Therapeutic Anticoagulation May Not Improve Outcomes In COVI
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Recent research has highlighted that in patients hospitalised with COVID-19 and elevated D-dimer concentration, in hospital therapeutic anticoagulation with rivaroxaban or enoxaparin followed by rivaroxaban to day 30 did not improve clinical outcomes and increased bleeding compared with prophylactic anticoagulation.

The study reports elaborated that use of therapeutic-dose rivaroxaban, and other direct oral anticoagulants, should be avoided in these patients in the absence of an evidence-based indication for oral anticoagulation. Researchers aimed to compare the efficacy and safety of therapeutic versus prophylactic anticoagulation in this population.

For the study design, the team did a pragmatic, open-label, multicentre, randomised, controlled trial, at 31 sites in Brazil. Patients (aged more than 18 years) hospitalised with COVID-19 and elevated D-dimer concentration, and who had COVID-19 symptoms for up to 14 days before randomisation, were randomly assigned (1:1) to receive either therapeutic or prophylactic anticoagulation.

Therapeutic anticoagulation was in-hospital oral rivaroxaban (20 mg or 15 mg daily) for stable patients, or initial subcutaneous enoxaparin (1 mg/kg twice per day) or intravenous unfractionated heparin (to achieve a 0·3–0·7 IU/mL anti-Xa concentration) for clinically unstable patients, followed by rivaroxaban to day 30. Prophylactic anticoagulation was standard in-hospital enoxaparin or unfractionated heparin.

The primary efficacy outcome was a hierarchical analysis of time to death, duration of hospitalisation, or duration of supplemental oxygen to day 30, analysed with the win ratio method (a ratio greater than 1 reflects a better outcome in the therapeutic anticoagulation group) in the intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding through 30 days.

Findings put forth some key facts:
• From June 24, 2020, to Feb 26, 2021, 3331 patients were screened and 615 were randomly allocated.

• 576 (94%) were clinically stable and 39 (6%) clinically unstable. One patient, in the therapeutic group, was lost to follow-up because of withdrawal of consent and was not included in the primary analysis.

• The primary efficacy outcome was not different between patients assigned therapeutic or prophylactic anticoagulation, with 28?899 (34·8%) wins in the therapeutic group and 34?288 (41·3%) in the prophylactic group.

• Consistent results were seen in clinically stable and clinically unstable patients.

• The primary safety outcome of major or clinically relevant non-major bleeding occurred in 26 (8%) patients assigned therapeutic anticoagulation and seven (2%) assigned prophylactic anticoagulation. Allergic reaction to the study medication occurred in two (1%) patients in the therapeutic anticoagulation group and three (1%) in the prophylactic anticoagulation group.

Source:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01203-4/fulltext
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