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Chirurgia 2018 December;31(6):242-6

DOI: 10.23736/S0394-9508.18.04800-3


lingua: Inglese

Outcome of isolated coronary surgery patients on dual antiplatelet therapy during the European suspension of aprotinin 2006-2014

Gunilla R. KJELLBERG 1 , Manne E. HOLM 1, Jan A. van der LINDEN 1, 2

1 Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden; 2 Cardiothoracic Anesthesia and Intensive Care, Karolinska University Hospital, Stockholm, Sweden


BACKGROUND: Patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB) are at risk for excessive bleeding. Between 2008-2012, the European Medicines Agency suspended the marketing authorization of aprotinin, but Swedish hospitals received permission from national health authorities to continue to use it in a selected and controlled manner. The objective of this study was to compare the use of aprotinin in patients undergoing isolated CABG surgery during two time periods, 2006-2007 and 2008-2014, before and after aprotinin European suspension.
METHODS: We performed a retrospective analysis of collected data. All consecutive patients who underwent isolated CABG surgery with CPB and received aprotinin at a University Hospital between 2006 and 2014 were identified. Redo and combined procedures were excluded from the analysis.
RESULTS: After 2007, aprotinin administration was limited to patients taking clopidogrel and presenting with platelet aggregation <85% on the day of surgery. Use of aprotinin decreased substantially, from 113 patients/year 2006-2007 to 6 patients/year 2008-2014. Mean EuroSCORE I and mean CPB time were higher in the second period, reflecting a greater operative risk and a higher bleeding risk. No significant differences were observed regarding postoperative mortality, postoperative complications, intra- and postoperative bleeding and transfusion requirements.
CONCLUSIONS: The use of aprotinin decreased significantly after 2007 at a single cardiothoracic center. Despite a higher operative risk and a longer CPB time, patients receiving aprotinin between 2008 and 2014 had similar clinical outcomes and transfusion requirements as those treated with aprotinin during the prior two years.

KEY WORDS: Aprotinin - Hemostatics - Coronary artery bypass - Surgery

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