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Aprotinin and cardiopulmonary bypass.
- Guillermo E. Lema (3 December 2007)
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Guillermo E. Lema, Professor, Department of Anaesthesia, Pontificia Universidad Católica de Chile. Santiago, Chile
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To the Editor: Further to the manuscript by Van der Linden et al. (1), aprotinin was withdrawn from the market by Bayer. The FDA has also cleared a warning about its use. This was a response to the early results of the BART study (Canada), which show an increase in morbidity and 30 day mortality in the group receiving aprotinin. The study was stopped and we are waiting for the final data and results. The study by Mangano (2) et al, published in New England Journal of Medicine in 2006, gave us a note of caution regarding the use of this drug. Those familiar with cardiac surgery with cardiopulmonary bypass will agree that aprotinin has been an improvement in the management of complex patients, adults and children. We have observed a reduction in reoperations for bleeding, blood products tranfusion, among others (3). Unfortunately, and probably due to marketting strategies, aprotinin was indicated erroneously in low risk patients. In those patients, there was never a clear benefit of the drug compared with other antyfibrinolytic agents. For complex patients with many preoperative risk factors it is very difficult to isolate aprotinin as a variable affecting outcomes. So we will have to wait for the final results of the BART study, subgroups analysis, high risk vs. low risk patients, among others. Only after that we will see if the drug has to be withdrawn completely and forever or its use restricted to some specific patients, as it was when first released for clinical use. Dr Guillermo Lema References. 1.- Van der Linden PJ, Hardy J, Daper A, et al. Cardiac Surgery with cardiopulmonary bypass: does aprotinin affect outcome?, Br J Anaesth 2007; 99: 646-52 2.- Mangano DT, Tudor JC, Dietzel C. The risk associated with aprotinin during in cardiac surgery. N Engl J Med 2006; 354: 353-65 3.- Sedrayan A, Treasure T, Elefteriades JA. Effect of aprotinin on clinical outcomes in coronary artery bypass graft surgery: a systemic review and meta-analysis of randomized clinical trials. J Thorac Cardiovasc Surg 2004; 128: 442-8 Conflict of Interest:None declared |
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