Residents and Fellows Research in Progress
Monday, October 14, 2024
01:00 PM–02:30 PM
Abstract
Introduction: Intracranial hemorrhage (ICH) is a serious complication that can occur in patients taking direct oral anticoagulants (DOAC). ICH, if left untreated, is associated with mortality. Andexanet alfa is a recombinant, modified anti-factor Xa agent approved for the reversal of DOACs apixaban and rivaroxaban. Four-factor prothrombin complex concentrate (4F-PCC) has also been used off-label to reverse DOAC-associated major bleeding events. The purpose of this systematic review and meta-analysis was to determine if there is any difference in mortality outcomes between patients with DOAC-associated ICH treated with andexanet alfa versus 4F-PCC.
Research Question or Hypothesis: What differences in mortality outcomes exist between patients with DOAC-associated ICH treated with andexanet alfa versus 4F-PCC?
Study Design: Systematic review and meta-analysis
Methods: A systematic search was conducted in PubMed, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), and Embase in August 2024. Clinical trials and observational studies involving human subjects and published in English that directly compared the rate of mortality with andexanet alfa versus 4F-PCC in patients with ICH were selected for inclusion. Poster abstracts, as well as studies evaluating concurrent or subsequent use of andexanet alfa with 4F-PCC, listing “prothrombin complex concentrate” without specifying “four-factor,” or including non-DOAC users in the treatment population were excluded. The primary outcome was mortality. Bias was evaluated using version 2 of the Cochrane risk-of-bias tool for randomized trials and the Newcastle-Ottawa Scale for nonrandomized studies. Collected data were analyzed using Comprehensive Meta-Analysis (CMA) software, version 4. If statistically significant heterogeneity was present, a random-effects model was used; a fixed-effects analysis was used in the absence of statistically significant heterogeneity. Publication bias was assessed using a funnel plot and the Egger’s test. This study was exempt from institutional review board review and approval.
Results: To be reported once research-in-progress concludes.
Conclusion: To be reported once research-in-progress concludes.
Presenting Author
Alyssa Hostert PharmDCreighton University
Authors
Stacey Dull PharmD, BCPS
Creighton University SPAHP
Darren Hein PharmD
Creighton University
Neil Patel MD
Creighton University