Reviewer: : Dr. İlyas Çetin

Name of the Study: Anticoagulation and Antiplatelet Therapy for the Prevention of Venous and Arterial Thrombotic Events in Critically Sick Patients with COVID-19: COVID-PACT

Published Congress: ESC 2022

Link : http://clinicaltrialresults.org/dr-david-berg-presents-covid-pact-antithrombotic-therapy-in-critically-ill-covid-19-patients/

Introduction:

Infection with SARS-CoV2 is associated with an increased risk of thrombosis. This risk is higher in intensive care patients. The efficacy and safety of prophylactic anticoagulant and antiaggregant therapy has not been clearly demonstrated.

Aims:

The efficacy and benefit of an anticoagulant and antiaggregant treatment strategy in covid-infected individuals was investigated by a multiple randomized COVID-PACT study.

Methods:

COVID-PACT was a multicenter double-blind randomized controlled trial in intensive care patients. Randomization was done as patients given full-dose and standard-dose anticoagulants. The indication for antiplatelet was not randomized to additional antiplatelet therapy. The primary efficacy outcome was venous or arterial thrombosis, pulmonary embolism, clinically while marked deep vein thrombosis (DVT), type 1 myocardial infarction, ischemic stroke, systemic embolic event, or death due to acute limb ischemia; The primary safety outcome was fatal or life-threatening bleeding.

Results:

The study was conducted at 34 centers in the United States. 390 patients were randomized in the anticoagulant arm and 292 patients in the antiaggregant arm. 99% of these patients needed advanced respiratory support and 15% were receiving invasive mechanical support. In the anticoagulation arm, standard dose anticoagulation (Full-dose anticoagulation showed greater benefit (12.3%) compared to 6.4%; win rate 1.95, 95% CI 1.08-3.55, p=0.028). The primary safety endpoint was observed in 4 (2%) patients receiving full-dose anticoagulation and 1 (0.5%) receiving standard doses (p=0.19). The secondary safety endpoint occurred in 15 (7.9%) versus 1 (0.5%; p=0.002). However, there was no difference in all-cause mortality (HR 0.91, 95% CI 0.56-1.48; p=0.70). There was no difference in the primary efficacy and safety endpoints of clopidogrel versus no antiplatelet therapy.

Conclusion:

In critical covid-19 patients requiring intensive care, full-dose anticoagulation reduced thrombotic complications with an increased risk of bleeding compared to clopidogrel. No significant difference in mortality was observed.