- •Female sex has been an embolic risk factor, with 1 point on CHA2DS2-VASc score.
- •However, female sex as risk factor has not been strongly confirmed in literature.
- •In FANTASIIA Registry, women were older with high comorbidity status and risk scores.
- •Women had less major cardiovascular events and mortality at long term follow-up.
- •Female sex had independent protective effect against adverse events.
While many risk factors for Atrial Fibrillation (AF) have been identified, there are important differences in their relative impact between sexes. The aim of our study was to investigate the influence of sex as a long-term predictor of adverse events in “real world” AF patients treated with direct oral anticoagulants.
The FANTASIIA registry is a prospective, national and multicentric study including outpatients with anticoagulated AF patients. Baseline characteristics and adverse events at 3 years of follow-up were collected and classified by sex. Cox multivariate analysis was performed to investigate the role of sex in major events and composite outcomes.
A total of 1956 patients were included in the study. 43.9% of them were women, with a mean age of 73.8 ± 9.4 years (women were older 76.5 ± 7.9 vs 71.7 ± 10.1, p<0.001). Women had higher rate of cardiovascular risk factors and higher mean of CHA2DS2-VASc (4.4 ± 1.4 vs 3.7 ± 1.6, p<0.001) and HAS-BLED (2.1 ± 1.0 vs 1.9 ± 1.1, p<0.001) than men. After 3 years of follow-up, rates of major events were similar in both groups with limit difference for all-cause mortality (4.4%/year in women vs 5.6%/year in men; p = 0.056). However, all the composite events were more frequent in women. We observed in the non-adjusted adverse events lower rate of all-cause mortality (HR 0.62, 95%CI 0.47–0.81; p<0.001), composite 1 outcomes (HR 0.80, 95%CI 0.65–0.98; p = 0.029) and composite 2 (HR 0.77, 95%CI 0.64–0.94; p = 0.010) in women compared with men. In multivariate Cox regression analysis observed that female sex was an independently protector factor for all-cause mortality and for the composite outcomes 1 and 2.
In this “real world” study of anticoagulated AF patients, women could have a protective role against development of adverse events, mainly on all-cause mortality and combined events.
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- ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS.Eur. Heart J. 2016; 37 (2016 Oct 7): 2893-2962
- Are cost benefits of anticoagulation for stroke prevention in atrial fibrillation underestimated?.Stroke. 2005; 36 (Feb): 360-366
- The natural history of atrial fibrillation: incidence, risk factors, and prognosis in the Manitoba follow-up study.Am. J. Med. 1995; 98 (May): 476-484
- Management of atrial fibrillation in seven European countries after the publication of the 2010 ESC guidelines on atrial fibrillation: primary results of the PREvention oF thromboemolic events–European registry in atrial fibrillation (PREFER in AF).Eur. Eur. Pacing Arrhythm Card Electrophysiol. J. Work Groups Card Pacing Arrhythm Card Cell Electrophysiol. Eur. Soc. Cardiol. 2014; 16 (Jan): 6-14
- A prospective survey in European society of cardiology member countries of atrial fibrillation management: baseline results of EURObservational research programme atrial fibrillation (EORP-AF) pilot general registry.Eur. Eur. Pacing Arrhythm Card Electrophysiol. J. Work Groups Card Pacing Arrhythm Card Cell Electrophysiol. Eur. Soc. Cardiol. 2014; 16: 308-319
- Prognosis and treatment of atrial fibrillation patients by European cardiologists: one year follow-up of the EURObservational research programme-atrial fibrillation general registry pilot phase (EORP-AF Pilot registry).Eur. Heart J. 2014; 35 (Dec 14): 3365-3376
- Population prevalence, incidence, and predictors of atrial fibrillation in the Renfrew/Paisley study.Heart Br. Card Soc. 2001; 86 (Nov): 516-521
- Validation of risk stratification schemes for predicting stroke and thromboembolism in patients with atrial fibrillation: nationwide cohort study.BMJ. 2011; 342: d124
- Atrial fibrillation as risk factor for cardiovascular disease and death in women compared with men: systematic review and meta-analysis of cohort studies.BMJ. 2016; 532 (Jan 19): h7013
