Comparative effectiveness and safety of direct oral anticoagulants versus vitamin K antagonists in nonvalvular atrial fibrillation: a Canadian multicentre observational cohort study.

Administration, Oral Aged Anticoagulants / therapeutic use Atrial Fibrillation / drug therapy Canada / epidemiology Cause of Death Dabigatran / therapeutic use Databases, Factual Embolism / epidemiology Female Hemorrhage / epidemiology Humans Male Meta-Analysis as Topic Mortality Myocardial Infarction / epidemiology Propensity Score Pyrazoles / therapeutic use Pyridones / therapeutic use Retrospective Studies Rivaroxaban / therapeutic use Stroke / epidemiology Treatment Outcome Vitamin K / antagonists & inhibitors Warfarin / therapeutic use

Journal

CMAJ open
ISSN: 2291-0026
Titre abrégé: CMAJ Open
Pays: Canada
ID NLM: 101620603

Informations de publication

Date de publication:
Historique:
entrez: 23 12 2020
pubmed: 24 12 2020
medline: 21 5 2021
Statut: epublish

Résumé

Direct oral anticoagulants (DOACs) have widely replaced warfarin for stroke prevention in nonvalvular atrial fibrillation. Our objective was to compare the safety and effectiveness of DOACs (dabigatran, rivaroxaban, apixaban) versus warfarin for stroke prevention in nonvalvular atrial fibrillation in the Canadian setting. We conducted a population-based observational multicentre cohort study with propensity score matching and subsequent meta-analysis. We used health care databases from 7 Canadian provinces (British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Quebec and Nova Scotia). Patients with nonvalvular atrial fibrillation who initiated anticoagulation therapy in 2009-2017 were matched to an equal number who initiated warfarin. The primary outcome was the pooled hazard ratio (HR) for ischemic stroke or systemic embolization. Secondary outcomes included pooled HRs for major bleeding; a composite outcome of stroke, systemic embolization, major bleeding and all-cause mortality; and myocardial infarction. We modelled HRs using proportional hazard Cox regression with inverse probability of censoring weights, and estimated pooled HRs with random-effect meta-analyses. We included 128 273 patients who initiated anticoagulation with a DOAC (40 503 dabigatran, 49 498 rivaroxaban and 38 272 apixaban) and 128 273 patients who initiated anticoagulation with warfarin. The pooled HR for ischemic stroke or systemic embolization comparing DOACs to warfarin was 1.02 (95% confidence interval [CI] 0.87 to 1.19). Direct oral anticoagulants were associated with lower rates of major bleeding (pooled HR 0.81, 95% CI 0.69 to 0.97), the composite outcome (pooled HR 0.81, 95% CI 0.74 to 0.89) and all-cause mortality (pooled HR 0.81, 95% CI 0.78 to 0.85). In this real-world study, DOACs were associated with similar risks of ischemic stroke or systemic embolization, and lower risks of bleeding and total mortality compared to warfarin. These findings support the use of DOACs for anticoagulation in nonvalvular atrial fibrillation. ClinicalTrials.gov, no. NCT03596502.

