• About Us
    • Contact Us
    • Login
    • ObGFirst
  • COVID-19
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • GrandRounds
  • My Bookshelf
  • Now@ObG
  • Media
About Us Contact Us Login ObGFirst
  • COVID-19
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • GrandRounds
  • My Bookshelf
  • Now@ObG
  • Media
COVID-19 Management

RCT Results: Therapeutic or Prophylactic Anticoagulation for Hospitalized COVID-19 Patients?

image_pdfFavoriteLoadingFavorite

BACKGROUND AND PURPOSE:

  • Lopes et al. (The Lancet, 2021) compared the efficacy and safety of therapeutic versus prophylactic anticoagulation in hospitalized COVID-19 patients

METHODS:

  • Pragmatic, open-label, multicenter, randomized, controlled trial
  • Setting
    • Brazil
  • Participants
    • Hospitalized with COVID-19 and elevated D-dimer concentration
    • COVID-19 symptoms for up to 14 days before randomization
  • Study design
    • Randomization to therapeutic vs prophylactic anticoagulation
  • Therapeutic anticoagulation
    • Stable patients: Oral rivaroxaban (20 mg or 15 mg daily)
    • Clinically unstable patients: Subcutaneous enoxaparin (1 mg/kg twice per day) or IV unfractionated heparin (to achieve a 0.3–0.7 IU/mL anti-Xa concentration) followed by rivaroxaban to day 30
  • Prophylactic anticoagulation
    • Standard in-hospital enoxaparin or unfractionated heparin at physicians discretion
  • Statistical Analysis
    • Analyzed with the win ratio method (a ratio >1 reflects a better outcome in the therapeutic anticoagulation group) in the intention-to-treat population
    • Can be used to stratify and evaluate pairs in studies with multiple composite outcomes
  • Primary efficacy outcome
    • Composite of: Time to death | Duration of hospitalization | Duration of supplemental oxygen to day 30
  • Primary safety outcome
    • Major or clinically relevant non-major bleeding through 30 days

RESULTS:

  • Therapeutic group: 311 patients | prophylactic group: 304 patients
    • Clinically stable: 94%
    • Clinically unstable: 6%
  • The primary efficacy outcome was not different between patients assigned therapeutic or prophylactic anticoagulation
    • Therapeutic group: 38.4% wins
    • Prophylactic group: 41.3% wins
    • Win ratio 0.86 (95% CI, 0.59 to 1.22); P = 0.40
  • Consistent results were seen in clinically stable and clinically unstable patients
  • The primary safety outcome occurred in more patients in the therapeutic group
    • Therapeutic group: 8%
    • Prophylactic group: 2%
    • Relative risk 3.64 (95% CI, 1.61 to 8.27); P = 0.0010
  • Allergic reactions
    • Therapeutic group: 1%
    • Prophylactic group: 1%

CONCLUSION:

  • For hospitalized COVID-19 patients with elevated D-dimer levels, routine therapeutic anticoagulation did not provide a clinical benefit vs prophylactic anticoagulation and resulted in more bleeding episodes
  • The authors conclude

Thus, the use of therapeutic-dose rivaroxaban, and other direct oral anticoagulants, should be avoided in hospitalised patients with COVID-19 who do not have an evidence-based indication for oral anticoagulation 

Learn More – Primary Sources:

Therapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID-19 and elevated D-dimer concentration (ACTION): an open-label, multicentre, randomised, controlled trial

Get Mobile-Friendly COVID-19 Research Summaries with ObGFirst

ObGFirst® – Try It Free! »

image_pdfFavoriteLoadingFavorite
< Previous
All COVID-19 Management Posts
Next >

Related ObG Topics:

Does Prophylactic Anticoagulation Reduce Mortality in Hospitalized COVID-19 Patients?
Is Anticoagulation Therapy in COVID-19 Patients Associated with Lower Mortality?
Thrombotic Events and COVID-19: How Often do they Occur and What are the Risk Factors?

Sections

  • COVID-19
  • Alerts
  • OB
  • GYN
    • GYN
    • Sexual Health
  • 2T US Atlas
  • The Genome
  • Primary Care
  • Your Practice
  • Grand Rounds
  • My Bookshelf
  • Now@ObG
  • Media

Are you an
ObG Insider?

Get specially curated clinical summaries delivered to your inbox every week for free

  • Site Map/
  • © ObG Project/
  • Terms and Conditions/
  • Privacy/
  • Contact Us/
© ObG Project
SSL Certificate


  • Already an ObGFirst Member?
    Welcome back

    Log In

    Want to sign up?
    Get guideline notifications
    CME Included

    Sign Up

Get Guideline Alerts Direct to Your Phone
Try ObGFirst Free!

Sign In

Lost your password?

Sign Up for ObGFirst and Stay Ahead

  • - Professional guideline notifications
  • - Daily summary of a clinically relevant
    research paper
  • - Includes 1 hour of CME every month

ObGFirst Free Trial

Already a Member of ObGFirst®?

Please log in to ObGFirst to access the 2T US Atlas

Password Trouble?

Not an ObGFirst® Member Yet?

  • - Access 2T US Atlas
  • - Guideline notifications
  • - Daily research paper summaries
  • - And lots more!
ObGFirst Free Trial

Media - Internet

Computer System Requirements

OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Jointly provided by

NOT ENOUGH CME HOURS

It appears you don't have enough CME Hours to take this Post-Test. Feel free to buy additional CME hours or upgrade your current CME subscription plan

Subscribe

JOIN OBGFIRST AND GET CME/CE CREDITS

One of the benefits of an ObGFirst subscription is the ability to earn CME/CE credits from the ObG entries you read. Tap the button to learn more about ObGFirst

Learn More
Leaving ObG Website

You are now leaving the ObG website and on your way to PRIORITY at UCSF, an independent website. Therefore, we are not responsible for the content or availability of this site