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Quality of Vitamin K antagonist control and 1-Year outcomes in patients with atrial fibrillation : a global perspective from the GARFIELD-AF registry

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Haas, Sylvia, ten Cate, Hugo, Accetta, Gabriele, Angchaisuksiri, Pantep, Bassand, Jean-Pierre, Camm, A. John, Corbalan, Ramon, Darius, Harald, Fitzmaurice, David A., Goldhaber, Samuel Z. et al.
(2016) Quality of Vitamin K antagonist control and 1-Year outcomes in patients with atrial fibrillation : a global perspective from the GARFIELD-AF registry. PLoS One, 11 (10). e0164076. doi:10.1371/journal.pone.0164076 ISSN 1932-6203.

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Official URL: http://dx.doi.org/10.1371/journal.pone.0164076

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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 VKA-treated 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.

Item Type: Journal Article
Subjects: R Medicine > RC Internal medicine
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Cerebrovascular disease -- Prevention, Atrial fibrillation, Vitamin K
Journal or Publication Title: PLoS One
Publisher: Public Library of Science
ISSN: 1932-6203
Official Date: 28 September 2016
Dates:
DateEvent
28 September 2016Published
18 September 2016Accepted
Volume: 11
Number: 10
Article Number: e0164076
DOI: 10.1371/journal.pone.0164076
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access (Creative Commons)
Date of first compliant deposit: 24 November 2017
Date of first compliant Open Access: 24 November 2017
Funder: bayer
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
UNSPECIFIEDBayer-Pharmahttps://viaf.org/viaf/155646271

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