Evidence map›Paper›PMID 34921756›Full record

Trial reportLancet (London, England)2022

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

Eduardo Ramacciotti, Leandro Barile Agati, Daniela Calderaro, Valéria Cristina Resende Aguiar, Alex C Spyropoulos, Caroline Candida Carvalho de Oliveira, Jessica Lins Dos Santos, Giuliano Giova Volpiani, Marcone Lima Sobreira, Edwaldo Edner Joviliano and 20 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lancet (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04662684 (Medically Ill Hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis With Rivaroxaban ThErapy), which is not on this map. Cited by 141 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
141citing papers in PubMed, 15 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04662684 phase3completednot on this map

Medically Ill Hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis With Rivaroxaban ThErapy: The MICHELLE Trial

TypeinterventionalSponsorScience Valley Research InstituteRan2020 to 2021Enrolled320ConditionsCovid19, Venous ThromboembolismArmsRivaroxaban 10 MG
3 · Its place in the literature

Who cites it

141 citing papers in PubMed, 15 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. SEOM clinical guidelines on venous thromboembolism (VTE) and cancer (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Prophylactic anticoagulants for non-hospitalised people with COVID-19.The Cochrane database of systematic reviews · 2023
    Pooled it
  10. Pooled it
  11. Guideline
  12. Pooled it
  13. Pooled it
  14. ESCMID rapid guidelines for assessment and management of long COVID.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2022
    Guideline
  15. Use of anticoagulants in patients with COVID-19: a living systematic review and meta-analysis.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2022
    Pooled it
  16. Trial
  17. Trial
  18. Article
  19. Review
  20. Review

81 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

30 authors.

Eduardo RamacciottiScience Valley Research Institute, São Paulo, Brazil; Hospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, São Paulo, Brazil. Electronic address: ramacciotti@svriglobal.com.
Leandro Barile AgatiScience Valley Research Institute, São Paulo, Brazil.
Daniela CalderaroUnidade de Medicina Interdisciplinar em Cardiologia, Instituto do Coração, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
Valéria Cristina Resende AguiarScience Valley Research Institute, São Paulo, Brazil; Hospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, São Paulo, Brazil.
Alex C SpyropoulosZucker School of Medicine at Hofstra/Northwell and the Feinstein Institutes for Medical Research, Manhasset, NY, USA; Department of Obstetrics and Gynecology, I M Sechenov First Moscow State Medical University, Moscow, Russia.
Caroline Candida Carvalho de OliveiraScience Valley Research Institute, São Paulo, Brazil; Hospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, São Paulo, Brazil.
Jessica Lins Dos SantosScience Valley Research Institute, São Paulo, Brazil.
Giuliano Giova VolpianiHospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, São Paulo, Brazil.
Marcone Lima SobreiraUniversidade Estadual Paulista, Botucatu, Brazil.
Edwaldo Edner JovilianoHospital das Clínicas de Ribeirão Preto, São Paulo University Medical School, Ribeirão Preto, São Paulo, Brazil.
Milton Sérgio Bohatch JúniorHospital das Clínicas de Ribeirão Preto, São Paulo University Medical School, Ribeirão Preto, São Paulo, Brazil.
Benedito Antônio Lopes da FonsecaHospital das Clínicas de Ribeirão Preto, São Paulo University Medical School, Ribeirão Preto, São Paulo, Brazil.
Maurício Serra RibeiroHospital das Clínicas de Ribeirão Preto, São Paulo University Medical School, Ribeirão Preto, São Paulo, Brazil.
Cesar DusilekHospital do Rocio, Campo Largo, Paraná, Brazil.
Kengi ItinoseHospital do Rocio, Campo Largo, Paraná, Brazil.
Suzanna Maria Viana SanchesInstituto Couto Maia, Salvador, Bahia, Brazil.
Karine de Almeida Araujo RamosInstituto Couto Maia, Salvador, Bahia, Brazil.
Nara Franzin de MoraesHospital Municipal de Barueri, São Paulo, Brazil.
Paulo Fernando Guimarães Morando Marzocchi TiernoHospital Municipal de Barueri, São Paulo, Brazil.
André Luiz Malavasi Longo de OliveiraSão Paulo State Public Women's Health Reference Center, São Paulo, Brazil.
Adriano TachibanaHospital Israelita Albert Einstein, São Paulo, Brazil.
Rodrigo Caruso ChateHospital Israelita Albert Einstein, São Paulo, Brazil.
Marcus Vinícius Barbosa SantosInstituto do Coração, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
Bruno Bezerra de Menezes CavalcanteInstitute of Teaching and Research Hapvida, Fortaleza, CE, Brazil.
Ricardo Cesar Rocha MoreiraHospital Nossa Senhora das Graças, Curitiba, Brazil.
Chiann ChangDepartment of Statistics, Institute of Mathematics and Statistics, University of São Paulo, São Paulo, Brazil.
Alfonso TafurNorthshore University Health System, Chicago, IL, USA.
Jawed FareedHemostasis and Thrombosis Research Laboratories at Loyola University Medical Center, Maywood, IL, USA.
Renato D LopesDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
MICHELLE investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients hospitalised with COVID-19 are at risk for thrombotic events after discharge; the role of extended thromboprophylaxis in this population is unknown.

methodsIn 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.

findingsFrom 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.

interpretationIn 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.

fundingBayer.

Indexed as

AftercareAdultAgedBlood CoagulationCOVID-19COVID-19 Drug TreatmentFactor Xa InhibitorsFemaleHeparinHospitalizationHumansMaleMiddle AgedPatient DischargeRivaroxabanTreatment OutcomeFactor Xa InhibitorsHeparinRivaroxaban

Identifiers

PMID34921756
PMCPMC8673881

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.