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      Global Oral Anticoagulation Use Varies by Region in Patients With Recent Diagnosis of Atrial Fibrillation: The GLORIA‐AF Phase III Registry

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          Abstract

          Background

          Effective stroke prevention with oral anticoagulants (OAC) is recommended for some patients with atrial fibrillation (AF). We aimed to describe OAC use by geographical region and type of site in patients with recent‐onset AF enrolled in a large global registry.

          Methods and Results

          Eligible participants were recruited into GLORIA‐AF (Global Registry on Long‐Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation), a prospective observational cohort study from 2014 to 2016 in 4 international regions: North America, Europe, Asia, and Latin America. Cumulative incidence functions were generated for direct OACs (DOAC), vitamin K antagonists, and antiplatelet drugs considering competing risks, stratified by region and type of site. Time‐to‐treatment initiation after AF diagnosis was analyzed with Fine‐Gray subdistribution hazard models. A total of 21 237 patients eligible for analysis were identified. By 30 days after AF diagnosis, 40%, 16%, and 8.6% of patients had DOAC, vitamin K antagonists, and antiplatelet drugs initiated, respectively. Earlier initiation of DOACs was observed in Europe, with Asia and Latin America having lower hazard rates of DOAC time‐to‐treatment initiation than Europe (hazard ratio [HR], 0.66; 95% CI, 0.62–0.70 and HR, 0.79; 95% CI, 0.73–0.85, respectively). DOAC initiation was highest in community hospitals, vitamin K antagonists in outpatient health care centers/anticoagulation clinics, and antiplatelet drugs in primary care clinics.

          Conclusions

          Important geographic variability exists with the use of OACs for patients with AF. Differences in the time‐to‐treatment initiation of OAC by type of site suggests suboptimal implementation of guideline recommendations and could result in less benefit and more harm. Optimizing OAC use for patients with AF may improve outcomes and reduce health care costs.

          Registration

          URL: http://www.clinicaltrials.gov ; Unique identifiers: NCT01468701, NCT01671007.

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          Most cited references38

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            An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies

            Peter C Austin (2011)
            The propensity score is the probability of treatment assignment conditional on observed baseline characteristics. The propensity score allows one to design and analyze an observational (nonrandomized) study so that it mimics some of the particular characteristics of a randomized controlled trial. In particular, the propensity score is a balancing score: conditional on the propensity score, the distribution of observed baseline covariates will be similar between treated and untreated subjects. I describe 4 different propensity score methods: matching on the propensity score, stratification on the propensity score, inverse probability of treatment weighting using the propensity score, and covariate adjustment using the propensity score. I describe balance diagnostics for examining whether the propensity score model has been adequately specified. Furthermore, I discuss differences between regression-based methods and propensity score-based methods for the analysis of observational data. I describe different causal average treatment effects and their relationship with propensity score analyses.
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              Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.

              Manesh R Patel, Kenneth Mahaffey, Jyotsna Garg … (2012)
              The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagulation than warfarin. In a double-blind trial, we randomly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban (at a daily dose of 20 mg) or dose-adjusted warfarin. The per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism. In the primary analysis, the primary end point occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (hazard ratio in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66 to 0.96; P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year) (hazard ratio, 0.88; 95% CI, 0.74 to 1.03; P<0.001 for noninferiority; P=0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group (14.9% per year) and in 1449 in the warfarin group (14.5% per year) (hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P=0.44), with significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, P=0.02) and fatal bleeding (0.2% vs. 0.5%, P=0.003) in the rivaroxaban group. In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. (Funded by Johnson & Johnson and Bayer; ROCKET AF ClinicalTrials.gov number, NCT00403767.).
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                Author and article information

                Contributors
                Valentina Bayer: (View ORCID Profile)
                Agnieszka Kotalczyk: (View ORCID Profile)
                Bory Kea: (View ORCID Profile)
                Christine Teutsch: (View ORCID Profile)
                Menno V. Huisman: (View ORCID Profile)
                Gregory Y. H. Lip: (View ORCID Profile)
                Brian Olshansky: (View ORCID Profile)
                Journal
                Title: Journal of the American Heart Association
                Abbreviated Title: JAHA
                Publisher: Ovid Technologies (Wolters Kluwer Health)
                ISSN (Electronic): 2047-9980
                Publication date Created: March 15 2022
                Publication date (Print): March 15 2022
                Volume: 11
                Issue: 6
                Affiliations
                [1 ]Biostatistics and Data Sciences Boehringer Ingelheim Pharmaceuticals Inc. Ridgefield CT
                [2 ]Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart &amp; Chest Hospital Liverpool United Kingdom
                [3 ]Department of Emergency Medicine School of Medicine Oregon Health &amp; Science University Portland OR
                [4 ]Department of Clinical Development and Medical Affairs Therapeutic Area Cardiometabolism Boehringer Ingelheim International GmbH Ingelheim Germany
                [5 ]MercyOne North Iowa Mason City IA
                [6 ]Department of Thrombosis and Hemostasis Leiden University Medical Center Leiden Netherlands
                [7 ]University of Iowa Hospitals and Clinics Iowa City IA
                Article
                DOI: 10.1161/JAHA.121.023907
                SO-VID: 032b3127-4dfd-449d-84a7-7c1db2eeca8f
                Copyright © © 2022
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