Table 2. Primary and Selected Secondary Outcomes of Critically Ill Participants.
| Outcomes | Pooled antiplatelets (n = 1020) | Aspirin (n = 565)a | P2Y12 inhibitors (n = 455)a | Control (n = 529) |
|---|---|---|---|---|
| Organ support–free days to day 21b | ||||
| No. of patients with known outcome | 1011 | 563 | 448 | 521 |
| Median (IQR), d | 7 (–1 to 16) | 8 (–1 to 16) | 7 (–1 to 16) | 7 (–1 to 16) |
| Adjusted proportional odds ratio (95% CrI) | 1.02 (0.86-1.23) | 1.05 (0.85-1.30) | 1.00 (0.80-1.27) | 1 [Reference] |
| Probability of futility, % | 95.7 | 88.6 | 93.4 | |
| Probability of efficacy, % | 58.0 | 66.5 | 51.8 | |
| Survival to hospital discharge | ||||
| No./total (%) | 723/1011 (71.5) | 402/563 (71.4) | 321/448 (71.7) | 354/521 (67.9) |
| Adjusted odds ratio (95% CrI) | 1.27 (0.99-1.62) | 1.30 (0.97-1.72) | 1.18 (0.86-1.62) | 1 [Reference] |
| Adjusted absolute risk difference, % (95% CrI) | 5.0 (–0.2 to 9.5) | 5.4 (–0.7 to 10.5) | 3.5 (–3.4 to 9.5) | |
| Probability of efficacy, % | 97.0 | 96.0 | 85.8 | |
| Thrombotic events or deathc,d | ||||
| No./total (%) with | ||||
| Venous thrombotic event | 87/998 (8.7) | 54/563 (9.6) | 33/448 (7.4) | 56/516 (10.9) |
| Arterial thrombotic event | 37/996 (3.7) | 22/556 (4.0) | 15/440 (3.4) | 12/513 (2.3) |
| Any thrombotic event | 112/996 (11.2) | 69/556 (12.4) | 43/440 (9.8) | 65/513 (12.7) |
| Death in hospital | 288/1011 (28.5) | 161/563 (28.6) | 127/448 (28.4) | 167/521 (32.1) |
| Thrombotic events or death | 355/1011 (35.1) | 204/563 (37.0) | 151/448 (36.2) | 212/521 (40.7) |
| Adjusted odds ratio for composite of death and/or thrombosis (95% CrI) | 0.70 (0.54-0.90) | 0.69 (0.52-0.93) | 0.73 (0.53-0.99) | 1 [Reference] |
| Adjusted absolute risk difference, % (95% CrI) | –8.2 (–13.7 to –2.5) | –8.6 (–14.4 to –1.7) | –7.3 (–14.0 to –0.2) | |
| Probability of efficacy, % | 99.7 | 99.3 | 98.0 | |
| Major bleedingc,e | ||||
| No./total (%) | 21/1002 (2.1) | 11/559 (2.0) | 10/443 (2.3) | 2/517 (0.4) |
| Adjusted odds ratio (95% CrI) | 2.97 (1.23-8.28)f | 2.34 (0.93-5.93) | 2.50 (0.95-6.56) | 1 [Reference] |
| Adjusted absolute risk difference, % (95% CrI) | 0.8 (0.1-2.7)f | 0.5 (0.0-1.9) | 0.6 (0.0-2.1) | |
| Probability of harm, % | 99.4f | 96.5 | 96.9 |
Abbreviation: CrI, credible interval.
The analysis of individual treatment effects was a secondary analysis conducted in the unblinded patient population (ie, excluding covariate adjustments for ongoing interventions).
Composite ordinal scale consisting of survival to hospital discharge and days free of organ support to day 21. An odds ratio greater than 1 indicates a benefit of treatment. Probabilities of efficacy (proportional odds ratio >1), harm (proportional odds ratio <1), and futility (proportional odds ratio <1.2) are computed from the posterior distribution. Dynamic borrowing was used across illness severity (ie, critically and non–critically ill patients), whereby like treatment effects are shrunk together based on their degree of similarity. Accordingly, observations about treatment effect are shared between groups.
An odds ratio greater than 1 indicates a harm of treatment. Probabilities of benefit (odds ratio <1) and harm (odds ratio >1) are computed from the posterior distribution.
Thrombotic events include pulmonary embolism, myocardial infarction, ischemic cerebrovascular event, systemic arterial thromboembolism, and deep venous thrombosis.
Major bleeding (according to International Society of Hemostasis and Thrombosis definition) is defined as fatal bleeding, symptomatic or clinically manifest bleeding in a critical area or organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or bleeding causing a decrease in hemoglobin of 2 g/dL or greater or leading to transfusion of 2 or more whole blood or red blood cell units.
Summaries are based on the post hoc analysis of major bleeding estimating a pooled antiplatelet treatment effect.