Comparison of international normalized ratio audit parameters in patients enrolled in GARFIELD-AF and treated with vitamin K antagonists

the GARFIELD-AF Investigators

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Vitamin K antagonist (VKA) therapy for stroke prevention in atrial fibrillation (AF) requires monitoring of the international normalized ratio (INR). We evaluated the agreement between two INR audit parameters, frequency in range (FIR) and proportion of time in the therapeutic range (TTR), using data from a global population of patients with newly diagnosed non-valvular AF, the Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF). Among 17 168 patients with 1-year follow-up data available at the time of the analysis, 8445 received VKA therapy (±antiplatelet therapy) at enrolment, and of these patients, 5066 with ≥3 INR readings and for whom both FIR and TTR could be calculated were included in the analysis. In total, 70 905 INRs were analysed. At the patient level, TTR showed higher values than FIR (mean, 56·0% vs 49·8%; median, 59·7% vs 50·0%). Although patient-level FIR and TTR values were highly correlated (Pearson correlation coefficient [95% confidence interval; CI], 0·860 [0·852–0·867]), estimates from individuals showed widespread disagreement and variability (Lin's concordance coefficient [95% CI], 0·829 [0·821–0·837]). The difference between FIR and TTR explained 17·4% of the total variability of measurements. These results suggest that FIR and TTR are not equivalent and cannot be used interchangeably.

Original languageEnglish (US)
Pages (from-to)610-623
Number of pages14
JournalBritish Journal of Haematology
Volume174
Issue number4
DOIs
StatePublished - Aug 1 2016

Fingerprint

International Normalized Ratio
Vitamin K
Anticoagulants
Registries
Therapeutics
Atrial Fibrillation
Reading
Stroke
Confidence Intervals

Keywords

  • atrial fibrillation
  • frequency in range
  • international normalized ratio
  • time in therapeutic range
  • vitamin K antagonists

ASJC Scopus subject areas

  • Hematology

Cite this

Comparison of international normalized ratio audit parameters in patients enrolled in GARFIELD-AF and treated with vitamin K antagonists. / the GARFIELD-AF Investigators.

In: British Journal of Haematology, Vol. 174, No. 4, 01.08.2016, p. 610-623.

Research output: Contribution to journalArticle

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abstract = "Vitamin K antagonist (VKA) therapy for stroke prevention in atrial fibrillation (AF) requires monitoring of the international normalized ratio (INR). We evaluated the agreement between two INR audit parameters, frequency in range (FIR) and proportion of time in the therapeutic range (TTR), using data from a global population of patients with newly diagnosed non-valvular AF, the Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF). Among 17 168 patients with 1-year follow-up data available at the time of the analysis, 8445 received VKA therapy (±antiplatelet therapy) at enrolment, and of these patients, 5066 with ≥3 INR readings and for whom both FIR and TTR could be calculated were included in the analysis. In total, 70 905 INRs were analysed. At the patient level, TTR showed higher values than FIR (mean, 56·0{\%} vs 49·8{\%}; median, 59·7{\%} vs 50·0{\%}). Although patient-level FIR and TTR values were highly correlated (Pearson correlation coefficient [95{\%} confidence interval; CI], 0·860 [0·852–0·867]), estimates from individuals showed widespread disagreement and variability (Lin's concordance coefficient [95{\%} CI], 0·829 [0·821–0·837]). The difference between FIR and TTR explained 17·4{\%} of the total variability of measurements. These results suggest that FIR and TTR are not equivalent and cannot be used interchangeably.",
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author = "{the GARFIELD-AF Investigators} and Fitzmaurice, {David A.} and Gabriele Accetta and Sylvia Haas and Gloria Kayani and {Lucas Luciardi}, Hector and Frank Misselwitz and Karen Pieper and {ten Cate}, Hugo and Turpie, {Alexander G.G.} and Kakkar, {Ajay K.} and Bassand, {Jean Pierre} and {John Camm}, A. and Goldhaber, {Samuel Z.} and Shinya Goto and Werner Hacke and Mantovani, {Lorenzo G.} and {van Eickels}, Martin and Verheugt, {Freek W.A.} and Fox, {Keith A.A.} and Gersh, {Bernard J.} and Harry Gibbs and Marianne Brodmann and Frank Cools and Barretto, {Antonio Carlos Pereira} and Connolly, {Stuart J.} and Alex Spyropoulos and John Eikelboom and Ramon Corbalan and Dayi Hu and Petr Jansky and Nielsen, {J{\o}rn Dalsgaard} and Hany Ragy and Pekka Raatikainen and {Le Heuzey}, {Jean Yves} and Harald Darius and Matyas Keltai and Sanjay Kakkar and Sawhney, {Jitendra Pal Singh} and Ambrosio, {Giancarlo Agnelli and Giuseppe} and Yukihiro Koretsune and D{\'i}az, {Carlos Jerjes S{\'a}nchez} and Dan Atar and Janina Stepinska and Elizaveta Panchenko and Lim, {Toon Wei} and Barry Jacobson and Seil Oh and Xavier Vi{\~n}olas and Marten Rosenqvist and Daniel Nishijima",
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AU - the GARFIELD-AF Investigators

AU - Fitzmaurice, David A.

