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International study: Five-year death rate higher in heart surgery patients who are given aprotinin

Feb 7, 2007 | Newsday

Patients who are given a widely used drug to prevent excessive bleeding during heart surgery are at increased risk of dying within five years following their operations, medical researchers have found in the largest study of its kind.

Results from an international analysis that focused on a drug called aprotinin, sold under the brand name Trasylol, revealed the risk of death increased by nearly 50 percent in patients given the drug during bypass operations. The medication, made by Bayer AG, was federally approved in 1993.

"I think something radical needs to be done," Dr. Dennis Mangano of the nonprofit Ischemia Research and Education Foundation in San Bruno, Calif., said, calling for a change in how the FDA approves drugs.

As lead investigator of the international research, Mangano found 20.8 percent of patients given aprotinin died of complications, which he said, could be directly traced to the drug. In the control group, only 12.7 percent of patients died. More than 3,800 patients at 62 medical centers in 16 countries were involved in the study.

Aprotinin obstructs the activity of enzymes that dissolve blood clots and thus affects numerous biological pathways involved in clotting. Because it affects so many pathways, Mangano said, the effects of the drug do not diminish after surgery. Vessels throughout the body continue to be affected, including the complex labyrinth of vessels throughout the kidneys. Mangano discovered last year that kidney failure can be a consequence. In this study, he found that patients were vulnerable to heart failure, heart attacks and strokes.

"The thrombosis takes months to years to manifest in death," he said.

In a statement yesterday, Bayer lambasted Mangano's study, which is published in today's issue of the Journal of the American Medical Association. The pharmaceutical giant labeled data in both of Mangano's studies "unreliable." Bayer officials said they "will work with regulatory agencies and external experts in the field to further evaluate the findings."

Even though aprotinin is not a household name, it has been given to an estimated 4 million patients. Not long after its approval, reports of liver toxicity began surfacing, doctors say.

"This is a very important study," said Dr. Stephen Lahey, chief of cardiovascular surgery at Maimonides Medical Center in Brooklyn. He said that while at Harvard University a decade ago, he and colleagues abandoned use of aprotinin after noticing complications.

Issues involving aprotinin are "unbelievably politically charged," Lahey said, "because the company that makes it is a very, very big company and it has a lot of literature saying aprotinin is fine." He was not involved in the research.

Mangano said if surgeons globally used either of two cheaper and less potent medications for a year, 10,000 lives would be spared over five years.