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Rivaroxaban versus no anticoagulation for post-discharge thromboprophylaxis after hospitalisation for COVID-19 (MICHELLE): an open-label, multicentre, randomised, controlled trial.

Publication ,  Journal Article
Ramacciotti, E; Barile Agati, L; Calderaro, D; Aguiar, VCR; Spyropoulos, AC; de Oliveira, CCC; Lins Dos Santos, J; Volpiani, GG; Sobreira, ML ...
Published in: Lancet
January 1, 2022

BACKGROUND: Patients hospitalised with COVID-19 are at risk for thrombotic events after discharge; the role of extended thromboprophylaxis in this population is unknown. METHODS: In this open-label, multicentre, randomised trial conducted at 14 centres in Brazil, patients hospitalised with COVID-19 at increased risk for venous thromboembolism (International Medical Prevention Registry on Venous Thromboembolism [IMPROVE] venous thromboembolism [VTE] score of ≥4 or 2-3 with a D-dimer >500 ng/mL) were randomly assigned (1:1) to receive, at hospital discharge, rivaroxaban 10 mg/day or no anticoagulation for 35 days. The primary efficacy outcome in an intention-to-treat analysis 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. Adjudication was blinded. The primary safety outcome was major bleeding. The primary and safety analyses were carried out in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT04662684. FINDINGS: From Oct 8, 2020, to June 29, 2021, 997 patients were screened. Of these patients, 677 did not meet eligibility criteria; the remaining 320 patients were enrolled and randomly assigned to receive rivaroxaban (n=160 [50%]) or no anticoagulation (n=160 [50%]). All patients received thromboprophylaxis with standard doses of heparin during hospitalisation. 165 (52%) patients were in the intensive care unit while hospitalised. 197 (62%) patients had an IMPROVE score of 2-3 and elevated D-dimer levels and 121 (38%) had a score of 4 or more. Two patients (one in each group) were lost to follow-up due to withdrawal of consent and not included in the intention-to-treat primary analysis. The primary efficacy outcome occurred in five (3%) of 159 patients assigned to rivaroxaban and 15 (9%) of 159 patients assigned to no anticoagulation (relative risk 0·33, 95% CI 0·12-0·90; p=0·0293). No major bleeding occurred in either study group. Allergic reactions occurred in two (1%) patients in the rivaroxaban group. INTERPRETATION: In patients at high risk discharged after hospitalisation due to COVID-19, thromboprophylaxis with rivaroxaban 10 mg/day for 35 days improved clinical outcomes compared with no extended thromboprophylaxis. FUNDING: Bayer.

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Published In

Lancet

DOI

EISSN

1474-547X

Publication Date

January 1, 2022

Volume

399

Issue

10319

Start / End Page

50 / 59

Location

England

Related Subject Headings

  • Venous Thromboembolism
  • Treatment Outcome
  • Rivaroxaban
  • Patient Discharge
  • Middle Aged
  • Male
  • Humans
  • Hospitalization
  • Heparin
  • General & Internal Medicine
 

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Ramacciotti, E., Barile Agati, L., Calderaro, D., Aguiar, V. C. R., Spyropoulos, A. C., de Oliveira, C. C. C., … MICHELLE investigators, . (2022). Rivaroxaban versus no anticoagulation for post-discharge thromboprophylaxis after hospitalisation for COVID-19 (MICHELLE): an open-label, multicentre, randomised, controlled trial. Lancet, 399(10319), 50–59. https://doi.org/10.1016/S0140-6736(21)02392-8
Ramacciotti, Eduardo, Leandro Barile Agati, Daniela Calderaro, Valéria Cristina Resende Aguiar, Alex C. Spyropoulos, Caroline Candida Carvalho de Oliveira, Jessica Lins Dos Santos, et al. “Rivaroxaban versus no anticoagulation for post-discharge thromboprophylaxis after hospitalisation for COVID-19 (MICHELLE): an open-label, multicentre, randomised, controlled trial.Lancet 399, no. 10319 (January 1, 2022): 50–59. https://doi.org/10.1016/S0140-6736(21)02392-8.
Ramacciotti E, Barile Agati L, Calderaro D, Aguiar VCR, Spyropoulos AC, de Oliveira CCC, 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):50–9.
Ramacciotti, Eduardo, et al. “Rivaroxaban versus no anticoagulation for post-discharge thromboprophylaxis after hospitalisation for COVID-19 (MICHELLE): an open-label, multicentre, randomised, controlled trial.Lancet, vol. 399, no. 10319, Jan. 2022, pp. 50–59. Pubmed, doi:10.1016/S0140-6736(21)02392-8.
Ramacciotti E, Barile Agati L, Calderaro D, Aguiar VCR, Spyropoulos AC, de Oliveira CCC, Lins Dos Santos J, Volpiani GG, Sobreira ML, Joviliano EE, Bohatch Júnior MS, da Fonseca BAL, Ribeiro MS, Dusilek C, Itinose K, Sanches SMV, de Almeida Araujo Ramos K, de Moraes NF, Tierno PFGMM, de Oliveira ALML, Tachibana A, Chate RC, Santos MVB, de Menezes Cavalcante BB, Moreira RCR, Chang C, Tafur A, Fareed J, Lopes RD, MICHELLE investigators. 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.
Journal cover image

Published In

Lancet

DOI

EISSN

1474-547X

Publication Date

January 1, 2022

Volume

399

Issue

10319

Start / End Page

50 / 59

Location

England

Related Subject Headings

  • Venous Thromboembolism
  • Treatment Outcome
  • Rivaroxaban
  • Patient Discharge
  • Middle Aged
  • Male
  • Humans
  • Hospitalization
  • Heparin
  • General & Internal Medicine