MICHELLE
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
60.0% male
N = 318
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
Symptomatic or fatal venous thromboembolism, asymptomatic venous thromboembolism on bilateral lower-limb venous ultrasound and CT pulmonary angiogram, symptomatic arterial thromboembolism, and CV death at day 35
3.14%
9.43%
9.4 %
7.1 %
4.7 %
2.4 %
0.0 %
Rivaroxaban
No
anticoagulation
Significant
decrease ▼
NNT = 15
Significant decrease in symptomatic or fatal VTE, asymptomatic VTE on bilateral lower-limb venous ultrasound and CT pulmonary angiogram, symptomatic arterial thromboembolism, and CV 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, MI stroke, CV 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 CV 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. 2022 Jan 1;399(10319):50-59.
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