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Aprotinin Associated With Increased Risk of Death Following Heart Surgery OTTAWA, Ontario -- May 15, 2008 -- Aprotinin is associated with a 50% increase in the relative risk of death, according to a major clinical trial comparing 3 drugs routinely used to prevent blood loss during heart surgery. The trial, published in the New England Journal of Medicine, shows that approximately 6% of patients who received aprotinin died within 30 days of surgery compared with 4% of patients who received tranexamic acid or aminocaproic acid. These are data that "every cardiac anaesthesiologist and cardiac surgeon needs to know," said study investigator C. David Mazer, MD, Professor, Department of Anesthesiology, University of Toronto, Toronto, Ontario. "Drugs that are thought to be more effective are not always safer. As physicians, we must always weigh the potential benefits against the associated risks and look for drugs that can achieve the optimal balance of providing better patient outcomes with safe cardiac surgery." BART (Blood Conservation Using Antifibrinolytics in a Randomized Trial) is one of the largest heart surgery trials ever conducted, involving more than 2,000 high-risk cardiac surgery patients and more than 100 cardiac surgeons, anaesthesiologists, pharmacists, and coordinators from 19 Canadian centres. This trial was led by Senior Scientists at the Ottawa Health Research Institute, the research arm of The Ottawa Hospital and an affiliated institute of the University of Ottawa, Ottawa, Ontario. "These 3 drugs have been routinely used in heart surgery for more than a decade, but this is the first trial to rigourously compare them in a meaningful setting with meaningful clinical outcomes," said BART Co-Principal Investigator Dean A. Fergusson, MHA, PhD, Senior Scientist, Ottawa Health Research Institute, Ottawa, Ontario. "The results demonstrate the great value of and the need for independent academic clinical trials." In this multicentre, blinded trial, high-risk cardiac surgical patients (N = 2,331) were randomised to 1 of 3 groups: aprotinin (n = 781), tranexamic acid (n = 770), or aminocaproic acid (n = 780). At 30 days, the rate of death from any cause was 6.0% in the aprotinin group, as compared with 3.9% in the tranexamic acid group (relative risk [RR], 1.55; 95% CI, 0.99-2.42) and 4.0% in the aminocaproic acid group (RR, 1.52; 95% CI, 0.98-2.36). The relative risk of death in the aprotinin group compared with that in both groups receiving lysine analogues was 1.53 (95% CI, 1.06-2.22). The rate of massive postoperative bleeding, the primary endpoint, was lower in the aprotinin group: 9.5% (n = 74) versus 12.1% (n = 93) in the tranexamic acid group and 12.1% (n = 94) in the aminocaproic acid group. The relative risk in the aprotinin group for both comparisons was 0.79 (95% CI, 0.59-1.05). "Overall, our study supports the use of tranexamic acid or aminocaproic acid over aprotinin during high-risk heart surgery," said BART Co-Principal Investigator and Critical Care Physician Paul C. Hébert. "I've treated many patients with complications from heart surgery, so I know how important these results are to patients, to their families, and to healthcare providers." BART was prematurely stopped by the trial's Steering Committee in October 2007 following advice from an independent Data Safety and Monitoring Board, which detected a trend toward increased mortality in 1 arm of the triple-blinded study. Shortly after these preliminary results were made public, the manufacturer of aprotinin announced that the drug would be suspended from the market pending analysis of the final results of the trial. The final results showed that although aprotinin appeared to decrease some of the consequences of massive bleeding, including the need for repeat surgery, these benefits were outweighed by the risks. The analysis showed that the increased aprotinin-associated mortality was related to cardiac complications. BART was funded by the Canadian Institutes of Health Research (CIHR) and the Ontario Ministry of Health and Long-Term Care. SOURCE: Ottawa Health Research Institute E-mail this page to a friend or colleague! To print, use this version