Andexanet Alfa in Emergency Cranial Neurosurgical Procedures: A Bicentric Analysis of Efficacy and Safety.

BACKGROUND

Factor Xa inhibitors are widely used anticoagulants but are associated with a known risk of bleeding complications. In 2018, andexanet alfa was approved as an antidote for the reversal of apixaban and rivaroxaban, demonstrating high efficacy in controlling intracranial hemorrhage. However, data on its use prior to neurosurgical procedures remain limited. Here, we present our experience with andexanet alfa in patients undergoing emergency cranial neurosurgical procedures.

METHODS

Here, we present a case series based on a retrospective analysis conducted over a four-year period, identifying patients who underwent cranial neurosurgical procedures while on factor Xa inhibitors and treated with andexanet alfa at two tertiary academic neurosurgical centers in Germany. We reviewed demographic, clinical, and medical data, including age, sex, diagnosis, neurological status, laboratory results, surgical protocols, and imaging studies. The primary end points were (1) the efficacy of andexanet alfa in preventing secondary bleeding during or after surgery (hemostatic efficacy) and (2) its safety concerning ischemic events. Hemostatic efficacy was assessed via postoperative computed tomography scans performed six hours after surgery.

RESULTS

A total of 29 patients (14 female, 15 male) underwent 34 neurosurgical procedures (18 burr-hole craniostomies [BHs] and 16 craniotomies [CRAs]). The patients' ages ranged from 55 to 94 years (mean 74.82 ± 10.65). The median Glasgow Coma Scale score was 7 at admission. In total, postoperative computed tomography scans revealed no or only minor hematoma in 94% of patients (BH in 94% vs. CRA in 94%; p > 0.99). Ischemic events occurred in 9 patients, including 8 cases of cerebral ischemia and one case of mesenteric ischemia (BH: 28%; CRA: 31%; p > 0.99). No cases of deep vein thrombosis or pulmonary embolism were recorded. The use of additional hemostatic agents was associated with the occurrence of ischemic events (p = 0.04, 95% confidence interval 1.11-122.77, odds ratio 11.7). Overall, in-hospital mortality was 28% in total.

CONCLUSIONS

Our findings suggest that andexanet alfa is highly effective in preventing secondary bleeding during neurosurgery in patients on factor Xa inhibitors. However, the risk for ischemic events must be carefully considered.