PMID- 33606006 OWN - NLM STAT- MEDLINE DCOM- 20210528 LR - 20210925 IS - 2473-9537 (Electronic) IS - 2473-9529 (Print) IS - 2473-9529 (Linking) VI - 5 IP - 4 DP - 2021 Feb 23 TI - Bleeding and related mortality with NOACs and VKAs in newly diagnosed atrial fibrillation: results from the GARFIELD-AF registry. PG - 1081-1091 LID - 10.1182/bloodadvances.2020003560 [doi] AB - In atrial fibrillation (AF), lower risks of death and bleeding with non-vitamin-K oral anticoagulants (NOACs) were reported in meta-analyses of controlled trials, but whether these findings hold true in real-world practice remains uncertain. Risks of bleeding and death were assessed in 52 032 patients with newly diagnosed AF enrolled in GARFIELD-AF (Global Anticoagulant Registry in the FIELD-Atrial Fibrillation), a worldwide prospective registry. Baseline treatment was vitamin K antagonists (VKAs) with or without antiplatelet (AP) agents (VKA +/- AP) (20 151; 39.3%), NOACs +/- AP agents (14 103; 27.5%), AP agents only (10 748; 21.0%), or no antithrombotics (6219; 12.1%). One-year follow-up event rates (95% confidence interval [CI]) of minor, clinically relevant nonmajor (CRNM), and major bleedings were 2.29 (2.16-2.43), 1.10 (1.01-1.20), and 1.31 (1.21-1.41) per 100 patient-years, respectively. Bleeding risk was lower with NOACs than VKAs for any bleeding (hazard ratio (HR) [95% CI]), 0.85 [0.73-0.98]) or major bleeding (0.79 [0.60-1.04]). Compared with no bleeding, the risk of death was higher with minor bleeding (adjusted HR [aHR], 1.53 [1.07-2.19]), CRNM bleeding (aHR, 2.59 [1.80-3.73]), and major bleeding (aHR, 8.24 [6.76-10.04]). The all-cause mortality rate was lower with NOACs than with VKAs (aHR, 0.73 [0.62-0.85]). Forty-five percent (114) of all deaths occurred within 30 days, and 40% of these were from intracranial/intraspinal hemorrhage (ICH). The rates of any bleeding and all-cause death were lower with NOACs than with VKAs. Major bleeding was associated with the highest risk of death. CRNM bleeding and minor bleeding were associated with a higher risk of death compared to no bleeding. Death within 30 days after a major bleed was most frequently related to ICH. This trial was registered at www.clinicaltrials.gov as #NCT01090362. CI - (c) 2021 by The American Society of Hematology. FAU - Bassand, Jean-Pierre AU - Bassand JP AD - Department of Cardiology, University of Besancon, Besancon, France. AD - Thrombosis Research Institute, London, United Kingdom. FAU - Virdone, Saverio AU - Virdone S AD - Thrombosis Research Institute, London, United Kingdom. FAU - Badoz, Marc AU - Badoz M AD - Department of Cardiology, University of Besancon, Besancon, France. FAU - Verheugt, Freek W A AU - Verheugt FWA AD - Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. FAU - Camm, A John AU - Camm AJ AD - Cardiology Clinical Academic Group, Molecular and Clinical Sciences Institute, St. George's University of London, London, United Kingdom. FAU - Cools, Frank AU - Cools F AD - Department of Cardiology, AZ Klina, Brasschaat, Belgium. FAU - Fox, Keith A A AU - Fox KAA AD - Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom. FAU - Goldhaber, Samuel Z AU - Goldhaber SZ AD - Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA. FAU - Goto, Shinya AU - Goto S AD - Department of Medicine (Cardiology), Tokai University School of Medicine, Kanagawa, Japan. FAU - Haas, Sylvia AU - Haas S AD - Department of Medicine, Technical University of