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0 0.5 1 1.5 2+ Mortality 16% Improvement Relative Risk Discharge 17% Progression 21% Progression (b) 5% primary Bradbury et al. NCT02735707 REMAP-CAP Aspirin RCT LATE Is late treatment with aspirin beneficial for COVID-19? RCT 1,084 patients in multiple countries (October 2020 - June 2021) Lower progression with aspirin (p=0.018) Bradbury et al., JAMA, doi:10.1001/jama.2022.2910 Favors aspirin Favors control
Effect of Antiplatelet Therapy on Survival and Organ Support–Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial
Bradbury et al., JAMA, doi:10.1001/jama.2022.2910, REMAP-CAP, NCT02735707 (history)
Bradbury et al., Effect of Antiplatelet Therapy on Survival and Organ Support–Free Days in Critically Ill Patients With.., JAMA, doi:10.1001/jama.2022.2910, REMAP-CAP, NCT02735707
Mar 2022   Source   PDF  
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RCT 1,557 critical patients, showing significantly lower mortality with aspirin, with 97.5% posterior probability of efficacy.
risk of death, 16.0% lower, HR 0.84, p = 0.05, treatment 165 of 563 (29.3%), control 170 of 521 (32.6%), NNT 30, inverted to make HR<1 favor treatment, Kaplan–Meier, day 90.
risk of no hospital discharge, 16.9% lower, RR 0.83, p = 0.08, treatment 161 of 563 (28.6%), control 167 of 521 (32.1%), NNT 29, adjusted per study, inverted to make RR<1 favor treatment, odds ratio converted to relative risk.
risk of progression, 21.0% lower, RR 0.79, p = 0.02, treatment 204 of 563 (36.2%), control 212 of 521 (40.7%), adjusted per study, odds ratio converted to relative risk, combined death/thrombosis.
risk of progression, 4.8% lower, OR 0.95, p = 0.67, treatment 563, control 521, adjusted per study, inverted to make OR<1 favor treatment, support-free days, primary outcome, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Bradbury et al., 22 Mar 2022, Randomized Controlled Trial, multiple countries, peer-reviewed, 73 authors, study period 30 October, 2020 - 23 June, 2021, trial NCT02735707 (history) (REMAP-CAP).
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Abstract: Research JAMA | Original Investigation | CARING FOR THE CRITICALLY ILL PATIENT Effect of Antiplatelet Therapy on Survival and Organ Support–Free Days in Critically Ill Patients With COVID-19 A Randomized Clinical Trial REMAP-CAP Writing Committee for the REMAP-CAP Investigators Visual Abstract IMPORTANCE The efficacy of antiplatelet therapy in critically ill patients with COVID-19 Editorial is uncertain. Supplemental content OBJECTIVE To determine whether antiplatelet therapy improves outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing adaptive platform trial (REMAP-CAP) testing multiple interventions within multiple therapeutic domains, 1557 critically ill adult patients with COVID-19 were enrolled between October 30, 2020, and June 23, 2021, from 105 sites in 8 countries and followed up for 90 days (final follow-up date: July 26, 2021). INTERVENTIONS Patients were randomized to receive either open-label aspirin (n = 565), a P2Y12 inhibitor (n = 455), or no antiplatelet therapy (control; n = 529). Interventions were continued in the hospital for a maximum of 14 days and were in addition to anticoagulation thromboprophylaxis. MAIN OUTCOMES AND MEASURES The primary end point was organ support–free days (days alive and free of intensive care unit–based respiratory or cardiovascular organ support) within 21 days, ranging from −1 for any death in hospital (censored at 90 days) to 22 for survivors with no organ support. There were 13 secondary outcomes, including survival to discharge and major bleeding to 14 days. The primary analysis was a bayesian cumulative logistic model. An odds ratio (OR) greater than 1 represented improved survival, more organ support–free days, or both. Efficacy was defined as greater than 99% posterior probability of an OR greater than 1. Futility was defined as greater than 95% posterior probability of an OR less than 1.2 vs control. Intervention equivalence was defined as greater than 90% probability that the OR (compared with each other) was between 1/1.2 and 1.2 for 2 noncontrol interventions. RESULTS The aspirin and P2Y12 inhibitor groups met the predefined criteria for equivalence at an adaptive analysis and were statistically pooled for further analysis. Enrollment was discontinued after the prespecified criterion for futility was met for the pooled antiplatelet group compared with control. Among the 1557 critically ill patients randomized, 8 patients withdrew consent and 1549 completed the trial (median age, 57 years; 521 [33.6%] female). The median for organ support–free days was 7 (IQR, −1 to 16) in both the antiplatelet and control groups (median-adjusted OR, 1.02 [95% credible interval {CrI}, 0.86-1.23]; 95.7% posterior probability of futility). The proportions of patients surviving to hospital discharge were 71.5% (723/1011) and 67.9% (354/521) in the antiplatelet and control groups, respectively (median-adjusted OR, 1.27 [95% CrI, 0.99-1.62]; adjusted absolute difference, 5% [95% CrI, −0.2% to 9.5%]; 97% posterior probability of efficacy). Among survivors, the median for organ support–free days was 14 in both groups. Major bleeding occurred in 2.1% and 0.4% of patients in the antiplatelet and control groups (adjusted OR, 2.97 [95% CrI, 1.23-8.28]; adjusted absolute risk increase, 0.8% [95% CrI, 0.1%-2.7%]; 99.4% probability of harm). CONCLUSIONS AND RELEVANCE Among critically ill patients with COVID-19, treatment with an antiplatelet agent, compared..
Late treatment
is less effective
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