In a study prematurely terminated for recruitment difficulties and a low event rate, rivaroxaban did not reduce a composite endpoint of venous and arterial thrombotic events, hospitalization, and death in ambulatory patients with COVID-19, a study shows.
In Aug. 2020 to Apr. 2022, ambulatory participants with symptomatic COVID-19 and at least 1 thrombosis risk factor were enrolled in the PREVENT-HD trial at 14 U.S. integrated healthcare delivery networks. Random assignment to rivaroxaban 10 mg orally or placebo daily for 35 days, results showed the following for a composite of symptomatic venous thromboembolism, myocardial infarction, ischemic stroke, acute limb ischemia, non–central nervous system systemic arterial embolism, hospitalization, or death through day 35: “The study was terminated prematurely because of enrollment challenges and a lower-than-expected blinded pooled event rate. A total of 1284 patients underwent randomization with complete accrual of primary events through May 2022. No patients were lost to follow-up. The primary efficacy outcome occurred in 22 of 641 in the rivaroxaban group and 19 of 643 in the placebo group (3.4% versus 3.0%; hazard ratio, 1.16 [95% CI, 0.63–2.15]; P = 0.63). No patient in either group experienced critical-site or fatal bleeding. One patient receiving rivaroxaban had a major bleed.”