Anticoagulation Strategies in Non-Critically Ill Patients with Covid-19

Zoe K McQuilten; Balasubramanian Venkatesh; Vivekanand Jha; Jason Roberts; Susan C Morpeth; James A Totterdell; Grace M McPhee; John Abraham; Niraj Bam; Methma Bandara; Ashpak K Bangi; Lauren A Barina; Bhupendra K Basnet; Hasan Bhally; Khema R Bhusal; Umesh Bogati; Asha C Bowen; Andrew J Burke; Devasahayam J Christopher; Sanjeev D Chunilal; Belinda Cochrane; Jennifer L Curnow; Santa Kumar Das; Ashesh Dhungana; Gian Luca Di Tanna; Ravindra Dotel; Hyjel DSouza; Jack Dummer; Sourabh Dutta; Hong Foo; Timothy L Gilbey; Michelle L Giles; Kasiram Goli; Adrienne Gordon; Pradip Gyanwali; Dipak Haksar; Bernard J Hudson; Manoj K Jani; Purnima R Jevaji; Sachin Jhawar; Aikaj Jindal; M Joseph John; Mary John; Flavita B John; Oommen John; Mark Jones; Rajesh D Joshi; Prashanthi Kamath; Gagandeep Kang; Achyut R Karki; Abhishek M Karmalkar; Baldeep Kaur; Kalyan Chakravarthy Koganti; Jency M Koshy; Mathew S Krishnamurthy; Jillian S Lau; Sharon R Lewin; Lyn-Li Lim; Ian C Marschner; Julie A Marsh; Michael J Maze; James M McGree; James H McMahon; Robert L Medcalf; Eileen G Merriman; Amol P Misal; Jocelyn M Mora; Vijaybabu K Mudaliar; Vi Nguyen; Matthew V O'Sullivan; Suman Pant; Pankaj Pant; David L Paterson; David J Price; Megan A Rees; James O Robinson; Benjamin A Rogers; Sandhya Samuel; Joe Sasadeusz; Deepak Sharma; Prabhat K Sharma; Roshan Shrestha; Sailesh K Shrestha; Prajowl Shrestha; Urvi Shukla; Omar Shum; Christine Sommerville; Tim Spelman; Richard P Sullivan; Umashankar Thatavarthi; Huyen A Tran; Nanette Trask; Clare L Whitehead; Robert K Mahar; Naomi E Hammond; James D McFadyen; Thomas L Snelling; Joshua S Davis; Justin T Denholm; Steven Y C Tong

doi:10.1056/EVIDoa2200293

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Anticoagulation Strategies in Non-Critically Ill Patients with Covid-19

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Anticoagulation Strategies in Non-Critically Ill Patients with Covid-19

Zoe K McQuilten, Balasubramanian Venkatesh, Vivekanand Jha, Jason Roberts, Susan C Morpeth, James A Totterdell, Grace M McPhee, John Abraham, Niraj Bam, Methma Bandara, …

NEJM evidence, Vol.2(2), p.EVIDoa2200293

01/02/2023

DOI: https://doi.org/10.1056/EVIDoa2200293

PMID: 38320033

Résumé

Anticoagulants - pharmacology

Aspirin - pharmacology

Blood Coagulation

COVID-19

Humans

BACKGROUND: Optimal thromboprophylaxis for hospitalized patients with coronavirus disease 2019 (Covid-19) is uncertain. METHODS: In an open-label, adaptive platform trial, we randomly assigned hospitalized adults with Covid-19 to low-dose low-molecular-weight heparin thromboprophylaxis or intermediate-dose or low-dose plus aspirin. In response to external evidence, the aspirin intervention was discontinued and a therapeutic-dose arm added. The primary end point was death or the requirement for new organ support by day 28, analyzed with a Bayesian logistic model. Enrolment was closed as a result of operational constraints. RESULTS: Between February 2021 and March 2022, 1574 patients were randomly assigned. Among 1526 participants included in the analysis (India, n=1273; Australia and New Zealand, n=138; and Nepal, n=115), the primary outcome occurred in 35 (5.9%) of 596 in low-dose, 25 (4.2%) of 601 in intermediate-dose, 20 (7.2%) of 279 in low-dose plus aspirin, and 7 (14%) of 50 in therapeutic-dose anticoagulation. Compared with low-dose thromboprophylaxis, the median adjusted odds ratio for the primary outcome for intermediate-dose was 0.74 (95% credible interval [CrI], 0.43 to 1.27; posterior probability of effectiveness [adjusted odds ratio<1; Pr], 86%), for low-dose plus aspirin 0.88 (95% CrI, 0.47 to 1.64; Pr, 65%), and for therapeutic-dose anticoagulation 2.22 (95% CrI, 0.77 to 6.20; Pr, 7%). Overall thrombotic and bleeding rates were 0.8% and 0.4%, respectively. There were 10 serious adverse reactions related to anticoagulation strategy, of which nine were grade 1 or 2 across study interventions and one grade 4 episode of retroperitoneal hematoma in a patient receiving intermediate-dose anticoagulation. CONCLUSIONS: In hospitalized non–critically ill adults with Covid-19, compared with low-dose, there was an 86% posterior probability that intermediate-dose, 65% posterior probability that low-dose plus aspirin, and a 7% posterior probability that therapeutic-dose anticoagulation reduced the odds of death or requirement for organ support. No treatment strategy met prespecified stopping criteria before trial closure, precluding definitive conclusions. (Funded by Australian National Health and Medical Research Council or Medical Research Future Fund Investigator and Practitioner Grants and others; ClinicalTrials.gov number, NCT04483960.)

