• De HertStefanSFrom the Department of Anaesthesiology and Perioperative Medicine, Ghent University Hospital - Ghent University, Corneel Heymanslaan 10, Ghent, Belgium (SDH), CHU Bordeaux, Department of Anaesthesia and Critical Care Diseases (AO), Univ. Bor, Alexandre Ouattara, David Royston, Jan van der Linden, and Kai Zacharowski.
• From the Department of Anaesthesiology and Perioperative Medicine, Ghent University Hospital - Ghent University, Corneel Heymanslaan 10, Ghent, Belgium (SDH), CHU Bordeaux, Department of Anaesthesia and Critical Care Diseases (AO), Univ. Bordeaux, INSERM, UMR 1034, Biology and Cardiovascular Diseases, Pessac, France (AO), Anaesthetics Department, RBH Foundation Trust, Harefield Hospital, Hill End Rd Harefield, Uxbridge, UK (DR), Department of Perioperative Medicine, Section of Cardiothoracic Anaesthesiology and Intensive Care, Karolinska University Hospital, Solna, Stockholm, Sweden (JVDL) and Department of Anaesthesiology, Intensive Care Medicine & Pain Therapy at the University Hospital Frankfurt, Theodor-Stern-Kai 7, Goethe University, Frankfurt am Main, Germany (KZ).
• Eur J Anaesthesiol. 2022 Aug 1; 39 (8): 685694685-694.

BackgroundAprotinin has been used to reduce blood loss and blood product transfusions in patients at high risk of major blood loss during cardiac surgery. Approval by the European Medicines Agency (EMA) for its current indication is limited to patients at high risk of major blood loss undergoing isolated coronary artery bypass graft surgery (iCABG).ObjectiveTo report current real-world data on the use and certain endpoints related to the safety of aprotinin in adult patients.DesignThe Nordic aprotinin patient registry (NAPaR) received data from 83 European centres in a noninterventional, postauthorisation safety study (PASS) performed at the request of the EMA.SettingCardiac surgical centres committed to enrolling patients in the NAPaR.PatientsPatients receiving aprotinin agreeing to participate.InterventionThe decision to administer aprotinin was made by the treating physicians.Main Outcome MeasuresAprotinin safety endpoints were in-hospital death, thrombo-embolic events (TEEs), specifically stroke, renal impairment, re-exploration for bleeding/tamponade.ResultsFrom 2016 to 2020, 5309 patients (male 71.5%; >75 years 18.9%) were treated with aprotinin; 1363 (25.7%) underwent iCABG and 3946 (74.3%) another procedure, including a surgical treatment for aortic dissection ( n  = 660, 16.7%); 54.5% of patients received the full-dose regimen. In-hospital mortality in iCABG patients was 1.3% (95% CI, 0.66 to 1.84%) vs. 8.3% (7.21 to 8.91%) in non-iCABG patients; incidence of TEEs and postoperative rise in creatinine level greater than 44 μmol l -1 2.3% (1.48 to 3.07%) and 2.7% (1.79 to 3.49%) vs. 7.2% (6.20 to 7.79%) and 15.5% (13.84 to 16.06%); patients undergoing re-exploration for bleeding 1.4% (0.71 to 1.93%) vs. 3.0% (2.39 to 3.44%). Twelve cases of hypersensitivity/anaphylactic reaction (0.2%) were reported as Adverse Drug Reactions.ConclusionThe data in the NApaR indicated that in this patient population, at high risk of death or blood loss undergoing cardiac surgery, including complex cardiac surgeries other than iCABG, the incidence of adverse events is in line with data from current literature, where aprotinin was not used.Trial RegistrationEU PAS register number: EUPAS11384.Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Society of Anaesthesiology.

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