Sections du résumé

BACKGROUND
Direct oral anticoagulants (DOACs) have widely replaced warfarin for stroke prevention in nonvalvular atrial fibrillation. Our objective was to compare the safety and effectiveness of DOACs (dabigatran, rivaroxaban, apixaban) versus warfarin for stroke prevention in nonvalvular atrial fibrillation in the Canadian setting.
METHODS
We conducted a population-based observational multicentre cohort study with propensity score matching and subsequent meta-analysis. We used health care databases from 7 Canadian provinces (British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Quebec and Nova Scotia). Patients with nonvalvular atrial fibrillation who initiated anticoagulation therapy in 2009-2017 were matched to an equal number who initiated warfarin. The primary outcome was the pooled hazard ratio (HR) for ischemic stroke or systemic embolization. Secondary outcomes included pooled HRs for major bleeding; a composite outcome of stroke, systemic embolization, major bleeding and all-cause mortality; and myocardial infarction. We modelled HRs using proportional hazard Cox regression with inverse probability of censoring weights, and estimated pooled HRs with random-effect meta-analyses.
RESULTS
We included 128 273 patients who initiated anticoagulation with a DOAC (40 503 dabigatran, 49 498 rivaroxaban and 38 272 apixaban) and 128 273 patients who initiated anticoagulation with warfarin. The pooled HR for ischemic stroke or systemic embolization comparing DOACs to warfarin was 1.02 (95% confidence interval [CI] 0.87 to 1.19). Direct oral anticoagulants were associated with lower rates of major bleeding (pooled HR 0.81, 95% CI 0.69 to 0.97), the composite outcome (pooled HR 0.81, 95% CI 0.74 to 0.89) and all-cause mortality (pooled HR 0.81, 95% CI 0.78 to 0.85).
INTERPRETATION
In this real-world study, DOACs were associated with similar risks of ischemic stroke or systemic embolization, and lower risks of bleeding and total mortality compared to warfarin. These findings support the use of DOACs for anticoagulation in nonvalvular atrial fibrillation.
TRIAL REGISTRATION
ClinicalTrials.gov, no. NCT03596502.

Identifiants

DOI: 10.9778/cmajo.20200055 PMID: 33355273 PMC: PMC7759115
pubmed: 33355273
pii: 8/4/E877
doi: 10.9778/cmajo.20200055
pmc: PMC7759115
doi:

Substances chimiques

Anticoagulants 0
Pyrazoles 0
Pyridones 0
Vitamin K 12001-79-5
apixaban 3Z9Y7UWC1J
Warfarin 5Q7ZVV76EI
Rivaroxaban 9NDF7JZ4M3
Dabigatran I0VM4M70GC

Banques de données

ClinicalTrials.gov
['NCT03596502']

Types de publication

Comparative Study Journal Article Multicenter Study Observational Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

E877-E886

Subventions

Organisme : CIHR
Pays : Canada

Informations de copyright

Copyright 2020, Joule Inc. or its licensors.

Déclaration de conflit d'intérêts

Competing interests: Min Jun has received unrestricted grant support from VentureWise, a wholly owned subsidiary of NPS MedicineWise funded by AstraZeneca. No other competing interests were declared.

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Auteurs

Madeleine Durand (M)

Internal Medicine Service (Durand), Centre hospitalier de l'Université de Montréal (CHUM) and CHUM Research Centre (Durand); Faculty of Pharmacy (Schnitzer) and Department of Social and Preventive Medicine (Schnitzer), Université de Montréal; Departments of Epidemiology, Biostatistics and Occupational Health (Schnitzer, Pang, Filion, Renoux), Medicine (Filion) and Neurology and Neurosurgery (Renoux), McGill University, Montréal, Que.; Departments of Anesthesiology, Pharmacology and Therapeutics (Carney, Fisher), Faculty of Medicine, University of British Columbia, Vancouver, BC; College of Pharmacy (Eltonsy, Kuo), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Man.; Centre for Clinical Epidemiology (Filion, Renoux), Lady Davis Institute, Jewish General Hospital, Montréal, Que.; The George Institute for Global Health (Jun), University of New South Wales, Sydney, Australia; ICES Central (Paterson); Institute of Health Policy, Management and Evaluation (Paterson), University of Toronto, Toronto, Ont.; Health Quality Council (Quail) and Department of Community Health and Epidemiology (Quail), University of Saskatchewan, Saskatoon, Sask.; Cardiology Service (Matteau), CHUM and CHUM Research Centre, Montréal, Que. madeleine.durand.chum@ssss.gouv.qc.ca.

