Abstract
Background: Thromboprophylaxis with rivaroxaban 10 mg once daily has been shown to reduce the risk of major thrombotic events in patients with COVID-19 both in-hospital and after discharge. The potential role of thromboprophylaxis with rivaroxaban in high-risk outpatients with COVID-19 was examined in 2 randomized, controlled trials; pooled analyses of these studies will enable evaluation of consistency of findings. Methods: PREVENT-HD (NCT04508023) and the Bill and Melinda Gates Medical Research Institute (Gates MRI) study (NCT04504032) are both virtually conducted, pragmatic trials which randomized patients with acute COVID-19 to rivaroxaban 10 mg daily or placebo (PREVENT-HD)/placebo equivalent (Gates MRI) on top of standard care (Figure). Both studies collected clinical outcomes including all-cause hospitalization, death, thrombotic and bleeding events. A patient-level meta-analysis was prespecified prior to PREVENT-HD database lock. Results: The 2 trials randomized a total of 1,781 patients. PREVENT-HD closeout is ongoing with anticipated unblinding in July 2022 and submission to AHA as an LBCT. Gates MRI study results have been reported; among the 497 randomized patients, clinical events were infrequent overall, with hospitalizations in 3 (1.4%) patients receiving rivaroxaban and 7 (3.2%) in the placebo group (RR 0.43, 95% CI 0.11, 1.65; p=0.21). A planned pooled analysis will occur after PREVENT-HD database lock enabling presentation at AHA 2022 if selected. Conclusions: A patient-level meta-analysis of 2 randomized, controlled trials of similar design evaluating rivaroxaban 10 mg daily for pre-hospital prevention of thrombotic complications, hospitalization, and death in outpatients with COVID-19 will be conducted. We hope to present the results at the AHA Scientific Sessions.
Published Version
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