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• Patients who are hospitalized with COVID-19 have been shown to have a high risk of thromboembolic events post discharge. In this open-label randomized trial, the authors showed that, in high-risk patients who are hospitalized for COVID-19, the use of thromboprophylaxis and rivaroxaban for 35 days after discharge improved composite outcomes of symptomatic/fatal VTE, asymptomatic VTE on bilateral lower-limb venous ultrasound and CTPA, symptomatic arterial thromboembolism, and cardiovascular death.
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• Thromboprophylaxis with rivaroxaban should be considered after discharge in high-risk patients who are hospitalized for COVID-19.

VTE (Venous thromboembolism): VTE is a disorder that includes deep vein thrombosis and pulmonary embolism.

Abstract:

Background: The thrombosis signal emerged early in the COVID-19 pandemic, and a number of trials have now been completed evaluating different anticoagulation regimens during hospitalization. Although the risk of thrombosis during hospitalization with COVID-19 is clear, what has been less apparent is whether this risk extends into the post-discharge setting. Retrospective analyses identified fairly modest rates of thrombosis after hospitalization (<3%) but noted a signal of hemorrhage even in the absence of anticoagulation. 

Objective: In this context, the authors conducted an open-label, multicenter, randomized trial evaluating rivaroxaban (10 mg) versus no anticoagulant following hospitalization for COVID-19.

Methods: The primary endpoint for the trial was a composite of venous and arterial thromboembolism (or cardiovascular death) at day 35. Eligibility for inclusion required high VTE risk defined as an IMPROVE VTE score of 2 to 3 along with a D-dimer above 500 ng/mL or an IMPROVE VTE score of 4 or greater. A unique element to this study was scheduled radiographic assessments for asymptomatic VTE at day 35 that included both a CT pulmonary angiogram along with bilateral lower-extremity ultrasound.

Results: A total of 320 patients were randomized, and the investigators observed a significant 67% reduction in the primary endpoint. Notably, there were no reported major hemorrhages in either arm. The therapeutic benefit derived primarily by a reduction of pulmonary emboli, with nine pulmonary emboli in the control arm (including three fatal events) and two pulmonary emboli in the rivaroxaban arm (no fatal events).

Conclusion: These data are quite compelling and suggest that a sufficiently high-risk COVID-19 population can be identified at the time of discharge to warrant post-discharge thromboprophylaxis. In patients at high risk discharged after hospitalization due to COVID-19, thromboprophylaxis with rivaroxaban 10 mg/day for 35 days improved clinical outcomes compared with no extended thromboprophylaxis.

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