Rivaroxaban vs no anticoagulation for post-discharge thromboprophylaxis after hospitalisation for COVID-19 (MICHELLE): An open-label, multicentre, randomised, controlled trial
The Lancet Dec 23, 2021
Ramacciotti E, Agati LB, Calderaro D, et al. - Thromboprophylaxis with rivaroxaban 10 mg/day for 35 days in patients at high risk discharged post-hospitalisation due to COVID-19 was found to result in improved clinical outcomes in comparison to no extended thromboprophylaxis.
In this open-label, multicentre, randomised trial, 320 patients hospitalised with COVID-19 at increased risk for venous thromboembolism were randomized to receive, at hospital discharge, rivaroxaban (n=160 [50%]) or no anticoagulation (n=160 [50%]) for 35 days.
The primary efficacy outcome was a composite of symptomatic or fatal venous thromboembolism, asymptomatic venous thromboembolism on bilateral lower-limb venous ultrasound and CT pulmonary angiogram, symptomatic arterial thromboembolism, and cardiovascular death at day 35.
In the rivaroxaban and no anticoagulation groups, the primary efficacy outcome occurred in 3% and 9% of the patients, respectively (relative risk 0·33, 95% CI 0·12–0·90).
In either study group, no major bleeding occurred.
In the rivaroxaban group, allergic reactions developed in 1%.
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