- Is female sex a risk factor for stroke and thromboembolism in patients with atrial fibrillation? A systematic review and meta-analysis.QJM Mon. J. Assoc. Physicians. 2014; 107 (Dec): 955-967
- Female sex is a risk modifier rather than a risk factor for stroke in atrial fibrillation: should we use a CHA2DS2-VA score rather than CHA2DS2-VASc?.Circulation. 2018; 137 (20): 832-840
- Sex differences and similarities in atrial fibrillation epidemiology, risk factors, and mortality in community cohorts: results from the biomarcare consortium (biomarker for cardiovascular risk assessment in Europe).Circulation. 2017; 136 (Oct 24): 1588-1597
- Atrial fibrillation in women: treatment.Nat. Rev. Cardiol. 2017; 14: 113-124
- Current antiarrhythmic therapy for nonvalvular atrial fibrillation in Spain. Data From the FANTASIIA Registry.Rev. Esp. Cardiol. (Engl. Ed.). 2016; 69: 54-60
- Sex-related differences in presentation, treatment, and outcome of patients with atrial fibrillation in europe: a report from the Euro observational research programme pilot survey on atrial fibrillation.Eur. Eur. Pacing Arrhythm Card Electrophysiol. J. Work Groups Card Pacing Arrhythm Card Cell Electrophysiol. Eur. Soc. Cardiol. 2015; 17 (Jan): 24-31
- Gender, race, and health insurance status in patients undergoing catheter ablation for atrial fibrillation.Am. J. Cardiol. 2016; 117 (Apr 1): 1117-1126
- Gender differences in patients with atrial fibrillation undergoing electrical cardioversion.J. Womens Health. 2002; 24 (2015 Jun): 466-470
- Impact of gender on the prognosis of patients with nonvalvular atrial fibrillation.Am. J. Cardiol. 2014; 113 (Mar 15): 957-962
- Quality of anticoagulation with vitamin K antagonists.Clin. Cardiol. 2015; 38 (Jun): 357-364
- The European heart rhythm association symptom classification for atrial fibrillation: validation and improvement through a simple modification.Eur. Eur. Pacing Arrhythm Card Electrophysiol. J. Work Groups Card Pacing Arrhythm Card Cell Electrophysiol. Eur. Soc. Cardiol. 2014; 16 (Jul): 965-972
- Subcommittee on control of anticoagulation of the scientific and standardization committee of the international society on thrombosis and haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients.J. Thromb. Haemost. (JTH). 2005; 3 (Apr): 692-694
- Gender differences in clinical presentation and 1-year outcomes in atrial fibrillation.Heart Br. Card Soc. 2017; 103: 1024-1030
- Prevalence of atrial fibrillation in Spain. OFRECE study results.Rev. Esp. Cardiol. Engl. Ed. 2014; 67 (Apr): 259-269
- Epidemiologic assessment of chronic atrial fibrillation and risk of stroke: the Framingham study.Neurology. 1978; 28 (Oct): 973-977
- Incidence of myocardial infarction and vascular death in elderly patients with atrial fibrillation taking anticoagulants: relation to atherosclerotic risk factors.Chest. 2015; 147 (Jun): 1644-1650
- Race- and sex-related differences in care for patients newly diagnosed with atrial fibrillation.Heart Rhythm. 2015; 12 (Jul): 1406-1412
- Sex differences in atrial fibrillation.Can. J. Cardiol. 2018; 34: 429-436
- Quality of INR control and switching to non-Vitamin K oral anticoagulants between women and men with atrial fibrillation treated with vitamin K antagonists in Spain. A population-based, real-world study.PloS One. 2019; 14e0211681
- Sex-based differences in outcomes of oral anticoagulation in patients with atrial fibrillation.J. Am. Coll. Cardiol. 2018; 72 (17): 271-282
- Differences in clinical and functional outcomes of atrial fibrillation in women and men: two-year results from the ORBIT-AF registry.JAMA Cardiol. 2016; 1 (01): 282-291
- Impact of gender on outcomes after atrial fibrillation ablation.Int. J. Cardiol. 2015; 187: 12-16
- Revisiting sex differences in outcomes in non-valvular atrial fibrillation: a population-based cohort study.Eur. Heart J. 2017; 38 (May 14): 1473-1479
Published online: April 14, 2020
Accepted: April 3, 2020
Received in revised form: March 27, 2020
Received: February 29, 2020
© 2020 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.