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Titre: Anticoagulation Strategies in Non-Critically Ill Patients with Covid-19
Créateurs - sans rôle: Zoe K McQuilten - Monash Health, Melbourne, Australia
Balasubramanian Venkatesh - UNSW Sydney
Vivekanand Jha - Imperial College, London, England, United Kingdom
Jason Roberts - Metro North Health, Brisbane, Queensland, Australia
Susan C Morpeth - Middlemore Hospital, Auckland, North Island, New Zealand
James A Totterdell - Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Grace M McPhee - Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia
John Abraham - Christian Medical College, Ludhiana, Punjab, India
Niraj Bam - Institute of Medicine, Maharajgunj Medical Campus, Kathmandu, Bagmati, Nepal
Methma Bandara - Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia
Ashpak K Bangi - Jivanrekha Multispeciality Hospital, Pune, Maharashtra, India
Lauren A Barina - Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia
Bhupendra K Basnet - National Academy of Medical Sciences, Bir Hospital, Kathmandu, Bagmati, Nepal
Hasan Bhally - North Shore Hospital, Auckland, North Island, New Zealand
Khema R Bhusal - Institute of Medicine, Tribhuvan University Teaching Hospital, Kathmandu, Bagmati, Nepal
Umesh Bogati - National Academy of Medical Sciences, Bir Hospital, Kathmandu, Bagmati, Nepal
Asha C Bowen - Perth Children's Hospital, Perth, Western Australia, Australia
Andrew J Burke - The Prince Charles Hospital, Brisbane, Queensland, Australia
Devasahayam J Christopher - Christian Medical College, Vellore, Tamil Nadu, India
Sanjeev D Chunilal - Monash Medical Centre, Melbourne, Victoria, Australia
Belinda Cochrane - Western Sydney University, Sydney, New South Wales, Australia
Jennifer L Curnow - Westmead Hospital, Sydney, New South Wales, Australia
Santa Kumar Das - Institute of Medicine, Tribhuvan University Teaching Hospital, Kathmandu, Bagmati, Nepal
Ashesh Dhungana - National Academy of Medical Sciences, Bir Hospital, Kathmandu, Bagmati, Nepal
Gian Luca Di Tanna - The George Institute for Global Health, Sydney, Australia
Ravindra Dotel - Blacktown Hospital, Sydney, New South Wales, Australia
Hyjel DSouza - The George Institute for Global Health, Delhi, Delhi, India
Jack Dummer - Dunedin Hospital, Dunedin, Otago, New Zealand
Sourabh Dutta - Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India
Hong Foo - NSW Health Pathology, Sydney, New South Wales, Australia
Timothy L Gilbey - Wagga Wagga Base Hospital, Wagga Wagga, New South Wales, Australia
Michelle L Giles - Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia
Kasiram Goli - Aditya Multi-speciality Hospital, Guntur, Andhra Pradesh, India
Adrienne Gordon - Royal Prince Alfred Hospital, Newborn Care, Melbourne, Victoria, Australia
Pradip Gyanwali - Institute of Medicine, Tribhuvan University Teaching Hospital, Kathmandu, Bagmati, Nepal
Dipak Haksar - ITC Hotels, Gurugram, Haryana, India
Bernard J Hudson - Royal North Shore Hospital, Sydney, New South Wales, Australia
Manoj K Jani - Apex Hospitals, Jaipur, Rajasthan, India
Purnima R Jevaji - The George Institute for Global Health, Delhi, Delhi, India
Sachin Jhawar - Apex Hospitals, Jaipur, Rajasthan, India
Aikaj Jindal - Satguru Partap Singh Hospitals, Ludhiana, Punjab, India
M Joseph John - Christian Medical College, Ludhiana, Punjab, India
Mary John - Christian Medical College, Ludhiana, Punjab, India
Flavita B John - Christian Medical College, Vellore, Tamil Nadu, India
Oommen John - Manipal Academy of Higher Education, Udupi, Karnataka, India
Mark Jones - Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Rajesh D Joshi - The George Institute for Global Health, Delhi, Delhi, India
Prashanthi Kamath - The George Institute for Global Health, Delhi, Delhi, India
Gagandeep Kang - Christian Medical College, Vellore, Tamil Nadu, India
Achyut R Karki - National Academy of Medical Sciences, Bir Hospital, Kathmandu, Bagmati, Nepal
Abhishek M Karmalkar - Sterling Multispeciality Hospital, Pune, Maharashtra, India
Baldeep Kaur - The George Institute for Global Health, Sydney, Australia
Kalyan Chakravarthy Koganti - Samishta Hospital & Research Institute, Guntur, Andhra Pradesh, India
