Prophylactic anticoagulation in critical COVID-19: Is full-dose or standard-dose preferred?

Prophylactic anticoagulation in critical COVID-19: Is full dose or standard dose preferred? | The latest news for doctors, nurses and pharmacists | Respirology

A full-dose prophylactic anticoagulation strategy reduced the risk of thrombosis in critically ill patients with COVID-19 who required intensive care unit (ICU) care compared with a standard-dose strategy, according to the results of the COVID-PACT trial.

Participants in this multicenter (34 US sites), open-label study included 382 patients (median age 61 years, 41 percent female, 68 percent with BMI
30 kg/m2) with COVID-19 warranting care at ICU level*. They were randomized 1:1 to receive full-dose or standard-dose prophylactic anticoagulation with either unfractionated heparin or low-molecular-weight heparin at the physician’s discretion. A total of 292 antiplatelet-naïve patients in each randomized group were further randomized 1:1 to either clopidogrel (300 mg loading dose on day 1 followed by 75 mg/day) or no antiplatelet therapy. The most common comorbidities in the population were hypertension and diabetes (59 and 32 percent, respectively).

At day 28 or hospital discharge, whichever occurred first, the risk of the primary endpoint** was reduced by 44 percent in patients assigned to the full dose vs. standard dose of prophylactic anticoagulation (9.9 percent vs. 15.2 percent; hazard ratio [HRon treatment]0.56, 95 percent confidence interval [CI], 0.32–0.99; p=0.046). The stratified odds ratio for full dose versus standard dose anticoagulation was 1.95 (p=0.028). [ESC 2022, Hot Line Session 10]

In patients with full dose vs. standard-dose anticoagulation (7.3 percent vs. 12.0 percent; HRabout treatment, 0.55, 95 percent CI, 0.28–1.08). The incidence of all-cause mortality was comparable between groups (18.8 percent vs 16.8 percent; HRabout treatment, 0.91, 95 percent CI, 0.56–1.48; p=0.70).

The primary safety endpoint of life-threatening or fatal bleeding was not significantly different between groups (2.1 percent vs 0.5 percent; HR 3.86; p=0.19). Outcome was affected by life-threatening bleeding in four and one patient on full and standard dose anticoagulation, respectively, with no fatal bleeding in any group. The incidence of moderate (requiring transfusion without hemodynamic compromise) or severe (fatal, intracranial, or causing hemodynamic deterioration) GUSTO bleeding occurred in more full-dose recipients than standard-dose anticoagulation recipients (moderate: 11 vs 0 events; severe: 4 vs 1 events; 7.9 percent vs 0.5 percent; HR, 12.30; p = .002).

Clopidogrel vs no antiplatelet agents

The risk of coagulation complications did not differ between patients assigned to clopidogrel or no antiplatelet therapy (HR, 0.90, 95% CI, 0.48–1.69; p=0.75), with no significant stratified win ratio benefit in favor of clopidogrel (1.04; p=0.90). There were two cases of life-threatening bleeding in the clopidogrel and no antiplatelet therapy groups, and no cases of fatal bleeding in either group. 31 percent of patients discontinued clopidogrel treatment prematurely.

Which strategy to choose?

“Guidelines for the treatment of COVID-19 recommend a full dose of anticoagulation for hospitalized patients outside the ICU and a standard dose for patients in the ICU,” said study author Dr David Berg of Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA. . “This discordant advice has left many doctors confused about what to do, especially for patients with COVID-19 in the border zone who need ICU-level care,” he added.

“Due to the risk of clotting and bleeding, full-dose anticoagulation should be considered to prevent blood clots in selected critically ill patients with COVID-19. “These findings may be relevant in revising current guidelines for the management of critically ill patients with COVID-19, including those treated with advanced, non-invasive respiratory support,” concluded Berg.

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