In Nordic countries 30-day mortality rate is half that estimated with EuroSCORE II in high-risk adult patients given aprotinin and undergoing mainly complex cardiac procedures

Abstract

Objectives. To describe current on- (isolated coronary arterty bypass grafting, iCABG) and off-label (non-iCABG) use of aprotinin and associated safety endpoints in adult patients undergoing high-risk cardiac surgery in Nordic countries. Design. Data come from 10 cardiac surgery centres in Finland, Norway and Sweden participating in the European Nordic aprotinin patient registry (NAPaR). Results. 486 patients were given aprotinin between 2016 and 2020. 59 patients (12.1%) underwent iCABG and 427 (87.9%) non-iCABG, including surgery for aortic dissection (16.7%) and endocarditis (36.0%). 89.9% were administered a full aprotinin dosage and 37.0% were re-sternotomies. Dual antiplatelet treatment affected 72.9% of iCABG and 7.0% of non-iCABG patients. 0.6% of patients had anaphylactic reactions associated with aprotinin. 6.4% (95 CI% 4.2%–8.6%) of patients were reoperated for bleeding. Rate of postoperative thromboembolic events, day 1 rise in creatinine >44μmol/L and new dialysis for any reason was 4.7% (95%CI 2.8%–6.6%), 16.7% (95%CI 13.4%–20.0%) and 14.0% (95%CI 10.9%–17.1%), respectively. In-hospital mortality and 30-day mortality was 4.9% (95%CI 2.8%–6.9%) and 6.3% (95%CI 3.7%–7.8%) in all patients versus mean EuroSCORE II 11.4% (95%CI 8.4%–14.0%, p < .01). 30-day mortality in patients undergoing surgery for aortic dissection and endocarditis was 6.2% (95%CI 0.9%–11.4%) and 6.3% (95%CI 2.7%–9.9%) versus mean EuroSCORE II 13.2% (95%CI 6.1%–21.0%, p = .11) and 14.5% (95%CI 12.1%–16.8%, p = .01), respectively. Conclusions. NAPaR data from Nordic countries suggest a favourable safety profile of aprotinin in adult cardiac surgery.

Keywords:

• Cardiac surgery
• bleeding
• cardiopulmonary bypass
• antifibrinolytic drugs
• aprotinin
• mortality

Acknowledgements

Presentation: preliminary data for this study were presented as a poster presentation at the Euroanaesthesia meeting, 4–6 June 2022, Milan and as a poster presentation at the European Association of Cardiothoracic Anaesthesiology and Intensive Care meeting 14–16 December 2022, Naples.

Disclosure statement

Jan van der Linden was a member of the Data Safety Monitoring Committee (DSMC) of the Nordic Aprotinin Patient Registry (NAPaR) for which Nordic Group B.V. (Hoofddorp, the Netherlands) was the sponsor and he has given honorary lectures financially supported by Nordic Pharma. The authors report there are no other competing interests to declare.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.