Badania Kliniczne i Doświadczalne w Chorobach Serca, Płuc i Naczyń
Aprotinin use in cardiac surgery, 2006

Cardiac surgeons face many challenges with a changing patient population. Bleeding is a major risk for death during cardiac surgery, and the use of blood products is a predictor of short-term morbidity (e.g. renal failure) and long-term mortality and morbidity [1, 2]. Many strategies have been have been explored to help reverse the effects of cardiopulmonary bypass – its effects on clotting factors and platelets – and of antiplatelet agents. Aprotinin was first reported to reduce blood loss and the need for transfusion in not only coronary bypass surgery (CABG) but also high-risk cases [3]. Considerable publicity surrounded the recent publication in the New England Journal of Medicine of an observational study entitled “The risk associated with aprotinin in cardiac surgery” authored by Mangano and colleagues [4]. This was followed some time later by limited correspondence [5-7]. Somewhat surprisingly, there was a wealth of interest shown by the lay press and law firms in many countries, no doubt engendered by the venomous press release surrounding the article’s publication (http://www.iref.org/ accessed July 1, 2006). The report was based on data collected from the McSpi database, with information being collected on some 7500 data elements from the period 1996-2000 from 5436 patients. The study aims were to assess the safety of ‘the use of either serine protease inhibitors or lysine analogues in patients with acute coronary syndromes presenting for coronary artery surgery (sic)’. As a guide to how the study was conducted, the authors have provided a CONSORT flow diagram. (The CONSORT Group provides guidelines and a checklist for reporting randomised controlled trials [8].) From the original 5436 patients, some 4374 were analysed. Exclusions from the analysis included incomplete data, did not undergo cardiopulmonary bypass or did not undergo treatment. A further 691 were unable to be included due to use of multiple antifibrinolytic agents, no validation of drug dose or type or received an inadequate dose of antifibrinolytic agent. The final comparison examined the use of the lysine analogues epsilon amino caproic acid and tranexamic acid and the serine protease inhibitor aprotinin compared to a ‘control’ group who received no drug. Each of these drugs has been utilised as part of blood conservation programmes for over 20 years where they are available. All have been subjected to numerous studies but...


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