Randomised controlled trial
Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19
- Randomised controlled trial
- multicentre
- 76 centres in 10 countries
- Enrolment August 26, 2020 – September 19, 2022
Authors' conclusion
Among noncritically ill patients hospitalized with COVID-19, the 30-day primary composite outcome was not significantly reduced with therapeutic-dose anticoagulation compared with prophylactic-dose anticoagulation. However, fewer patients who were treated with therapeutic-dose anticoagulation required intubation and fewer died
Study context
- Population
- Noncritically ill patients hospitalised with COVID-19 not requiring ICU treatment
- Participants
- 3,398 patients
- Comparison
- Therapeutic-dose anticoagulation vs prophylactic-dose enoxaparin
- Prophylactic-dose enoxaparinn = 1,141reference
- Therapeutic-dose enoxaparinn = 1,136
- Therapeutic-dose apixabann = 1,121
- Primary endpoint
- Composite of:
- All-cause mortality
- ICU-level care
- Systemic thromboembolism
- Ischemic stroke (combined therapeutic-dose groups vs prophylactic-dose)
- Follow-up
- 30 days
Primary result
As reported in the abstract
Hazard ratio
0.85
95% CI 0.69–1.04
P = 0.11
By group
Combined therapeutic-dose vs Prophylactic-dose enoxaparin
HR 0.85 (95% CI 0.69–1.04); P = 0.11
Further findings
| Outcome | Prophylactic-dose enoxaparin | Therapeutic-dose enoxaparin | Therapeutic-dose apixaban | HR (95% CI) | P value | |
|---|---|---|---|---|---|---|
| All-cause mortality | 7.0% | Not reported in the abstract | Not reported in the abstract | 0.70 (0.52–0.93) | P = 0.01 | |
| Intubation | 8.4% | Not reported in the abstract | Not reported in the abstract | 0.75 (0.58–0.98) | P = 0.03 | |
| 0.512Hazard ratio (log scale) |
- All-cause mortality: Therapeutic-dose anticoagulation 4.9%
- Intubation: Therapeutic-dose anticoagulation 6.4%
Therapeutic-dose enoxaparin vs therapeutic-dose apixaban
- Results similar in the 2 therapeutic-dose groups
Safety
Major bleeding
- Infrequent in all 3 groups
Original publication
Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19. J Am Coll Cardiol. Published 6 March 2023. doi:10.1016/j.jacc.2023.02.041
Summarised from the published abstract; every number is checked against it