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Evaluation of the effect of oral anticoagulants on all-cause mortality within 3 months of the diagnosis of atrial fibrillation: results from the GARFIELD-AF prospective registry
2018

Congress : ESC Congress

  • Topic : arrhythmias and device therapy
  • Sub-topic : Oral Anticoagulation
  • Session type : Poster Session
  • FP Number : P2895

Authors : K A A Fox (Edinburgh,GB), S Berchuck (Durham,US), A J Camm (London,GB), J-P Bassand (Besancon,FR), D A Fitzmaurice (Coventry,GB), B J Gersh (Rochester,US), S Z Goldhaber (Boston,US), S Goto (Kanagawa,JP), S Haas (Munich,DE), F Misselwitz (Berlin,DE), K Pieper (London,GB), A G G Turpie (Hamilton,CA), F W A Verheugt (Amsterdam,NL), A K Kakkar (London,GB)

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Authors:
K.A.A. Fox1 , S. Berchuck2 , A.J. Camm3 , J.-P. Bassand4 , D.A. Fitzmaurice5 , B.J. Gersh6 , S.Z. Goldhaber7 , S. Goto8 , S. Haas9 , F. Misselwitz10 , K. Pieper11 , A.G.G. Turpie12 , F.W.A. Verheugt13 , A.K. Kakkar14 , 1University of Edinburgh - Edinburgh - United Kingdom , 2Duke Clinical Research Institute - Durham - United States of America , 3St. George's University of London and Imperial College - London - United Kingdom , 4Thrombosis Research Institute, London, UK & University of Besançon - Besancon - France , 5University of Warwick Medical School - Coventry - United Kingdom , 6Mayo Clinic - Rochester - United States of America , 7Brigham and Women's Hospital and Harvard Medical School - Boston - United States of America , 8Tokai University School of Medicine - Kanagawa - Japan , 9Formerly Department of Medicine, Technical University of Munich - Munich - Germany , 10Bayer AG - Berlin - Germany , 11Duke Clinical Research Institute, Durham, NC, USA & Thrombosis Research Institute - London - United Kingdom , 12McMaster University - Hamilton - Canada , 13Onze Lieve Vrouwe Gasthuis (OLVG) - Amsterdam - Netherlands , 14Thrombosis Research Institute & University College London - London - United Kingdom ,

On behalf: GARFIELD-AF Investigators

Citation:
European Heart Journal ( 2018 ) 39 ( Supplement ), 609-610

Purpose: Using data from the largest multinational prospective registry in atrial fibrillation (the Global Anticoagulant Registry in the FIELD–Atrial Fibrillation, GARFIELD-AF), we examined whether treatment effects of oral anticoagulation (OACs) vs no OAC and, non-vitamin K antagonist oral anticoagulants (NOACs) vs VKAs on all-cause mortality are manifest within 3 months of diagnosis of AF in patients with a CHA2DS2-VASc score ≥2 (including gender).

Methods: Patients were enrolled consecutively into GARFIELD-AF and followed prospectively. The analyses were conducted in patients enrolled between Apr-2013 and Sep-2016, during which time NOACs became available in many countries. Within each comparison, overlap probability weighting was used to evaluate the adjusted associations between drug use (at baseline) and outcomes within 3 months. Weights were applied to Cox proportional hazards models to estimate the effects for OAC vs no OAC and NOAC vs VKA use for each endpoint, respectively.

Results: The study population comprised 20,457 anticoagulated patients (10,330 [NOACs]; 10,127 [VKAs]) and 8,019 patients without OAC (of the latter, 60% received anti-platelets). 442 patients died within 3 months of diagnosis of AF; the Kaplan-Meier survival rate at 3 months was 98%. The causes of death were: cardiovascular (in 41% of cases), non-cardiovascular (36%) and unknown (22%). Congestive heart failure (16%), cancer (8%) and respiratory failure (6%) were the most common known causes of death followed by: myocardial infarction (5%), ischaemic stroke (5%), sudden death (5%), infection (5%) and sepsis (5%). After weighting, standardised differences showed an accurate balance between the 29 baseline variables and drug use. Weighted hazard ratios (HR) for all-cause mortality were: 0.57 (95% CI, 0.46–0.71); P<0.001 for the comparison of OAC vs non OAC; and 0.69 (95% CI, 0.52–0.92); P=0.010 for NOACS vs VKAs (figure). Stroke/systemic embolism (117 events, overall) and major bleeding (99 events) were not significantly different for the treatment comparisons.

Conclusion: GARFIELD-AF reveals significant early mortality in patients with newly diagnosed AF and significant mortality differences in favour of OACs, even after adjustment for 29 baseline variables. These differences are manifest within 3 months after diagnosis (number needed to treat, NNT=80). Strokes constituted only a minority of the events prevented. The benefit of NOACs (relative to VKAs) on mortality was also observed by 3 months (NNT=188). These findings extend the evidence from randomised trials with data from a prospective multinational registry population with newly diagnosed AF and raise questions about the impact of anticoagulation, beyond stroke prevention.

3-month Kaplan-Meier survival

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