Half-Dose versus Full Dose of Aprotinin in Cardiac Surgery: A Post-hoc Analysis of the Aprotinin European Registry.

Objectives: To compare the effectiveness and safety of the full and half doses of aprotinin, using the extended version of the Nordic Aprotinin Patient Registry, which was imposed by the European Medicines Agency following the reintroduction of aprotinin in cardiac surgery in the European market.

Methods: A post-hoc analysis was performed on data prospectively collected from adult patients exposed to aprotinin during cardiac surgery, in 83 cardiovascular surgical centres in 9 European countries, from February 26, 2016 to October 5, 2022. Full-dose (FD) and half-dose (HD) regimens were used at the surgical team's discretion. The FD loading, priming, and infusion doses were 2 MKIU, 2 MKIU, and 0.5 MKIU/h, respectively. Incidence of re-exploration for bleeding/tamponade 2 days after surgery (2 D-re-exploration), 7 D-mortality, 3 D-MACCE (major adverse cardiac and cerebral events), and 1 D-AKI (acute kidney injury) were compared between FD and HD patients using propensity score methods to reduce confounders.

Results: A total of 2961 (44.4%) patients received the FD regimen and 3703 (55.6%) the HD regimen. After adjustment, the incidence of 2 D-re-exploration was estimated at 3.2% in the FD group and 4.4% in the HD group: OR [95% CI] = 0.70 [0.53-0.94] (P = .015). No difference in 7 D-mortality or 3 D-MACCE was observed between the 2 regimens. The incidence of 1 D-AKI was higher in patients with pre-operative renal dysfunction who received the FD regimen.

Conclusions: Patients receiving the FD aprotinin regimen had less surgical re-exploration than those receiving the HD regimen. An increased risk of early postoperative AKI was observed in the FD group, mainly for patients with pre-operative chronic kidney disease.