Munich, Munich, Germany. FAU - Hacke, Werner AU - Hacke W AD - Department of Neurology, University of Heidelberg, Heidelberg, Germany. FAU - Kayani, Gloria AU - Kayani G AD - Thrombosis Research Institute, London, United Kingdom. FAU - Misselwitz, Frank AU - Misselwitz F AD - Bayer AG, Berlin, Germany. FAU - Pieper, Karen S AU - Pieper KS AD - Thrombosis Research Institute, London, United Kingdom. FAU - Turpie, Alexander G G AU - Turpie AGG AD - Department of Medicine, McMaster University, Hamilton, ON, Canada; and. FAU - van Eickels, Martin AU - van Eickels M AD - Bayer AG, Berlin, Germany. FAU - Kakkar, Ajay K AU - Kakkar AK AD - Thrombosis Research Institute, London, United Kingdom. AD - University College London, London, United Kingdom. LA - eng SI - ClinicalTrials.gov/NCT01090362 PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - Blood Adv JT - Blood advances JID - 101698425 RN - 0 (Anticoagulants) RN - 12001-79-5 (Vitamin K) SB - IM MH - Administration, Oral MH - Anticoagulants/adverse effects MH - *Atrial Fibrillation/complications/drug therapy MH - Hemorrhage/chemically induced MH - Humans MH - Registries MH - *Vitamin K/therapeutic use PMC - PMC7903226 COIS- Conflict-of-interest disclosure: F.W.A.V. has received grants from Bayer Healthcare and personal fees from Bayer Healthcare, BMS/Pfizer, Daiichi-Sankyo, and Boehringer-Ingelheim. A.J.C. has received institutional grants and personal fees from Bayer, Boehringer-Ingelheim, Pfizer/BMS, and Daiichi-Sankyo. F.C. reports minor speaking and consultancy fees from Boehringer-Ingelheim, Bayer, Daiichi-Sankyo, BMS, and Pfizer outside the submitted work. K.A.A.F. reports grants and personal fees from Bayer/Janssen AstraZeneca and personal fees from Sanofi/Regeneron outside the submitted work. S.Z.G. has received research support from BiO2 Medical, Boehringer-Ingelheim, BMS, Boston Scientific, Daiichi, Janssen, National Heart, Lung, and Blood Institute, and the Thrombosis Research Institute and has served as a consultant for Agile, Bayer, Boehringer-Ingelheim, BMS, Daiichi, Janssen, Portola, and Zafgen. S.G. has received personal fees from the Thrombosis Research Institute, Harvard University, and the American Heart Association and grants from the Vehicle Racing Commemorative Foundation, Nakatani Foundation for Advancement of Measuring Technologies in Biomedical Engineering, Bristol-Myers Squibb, Sanofi, Ono, and Pfizer. S.H. has received personal fees from Aspen, Bayer Healthcare, BMS/Pfizer, Daiichi-Sankyo, and Sanofi. F.M. is an employee of Bayer AG. K.S.P. reports personal fees from the Thrombosis Research Institute during the conduct of the study. A.G.G.T. has received personal fees from Bayer Healthcare, Janssen Pharmaceutical Research & Development, Astellas, and Portola. A.K.K. has received grants from Bayer AG and Sanofi and personal fees from Bayer AG, Janssen, Pfizer, Sanofi, Verseon, and Anthos Therapeutics. The remaining authors declare no competing financial interests. EDAT- 2021/02/20 06:00 MHDA- 2021/05/29 06:00 PMCR- 2021/02/19 CRDT- 2021/02/19 12:11 PHST- 2020/10/16 00:00 [received] PHST- 2020/12/02 00:00 [accepted] PHST- 2021/02/19 12:11 [entrez] PHST- 2021/02/20 06:00 [pubmed] PHST- 2021/05/29 06:00 [medline] PHST- 2021/02/19 00:00 [pmc-release] AID - S2473-9529(21)00130-0 [pii] AID - 2020/ADV2020003560 [pii] AID - 10.1182/bloodadvances.2020003560 [doi] PST - ppublish SO - Blood Adv. 2021 Feb 23;5(4):1081-1091. doi: 10.1182/bloodadvances.2020003560.