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.

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

Accetta G.;Wang Y.;Wang Y.;Li X.;Chen P.;Zhou Z. H.;Roy D.;Shah S.;Rao M.;Shah D.;Murakami H.;Kubo H.;Kim J.;Saito Y.;Suzuki S.;Suzuki S.;Suzuki S.;Watanabe M.;Yoshida K.;Kim J.;An H. J.;Lee S. E.;Lee S.;Park M.;Park Y.;Ferroni F.;Campisi V.;Lopez A.;Del Carlo C. H.;Mortari L.;Pereira L.;Spolaor L.;Paparella G.;Sanchez D.;Schafer T.;Mueller H.;Klein V.;Szalai G.;Cappelli R.;Cosmi F.;Pancaldi L.;Feola M.;Grilli P.;Duranti G.;Berardi M.;Nicoli S.;Donzelli L.;Lillo F.;Bongiorni M. G.;Tondo C.;Iacopino S.;Banfi E.;Biagioli V.;Campagna G.;Guerra F.;Lo Buglio A.;Rangel G.;Salomone L.;Segreti L.;Alvarez D.;Alvarez M.;Austria A.;Moreno M. C.;Garcia A. I.;Palma A. N.;Malmqvist L.;Nilsson C.;Shah D.;Ross A.;Thompson J.;Jones H.;Ahmad N.;Gray D.;Jacobs M.;Thompson R.;Davies R.;Jackson D.;Cooke P.;Bennett J.;Thomson A.;Singh B.;Phan T.;Lee A.;Carroll P.;Campo M.;Singh C.;Wong K.;Gupta M.;Jackson A. M.;Kelly S.;Robinson M.;Wong S.;Salem H.;Soliman A.;Smith L.;Canova M.;Jones L.;Lee J. A.;Smith K.;
2016-01-01

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.
2016
Haas, S.; Cate, H. T.; Accetta, G.; Angchaisuksiri, P.; Bassand, J. -P.; John Camm, A.; Corbalan, R.; Darius, H.; Fitzmaurice, D. A.; Goldhaber, S. Z....espandi
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11568/1151600
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