Andexanet alfa vs standard of care for factor Xa inhibitor-induced intracranial hemorrhage—a systematic review and meta-analysis
Bibliographic record
Abstract
Background Direct oral anticoagulants (DOACs) are activated factor X (FXa) or thrombin inhibitors. Patients on FXa inhibitors are at increased risk for major bleeding events that require anticoagulation reversal. Andexanet alfa is a FXa inhibitor reversal agent, potentially offering better efficacy compared to standard of care options. Objectives To conduct a systematic review and meta-analysis comparing the efficacy and safety of Andexanet alfa versus standard of care for reversing FXa inhibitorinduced ICH. Methods Random-effects meta-analysis. Ovid Medline, EMBASE, and CINAHL were searched from inception until February 1 st , 2025. Primary outcomes included hemostatic efficacy, thrombotic events, and mortality. Subgroup analyses isolated studies using 4F-PCC as standard-of-care and ANNEXA-4 definitions of hemostatic efficacy. Results 3039 studies were identified, with 23 studies (1 RCT, 452 participants; 22 nonrandomized, 4085 participants) included in the final analysis. Thirteen studies assessed hemostatic efficacy, with a pooled odds ratio of 1.68 (95%CI 1.20-2.36, p=0.003, I 2 =0%) favoring Andexanet over standard of care. Thirteen studies reported thrombotic events, with a pooled odds ratio of 0.97 (95%CI 0.59-1.60, p=0.90, I 2 =0%). Thirteen studies assessed mortality, noted a pooled OR of 0.69 (95%CI 0.50-0.96, p=0.03, I 2 =27%) favoring the Andexanet group. Published RCTs showed similar hemostatic improvements but no mortality benefit and a higher rate of thrombotic events. Conclusions Our meta-analysis found low-certainty evidence supporting improved hemostatic efficacy with Andexanet alfa compared to standard-of-care, with a decrease in mortality and no effect on thrombotic complications. Further randomized data is required to establish a conclusive clinical benefit favoring Andexanet alfa.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.011 | 0.023 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.019 | 0.042 |
| Bibliometrics | 0.005 | 0.006 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".