Tuesday, April 1, 2008

Late-breaking clinical trial at ACC: MEND-CABG II trial results
By Kelly Winget

A new clinical trial testing a drug therapy intended to reduce heart attacks during bypass surgery found the drug was not any more effective than the placebo. The DCRI's John Alexander, MD, presented the findings during a late-breaking clinical trial session at ACC on April 1.

The results were also published online yesterday in the Journal of the American Medical Association.

Coronary artery bypass graft (CABG) surgery is a very common and often vital surgery to restore blood flow to the heart, especially when less invasive procedures such as angioplasty is not an option or in patients with multi-vessel coronary artery disease. Although the surgery is an effective technique and mortality rates have decreased over the years, patients face serious complications that can include heart attack, stroke or death.

Earlier, smaller trials had indicated that MC-1, a naturally-occurring metabolite, might lessen the damage to the heart muscle during the CABG surgery in high-risk patients. However, the findings from the MEND-CABG II trial were disappointing to researchers, who were hoping to replicate the earlier positive results.

The trial enrolled more than 3,000 patients in 130 sites in the U.S., Canada and Germany. The patients were considered intermediate- to high-risk and were all undergoing CABG surgery. Patients were randomized to receive either MC-1 or a placebo before and for 30 days following the CABG surgery.

In the trial, 9.3 percent of patients who received MC-1 had a heart attack or other major complication within 30 days of having the surgery. In the placebo control group, 9 percent of patients had a major complication during the same time frame.

During CABG surgery, the heart can often sustain damage when the patient is taken off the bypass machine and blood is reintroduced to their system. Researchers note that better strategies to reduce the damage to the heart muscle are necessary in order to improve outcomes for patients undergoing CABG surgery. MC-1 is one of several recent therapies intended to reduce the heart muscle damage during this surgery, but the other therapies have also been unsuccessful.

Other DCRI researchers involved with the trial include Elliott Bennett-Guerrero, MD, Stephen Ellis, Ph.D., Bob Harrington, MD, and Victor Hasselblad, Ph.D.