Mireille E Schnitzer (ME)

Internal Medicine Service (Durand), Centre hospitalier de l'Université de Montréal (CHUM) and CHUM Research Centre (Durand); Faculty of Pharmacy (Schnitzer) and Department of Social and Preventive Medicine (Schnitzer), Université de Montréal; Departments of Epidemiology, Biostatistics and Occupational Health (Schnitzer, Pang, Filion, Renoux), Medicine (Filion) and Neurology and Neurosurgery (Renoux), McGill University, Montréal, Que.; Departments of Anesthesiology, Pharmacology and Therapeutics (Carney, Fisher), Faculty of Medicine, University of British Columbia, Vancouver, BC; College of Pharmacy (Eltonsy, Kuo), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Man.; Centre for Clinical Epidemiology (Filion, Renoux), Lady Davis Institute, Jewish General Hospital, Montréal, Que.; The George Institute for Global Health (Jun), University of New South Wales, Sydney, Australia; ICES Central (Paterson); Institute of Health Policy, Management and Evaluation (Paterson), University of Toronto, Toronto, Ont.; Health Quality Council (Quail) and Department of Community Health and Epidemiology (Quail), University of Saskatchewan, Saskatoon, Sask.; Cardiology Service (Matteau), CHUM and CHUM Research Centre, Montréal, Que.

Menglan Pang (M)

Internal Medicine Service (Durand), Centre hospitalier de l'Université de Montréal (CHUM) and CHUM Research Centre (Durand); Faculty of Pharmacy (Schnitzer) and Department of Social and Preventive Medicine (Schnitzer), Université de Montréal; Departments of Epidemiology, Biostatistics and Occupational Health (Schnitzer, Pang, Filion, Renoux), Medicine (Filion) and Neurology and Neurosurgery (Renoux), McGill University, Montréal, Que.; Departments of Anesthesiology, Pharmacology and Therapeutics (Carney, Fisher), Faculty of Medicine, University of British Columbia, Vancouver, BC; College of Pharmacy (Eltonsy, Kuo), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Man.; Centre for Clinical Epidemiology (Filion, Renoux), Lady Davis Institute, Jewish General Hospital, Montréal, Que.; The George Institute for Global Health (Jun), University of New South Wales, Sydney, Australia; ICES Central (Paterson); Institute of Health Policy, Management and Evaluation (Paterson), University of Toronto, Toronto, Ont.; Health Quality Council (Quail) and Department of Community Health and Epidemiology (Quail), University of Saskatchewan, Saskatoon, Sask.; Cardiology Service (Matteau), CHUM and CHUM Research Centre, Montréal, Que.

Greg Carney (G)

Internal Medicine Service (Durand), Centre hospitalier de l'Université de Montréal (CHUM) and CHUM Research Centre (Durand); Faculty of Pharmacy (Schnitzer) and Department of Social and Preventive Medicine (Schnitzer), Université de Montréal; Departments of Epidemiology, Biostatistics and Occupational Health (Schnitzer, Pang, Filion, Renoux), Medicine (Filion) and Neurology and Neurosurgery (Renoux), McGill University, Montréal, Que.; Departments of Anesthesiology, Pharmacology and Therapeutics (Carney, Fisher), Faculty of Medicine, University of British Columbia, Vancouver, BC; College of Pharmacy (Eltonsy, Kuo), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Man.; Centre for Clinical Epidemiology (Filion, Renoux), Lady Davis Institute, Jewish General Hospital, Montréal, Que.; The George Institute for Global Health (Jun), University of New South Wales, Sydney, Australia; ICES Central (Paterson); Institute of Health Policy, Management and Evaluation (Paterson), University of Toronto, Toronto, Ont.; Health Quality Council (Quail) and Department of Community Health and Epidemiology (Quail), University of Saskatchewan, Saskatoon, Sask.; Cardiology Service (Matteau), CHUM and CHUM Research Centre, Montréal, Que.

