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 - Diercks, Deborah B
AU - Nishijima, D.
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.
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U2 - 10.1371/journal.pone.0164076
DO - 10.1371/journal.pone.0164076
M3 - Article
C2 - 27792741
AN - SCOPUS:84994045395
VL - 11
JO - PLoS One
JF - PLoS One
SN - 1932-6203
IS - 10
M1 - e0164076
ER -