 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 CABG patients also had significantly fewer 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, MD, (pictured) professor of medicine and heart failure specialist at DCRI. Velazquez led the study, called Surgical Treatment for Ischemic Heart Failure Extension Study (STICH) , and reported the 10-year results at the annual meeting of the American College of Cardiology 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 in 99 sites throughout 22 countries. The purpose of the study was to determine whether bypass surgery offered any extra benefit or excessive risk compared to medical therapies, which had become increasingly available in the decades after CABG was first performed to treat clogged coronary arteries.
All the study participants were taking standard 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 others.
Roughly half the patients were then randomly assigned to receive a CABG procedure, while the other half were maintained on guideline-directed medication regimens.
Over the follow-up period that spanned a median 9.8 years:
- Significantly fewer of the CABG patients died compared to those on medication alone – 359 vs. 398.
- The median survival time for those in the CABG 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 CABG, one patient’s life was saved – a significant absolute risk reduction.
Velazquez said the benefits of bypass surgery might be understated in real-world applications, because patients undergo the procedure when warranted, rather than by a random assignment required in a clinical study. In the study, 20 percent of patients assigned to medical therapy alone had undergone CABG by the end of the study which would underestimate the differences between groups using standard statistical testing.
Study co-author George Sopko, MD, of the National Heart, Lung, and Blood Institute, 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 should become the indicated approach.”
The trial was sponsored by the NHLBI, which is part of the National Institutes of Health.
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, Venessa L. Moore, Patrice Desvigne-Nickens and Jean L. Rouleau on behalf of the Surgical Treatment for Ischemic Heart Failure Extension Study investigators.