Sherif Eltonsy (S)

Internal Medicine Service (Durand), Centre hospitalier de l'Université de Montréal (CHUM) and CHUM Research Centre (Durand); Faculty of Pharmacy (Schnitzer) and Department of Social and Preventive Medicine (Schnitzer), Université de Montréal; Departments of Epidemiology, Biostatistics and Occupational Health (Schnitzer, Pang, Filion, Renoux), Medicine (Filion) and Neurology and Neurosurgery (Renoux), McGill University, Montréal, Que.; Departments of Anesthesiology, Pharmacology and Therapeutics (Carney, Fisher), Faculty of Medicine, University of British Columbia, Vancouver, BC; College of Pharmacy (Eltonsy, Kuo), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Man.; Centre for Clinical Epidemiology (Filion, Renoux), Lady Davis Institute, Jewish General Hospital, Montréal, Que.; The George Institute for Global Health (Jun), University of New South Wales, Sydney, Australia; ICES Central (Paterson); Institute of Health Policy, Management and Evaluation (Paterson), University of Toronto, Toronto, Ont.; Health Quality Council (Quail) and Department of Community Health and Epidemiology (Quail), University of Saskatchewan, Saskatoon, Sask.; Cardiology Service (Matteau), CHUM and CHUM Research Centre, Montréal, Que.

Kristian B Filion (KB)

Internal Medicine Service (Durand), Centre hospitalier de l'Université de Montréal (CHUM) and CHUM Research Centre (Durand); Faculty of Pharmacy (Schnitzer) and Department of Social and Preventive Medicine (Schnitzer), Université de Montréal; Departments of Epidemiology, Biostatistics and Occupational Health (Schnitzer, Pang, Filion, Renoux), Medicine (Filion) and Neurology and Neurosurgery (Renoux), McGill University, Montréal, Que.; Departments of Anesthesiology, Pharmacology and Therapeutics (Carney, Fisher), Faculty of Medicine, University of British Columbia, Vancouver, BC; College of Pharmacy (Eltonsy, Kuo), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Man.; Centre for Clinical Epidemiology (Filion, Renoux), Lady Davis Institute, Jewish General Hospital, Montréal, Que.; The George Institute for Global Health (Jun), University of New South Wales, Sydney, Australia; ICES Central (Paterson); Institute of Health Policy, Management and Evaluation (Paterson), University of Toronto, Toronto, Ont.; Health Quality Council (Quail) and Department of Community Health and Epidemiology (Quail), University of Saskatchewan, Saskatoon, Sask.; Cardiology Service (Matteau), CHUM and CHUM Research Centre, Montréal, Que.

Anat Fisher (A)

Internal Medicine Service (Durand), Centre hospitalier de l'Université de Montréal (CHUM) and CHUM Research Centre (Durand); Faculty of Pharmacy (Schnitzer) and Department of Social and Preventive Medicine (Schnitzer), Université de Montréal; Departments of Epidemiology, Biostatistics and Occupational Health (Schnitzer, Pang, Filion, Renoux), Medicine (Filion) and Neurology and Neurosurgery (Renoux), McGill University, Montréal, Que.; Departments of Anesthesiology, Pharmacology and Therapeutics (Carney, Fisher), Faculty of Medicine, University of British Columbia, Vancouver, BC; College of Pharmacy (Eltonsy, Kuo), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Man.; Centre for Clinical Epidemiology (Filion, Renoux), Lady Davis Institute, Jewish General Hospital, Montréal, Que.; The George Institute for Global Health (Jun), University of New South Wales, Sydney, Australia; ICES Central (Paterson); Institute of Health Policy, Management and Evaluation (Paterson), University of Toronto, Toronto, Ont.; Health Quality Council (Quail) and Department of Community Health and Epidemiology (Quail), University of Saskatchewan, Saskatoon, Sask.; Cardiology Service (Matteau), CHUM and CHUM Research Centre, Montréal, Que.

