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RCT | Rivaroxaban doesn’t reduce thrombotic events, hospitalization, or death in outpatients with COVID-19

15 May, 2023 | 13:19h | UTC

Summary: The PREVENT-HD trial, a double-blind, placebo-controlled randomized study, was conducted to evaluate the effectiveness of prophylactic anticoagulation in reducing venous and arterial thrombosis, hospitalization, and death in nonhospitalized patients with symptomatic COVID-19 and at least one thrombosis risk factor. The trial took place between August 2020 and April 2022 across 14 US integrated healthcare delivery networks, with 1,284 patients enrolled and randomly assigned to receive either 10 mg of oral rivaroxaban or placebo daily for 35 days.

However, the study was terminated prematurely due to enrollment challenges and lower-than-expected event rates. The primary efficacy outcome, a composite of various hazardous events, occurred in 3.4% of the rivaroxaban group and 3.0% of the placebo group, with no significant difference between the two groups (hazard ratio, 1.16 [95% CI, 0.63–2.15]; P=0.63). No critical-site or fatal bleeding was observed, and only one patient in the rivaroxaban group experienced a major bleed.

In conclusion, rivaroxaban prescribed for 35 days in nonhospitalized patients with symptomatic COVID-19 at risk for thrombosis does not appear to reduce the composite end point of venous and arterial thrombotic events, hospitalization, and death. The study’s premature termination and lower-than-expected event rates may limit the generalizability of these findings.

Article: Rivaroxaban for Prevention of Thrombotic Events, Hospitalization, and Death in Outpatients With COVID-19: A Randomized Clinical Trial – Circulation


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