Quality of vitamin k antagonist control and 1-year outcomes in patients with atrial fibrillation: A global perspective from the GARFIELD-AF registry

GARFIELD-AF Investigators

Research output: Contribution to journalArticlepeer-review

80 Citations (Scopus)

Abstract

Aims Vitamin K antagonists (VKAs) need to be individually dosed. International guidelines recommend a target range of international normalised ratio (INR) of 2.0-3.0 for stroke prevention in atrial fibrillation (AF). We analysed the time in this therapeutic range (TTR) of VKAtreated patients with newly diagnosed AF in the ongoing, global, observational registry GARFIELD-AF. Taking TTR as a measure of the quality of patient management, we analysed its relationship with 1-year outcomes, including stroke/systemic embolism (SE), major bleeding, and all-cause mortality. Methods and Results TTR was calculated for 9934 patients using 136,082 INR measurements during 1-year follow-up. The mean TTR was 55.0%; values were similar for different VKAs. 5851 (58.9%) patients had TTR<65%; 4083 (41.1%) TTR≥65%. The proportion of patients with TTR≥65% varied from 16.7% in Asia to 49.4% in Europe. There was a 2.6-fold increase in the risk of stroke/SE, 1.5-fold increase in the risk of major bleeding, and 2.4-fold increase in the risk of all-cause mortality with TTR<65% versus ≥65% after adjusting for potential confounders. The population attributable fraction, i.e. the proportion of events attributable to suboptimal anticoagulation among VKA users, was 47.7% for stroke/SE, 16.7% for major bleeding, and 45.4% for all-cause mortality. In patients with TTR<65%, the risk of first stroke/SE was highest in the first 4 months and decreased thereafter (test for trend, p = 0.021). In these patients, the risk of first major bleed declined during follow-up (p = 0.005), whereas in patients with TTR≥65%, the risk increased over time (p = 0.027). Conclusion A large proportion of patients with AF had poor VKA control and these patients had higher risks of stroke/SE, major bleeding, and all-cause mortality. Our data suggest that there is room for improvement of VKA control in routine clinical practice and that this could substantially reduce adverse outcomes.

Original languageEnglish
Article numbere0164076
JournalPloS one
Volume11
Issue number10
DOIs
Publication statusPublished - 2016 Oct 1

Bibliographical note

Funding Information:
SH: personal fees from Aspen, Bayer Healthcare, BMS, Daiichi-Sankyo, Pfizer, and Sanofi. HtC: invited talks for Bayer, Boehringer Ingelheim, GSK, Leo, and Roche; consultant for Stago and Philips; research funding from Bayer, Boehringer Ingelheim, and AstraZeneca; and Chair of board, Dutch Federation of Anticoagulation Clinics. J-PB: speakers’ bureau for Aspen. AJC: consultant for Bayer, Boehringer Ingelheim, and Daiichi; remuneration from Bayer, Boehringer Ingelheim, and Daiichi; research funding from Daiichi. HD: advisory boards for AstraZeneca, Bayer, Berlin-Chemie, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Lilly, and MSD Sharp & Dohme; Steering Committees of clinical trials and registries sponsored by AstraZeneca, Bayer, Berlin-Chemie, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Lilly, MSD Sharp & Dohme, BMFT, Harvard Med. Res. Inst., and Thrombosis Research Institute; participation of affiliated hospital in clinical trials involving NOACs conducted by Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, and Pfizer (no personal financial benefits); travel grants and speakers’ honoraria from AstraZeneca, Bayer, Berlin-Chemie, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Lilly, MSD Sharp & Dohme, and Thrombosis Research Institute. DAF: advisory board for Bayer. SZG: research funding from BiO2 Medical, Boehringer-Ingelheim, Bristol Meyers Squibb, BTG EKOS, Daiichi Sankyo, National Heart Lung and Blood Institute of the National Institutes of Health, Janssen, and Thrombosis Research Group; and consultant for Bayer, Boehringer-Ingelheim, Bristol Meyers Squibb, Daiichi Sankyo, Janssen, and Portola. SG: remuneration from Sanofi, AstraZeneca, and Bayer; and research funding from Sanofi. BJ: remuneration from Bayer Healthcare and Sanofi-Aventis. LGM: personal fees from Bayer Healthcare, Pfizer, and Daiichi Sankyo; and research funding from Bayer, Boehringer Ingelheim, and Pfizer. FM and MvE: employees of Bayer Pharma AG. KP: consultant for Thrombosis Research Institute, AstraZeneca, and Bayer. SMS: consultant for Bayer Healthcare, Boehringer Ingelheim, and Daiichi Sankyo; travel grants and honoraria for speaking or participation at meetings from Bayer Healthcare, Boehringer Ingelheim, Daiichi Sankyo, BMS, and Pfizer. JS: research funding from Bayer; honoraria from Bayer, Boehringer Ingelheim, and BMS/Pfizer; and expert witness and consultant/advisory board for Boehringer Ingelheim. AGGT: consultant for Bayer Pharma AG; and speakers’ bureau for Janssen. AKK: personal fees from Bayer Healthcare, Boehringer-Ingelheim Pharma, Daiichi Sankyo Europe, Sanofi SA, Janssen Pharma; and research funding from Bayer Healthcare. We confirm that the information stated in the Competing Interests section does not alter our adherence to PLOS ONE policies on sharing data and materials.

Publisher Copyright:
© 2016 Haas et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

All Science Journal Classification (ASJC) codes

  • General

Fingerprint

Dive into the research topics of 'Quality of vitamin k antagonist control and 1-year outcomes in patients with atrial fibrillation: A global perspective from the GARFIELD-AF registry'. Together they form a unique fingerprint.

Cite this