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Eur J Cardiothorac Surg 1998;14:360-366
© 1998 Elsevier Science NL

Aprotinin counterbalances an increased risk of peri-operative haemorrhage in CABG patients pre-treated with Aspirin¹

^a Heinrich-Heine-University Duesseldorf, Department of Thoracic- and Cardiovascular Surgery, Moorenstrasse 5, D-40225 Duesseldorf, Germany
^b University of Wuerzburg, Dept. of Cardiothoracic Surgery, Josef-Schneider-Strasse 6, D-97080 Wuerzburg, Germany
^c Bayer Vital GmbH, Bayerwerk, D-51368 Leverkusen, Germany

Received 1 October 1997; received in revised form 18 May 1998; accepted 22 June 1998.

Corresponding author. Tel.: +49 211 8117384; fax: +49 211 8117384; e-mail: kleinmi@uni-duesseldorf.de

Objective: As Aspirin (ASA) has proven efficacy in preventing patients with CAD from complications related to cardiovascular diseases, most patients scheduled for CABG are treated with ASA therapy. Consequently, impaired haemostasis is a problem in the management of CABG patients. Clinical studies have shown that Aprotinin can reduce bleeding and the use of blood products by 50% in patients both with and without pre-operative ASA therapy. Concerning the combined effect of peri-operative low-dose ASA therapy and intra-operative high-dose Aprotinin therapy, the gathering of additional and prospective data seemed to be necessary. Methods: We conducted a double-blind two-centre randomised three-arm study in patients with elective primary CABG surgery. Three groups have been tested, comprising 119 patients in total (group A: ASA+Aprotinin, group B: placebo+Aprotinin, group C: placebo+placebo) to investigate a possible reduction of bleeding in Aprotinin treated patients. For all patients, thromboxane levels were used to identify ASA or placebo treatment. Results: The post-operative blood loss is significantly reduced by 21% after Trasylol® administration (B vs. C; P=0.009). The unexpected result of this study has been that the pre-treatment with ASA led to a further reduction of 18% (A vs. C; P<0.0001). The difference between the two Aprotinin groups (A and B) is significant (P=0. 01) in favour of ASA pre-treatment. Myocardial infarction (MI) had been diagnosed at levels of 1.8% in total (2/113), 2.6% (1/38) in group B and 3.2% (1/31) in group C. An additional blinded evaluation of ECG, enzyme levels and clinical status revealed `definite, probable and possible' MIs of 5% in group A, compared to 16% in group B and 13% in group C, thus providing no evidence for a higher risk of infarction by Aprotinin treatment. When comparing the ASA group to non-ASA pre-treatment, a strong trend towards a reduction in MI rate becomes obvious, from 15% to 5% in favour of the ASA pre-treatment (P=0.08). Concerning other peri-operative complications, no statistical difference between the groups could be detected. Conclusions: A reduction in post-operative blood loss in primary elective CABG surgery with intra-operative Aprotinin treatment could be confirmed. A low-dose ASA treatment combined with a high-dose aprotinin administration during surgery not only neutralised a potentially higher risk of bleeding, but did in fact reduce the post-operative blood loss. The protective effect of ASA on peri-operative MI has been evident through a reduction of MI rate in ASA treated patients.

Key Words: Aspirin therapy • Aprotinin therapy • Cardiac surgery • Blood loss • Myocardial infarction

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