Effect of P2Y12 Inhibitors on Organ Support–Free Survival in Critically Ill Patients Hospitalized for COVID-19: A Randomized Clinical Trial
Primary result · Organ support-free daysResult — go to the resultAdjusted odds ratio 1.07 95% CrI 0.85–1.33Authors' conclusion
In this randomized clinical trial of critically ill participants hospitalized for COVID-19, treatment with a P2Y12 inhibitor did not improve the number of days alive and free of cardiovascular or respiratory organ support. The use of the P2Y12 inhibitor did not increase major bleeding compared with usual care.
Study context
- Population
- Critically ill (requiring ICU-level support) patients hospitalised with COVID-19enrollment stopped early
- Participants
- 949 participants
- Comparison
- P2Y12 inhibitor vs usual care for 14 days or until hospital discharge
- P2Y12 inhibitorn = 479
- Usual caren = 470reference
- Primary endpoint
- Organ support-free days (ordinal scale combining in-hospital death and, for survivors to discharge, days free of cardiovascular or respiratory organ support)
- Follow-up
- Up to day 21
Methodological detailsinternational, open-label, adaptive platform, 1:1 randomisation, Enrolled February 26, 2021 to June 22, 2022; enrollment discontinued for marked slowing of enrollment rate, In P2Y12 inhibitor group: ticagrelor 372 (78.8%), clopidogrel 100 (21.2%)
- International
- Open-label
- Adaptive platform
- 1:1 randomisation
- Enrolled February 26, 2021 to June 22, 2022; enrollment discontinued for marked slowing of enrollment rate
- In P2Y12 inhibitor group: ticagrelor 372 (78.8%), clopidogrel 100 (21.2%)
Primary result
Organ support-free days
Adjusted odds ratio
1.07
95% CrI 0.85–1.33
P2Y12 inhibitor vs Usual care
aOR 1.07 (95% CrI 0.85–1.33)
As reported in the abstract
Further findings
| Outcome | P2Y12 inhibitor | Usual care | Estimate | P value | |
|---|---|---|---|---|---|
| Survival to hospital dischargePosterior probability of superiority 80.8% | 74.5% | 72.4% | median aOR 1.15 (95% CI 0.84–1.55) | ||
| Mortality · 90 daysEstimated rates | 25.5% | 27.0% | aHR 0.96 (95% CI 0.76–1.23) | P = 0.77 | |
| 0.512Ratio (log scale) |
- Survival to hospital discharge: 95% CrI
Safety
Major bleeding (ISTH definition; primary safety outcome)
Original publication
Effect of P2Y12 Inhibitors on Organ Support–Free Survival in Critically Ill Patients Hospitalized for COVID-19: A Randomized Clinical Trial. JAMA Netw Open. Published 1 May 2023. doi:10. 1001/ jamanetworkopen. 2023. 14428
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