Min Jun (M)

Internal Medicine Service (Durand), Centre hospitalier de l'Université de Montréal (CHUM) and CHUM Research Centre (Durand); Faculty of Pharmacy (Schnitzer) and Department of Social and Preventive Medicine (Schnitzer), Université de Montréal; Departments of Epidemiology, Biostatistics and Occupational Health (Schnitzer, Pang, Filion, Renoux), Medicine (Filion) and Neurology and Neurosurgery (Renoux), McGill University, Montréal, Que.; Departments of Anesthesiology, Pharmacology and Therapeutics (Carney, Fisher), Faculty of Medicine, University of British Columbia, Vancouver, BC; College of Pharmacy (Eltonsy, Kuo), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Man.; Centre for Clinical Epidemiology (Filion, Renoux), Lady Davis Institute, Jewish General Hospital, Montréal, Que.; The George Institute for Global Health (Jun), University of New South Wales, Sydney, Australia; ICES Central (Paterson); Institute of Health Policy, Management and Evaluation (Paterson), University of Toronto, Toronto, Ont.; Health Quality Council (Quail) and Department of Community Health and Epidemiology (Quail), University of Saskatchewan, Saskatoon, Sask.; Cardiology Service (Matteau), CHUM and CHUM Research Centre, Montréal, Que.

I Fan Kuo (IF)

Internal Medicine Service (Durand), Centre hospitalier de l'Université de Montréal (CHUM) and CHUM Research Centre (Durand); Faculty of Pharmacy (Schnitzer) and Department of Social and Preventive Medicine (Schnitzer), Université de Montréal; Departments of Epidemiology, Biostatistics and Occupational Health (Schnitzer, Pang, Filion, Renoux), Medicine (Filion) and Neurology and Neurosurgery (Renoux), McGill University, Montréal, Que.; Departments of Anesthesiology, Pharmacology and Therapeutics (Carney, Fisher), Faculty of Medicine, University of British Columbia, Vancouver, BC; College of Pharmacy (Eltonsy, Kuo), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Man.; Centre for Clinical Epidemiology (Filion, Renoux), Lady Davis Institute, Jewish General Hospital, Montréal, Que.; The George Institute for Global Health (Jun), University of New South Wales, Sydney, Australia; ICES Central (Paterson); Institute of Health Policy, Management and Evaluation (Paterson), University of Toronto, Toronto, Ont.; Health Quality Council (Quail) and Department of Community Health and Epidemiology (Quail), University of Saskatchewan, Saskatoon, Sask.; Cardiology Service (Matteau), CHUM and CHUM Research Centre, Montréal, Que.

Christel Renoux (C)

Internal Medicine Service (Durand), Centre hospitalier de l'Université de Montréal (CHUM) and CHUM Research Centre (Durand); Faculty of Pharmacy (Schnitzer) and Department of Social and Preventive Medicine (Schnitzer), Université de Montréal; Departments of Epidemiology, Biostatistics and Occupational Health (Schnitzer, Pang, Filion, Renoux), Medicine (Filion) and Neurology and Neurosurgery (Renoux), McGill University, Montréal, Que.; Departments of Anesthesiology, Pharmacology and Therapeutics (Carney, Fisher), Faculty of Medicine, University of British Columbia, Vancouver, BC; College of Pharmacy (Eltonsy, Kuo), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Man.; Centre for Clinical Epidemiology (Filion, Renoux), Lady Davis Institute, Jewish General Hospital, Montréal, Que.; The George Institute for Global Health (Jun), University of New South Wales, Sydney, Australia; ICES Central (Paterson); Institute of Health Policy, Management and Evaluation (Paterson), University of Toronto, Toronto, Ont.; Health Quality Council (Quail) and Department of Community Health and Epidemiology (Quail), University of Saskatchewan, Saskatoon, Sask.; Cardiology Service (Matteau), CHUM and CHUM Research Centre, Montréal, Que.

