(HealthDay News) — Administration of acadesine before, during, and immediately after coronary artery bypass graft (CABG) surgery to regulate adenosine does not reduce the composite measure of all-cause mortality, nonfatal stroke, or the need for mechanical support for severe left ventricular dysfunction (SLVD), according to a study published in the July 11 issue of the Journal of the American Medical Association.
Mark F. Newman, M.D., from Duke University in Durham, N.C., and colleagues conducted the Reduction in Cardiovascular Events by Acadesine in Patients Undergoing CABG international trial, a randomized, double-blind, placebo-controlled, parallel-group evaluation of intermediate- to high-risk patients (median age, 66 years) undergoing nonemergency, on-pump CABG surgery at 300 sites. Just before anesthesia induction, patients were randomized 1:1 to receive acadesine (0.1 mg/kg per minute for seven hours) or placebo (both added to cardioplegic solutions).
The researchers stopped the trial after 3,080 of the originally intended 7,500 study participants were randomized because results of a prespecified futility analysis indicated a very low likelihood of a statistically significant efficacious outcome. The primary outcome measure, a composite of all-cause mortality, nonfatal stroke, or need for mechanical support for SLVD, occurred in 75 of 1,493 participants (5.0 percent) in the placebo group and 76 of 1,493 (5.1 percent) in the acadesine group (odds ratio, 1.01; 95 percent confidence interval, 0.73 to 1.41).
“In this population of intermediate- to high-risk patients undergoing CABG surgery, acadesine did not reduce the composite of all-cause mortality, nonfatal stroke, or SLVD,” the authors write.
Several authors disclosed financial ties to the pharmaceutical industry.