By Em Brown
ORLANDO, Fla -- March 31, 2009 -- Surgical left-ventricular reconstruction (SVR) during coronary artery bypass graft (CABG) surgery does not add to the clinical or survival benefits in patients with heart failure, according to research presented here at the American College of Cardiology (ACC) 58th Annual Scientific Session.
The Surgical Treatment for Ischemic Heart Failure (STICH) trial, reported here during a late-breaking clinical trials session at ACC, was also published online in The New England Journal of Medicine (Jones RH et al. [Published online ahead of print, March 29, 2009]. doi:10.1056/NEJMoa0900559).
For the STICH study, principal investigator Robert H. Jones, MD, Duke University Medical Center, Durham, North Carolina and colleagues studied 1,000 patients with ischaemic heart failure and left ventricular ejection fractions of 35% or less treated between September 2002 and January 2006.
Patients were randomised to CABG plus SVR (n = 501) or CABG alone (n = 499) and were followed for a median of 48 months.
The primary endpoint was all-cause death and cardiovascular-related hospitalisation.
Ventricular volume was reduced by 19% in the SVR group compared with a reduction of 6% with CABG alone. "SVR does not remove heart tissue, but it closes the mouth of scar tissue left from myocardial infarction," Dr. Jones explained.
"After 4 years of follow-up, there were no significant differences between the 2 groups in combined rates of death and heart-related hospitalisations," Dr. Jones said in a late-breaking session on March 29. There were 289 deaths or rehospitalisations in patients assigned to CABG plus SVR and 292 in CABG-only patients.
Cardiac symptoms and exercise tolerance improved by 58% over baseline with SVR plus CABG group and by 59% with CABG alone (hazard ratio for the combined approach, 0.99; confidence interval, 0.84-1.17; P = .90).
"Both treatment approaches improved quality of life after surgery, but there was no difference between the 2 groups through 3 years of follow-up," said Daniel Mark, MD, MPH, Duke Clinical Research Institute, Durham, North Carolina, who was lead investigator of a STICH substudy 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 hospitalisation costs, using the 2008 Medicare Fee Schedule, were $14,595 USD higher for CABG plus SVR than CABG alone, Dr. Mark reported.
"Intensive medical therapy is so good, that surgery doesn't improve the outcome. There is no additional therapeutic effect with SVR," Dr. Jones asserted.
[Presentation titles: Surgical Treatment for Ischemic Heart Failure (STICH) Trial: CABG Versus CABG + SVR.
and
Quality of Life Outcomes With Surgical Ventricular Reconstruction in Symptomatic Heart Failure: Results From the STICH Trial.]
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