Wirksamkeit und Sicherheit der Anwendung von Andexanet alfa bei Notfalltrepanationen: ein bizentrischer Erfahrungsbericht

Factor Xa inhibitors are widely used anticoagulation agents which are associated with a notable risk of bleeding. In 2019, the antidote Andexanet alfa has been approved for reversal of Apixaban and Rivaroxaban and showed high efficacy in controlling intracerebral hematoma. However, data about its use before neurosurgical procedures are scarce. Here, we report our experience with the use of Andexanet alpha before emergency trepanation.

We performed a retrospective data analysis over the past 4 years and identified patients undergoing trepanation under factor Xa inhibitors and Andexanet alpha in two high volume neurosurgical university centers in Germany. We reviewed demographic and medical data including age, sex, diagnosis, neurological status, laboratory results, surgery protocols and imaging. The primary endpoints of this study were 1) the efficacy of Andexanet alpha in terms of preventing a secondary bleeding during or after surgery and 2) its safety regarding thromboembolic events. The efficacy was determined on the postoperative CT scan (6 hours after surgery) and categorized in excellent, good or weak.

A total of 29 patients (female n=14; male n=15) were treated with andexanet alfa and underwent 33 operations in total (18 burr-hole craniostomies (BH) and 15 craniotomies (CRA)). Burr-hole craniostomy was performed for external ventricular drainage (N=13), intracranial pressure monitoring (N=3), or evacuation of a subdural hematoma (N=2). Patients were aged between 55 and 94 years (Mean: 74.82 ± 10.65). Coma/sopor was present in 64% of the patients (BH: 72% vs CRA: 53%; p = 0.3). In total, efficacy was good or excellent in 94% (BH: 94% vs. CRA:93%; p >0.99). Cerebral ischemia was detected in 24% of the cases (BH: 22% vs. CRA: 27%; p > 0.99). There was no case of deep vein thrombosis or pulmonary embolism. Surgery duration was significantly longer in the craniotomy group (p < 0.0001).

Our data indicate a high efficacy of Andexanet alpha in preventing secondary bleeding during brain surgery in patients under Factor Xa inhibition. However, the occurrence of cerebral ischemia should be considered. Larger studies are needed to validate our findings.