Effect of Thromboprophylaxis on Clinical Outcomes After COVID-19 Hospitalization.
Ann Intern Med
; 176(4): 515-523, 2023 04.
Article
in English
| MEDLINE | ID: covidwho-2286161
ABSTRACT
BACKGROUND:
Patients hospitalized with COVID-19 have an increased incidence of thromboembolism. The role of extended thromboprophylaxis after hospital discharge is unclear.OBJECTIVE:
To determine whether anticoagulation is superior to placebo in reducing death and thromboembolic complications among patients discharged after COVID-19 hospitalization.DESIGN:
Prospective, randomized, double-blind, placebo-controlled clinical trial. (ClinicalTrials.gov NCT04650087).SETTING:
Done during 2021 to 2022 among 127 U.S. hospitals.PARTICIPANTS:
Adults aged 18 years or older hospitalized with COVID-19 for 48 hours or more and ready for discharge, excluding those with a requirement for, or contraindication to, anticoagulation. INTERVENTION 2.5 mg of apixaban versus placebo twice daily for 30 days. MEASUREMENTS The primary efficacy end point was a 30-day composite of death, arterial thromboembolism, and venous thromboembolism. The primary safety end points were 30-day major bleeding and clinically relevant nonmajor bleeding.RESULTS:
Enrollment was terminated early, after 1217 participants were randomly assigned, because of a lower than anticipated event rate and a declining rate of COVID-19 hospitalizations. Median age was 54 years, 50.4% were women, 26.5% were Black, and 16.7% were Hispanic; 30.7% had a World Health Organization severity score of 5 or greater, and 11.0% had an International Medical Prevention Registry on Venous Thromboembolism risk prediction score of greater than 4. Incidence of the primary end point was 2.13% (95% CI, 1.14 to 3.62) in the apixaban group and 2.31% (CI, 1.27 to 3.84) in the placebo group. Major bleeding occurred in 2 (0.4%) and 1 (0.2%) and clinically relevant nonmajor bleeding occurred in 3 (0.6%) and 6 (1.1%) apixaban-treated and placebo-treated participants, respectively. By day 30, thirty-six (3.0%) participants were lost to follow-up, and 8.5% of apixaban and 11.9% of placebo participants permanently discontinued the study drug treatment.LIMITATIONS:
The introduction of SARS-CoV-2 vaccines decreased the risk for hospitalization and death. Study enrollment spanned the peaks of the Delta and Omicron variants in the United States, which influenced illness severity.CONCLUSION:
The incidence of death or thromboembolism was low in this cohort of patients discharged after hospitalization with COVID-19. Because of early enrollment termination, the results were imprecise and the study was inconclusive. PRIMARY FUNDING SOURCE National Institutes of Health.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Venous Thromboembolism
/
COVID-19 Vaccines
/
COVID-19
/
Hemorrhage
Type of study:
Cohort study
/
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Topics:
Vaccines
/
Variants
Limits:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Language:
English
Journal:
Ann Intern Med
Year:
2023
Document Type:
Article
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