Evidence map›Paper›PMID 37753225›Full record

ArticleResearch and practice in thrombosis and haemostasis2023

Lower mortality with andexanet alfa vs 4-factor prothrombin complex concentrate for factor Xa inhibitor-related major bleeding in a U.S. hospital-based observational study.

Paul P Dobesh, Gregory J Fermann, Mary J Christoph, Bruce Koch, Eva Lesén, Hungta Chen, Belinda Lovelace, Theresa Dettling, Mark Danese, Julie Ulloa and 2 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Research and practice in thrombosis and haemostasis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05548777 (Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
5.9field-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.

NCT05548777 completednot on this map

Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed

TypeobservationalSponsorAstraZenecaRan2022 to 2022Enrolled5,480ConditionsAnticoagulant-related Major BleedArmsAndexanet alfa, 4F-PCC
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 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

12 authors at 6 institutions in 2 countries.

Paul P DobeshUniversity of Nebraska Medical Center, College of Pharmacy, Omaha, Nebraska, USA.
Gregory J FermannDepartment of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio, USA.
Mary J ChristophAstraZeneca, Wilmington, Delaware, USA.
Bruce KochAstraZeneca, Wilmington, Delaware, USA.
Eva LesénAstraZeneca, Gothenburg, Sweden.
Hungta ChenAstraZeneca, Wilmington, Delaware, USA.
Belinda LovelaceAstraZeneca, Wilmington, Delaware, USA.
Theresa DettlingAstraZeneca, Wilmington, Delaware, USA.
Mark DaneseOutcomes Insights, Agoura Hills, California, USA.
Julie UlloaOutcomes Insights, Agoura Hills, California, USA.
Sherry DaneseOutcomes Insights, Agoura Hills, California, USA.
Craig I ColemanUniversity of Connecticut School of Pharmacy, Storrs, Connecticut, USA.
AstraZeneca (United States) · USAstraZeneca (Sweden) · SEHartford Hospital · USNebraska Medical Center · USUniversity of Cincinnati · USUniversity of Nebraska at Omaha · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Well-designed studies with sufficient sample size comparing andexanet alfa vs 4-factor prothrombin complex concentrate (4F-PCC) in routine clinical practice to evaluate clinical outcomes are limited. Objectives: To compare in-hospital mortality in patients hospitalized with rivaroxaban- or apixaban-related major bleeding who were treated with andexanet alfa or 4F-PCC. Methods: An observational cohort study (ClinicalTrials.gov identifier: NCT05548777) was conducted using electronic health records between May 2018 and September 2022 from 354 U.S. hospitals. Inclusion criteria were age ≥18 years, inpatient admission with diagnosis code D68.32 (bleeding due to extrinsic anticoagulation), a record of use of the factor Xa inhibitors rivaroxaban or apixaban, andexanet alfa or 4F-PCC treatment during index hospitalization, and a documented discharge disposition. Multivariable logistic regression on in-hospital mortality with andexanet alfa vs 4F-PCC was performed. The robustness of the results was assessed via a supportive propensity score-weighted logistic regression. Results: The analysis included 4395 patients (andexanet alfa, Conclusion: In this large observational study, treatment with andexanet alfa in patients hospitalized with rivaroxaban- or apixaban-related major bleeds was associated with 50% lower odds of in-hospital mortality than 4F-PCC. The magnitude of the risk reduction was similar in ICH and GI bleeds.

Indexed as

4-factor prothrombin complex concentrateandexanet alfaanticoagulant reversal agentscerebral hemorrhagefactor Xa inhibitorsgastrointestinal hemorrhage

Identifiers

PMID37753225
PMCPMC10518480
OpenAlexW4386270663

What OpenQuestion holds

Textmetadata
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.