ORLANDO (Reuters Health) – In patients with coronary artery disease and an ejection fraction of 35% or less, surgical reduction of the enlarged left ventricle along with coronary artery bypass graft (CABG) surgery does not improve outcome or mortality over CABG alone, investigators with the STICH trial reported here during the annual meeting of the American College of Cardiology.
The STICH (Surgical Treatment for Ischemic Heart Failure) results have been simultaneously published in an Online First edition of The New England Journal of Medicine (and due in print April 23), and were reported at the meeting by principal investigator Dr. Robert H. Jones of Duke University Medical Center in Durham, North Carolina.
STICH involved 1,000 patients with ischemic heart failure who were randomized to CABG plus surgical ventricular reconstruction (SVR) or CABG alone.
“SVR does not remove heart tissue, but it closes the mouth of scar tissue left from myocardial infarction,” Dr. Jones explained.
The primary endpoint was all-cause death and cardiovascular-related hospitalization. Median follow-up was 48 months.
SVR reduced ventricular volume by 19% compared with a reduction of 6% after CABG alone.
“After 4 years of follow-up, there were no significant differences between the two groups in combined rates of death and heart-related hospitalizations,” Dr. Jones said. There were 292 deaths or rehospitalizations in CABG-only patients compared with 289 in patients assigned to CABG plus SVR, for a hazard ratio of 0.99.
Cardiac symptoms and exercise tolerance improved 58% over baseline in the SVR plus CABG group and 59% in those undergoing CABG alone.
“Intensive medical therapy is so good, that surgery doesn’t improve the outcome. There is no additional therapeutic effect with SVR,” Dr. Jones told Reuters Health.
“Both treatment approaches improved quality of life after surgery, but there was no difference between the two groups,” Dr. Daniel Mark of the Duke Clinical Research Institute in Durham, NC, told meeting attendees. Dr. Mark was lead investigator of a substudy of STICH evaluating quality of life and economic issues.
“Functional status improved substantially in both groups,” Dr. Mark announced. Symptoms of angina decreased and exercise tolerance increased, but SVR was not associated with an added benefit, he noted.
Total hospitalization costs, using the 2008 Medicare Fee Schedule, were $14,595 higher for CABG plus SVR than CABG alone, Dr. Mark reported.
N Engl J Med 2009;360.