Evidence map›Paper›PMID 35280921›Full record

ArticleJournal of the American College of Emergency Physicians open2022

Thirty-day mortality with andexanet alfa compared with prothrombin complex concentrate therapy for life-threatening direct oral anticoagulant-related bleeding.

Alexander T Cohen, Megan Lewis, Augusta Connor, Stuart J Connolly, Patrick Yue, John Curnutte, Raza Alikhan, Peter MacCallum, Joachim Tan, Laura Green

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of the American College of Emergency Physicians open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05898412 (Retrospective Real World Evidence Study to Describe Characteristics and Outcomes in Dutch Patients Admitted to the Hospital With a Factor Xa Inhibitor-associated Bleeding Treated With Andexanet Alfa), which is not on this map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
6.2field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05898412 completednot on this mapstarted 2023, after this paper: background citation

Retrospective Real World Evidence Study to Describe Characteristics and Outcomes in Dutch Patients Admitted to the Hospital With a Factor Xa Inhibitor-associated Bleeding Treated With Andexanet Alfa

TypeobservationalSponsorAstraZenecaRan2023 to 2025Enrolled217ConditionsHemorrhageArmsAndexanet alfa
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 38 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 3 countries.

Alexander T CohenDepartment of Haematological Medicine Guy's and St Thomas' Hospitals London UK.ORCID https://orcid.org/0000-0002-9398-4621
Megan LewisHEOR and Access FIECON Ltd St Albans UK.
Augusta ConnorHEOR and Access FIECON Ltd St Albans UK.
Stuart J ConnollyPopulation Health Research Institute McMaster University Hamilton Ontario Canada.
Patrick YuePortola Pharmaceuticals, Inc. now Alexion Pharmaceuticals, Inc. South San Francisco California USA.
John CurnuttePortola Pharmaceuticals, Inc. now Alexion Pharmaceuticals, Inc. South San Francisco California USA.
Raza AlikhanUniversity Hospital of Wales, Cardiff and Vale University Health Board Cardiff UK.
Peter MacCallumHaemostasis and Transfusion Barts Health NHS Trust London UK.
Joachim TanPopulation Health Research Institute St George's, University of London London UK.
Laura GreenHaemostasis and Transfusion Barts Health NHS Trust London UK.
Portola Pharmaceuticals (United States) · USCardiff and Vale University Health Board · GBNHS Blood and Transplant · GBPopulation Health Research Institute · CAQueen Mary University of London · GBSt George's, University of London · GBSt Thomas' Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: Compare 30-day mortality among patients receiving the specific reversal agent andexanet alfa versus replacement prothrombin complex concentrate (PCC) in the management of direct-acting oral anticoagulant (DOAC)-related bleeds. Methods: Two patient-level datasets were used: ANNEXA-4, a prospective, single-arm trial of patients taking apixaban or rivaroxaban who received andexanet alfa and ORANGE, a prospective, observational study of anticoagulated patients in UK hospitals, some of whom received PCC. Patients were propensity score matched based on demographic and clinical characteristics. Subgroup analyses were performed by bleed type (intracranial hemorrhage [ICH], gastrointestinal [GI], other). Relative risk (RR) of all-cause 30-day mortality was calculated. Results: 322 ANNEXA-4 patients treated with andexanet alfa (mean age = 77.7 years; 64.9% ICH) were matched with 88 ORANGE patients treated with PCC (mean age = 74.9 years, 67.1% ICH). Adjusted 30-day mortality for patients treated with andexanet alfa (14.6%) was lower than patients treated with PCC (34.1%; RR, 0.43; 95% CI, 0.29-0.63). In the ICH subgroup, patients treated with andexanet alfa had lower mortality (15.3%) than patients treated with PCC (48.9%; RR, 0.31; 95% CI, 0.20-0.48). Mortality risk was lowest for patients in the GI subgroup but did not differ significantly by treatment (12.2% for andexanet alfa vs 25.0% for PCC; RR, 0.49; 95% CI, 0.21-1.16). Conclusions: In this propensity score-matched comparison across 2 independent datasets, adjusted 30-day mortality rates were lower for patients treated with andexanet alfa than in matched patients receiving PCC. This indirect comparison was limited in that it could not account for several highly predictive variables including GCS score, hematoma volume, and expected survival. Further research is warranted to confirm the mortality differences between reversal/replacement agents for DOAC-related bleeding.

Identifiers

PMID35280921
PMCPMC8898077
OpenAlexW4220868757

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.