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Medically Ill Hospitalized Patients for COVID-19 Thrombosis Extended Prophylaxis With Rivaroxaban Therapy – MICHELLE
The MICHELLE trial showed that rivaroxaban after hospitalization for COVID-19 improved clinical outcomes without increasing bleeding.
Description:
The goal of the trial was to evaluate rivaroxaban compared with control among patients discharged after hospitalization for coronavirus 2019 (COVID-19) infection.
Study Design
- Randomization
- Parallel
Participants discharged after COVID-19 infection were randomized to rivaroxaban 10 mg daily (n = 160) versus control (n = 160).
- Total number of enrollees: 320
- Duration of follow-up: 35 days
- Mean patient age: 58 years
- Percentage female: 39%
Inclusion criteria:
- ≥18 years of age
- Hospitalized for minimum of 3 days with COVID-19 infection
- On standard-dose thromboprophylaxis
- Total modified IMPROVE venous thromboembolism (VTE) Risk Score ≥4, or
- Total modified IMPROVE VTE Risk Score 2 or 3 and D-dimer >500 ng/ml
Exclusion criteria:
- Any bleeding within the last 3 months
- Surgery, biopsy, or trauma within the last 4 weeks or planned
- Required anticoagulation after discharge
- Use of dual antiplatelet therapy during hospitalization
- Chronic kidney disease
Principal Findings:
The primary outcome, composite of symptomatic VTE, VTE-related death, bilateral VTE, symptomatic arterial thromboembolism, myocardial infarction, nonhemorrhagic stroke, major adverse limb event, or cardiovascular death at 35 days, was 3.14% in the rivaroxaban group compared with 9.43% in the control group (p = 0.03).
Secondary outcomes:
- Incidence of major bleeding according to International Society on Thrombosis and Haemostasis (ISTH) criteria: 0% vs. 0%
Interpretation:
Among patients discharged after COVID-19 infection, rivaroxaban for 35 days was beneficial. Rivaroxaban was associated with a reduction in clinical events without increasing major bleeding.
References:
Presented by Dr. Eduardo Ramacciotti at the European Society of Cardiology Virtual Congress, August 29, 2021.
Créditos: Comité científico Covid