AU - Accetta, Gabriele

AU - Haas, Sylvia

AU - Kayani, Gloria

AU - Lucas Luciardi, Hector

AU - Misselwitz, Frank

AU - Pieper, Karen

AU - ten Cate, Hugo

AU - Turpie, Alexander G.G.

AU - Kakkar, Ajay K.

AU - Bassand, Jean Pierre

AU - John Camm, A.

AU - Goldhaber, Samuel Z.

AU - Goto, Shinya

AU - Hacke, Werner

AU - Mantovani, Lorenzo G.

AU - van Eickels, Martin

AU - Verheugt, Freek W.A.

AU - Fox, Keith A.A.

AU - Gersh, Bernard J.

AU - Gibbs, Harry

AU - Brodmann, Marianne

AU - Cools, Frank

AU - Barretto, Antonio Carlos Pereira

AU - Connolly, Stuart J.

AU - Spyropoulos, Alex

AU - Eikelboom, John

AU - Corbalan, Ramon

AU - Hu, Dayi

AU - Jansky, Petr

AU - Nielsen, Jørn Dalsgaard

AU - Ragy, Hany

AU - Raatikainen, Pekka

AU - Le Heuzey, Jean Yves

AU - Darius, Harald

AU - Keltai, Matyas

AU - Kakkar, Sanjay

AU - Sawhney, Jitendra Pal Singh

AU - Ambrosio, Giancarlo Agnelli and Giuseppe

AU - Koretsune, Yukihiro

AU - Díaz, Carlos Jerjes Sánchez

AU - Atar, Dan

AU - Stepinska, Janina

AU - Panchenko, Elizaveta

AU - Lim, Toon Wei

AU - Jacobson, Barry

AU - Oh, Seil

AU - Viñolas, Xavier

AU - Rosenqvist, Marten

AU - Nishijima, Daniel

PY - 2016/8/1

Y1 - 2016/8/1

N2 - Vitamin K antagonist (VKA) therapy for stroke prevention in atrial fibrillation (AF) requires monitoring of the international normalized ratio (INR). We evaluated the agreement between two INR audit parameters, frequency in range (FIR) and proportion of time in the therapeutic range (TTR), using data from a global population of patients with newly diagnosed non-valvular AF, the Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF). Among 17 168 patients with 1-year follow-up data available at the time of the analysis, 8445 received VKA therapy (±antiplatelet therapy) at enrolment, and of these patients, 5066 with ≥3 INR readings and for whom both FIR and TTR could be calculated were included in the analysis. In total, 70 905 INRs were analysed. At the patient level, TTR showed higher values than FIR (mean, 56·0% vs 49·8%; median, 59·7% vs 50·0%). Although patient-level FIR and TTR values were highly correlated (Pearson correlation coefficient [95% confidence interval; CI], 0·860 [0·852–0·867]), estimates from individuals showed widespread disagreement and variability (Lin's concordance coefficient [95% CI], 0·829 [0·821–0·837]). The difference between FIR and TTR explained 17·4% of the total variability of measurements. These results suggest that FIR and TTR are not equivalent and cannot be used interchangeably.

AB - Vitamin K antagonist (VKA) therapy for stroke prevention in atrial fibrillation (AF) requires monitoring of the international normalized ratio (INR). We evaluated the agreement between two INR audit parameters, frequency in range (FIR) and proportion of time in the therapeutic range (TTR), using data from a global population of patients with newly diagnosed non-valvular AF, the Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF). Among 17 168 patients with 1-year follow-up data available at the time of the analysis, 8445 received VKA therapy (±antiplatelet therapy) at enrolment, and of these patients, 5066 with ≥3 INR readings and for whom both FIR and TTR could be calculated were included in the analysis. In total, 70 905 INRs were analysed. At the patient level, TTR showed higher values than FIR (mean, 56·0% vs 49·8%; median, 59·7% vs 50·0%). Although patient-level FIR and TTR values were highly correlated (Pearson correlation coefficient [95% confidence interval; CI], 0·860 [0·852–0·867]), estimates from individuals showed widespread disagreement and variability (Lin's concordance coefficient [95% CI], 0·829 [0·821–0·837]). The difference between FIR and TTR explained 17·4% of the total variability of measurements. These results suggest that FIR and TTR are not equivalent and cannot be used interchangeably.

KW - atrial fibrillation

KW - frequency in range

KW - international normalized ratio

KW - time in therapeutic range

KW - vitamin K antagonists

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JO - British Journal of Haematology

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