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. 2020 Mar 10;36(3):408-416.
doi: 10.1002/joa3.12321. eCollection 2020 Jun.

Stroke prevention in atrial fibrillation changes after dabigatran availability in China: The GLORIA-AF registry

Changsheng Ma  1 , Lionel Riou França  2 , Shihai Lu  3 , Hans-Christoph Diener  4 , Sergio J Dubner  5 , Jonathan L Halperin  6 , Qiang Li  7 , Miney Paquette  8 , Christine Teutsch  2 , Menno V Huisman  9 , Gregory Y H Lip  10   11 , Kenneth J Rothman  12 ; GLORIA‐AF Investigators
Affiliations

Stroke prevention in atrial fibrillation changes after dabigatran availability in China: The GLORIA-AF registry

Changsheng Ma et al. J Arrhythm. .

Abstract

Background: Until the approval of dabigatran etexilate, treatment choices for stroke prevention in patients with atrial fibrillation (AF) were vitamin K antagonists (VKAs) or antiplatelet drugs. This analysis explored whether availability of non-vitamin K antagonist oral anticoagulants post-dabigatran approval was associated with changing treatment patterns in China.

Methods: Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) collected data on antithrombotic therapy choices for patients with newly diagnosed nonvalvular AF at risk for stroke. In China, enrollment in phase 1 (before dabigatran approval) and phase 2 (after dabigatran approval) occurred from 2011 to 2013 and 2013 to 2014, respectively. Analyses were restricted to sites within China that contributed patients to both phases. The weighted average of the site-specific results was estimated for standardization. Sensitivity analyses used multiple regression.

Results: Thirteen sites participated in both phase 1 (419 patients) and phase 2 (276 patients), 76.1% and 16.0% were known to be at high risk for stroke (CHA2DS2-VASc ≥2) and bleeding (HAS-BLED ≥3); 55.5% were male. In phase 1, 16.7%, 61.6%, and 21.7% of patients were prescribed oral anticoagulants (OACs), antiplatelet agents, and no treatment, respectively. Respective proportions were 26.4%, 40.6%, and 33.0% in phase 2. The absolute increase in the site-standardized proportion of patients prescribed OACs after dabigatran availability was 9.9% (95% confidence interval [CI]: 3.7%-16.0%). There was a standardized 17.3% (95% CI: -24.3% to -10.4%) absolute decrease in antiplatelet agent use.

Conclusions: There was an increase in OAC and decrease in antiplatelet agent prescription since dabigatran availability in China. However, a large proportion of AF patients at risk for stroke remained untreated.

Keywords: anticoagulants; antiplatelet agents; atrial fibrillation; delivery of health care; stroke.

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Conflict of interest statement

This registry is registered in ClinicalTrials.gov with clinical trial identifier NCT01468701. The protocol for this research project has been approved by a suitably constituted Ethics Committee of the institutions, where required, and it conforms to the provisions of the Declaration of Helsinki. Beijing Anzhen Hospital, Capital Medical University, Beijing, China, institutional review board approval 11 July 2013. CM has received honoraria for presentations as well as research grants from Bristol‐Myers Squibb, Boehringer Ingelheim, Bayer HealthCare, Pfizer, AstraZeneca, and Johnson & Johnson. LRF was an employee of Boehringer Ingelheim at the time of manuscript writing and is now employed by Sanofi‐Aventis. MVH has received honoraria for presentations and research grants from Boehringer Ingelheim, Bayer HealthCare, Pfizer, GlaxoSmithKline, and Actelion Pharmaceuticals. H‐CD has received honoraria for participation in clinical trials, contribution to advisory boards or oral presentations from Abbott, Allergan, AstraZeneca, Bayer Vital, Bristol‐Myers Squibb, Boehringer Ingelheim, CoAxia, Corimmun, Covidien, Daiichi‐Sankyo, D‐Pharm, Fresenius, GlaxoSmithKline, Janssen‐Cilag, Johnson & Johnson, Knoll, Lilly, MSD, Medtronic, MindFrame, Neurobiological Technologies, Novartis, Novo‐Nordisk, Paion, Parke‐Davis, Pfizer, Sanofi‐Aventis, Schering‐Plough, Servier, Solvay, St. Jude, Synagis, Talecris, ThromboGenics, WebMD Global, Wyeth and Yamanouchi. Financial support for research projects was provided by AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Lundbeck, Novartis, Janssen‐Cilag, Sanofi‐Aventis, Synagis, and Talecris. The Department of Neurology at the University Duisburg‐Essen received research grants from the German Research Council (DFG), the German Ministry of Education and Research (BMBF), the European Union, the National Institutes of Health (NIH), the Bertelsmann Foundation, and the Heinz‐Nixdorf Foundation; H‐CD has no ownership interest and does not own stocks of any pharmaceutical company; within the past year he served as the editor of Aktuelle Neurologie, Arzneimitteltherapie, Kopfschmerznews, and Stroke News, as the co‐editor of Cephalalgia, and was on the editorial board of Lancet Neurology, Stroke, European Neurology, and Cerebrovascular Disorders; he chairs the Treatment Guidelines Committee of the German Society of Neurology and has contributed to the European Heart Rhythm Association (EHRA) and the European Society of Cardiology (ESC) guidelines for the treatment of atrial fibrillation. SJD has received consultancy fees for serving as a steering committee member for Boehringer Ingelheim. He also holds research grants from St Jude Medical. JLH has received consulting fees from Bayer HealthCare, Janssen‐Ortho‐McNeil and Pfizer for advisory activities involving the development of anticoagulant drugs. GYHL has been a consultant for Bayer/Janssen, Bristol‐Myers Squibb/Pfizer, Medtronic, Boehringer Ingelheim, Novartis, Verseon, and Daiichi‐Sankyo; and speaker for Bayer, Bristol‐Myers Squibb/Pfizer, Medtronic, Boehringer Ingelheim, and Daiichi‐Sankyo. He has not received any personal fees. KJR is an employee of RTI Health Solutions, an independent nonprofit research organization that does work for government agencies and pharmaceutical companies. SL, QL, MP, and CT are employees of Boehringer Ingelheim.

Figures

FIGURE 1
FIGURE 1
Flow chart of patients considered for the analysis. AP, antiplatelet agent; OAC, oral anticoagulant
FIGURE 2
FIGURE 2
Enrolled patient numbers and crude proportion of OAC use over time. Numbers in the lines correspond to the number of patients enrolled in each month. OAC, oral anticoagulant
FIGURE 3
FIGURE 3
Site‐standardized antithrombotic treatment prescription probability differences and probability ratios from phase 1 to phase 2. AP, antiplatelet agent; ATT, antithrombotic treatment; CI, confidence interval; OAC, oral anticoagulant
See this image and copyright information in PMC

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