Jency M Koshy - Believers Church Medical College Hospital, Thiruvalla, Kerala, India
Mathew S Krishnamurthy - Believers Church Medical College Hospital, Thiruvalla, Kerala, India
Jillian S Lau - The Alfred Hospital, Melbourne, Victoria, Australia
Sharon R Lewin - Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia
Lyn-Li Lim - Monash University, Melbourne, Australia
Ian C Marschner - Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Julie A Marsh - Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Perth, Western Australia, Australia
Michael J Maze - University of Otago, Dunedin, Otago, New Zealand
James M McGree - Queensland University of Technology, Brisbane, Queensland, Australia
James H McMahon - The Alfred Hospital, Melbourne, Victoria, Australia
Robert L Medcalf - Monash University, Melbourne, Australia
Eileen G Merriman - North Shore Hospital, Auckland, North Island, New Zealand
Amol P Misal - Core Hospital, Chakan, Maharashtra, India
Jocelyn M Mora - Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia
Vijaybabu K Mudaliar - The George Institute for Global Health, Delhi, Delhi, India
Vi Nguyen - Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia
Matthew V O'Sullivan - NSW Health Pathology, Sydney, New South Wales, Australia
Suman Pant - Institute of Medicine, Tribhuvan University Teaching Hospital, Kathmandu, Bagmati, Nepal
Pankaj Pant - Institute of Medicine, Maharajgunj Medical Campus, Kathmandu, Bagmati, Nepal
David L Paterson - National Institute of Singapore, Singapore, Singapore, Singapore
David J Price - Melbourne School of Population & Global Health, University of Melbourne, Melbourne, Victoria, Australia
Megan A Rees - Respiratory and Sleep Medicine, The Royal Melbourne Hospital, Melbourne, Victoria, Australia
James O Robinson - PathWest Laboratory Medicine, Perth, Western Australia, Australia
Benjamin A Rogers - Monash Health, Melbourne, Australia
Sandhya Samuel - Christian Medical College, Ludhiana, Punjab, India
Joe Sasadeusz - Victorian Infectious Diseases Service, The Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia
Deepak Sharma - Maharaja Agrasen Superspeciality Hospital, Delhi, Delhi, India
Prabhat K Sharma - Maharaja Agrasen Superspeciality Hospital, Delhi, Delhi, India
Roshan Shrestha - Institute of Medicine, Tribhuvan University Teaching Hospital, Kathmandu, Bagmati, Nepal
Sailesh K Shrestha - National Academy of Medical Sciences, Bir Hospital, Kathmandu, Bagmati, Nepal
Prajowl Shrestha - National Academy of Medical Sciences, Bir Hospital, Kathmandu, Bagmati, Nepal
Urvi Shukla - Symbiosis University Hospital & Research Centre, Pune, Maharashtra, India
Omar Shum - University of Wollongong, Wollongong, New South Wales, Australia
Christine Sommerville - Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia
Tim Spelman - Burnet Institute, Melbourne, Victoria, Australia
Richard P Sullivan - Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia
Umashankar Thatavarthi - Samishta Hospital & Research Institute, Guntur, Andhra Pradesh, India
Huyen A Tran - The Alfred Hospital, Melbourne, Victoria, Australia
Nanette Trask - Chartered Accountants Australia and New Zealand, Perth, Western Australia, Australia
Clare L Whitehead - The Royal Women's Hospital, The University of Melbourne, Melbourne, Victoria, Australia
Robert K Mahar - Murdoch Children's Research Institute, Perth, Western Australia, Australia
Naomi E Hammond - Royal North Shore Hospital
James D McFadyen - Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia
Thomas L Snelling - Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Perth, Western Australia, Australia
Joshua S Davis - University of Newcastle, Newcastle, New South Wales, Australia
Justin T Denholm - Peter Doherty Institute
Steven Y C Tong - Victorian Infectious Diseases Service, The Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia
Détails de publication: NEJM evidence, Vol.2(2), p.EVIDoa2200293
Identifiants: 99153953909311
Unité académique: Initial MAnagement & prevent of acute orGan failures IN critically ill patiEnts - IMAGINE
Langue: English
Type de ressource: Journal article