Recent Scientific Debate
Both of these are observational studies. The first represents patient data from the McSPI EPI-2 database, and members may be aware that a substantial number of these patients will have been drawn from the 25 European centres participating in this study.
In response to these publications, on Feb 8th 2006 the United States Food and Drug Administration ( FDA) issued an "FDA Public Health Advisory" concerning the use of Aprotinin in cardiac surgery.
The advisory can be found in full at ; www.fda.gov/CDER/drug/advisory/aprotinin.htm.
The paragraph below is extracted from the report verbatim;
".........While FDA is continuing its evaluation, we are providing the following recommendations to healthcare providers and patients:
The Society of Cardiovascular Anaesthesiologists ( SCA) comments can be found at ; www.scahq.org/sca3/aprotinin.shtml
The Association of Cardiothoracic Anaesthetists ( ACTA) comments can be found at ; www.acta.org.uk/ACTAS4Aprotonin.asp
EACTA members may be interested to read the views of these specialist societies also.
In Europe, Trasylol is licensed on a country-by-country basis, rather than centrally through the EMEA. As a result, as many members may be aware, aprotinin is not available in some EU countries. The EMEA does have a safety role even for products licensed nationally if an issue is drawn to its attention by an appropriate authority. The EMEA may therefore make a comment in due course.
There are a number of issues involved in this controversy. These include the value of observational and phase 4 studies, as well as the primary issue of the safety of Aprotinin and the extent to which these additions to the literature shed light on the subject. EACTA will endeavour to provide a lively debate for its members on these issues in the coming months.
In the meantime, for those European anaesthesiologists who have access to Aprotinin we would endorse the FDA’s recommendations.
EACTA Directory Board.
1.Mangano DT, Tudor IC, Dietzel C; Multicenter Study of Perioperative Ischemia Research Group; Ischemia Research and Education Foundation.
The risk associated with aprotinin in cardiac surgery.
N Engl J Med. 2006 Jan 26;354(4):353-65.
2. Karkouti K, Beattie WS, Dattilo KM, McCluskey SA, Ghannam M, Hamdy A, Wijeysundera DN, Fedorko L, Yau TM.
A propensity score case-control comparison of aprotinin and tranexamic acid in high-transfusion-risk cardiac surgery. Transfusion. 2006 Mar;46(3):327-38.
Conflict of Interest;
Bayer Inc. has supported a number of educational initiatives and programmes for EACTA
Dear EACTA member
EACTA has decided to undertake an European Survey on Perioperative Coagulation Management in Cardiac Surgery. The results of this survey will be preliminary released at our next Annual Meeting, in Venice, within the context of a dedicated Symposium. A scientific paper will be prepared and sent to a peer-reviewd journal after the Symposium. All the contributors from the participating Institutions will be mentioned in the article, in a specific appendix. We consider the possibility to include within the Authors as much as 12 names, that will be subsequently chosen on the basis of their contribution and their will to discuss the manuscript before presentation to the chosen Journal.
We are therefore asking you to fill the attached questionnaire and to send it back, via e-mail, to my address.
Of course, we will probably receive more than one contribution from a single Institution. In this case, we will settle a "mean" report for the Institution, weighting the different questionnaires.
Please complete and send the questionnaire ASAP. It just takes a few minutes
Thank you, best regards and see you all in Venice
Marco Ranucci, MD
EACTA 2006 Chiarman