Contrary to recent studies, proper use of a drug called aprotinin to reduce bleeding during heart surgery does not increase the risk of heart attack or stroke, according to a study in the June issue of The Journal of Thoracic and Cardiovascular Surgery.
"Our study is important because it shows that if aprotinin is used selectively and a drug/lab test interaction is avoided, the drug does not hurt patients' hearts or brains while reducing their need for blood transfusions and reoperations for bleeding," said C. Michael White, Pharm.D., of Hartford Hospital in Hartford, Conn., one of the study authors.
The study was prompted by recent reports suggesting an increased risk of complications including heart attacks, strokes, and kidney problems in patients who received aprotinin to reduce bleeding during heart bypass or valve replacement surgery. In response, the U.S. Food and Drug Administration issued an alert limiting the use of aprotinin during heart surgery.
Dr. White and colleagues performed a similar study, but limited to patients treated at Hartford Hospital, where aprotinin was used differently than at most other hospitals. "We thought our results might be different than what most hospitals had seen, because at Hartford Hospital, we reserved drug therapy to patients who would most benefit and we avoided a drug/laboratory test interaction that could have resulted in an increased risk of blood clots," according to Dr. White.
The analysis included 3,348 patients undergoing bypass or valve replacement surgery at Hartford Hospital from 2000 through 2005. In contrast to the previous study, there was no increase in heart attack risk among patients receiving aprotinin, while the risk of stroke was 35 percent lower.
As in the previous study, patients receiving aprotinin had an increased risk of kidney dysfunction after surgery. It was not clear whether the kidney problems were permanent or temporary.
One reason for the conflicting results is that Hartford Hospital limited the use of aprotinin to patients undergoing particularly complex operations (and to patients like Jehovah's Witnesses, who refuse blood transfusions).