The final Hot Line session of ESC Congress 2022 – focussing on new CV findings related to COVID-19 – began with a presentation of results from the COVID-PACT trial on the optimal anticoagulation regimen for COVID-19 patients in the intensive care unit (ICU). Presenter, Doctor David Berg (Brigham And Women's Hospital - Boston, USA), explains the rationale: “COVID-19 treatment guidelines recommend full-dose anticoagulation for hospitalised patients outside the ICU and the standard dose for those in the ICU.1,2 This discordant advice has left many clinicians confused about what to do, particularly in COVID-19 patients at the border-zone of needing ICU-level care. The recommendation for ICU patients is largely based on a trial which found that full-dose anticoagulation, compared with the standard dose, did not decrease the number of days alive without organ support in critically ill patients with COVID-19.”
COVID-PACT was a 2x2 factorial trial in which 390 patients with COVID-19 requiring ICU-level care were randomised 1:1 to either full-dose anticoagulation or standard-dose prophylactic anticoagulation – unfractionated heparin or low-molecular-weight heparin was used for either regimen at the discretion of the managing clinicians. In patients without another indication for antiplatelet therapy (n=292), there was an additional randomisation to either clopidogrel or no antiplatelet therapy. The primary efficacy outcome was the hierarchical composite of death due to venous or arterial thrombosis, pulmonary embolism, clinically evident deep venous thrombosis (DVT), type 1 myocardial infarction, ischaemic stroke, systemic embolic event or acute limb ischaemia, or clinically silent DVT, until hospital discharge or 28 days, whichever occurred first.
Full-dose anticoagulation lowered the risk of the primary efficacy outcome by 44% compared with the standard dose in the time-to-event analysis (9.9% versus 15.2%; hazard ratio [HR] 0.56; 95% CI 0.32 to 0.99, p=0.046). The primary safety outcome of fatal or life-threatening bleeding occurred in 2.1% of patients on full-dose anticoagulation and 0.5% of patients on standard-dose anticoagulation (p=0.19). No difference in all-cause mortality was reported between the groups (HR 0.91; 95% CI 0.56 to 1.48, p=0.70). Furthermore, there were no differences in the primary efficacy or safety outcomes in patients treated with clopidogrel compared with no antiplatelet therapy.
Dr. Berg comments, “COVID-PACT shows that full-dose anticoagulation more effectively prevents the clotting complications of COVID-19, which may be a more appropriate focus for antithrombotic therapy as a preventive intervention, and is the basis for anticoagulation recommendations in ICU patients without COVID-19.”