TY - JOUR
T1 - Impact of different anticoagulation management strategies on outcomes in atrial fibrillation
T2 - Dutch and Belgian results from the GARFIELD-AF registry
AU - Seelig, Jaap
AU - Hemels, Martin E. W.
AU - Xhaet, Olivier
AU - Bongaerts, Maarten C. M.
AU - de Wolf, Axel
AU - Groenemeijer, Bjorn E.
AU - Heyse, Alex
AU - Hoogslag, Pieter
AU - Voet, Joeri
AU - Herrman, Jean-Paul R.
AU - Vervoort, Geert
AU - Hermans, Walter
AU - Wollaert, Bart
AU - Boersma, Lucas V. A.
AU - Hermans, Kurt
AU - Lucassen, Andreas
AU - Verstraete, Stefan
AU - Adriaansen, Henk J.
AU - Mairesse, Georges H.
AU - Terpstra, Willem F.
AU - Faes, Dirk
AU - Pieterse, Mathijs
AU - Virdone, Saverio
AU - Verheugt, Freek W. A.
AU - Cools, Frank
AU - ten Cate, Hugo
AU - GARFIELD-AF Investigators
N1 - Funding Information:
The Global Anticoagulant Registry in the FIELD–Atrial Fibrillation was sponsored by the Thrombosis Research Institute, London, United Kingdom. Funding of the registry was provided through an unrestricted research grant from Bayer Pharma AG, Berlin, Germany. We thank the physicians, nurses, and patients involved in the GARFIELD-AF registry. We also thank Madhusudana Rao (TRI) and Saverio Virdone (TRI) for providing data analyses. The authors of this manuscript extend their gratitude to the 15 Dutch and 25 Belgian medical centers whose participation in GARFIELD-AF has made the results presented in this paper possible (listed in the Appendix).
Funding Information:
J. Seelig is supported by an unrestricted research grant from the Dutch Federation of Anticoagulation clinics (“FNT”). F. W. A. Verheugt has received honoraria for consulting and presentations from Bayer HealthCare, Boehringer‐Ingelheim, BMS/Pfizer, and Daiichi‐Sankyo. F. Cools reports speaker fees from Boehringer‐Ingelheim Pharma, Bayer AG, Pfizer, and speaker fees and a modest research grant from Daiichi‐Sankyo Europe. F. Cools is national coordinator for Garfield‐AF in Belgium. H. ten Cate received compensation for presentations from Boehringer, Bayer, Leo, Daiichi; is advisor for Alveron; and receives research support from Bayer and Pfizer. He is an unpaid chairman of the board of the Dutch Federation of Anticoagulation Clinics and national coordinator for Garfield‐AF in the Netherlands. H. ten Cate is adjunct professor at the Center for Thrombosis and Haemostasis, Gutenberg Medical Center, Mainz, Germany. The other authors declare that they have no competing interests.
Publisher Copyright:
© 2020 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis
PY - 2020/12
Y1 - 2020/12
N2 - Background The uptake rate of non-vitamin K oral anticoagulants (NOAC) for the treatment of non-valvular atrial fibrillation (AF) was far lower in the Netherlands (NL) compared to Belgium (BE). Also, patients on VKA in NL were treated with a higher target international normalized ratio (INR) range of 2.5 to 3.5. Objectives To explore the effect of these differences on thromboembolism (TE) and bleeding. Methods Data from the GARFIELD-AF registry was used. Patients with new-onset AF and >= 1 investigator-determined risk factor for stroke were included between 2010 and 2016. Event rates from 2 years of follow-up were used. Results In NL and BE, 1186 and 1705 patients were included, respectively. Female sex (42.3% vs 42.2%), mean age (70.7 vs 71.3 years), CHA(2)DS(2)-VASc (3.1 vs 3.1), and HAS-BLED score (1.4 vs 1.5) were comparable between NL and BE. At diagnosis in NL vs BE, 72.1% vs 14.6% received vitamin K antagonists (VKA) and 17.8% vs 65.5% NOACs, varying greatly across cohorts. Mean INR was 2.9 (+/- 1.0) and 2.4 (+/- 1.0) in NL and BE, respectively. Event rates per 100 patient-years in NL and BE, respectively, of all-cause mortality (3.38 vs 3.90; hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15), ischemic stroke/TE (0.82 vs 0.72; HR 1.14, 95% CI 0.62-2.11), and major bleeding (2.06 vs 1.54; HR 1.33, 95% CI 0.89-1.99) did not differ significantly. Conclusions In GARFIELD-AF, despite similar characteristics, patients on anticoagulants were treated differently in NL and BE. Although the rate of major bleeding was 33% higher in NL, variations in bleeding, mortality, and TE rates were not statistically significant.
AB - Background The uptake rate of non-vitamin K oral anticoagulants (NOAC) for the treatment of non-valvular atrial fibrillation (AF) was far lower in the Netherlands (NL) compared to Belgium (BE). Also, patients on VKA in NL were treated with a higher target international normalized ratio (INR) range of 2.5 to 3.5. Objectives To explore the effect of these differences on thromboembolism (TE) and bleeding. Methods Data from the GARFIELD-AF registry was used. Patients with new-onset AF and >= 1 investigator-determined risk factor for stroke were included between 2010 and 2016. Event rates from 2 years of follow-up were used. Results In NL and BE, 1186 and 1705 patients were included, respectively. Female sex (42.3% vs 42.2%), mean age (70.7 vs 71.3 years), CHA(2)DS(2)-VASc (3.1 vs 3.1), and HAS-BLED score (1.4 vs 1.5) were comparable between NL and BE. At diagnosis in NL vs BE, 72.1% vs 14.6% received vitamin K antagonists (VKA) and 17.8% vs 65.5% NOACs, varying greatly across cohorts. Mean INR was 2.9 (+/- 1.0) and 2.4 (+/- 1.0) in NL and BE, respectively. Event rates per 100 patient-years in NL and BE, respectively, of all-cause mortality (3.38 vs 3.90; hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15), ischemic stroke/TE (0.82 vs 0.72; HR 1.14, 95% CI 0.62-2.11), and major bleeding (2.06 vs 1.54; HR 1.33, 95% CI 0.89-1.99) did not differ significantly. Conclusions In GARFIELD-AF, despite similar characteristics, patients on anticoagulants were treated differently in NL and BE. Although the rate of major bleeding was 33% higher in NL, variations in bleeding, mortality, and TE rates were not statistically significant.
KW - anticoagulants
KW - hemorrhage
KW - international normalized ratio
KW - registries
KW - stroke
KW - VENOUS THROMBOEMBOLIC DISEASE
KW - ORAL ANTICOAGULANTS
KW - STROKE
KW - RISK
KW - METAANALYSIS
KW - DEFINITION
KW - INTENSITY
KW - WARFARIN
KW - THERAPY
KW - SAFETY
U2 - 10.1111/jth.15081
DO - 10.1111/jth.15081
M3 - Article
C2 - 32886853
SN - 1538-7933
VL - 18
SP - 3280
EP - 3288
JO - Journal of Thrombosis and Haemostasis
JF - Journal of Thrombosis and Haemostasis
IS - 12
ER -