Therapeutic anticoagulation not superior to prophylactic anticoagulation in COVID-19

Rivaroxaban did not demonstrate improved clinical outcomes when compared with in-hospital prophylactic anticoagulation in patients who were hospitalised for COVID-19 and had elevated D-dimer levels. Furthermore, those treated with rivaroxaban showed increased rates of bleeding compared with those receiving prophylactic anticoagulation in the Coalition ACTION trial [1,2].

Patients with COVID-19 frequently experience venous and arterial thromboembolism. Elevated levels of D-dimer, a thrombotic biomarker, are harbingers of poorer clinical outcomes (i.e. disease progression and mortality). Data is needed regarding the type, dosage, and duration of an anticoagulation strategy.

Prof. Renato Lopes (Duke University Medical Center, NC, USA) presented the results of the Coalition ACTION trial (NCT04394377), which was designed to investigate the effectiveness of a full anticoagulation strategy compared with a prophylactic anticoagulation strategy in patients who had been hospitalised for COVID-19 and had elevated D-dimer levels. One group (n=311) received a 30-day course of rivaroxaban (20 mg once daily); the comparison group (n=304) received the standard in-hospital prophylactic venous thromboembolism protocol. The primary outcome was a hierarchical analysis of mortality, length of hospital stay, and duration of oxygen therapy over the 30-day intervention period. Results were analysed using an unmatched win ratio method, stratified by clinical severity.

At 30 days, analysis of primary outcome data demonstrated that 41.3% of participants in the prophylactic group had won compared with only 34.8% of participants in the rivaroxaban group. The remaining 23.9% were tied (see Figure).

 

Figure: Primary outcome results at 30 days in the COALITION ACTION trial [1]



The primary safety outcome of the study was a major or clinically relevant non-major bleed, as designated by the International Society on Thrombosis and Haemostasis criteria. In the rivaroxaban group, 26 bleeds occurred (8.4%) versus 7 bleeds in the prophylactic group (2.3%), yielding a relative risk ratio of 3.64% (95% CI 1.61–8.27). In terms of all-cause mortality, 35/310 patients (11.3%) in the rivaroxaban group died compared with 23/304 patients in the prophylactic anticoagulation group (7.6%), yielding a relative risk ratio of 1.49 (95% CI 0.90–2.46).

The investigators concluded that therapeutic anticoagulation with rivaroxaban in patients hospitalised for COVID-19 did not improve clinical outcomes and increased bleeding when compared with in-hospital prophylactic anticoagulation.

1. 
   
   1. Lopes RD. Randomised Clinical Trial to Evaluate A Routine Full Anticoagulation Strategy in Patients with Coronavirus Infection (SARS-CoV-2) Admitted to Hospital: The Coalition ACTION Trial. Abstract 409-14, ACC 2021 Scientific Session, 15–17 May.
   2. Lopes RD, et al. Lancet 2021;397(10291):2253-63.

 

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Posted on 9 July, 202129 July, 2021