Trasylol News
Aprotinin and Ace Inhibitors During Off-Pump Cardiac Surgery Associated with Postoperative Renal Dysfunction
-PharmaLive
02/07/2008 - The blood saving-drug aprotinin appears safe during on-pump cardiac surgery. However, the combination of aprotinin and angiotensin-converting enzyme (ACE) inhibitors during off-pump cardiac surgery is associated with a significant risk of postoperative renal dysfunction. These are the conclusions of authors of an Article published in this week’s edition of The Lancet.
Aprotinin is a serine protease inhibitor with anti-inflammatory, antifibrinolytic, and blood-sparing effects. Several randomised controlled trials have shown that aprotinin reduces perioperative bleeding and reduces the need for blood transfusion during cardiac surgery, but other studies have noted an association between aprotinin use and renal failure. And, following advice from The Commission on Human Medicines, (CHM), the product licence holder for aprotinin, Bayer plc, UK, voluntarily suspended worldwide marketing of aprotinin—following preliminary findings from a Canadian study (BART trial—terminated in October 2007) which suggested it increased mortality.
Professor Kai Zacharowski and Dr Ronelle Moulton, Department of Anaesthesia, Bristol Royal Infirmary, United Bristol Healthcare Trust, Bristol, UK, and colleagues, did a retrospective study of the effect of aprotinin on renal dysfunction—looking specifically at on-pump versus off-pump cardiac surgery, and co-medication with ACE inhibitors.The analysis included 9875 patients undergoing cardiac surgery between Jan 2000 and Sept 2007. They analysed separately the incidence of renal dysfunction in patients receiving aprotinin, tranexamic acid, or no antifibrinolytic treatment in the presence or absence of pre-operative ACE inhibitor treatment, for both on-pump and off-pump surgical techniques.
Most cardiac surgery is performed with the patient on a bypass pump and this is called "on-pump surgery". The majority of patients in this study (5434) had undergone on-pump cardiac surgery. Today, cardiac surgeons also use an alternative technique where they operate on a beating heart and patients do not go on a bypass machine. This is called "off pump" cardiac surgery.
The researchers found that, in the 5434 "on-pump" patients, the association between aprotinin and postoperative renal dysfunction in patients undergoing on-pump cardiac surgery was not significant, irrespective of use of ACE inhibitors. However, in the 848 patients taking ACE inhibitors and undergoing off-pump cardiac surgery, aprotinin was associated with a greater than two-fold increase in the risk of renal dysfunction.
The authors say: "We recommend that it might be beneficial for patients to discontinue any use of an ACE inhibitor before elective off-pump surgery, particularly patients with a history of renal impairment."
They conclude: "The international communities of cardiac anaesthesia and surgery face controversy regarding the use of aprotinin. In the UK, the CHM is awaiting the decision of the European Commission which is undertaking a full review for the risks and benefits of aprotinin. In our study, we recorded little association between use of aprotinin and the occurrence of renal dysfunction in patients undergoing on-pump cardiac surgery, irrespective of ACE inhibitor use."
In an accompanying Comment, Dr Derek Hausenloy, The Hatter Cardiovascular Institute, University College London Hospital and Medical School, London, UK, and colleagues, say: "The [full] outcome of the BART analysis will not be known for some time—will the results support or refute the findings of 64 randomised trials? While waiting for that analysis, the use of aprotinin in the US and in some European countries has been necessarily restricted, with the consequence that some high-risk patients having cardiac surgery might not receive optimum therapy."
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