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Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale

Eduardo Ramacciotti1, Leandro Barile Agati2, Daniela Calderaro3

  • 1Science Valley Research Institute, Santo André, São Paulo, Brazil; Hospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, São Paulo, Brazil.

American Heart Journal
|September 4, 2021
PubMed

Insights

The MICHELLE trial investigated extended rivaroxaban prophylaxis for COVID-19 patients at high risk for venous thromboembolism (VTE). Results will inform optimal post-discharge treatment strategies to prevent blood clots.

Area of Science:

  • Cardiology
  • Hematology
  • Infectious Diseases

Background:

  • The Coronavirus disease (COVID-19) pandemic is linked to a significant prothrombotic state.
  • Mechanisms causing COVID-19-associated coagulation abnormalities, including direct SARS-CoV-2 effects, cytokine storm, and endothelial damage, are not fully understood.
  • Pharmacological thromboprophylaxis is recommended for hospitalized COVID-19 patients, but optimal dosage and duration, particularly extended prophylaxis post-discharge, remain debated.

Purpose of the Study:

  • To evaluate the safety and efficacy of extended rivaroxaban prophylaxis in COVID-19 patients at increased risk for venous thromboembolism (VTE) after hospital discharge.
  • To compare rivaroxaban 10 mg once daily for 35 ± 4 days against no intervention in preventing VTE and arterial thromboembolism.
  • To assess the incidence of major bleeding as a key safety outcome.

Main Methods:

  • The MICHELLE trial is a prospective study involving COVID-19 patients at increased risk for VTE who received standard in-hospital VTE prophylaxis.
  • Participants were randomized to receive either rivaroxaban 10 mg once daily for 35 ± 4 days or no intervention after hospital discharge.
  • Efficacy endpoints included symptomatic VTE, VTE-related death, imaging-confirmed VTE, symptomatic arterial thromboembolism, and cardiovascular death. Safety was assessed by major bleeding incidence.

Main Results:

  • This section is not available in the provided abstract.

Conclusions:

  • The MICHELLE trial is expected to provide high-quality evidence on the role of extended thromboprophylaxis in COVID-19 patients.
  • Findings will aid in guiding clinical practice decisions regarding post-discharge VTE prevention strategies.
  • The study aims to clarify the optimal management of thrombotic risk in the post-acute phase of COVID-19.
Abstract

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