J Michael Paterson (JM)

Internal Medicine Service (Durand), Centre hospitalier de l'Université de Montréal (CHUM) and CHUM Research Centre (Durand); Faculty of Pharmacy (Schnitzer) and Department of Social and Preventive Medicine (Schnitzer), Université de Montréal; Departments of Epidemiology, Biostatistics and Occupational Health (Schnitzer, Pang, Filion, Renoux), Medicine (Filion) and Neurology and Neurosurgery (Renoux), McGill University, Montréal, Que.; Departments of Anesthesiology, Pharmacology and Therapeutics (Carney, Fisher), Faculty of Medicine, University of British Columbia, Vancouver, BC; College of Pharmacy (Eltonsy, Kuo), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Man.; Centre for Clinical Epidemiology (Filion, Renoux), Lady Davis Institute, Jewish General Hospital, Montréal, Que.; The George Institute for Global Health (Jun), University of New South Wales, Sydney, Australia; ICES Central (Paterson); Institute of Health Policy, Management and Evaluation (Paterson), University of Toronto, Toronto, Ont.; Health Quality Council (Quail) and Department of Community Health and Epidemiology (Quail), University of Saskatchewan, Saskatoon, Sask.; Cardiology Service (Matteau), CHUM and CHUM Research Centre, Montréal, Que.

Jacqueline Quail (J)

Internal Medicine Service (Durand), Centre hospitalier de l'Université de Montréal (CHUM) and CHUM Research Centre (Durand); Faculty of Pharmacy (Schnitzer) and Department of Social and Preventive Medicine (Schnitzer), Université de Montréal; Departments of Epidemiology, Biostatistics and Occupational Health (Schnitzer, Pang, Filion, Renoux), Medicine (Filion) and Neurology and Neurosurgery (Renoux), McGill University, Montréal, Que.; Departments of Anesthesiology, Pharmacology and Therapeutics (Carney, Fisher), Faculty of Medicine, University of British Columbia, Vancouver, BC; College of Pharmacy (Eltonsy, Kuo), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Man.; Centre for Clinical Epidemiology (Filion, Renoux), Lady Davis Institute, Jewish General Hospital, Montréal, Que.; The George Institute for Global Health (Jun), University of New South Wales, Sydney, Australia; ICES Central (Paterson); Institute of Health Policy, Management and Evaluation (Paterson), University of Toronto, Toronto, Ont.; Health Quality Council (Quail) and Department of Community Health and Epidemiology (Quail), University of Saskatchewan, Saskatoon, Sask.; Cardiology Service (Matteau), CHUM and CHUM Research Centre, Montréal, Que.

Alexis Matteau (A)

Internal Medicine Service (Durand), Centre hospitalier de l'Université de Montréal (CHUM) and CHUM Research Centre (Durand); Faculty of Pharmacy (Schnitzer) and Department of Social and Preventive Medicine (Schnitzer), Université de Montréal; Departments of Epidemiology, Biostatistics and Occupational Health (Schnitzer, Pang, Filion, Renoux), Medicine (Filion) and Neurology and Neurosurgery (Renoux), McGill University, Montréal, Que.; Departments of Anesthesiology, Pharmacology and Therapeutics (Carney, Fisher), Faculty of Medicine, University of British Columbia, Vancouver, BC; College of Pharmacy (Eltonsy, Kuo), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Man.; Centre for Clinical Epidemiology (Filion, Renoux), Lady Davis Institute, Jewish General Hospital, Montréal, Que.; The George Institute for Global Health (Jun), University of New South Wales, Sydney, Australia; ICES Central (Paterson); Institute of Health Policy, Management and Evaluation (Paterson), University of Toronto, Toronto, Ont.; Health Quality Council (Quail) and Department of Community Health and Epidemiology (Quail), University of Saskatchewan, Saskatoon, Sask.; Cardiology Service (Matteau), CHUM and CHUM Research Centre, Montréal, Que.

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Classifications MeSH

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