Rivaroxaban for prophylactic anticoagulation in COVID-19 strikes out
The use of rivaroxaban in nonhospitalized patients with symptomatic COVID-19 falls short of reducing the composite endpoint of venous and arterial thrombotic events, hospitalization, and death, according to data from PREVENT-HD*.
PREVENT-HD was conducted across 14 integrated healthcare delivery networks in the US. Nonhospitalized patients with symptomatic COVID-19 and at least one thrombosis risk factor were enrolled and randomly assigned to receive either 10 mg of oral rivaroxaban or placebo daily for 35 days.
The primary efficacy endpoint was time to first occurrence of a composite of symptomatic venous thromboembolism, myocardial infarction, ischaemic stroke, acute limb ischemia, noncentral nervous system systemic arterial embolism, hospitalization, or death through day 35. Safety was also assessed with International Society on Thrombosis and Hemostasis critical-site or fatal bleeding as the outcome. The last study visit was on day 49.
PREVENT-HD was terminated after enrolment of 32 percent of planned accrual because of recruitment challenges and lower-than-expected event rate. The analysis included 1,284 patients, of which 641 received rivaroxaban and 643 received placebo. None of them were lost to follow-up.
The primary efficacy outcome occurred in 3.4 percent of patients in the rivaroxaban group and in 3.0 percent in the placebo group. The difference was not significant (hazard ratio, 1.16, 95 percent confidence interval, 0.63–2.15; p=0.63).
None of the patients in either group experienced critical-site or fatal bleeding. A single patient on rivaroxaban had a major bleed.
*A Study of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic COVID-19] Infection