TY - JOUR
T1 - Quality of vitamin k antagonist control and 1-year outcomes in patients with atrial fibrillation
T2 - A global perspective from the GARFIELD-AF registry
AU - GARFIELD-AF Investigators
AU - Haas, Sylvia
AU - Cate, Hugo Ten
AU - Accetta, Gabriele
AU - Angchaisuksiri, Pantep
AU - Bassand, Jean Pierre
AU - John Camm, A.
AU - Corbalan, Ramon
AU - Darius, Harald
AU - Fitzmaurice, David A.
AU - Goldhaber, Samuel Z.
AU - Goto, Shinya
AU - Jacobson, Barry
AU - Kayani, Gloria
AU - Mantovani, Lorenzo G.
AU - Misselwitz, Frank
AU - Pieper, Karen
AU - Schellong, Sebastian M.
AU - Stepinska, Janina
AU - Turpie, Alexander G.G.
AU - Eickels, Martin Van
AU - Kakkar, Ajay K.
AU - Hacke, Werner
AU - Gersh, Bernard J.
AU - Luciardi, Hector Lucas
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 - Hu, Dayi
AU - Jansky, Petr
AU - Nielsen, Jørn Dalsgaard
AU - Ragy, Hany
AU - Raatikainen, Pekka
AU - Le Heuzey, Jean Yves
AU - Keltai, Matyas
AU - Kakkar, Sanjay
AU - Sawhney, Jitendra Pal Singh
AU - Agnelli, Giancarlo
AU - Ambrosio, Giuseppe
AU - Koretsune, Yukihiro
AU - Díaz, Carlos Jerjes Sánchez
AU - Atar, Dan
AU - Panchenko, Elizaveta
AU - Lim, Toon Wei
AU - Oh, Seil
AU - Viñolas, Xavier
AU - Mntla, P.
N1 - 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.
PY - 2016/10/1
Y1 - 2016/10/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84994045395&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0164076
DO - 10.1371/journal.pone.0164076
M3 - Article
C2 - 27792741
AN - SCOPUS:84994045395
SN - 1932-6203
VL - 11
JO - PLoS ONE
JF - PLoS ONE
IS - 10
M1 - e0164076
ER -
