Do baseline characteristics and treatments account for geographical disparities in the outcomes of patients with newly diagnosed atrial fibrillation? The prospective GARFIELD-AF registry.

In patients with newly diagnosed atrial fibrillation (AF), do baseline risk factors and stroke prevention strategies account for the geographically diverse outcomes. Global Anticoagulant Registry in the FIELD-Atrial Fibrillation is a prospective multinational non-interventional registry of patients with newly diagnosed AF (n=52 018 patients). Investigator sites (n=1317) were representative of the care settings/locations in each of the 35 participating countries. Treatment decisions were all determined by the local responsible clinicians. The patients (18 years and over) with newly diagnosed AF had at least 1 investigator-determined stroke risk factor and patients were not required to meet specific thresholds of risk score for anticoagulant treatment. Observed 1-year event rates and risk-standardised rates were derived. Rates of death, non-haemorrhagic stroke/systemic embolism and major bleeding varied more than three-to-four fold across countries even after adjustment for baseline factors and antithrombotic treatments. Rates of anticoagulation and antithrombotic treatment varied widely. Patients from countries with the highest rates of cardiovascular mortality and stroke were among the least likely to receive oral anticoagulants. Beyond anticoagulant treatment, variations in the treatment of comorbidities and lifestyle factors may have contributed to the variations in outcomes. Countries with the lowest healthcare Access and Quality indices (India, Ukraine, Argentina, Brazil) had the highest risk-standardised mortality. The variability in outcomes across countries for patients with newly diagnosed AF is not accounted for by baseline characteristics and antithrombotic treatments. Residual mortality rates were correlated with Healthcare Access and Quality indices. The findings suggest the management of patients with AF needs to not only address guideline indicated and sustained anticoagulation, but also the treatment of comorbidities and lifestyle factors. NCT01090362.

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Competing interests: KAAF has received grants and personal fees from Bayer/Janssen and AstraZeneca and personal fees from Sanofi/Regeneron and Verseon. AJC: Institutional grants and personal fees from Bayer, Boehringer Ingelheim, BMS/Pfizer and Daichi Sankyo; SG has received Personal fees from Thrombosis Research Institute and the American Heart Association, grants from Sanofi, Pfizer, Ono, Bristol Myer Squibb, the Vehicle Racing Commemorative Foundation and Nakatani Foundation for Advancement of Measuring Technologies in Biomedical Engineering. SZG has received research support from Boehringer-Ingelheim, BMS, BTG EKOS, Daiichi, Janssen, NHLBI, and the Thrombosis Research Institute; has served as a consultant for Agile, Bayer, Boehringer-Ingelheim, BMS, Daiichi, Janssen and Zafgen. SH has received personal fees from Aspen, Bayer Healthcare, BMS/Pfizer, Daiichi-Sankyo, and Sanofi. YK: Research grant from Daiichi Sankyo and Boeringer Ingelheim. Personal fees from: Daiichi Sankyo, Boehringer Ingelheim, Bayer, Bristol Meyers and Pfizer; FM is a former employee of Bayer AG. SO: consultant/advisory board payments from Bayer Pharma AG, Bristol-Myers Squibb Korea, Boehringer-Ingelheim Korea, Pfizer Korea, Sanofi-Aventis, and St Jude Medical. JPSS: Personal fee from Pfizer, Astra Zeneca, Novartis, Sanofi & BMS; JPP: Reported grants for clinical research from Abbott, American Heart Association, Boston Scientific, Gilead, Janssen Pharmaceuticals, NHLBI, and Philips and serves as a consultant to Abbott, Allergan, ARCA Biopharma, Biotronik, Boston Scientific, Johnson & Johnson, LivaNova, Medtronic, Milestone, Oliver Wyman Health, Sanofi, Philips, and Up-to-Date. JS: Research grants from Bayer; personal fees from Amgen, Astra Zeneca, Bayer, Boehringer Ingelheim, BMS/Pfizer, Novartis, Sanofi, Servier; Expert witness for Boehringer Ingelheim; AGGT has received personal fees from Bayer Healthcare, Janssen Pharmaceutical Research & Development, and Portola. FV has received grants from Bayer Healthcare; personal fees from Bayer Healthcare, BMS/Pfizer, DaiichiSankyo, and Boehringer-Ingelheim. AKK has received research support from Bayer AG and Sanofi; personal fees from Bayer AG, Pfizer, Janssen, Sanofi, Verseon and Anthos Therapeutics. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.