Effect of Antiplatelet Therapy on Survival and Organ Support–Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial
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).
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
Please send us corrections, updates, or comments. Vaccines and
treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, or intervention
is 100% available and effective for all current and future variants. We do not
provide medical advice. Before taking any medication, consult a qualified
physician who can provide personalized advice and details of risks and
benefits based on your medical history and situation.
FLCCC and
WCH
provide treatment protocols.
Submit