The controversial drug was withdrawn last year when evidence showed an increased risk of death, but appears unlikely to be available again for reducing bleeding in certain types of heart surgery, according to an eagerly awaited a study in The New England Journal of Medicine and an accompanying editorial.

The study, called BART, showed patients given Trasylol had a more than 50 percent higher death rate than patients who got other, cheaper drugs. “Thus, in all likelihood, this is the end of the aprotinin story,” Wayne Ray and Michael Stein of Vanderbilt University in Tennessee wrote in their editorial. Aprotinin is the chemical name for Trasylol.

Indeed, Bayer notified the FDA that it will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician’s stock, but the drug remains available for investigational use. (See the FDA statement).

Bayer yanked the med last November and vowed to review its options once the new study was completed. But the med was already mired in controversy, including an alleged Bayer cover-up of side effects prior to an FDA panel meeting. Earlier this year, a doctor charged that 22,000 lives could have been saved if the FDA removed Bayer’s Trasylol two years ago, when his study revealed a growing number of deaths linked to the drug, which was widely used for heart bypass surgery.

In the comparison with two cheaper drugs, Pfizer’s Cyklolapron, and Xanodyne’s Amicar, the death rate among Trasylol patients was 53 percent higher at 30 days, even though Trasylol seemed to do a slightly better job of controlling bleeding.

“Of the 108 patients who died, the proportion who were believed to have died of cardiogenic shock, right ventricular failure, congestive heart failure or myocardial infarction (heart attack) was higher in the aprotinin group than in the other two groups,” according to the BART study. Healthy patients under 65 and without any co-existing illness may also have faces a higher risk of death.