6/28/23, 11:16 PM MICHELLE Pathway Feedback Search Clinical Topics Home Studies MICHELLE MICHELLE Disease COVID 19 infection Trial question What is the role of rivaroxaban in patients at high risk for VTE discharged after hospitalization due to COVID-19? Study design Multi-center Open label RCT Population Characteristics of study participants 40.0% female N = 318 60.0% male 318 patients (127 female, 191 male) Inclusion criteria: patients hospitalized with COVID-19 at increased risk for VTE Key exclusion criteria: IMPROVE-VTE score < 4 and D-dimer within normal range, severe renal failure, indication for anticoagulation therapy, contraindications to anticoagulation Interventions N=159 rivaroxaban (10 mg/day for 35 days) N=159 no anticoagulation (regular follow-up for 35 days) Primary outcome https://web.pathway.md/studies/recZ4IWYy6S2Jt0mH 1/2 6/28/23, 11:16 PM MICHELLE Pathway 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 9.4 % 9.43 7.1 % 4.7 % Significant decrease 3.14 NNT = 16 2.4 % 0.0 % Rivaroxaban No anticoagulation Significant decrease in symptomatic or fatal VTE, asymptomatic VTE on bilateral lower-limb venous ultrasound and CT pulmonary angiogram, symptomatic arterial thromboembolism, and cardiovascular death at day 35 (3.14% vs. 9.43%; RR 0.33, 95% CI 0.13 to 0.9) Secondary outcomes Significant decrease in symptomatic and fatal VTE (0.63% vs. 5.03%; RR 0.13, 95% CI 0.02 to 0.99) No significant difference in symptomatic VTE and all-cause mortality (2.52% vs. 5.66%; RR 0.44, 95% CI 0.14 to 1.41) Significant decrease in symptomatic VTE, myocardial infarction stroke, cardiovascular death (0.63% vs. 5.66%; RR 0.11, 95% CI 0.01 to 0.87) Safety outcomes No significant differences in clinically relevant non-major bleeding, other bleeding. Conclusion In patients hospitalized with COVID-19 at increased risk for VTE, rivaroxaban was superior to no anticoagulation with respect to symptomatic or fatal VTE, asymptomatic VTE on bilateral lower-limb venous ultrasound and CT pulmonary angiogram, symptomatic arterial thromboembolism, and cardiovascular death at day 35. Reference Eduardo Ramacciotti, Leandro Barile Agati, Daniela Calderaro et al. Rivaroxaban versus no anticoagulation for post-discharge thromboprophylaxis after hospitalisation for COVID-19 (MICHELLE): an open-label, multicentre, randomised, controlled trial. Lancet. 2021 Dec 15;S0140- 6736(21)02392-8. Open reference URL https://web.pathway.md/studies/recZ4IWYy6S2Jt0mH 2/2