Impact of gender on event rates at 1 year in patients with newly diagnosed non-valvular atrial fibrillation: contemporary perspective from the GARFIELD-AF registry

A John Camm, Gabriele Accetta, Wael Al Mahmeed, Giuseppe Ambrosio, Samuel Z Goldhaber, Sylvia Haas, Petr Jansky, Gloria Kayani, Frank Misselwitz, Seil Oh, Ali Oto, Pekka Raatikainen, Jan Steffel, Martin van Eickels, Ajay K Kakkar
BMJ Open. 2017-03-01; 7(3): e014579
DOI: 10.1136/BMJOPEN-2016-014579

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1. BMJ Open. 2017 Mar 6;7(3):e014579. doi: 10.1136/bmjopen-2016-014579.

Impact of gender on event rates at 1 year in patients with newly diagnosed
non-valvular atrial fibrillation: contemporary perspective from the GARFIELD-AF
registry.

Camm AJ(1), Accetta G(2), Al Mahmeed W(3), Ambrosio G(4), Goldhaber SZ(5), Haas
S(6), Jansky P(7), Kayani G(2), Misselwitz F(8), Oh S(9), Oto A(10), Raatikainen
P(11), Steffel J(12), van Eickels M(8), Kakkar AK(2)(13); GARFIELD-AF
Investigators.

Author information:
(1)St George’s University of London, and Imperial College, London, UK.
(2)Thrombosis Research Institute, London, UK.
(3)Heart and Vascular Institute, Cleveland Clinic, Abu Dhabi, United Arab
Emirates.
(4)University of Perugia School of Medicine, Perugia, Italy.
(5)Harvard Medical School, Boston, USA.
(6)Formerly Technical University of Munich, Munich, Germany.
(7)Motol University Hospital, Prague, Czech Republic.
(8)Bayer HealthCare Pharmaceuticals, Berlin, Germany.
(9)Seoul National University College of Medicine, Seoul, Republic of Korea.
(10)Hacettepe University, Ankara, Turkey.
(11)Tampere University Hospital, Tampere, Finland.
(12)University Hospital Zurich, Zurich, Switzerland.
(13)University College London, London, UK.

OBJECTIVES: Global Anticoagulant Registry in the FIELD-Atrial Fibrillation
(GARFIELD-AF) explored the impact of gender, risk factors and anticoagulant (AC)
treatment on 1-year outcomes in patients with non-valvular atrial fibrillation
(NVAF).
DESIGN: GARFIELD-AF is a prospective non-interventional registry.
SETTING: Investigator sites (n=1048) are representative of the care
settings/locations in each of the 35 countries.
PARTICIPANTS: Patients ≥18yrs with newly diagnosed (≤6 weeks’ duration) NVAF and
≥1 investigator-determined stroke risk factors.
MAIN OUTCOME MEASURES: Event rates per 100 person-years were estimated from the
Poisson model and HRs and 95% CIs calculated.
RESULTS: Of 28 624 patients (women 44.4%; men 55.6%) enrolled, there were more
elderly (≥75 years) women (46.9%) than men (30.4%). All-cause mortality rates per
100 person-years (95% CI) for women and men were 4.48 (4.12 to 4.87) and 4.04
(3.74 to 4.38), respectively, stroke/systemic embolism (SE) (1.62 (1.41 to 1.87)
and 1.17 (1.01 to 1.36)) and major bleeding (0.93 (0.78 to 1.13) and 0.79 (0.66
to 0.95)). After adjustment for baseline risk factors in treated and untreated
patients, HRs (95% CI) for women (relative to men) for stroke/SE rates were
1.3-fold higher in women (HR 1.30 (1.04 to 1.63)), and similar for major bleeding
(1.13 (0.85 to 1.50)) and all-cause mortality (1.05 (0.92 to 1.19)).
Antithrombotic treatment patterns in men and women were almost identical. 63.8%
women and 62.9% men received AC± antiplatelets. Relative to no AC treatment, the
reduction in stroke/SE rates with AC treatment was greater (p=0.01) in men (HR
0.45 (0.33 to 0.61)) than women 0.77 (0.57 to 1.03). All-cause mortality
reduction with AC treatment was similar (women: 0.65 (0.54 to 0.77); men: 0.57
(0.48 to 0.68)). The risk of major bleeding when treated with AC versus no AC was
2.33 (1.41 to 3.84) in men and 1.86 (1.16 to 2.99) in women (p value=0.53).
CONCLUSIONS: Women have a higher risk of stroke/SE and the reduction in stroke/SE
events rates with AC treatment is less in women than in men.
TRIAL REGISTRATION NUMBER: NCT01090362.

Published by the BMJ Publishing Group Limited. For permission to use (where not
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DOI: 10.1136/bmjopen-2016-014579
PMCID: PMC5353285
PMID: 28264833 [Indexed for MEDLINE]

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