Clinical Outcomes With the Use of Prophylactic Versus Therapeutic Anticoagulation in Coronavirus Disease 2019

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Abstract

To determine the impact of anticoagulation on inhospital mortality among coronavirus disease 2019-positive patients with the a priori hypothesis that there would be a lower risk of inhospital mortality with use of preemptive therapeutic over prophylactic dose enoxaparin or heparin.

Design Setting:

Retrospective cohort study from April 1, 2020, to April 25, 2020. The date of final follow-up was June 12, 2020 Two large, acute-care hospitals in Western Connecticut.

Patients:

Five hundred and one inpatients were identified after discharge as 18 years or older and positive for severe acute respiratory syndrome coronavirus 2. The final sample size included 374 patients after applying exclusion criteria. Demographic variables were collected via hospital billing inquiries, whereas the clinical variables were abstracted from patients’ medical records.

Exposure:

Preemptive enoxaparin or heparin at a therapeutic or prophylactic dose.

Main Results:

When comparing treatments through multivariable analysis, risk of inhospital mortality was 2.3 times greater in patients receiving preemptive therapeutic anticoagulation (95% CI = 1.0–4.9; p = 0.04). Additionally, the average treatment effects were higher (β = 0.11, p = 0.01) in the therapeutic group.

Conclusions:

An increase in inhospital mortality was observed among patients on preemptive therapeutic anticoagulation. Thus, in the management of coronavirus disease 2019 and its complications, we recommend further research and cautious use of preemptive therapeutic over prophylactic anticoagulation.

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  1. SciScore for 10.1101/2020.07.20.20147769: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: The protocol and subsequent work were granted exempt status by the Biomedical Research Alliance of New York (BRANY) Institutional Review Board under category #4(iii), as detailed in 45 CFR 46.104(d) and BRANY’s Standard Operating Procedure.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.


    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).


    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    There were several limitations recognized in this study. First, this is a retrospective study that did not randomize patients to treatment groups. Group assignments may be biased by prescriber preferences or differences in unmeasured clinical variables that may bias the effect sizes of these variables. Second, clinical outcomes, such as mortality after the patients left the hospital, were not captured in this study. Therefore, there may be some misclassification bias in the outcome. Additionally, we included variables in our model that we hypothesized would impact mortality among patients on AC. However, it is likely there is unmeasured confounding present in the model. The patients in this sample were selected from two institutions in Western Connecticut and were predominantly older, non-Hispanic, and White. Interpretation of the results should only be generalized to similar patient populations. Future research should utilize a randomized control design and include additional factors related to mortality, bleeding, and complications of AC utilization.

    Results from TrialIdentifier: No clinical trial numbers were referenced.


    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.


    Results from JetFighter: We did not find any issues relating to colormaps.


    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. SciScore for 10.1101/2020.07.20.20147769: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementThe protocol and subsequent work were granted exempt status by the Biomedical Research Alliance of New York (BRANY) Institutional Review Board under category #4(iii), as detailed in 45 CFR 46.104(d) and BRANY’s Standard Operating Procedure.RandomizationFuture research should utilize a randomized control design and include additional factors related to mortality, bleeding, and complications of AC utilization.Blindingnot detected.Power Analysisnot detected.Sex as a biological variableThe average age was 64.7 years old, more than half of the sample was male (58.6%), and the majority was White (54.0%) and non-Hispanic (63.6%).

    Table 2: Resources

    Data from additional tools added to each annotation on a weekly basis.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore is not a substitute for expert review. SciScore checks for the presence and correctness of RRIDs (research resource identifiers) in the manuscript, and detects sentences that appear to be missing RRIDs. SciScore also checks to make sure that rigor criteria are addressed by authors. It does this by detecting sentences that discuss criteria such as blinding or power analysis. SciScore does not guarantee that the rigor criteria that it detects are appropriate for the particular study. Instead it assists authors, editors, and reviewers by drawing attention to sections of the manuscript that contain or should contain various rigor criteria and key resources. For details on the results shown here, including references cited, please follow this link.