Maria Giner-Soriano1,2, Albert Roso-Llorach1,2, Cristina Vedia Urgell2,3, Xavier Castells4, Dolors Capellà4, Ignacio Ferreira-González5, Josep Maria Elorza-Ricart6, Marc Casajuana1,2, Amelia Troncoso Mariño7, Eduard Diògene8, Bonaventura Bolíbar1,2, Concepció Violan1,2, Rosa Morros1,2. 1. Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain. 2. Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain. 3. Unitat de farmàcia, Servei d'Atenció Primària Barcelonès Nord i Maresme, Institut Català de la Salut, Badalona, Spain. 4. Translab Research Group, Unitat de Farmacologia Clínica, Departament de Ciències Mèdiques, Facultat de Medicina, UdG, Girona, Spain. 5. Unidad de Epidemiología del Servicio de Cardiología, Hospital Vall d'Hebron y CIBER de Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain. 6. System for the Improvement of Research in Primary Care (SIDIAP), Barcelona, Spain. 7. Unitat de Coordinació i Estratègia del Medicament, Institut Català de la Salut, Barcelona, Spain. 8. Servei de Farmacologia, Hospital Vall d'Hebron, Barcelona, Spain.
Abstract
PURPOSE: The aim of this study was to assess effectiveness and safety of antithrombotics for stroke prevention in non-valvular atrial fibrillation in real-use conditions. METHODS: We used a population-based retrospective cohort study. Information emerges from SIDIAP, a database containing anonymized information from electronic health records from 274 primary healthcare centres of the Catalan Health Institute, Catalonia (Spain), with a reference population of 5 835 000 people. Population includes all adults with a new diagnosis of non-valvular atrial fibrillation registered in SIDIAP from 2007 to 2012. The main outcome of antithrombotics' effectiveness was stroke. The main outcomes of safety were cerebral and gastrointestinal haemorrhages. We also estimated all-cause mortality. We used multivariable Cox proportional hazard models to examine association between antithrombotic treatment and main outcomes. RESULTS: We included 22 205 subjects with non-valvular atrial fibrillation; 40.8% initiated on vitamin K antagonists (VKA), 33.4% on antiplatelets and 25.8% untreated. We found stroke-risk reduction with VKA, hazard ratio (HR) 0.72 (95% confidence interval (CI), 0.58-0.91), also seen in patients with CHADS2 ≥ 2, HR 0.65 (95%CI, 0.49-0.86), and CHA2 DS2 -VASc ≥ 2, HR 0.66 (95%CI, 0.52-0.84). We observed a higher risk of digestive bleeding with antiplatelets, HR 1.32 (95%CI, 1.01-1.73). Both VKA and antiplatelets were associated with reduction of all-cause mortality risk; HR 0.55 (95%CI, 0.49-0.62) and HR 0.89 (95%CI, 0.80-0.97), respectively. CONCLUSIONS: This study found a stroke-risk reduction associated with VKA and an increased risk of gastrointestinal bleeding associated with platelet-aggregation inhibitors in comparison with untreated patients. Both antithrombotic groups showed a reduction in all-cause mortality.
PURPOSE: The aim of this study was to assess effectiveness and safety of antithrombotics for stroke prevention in non-valvular atrial fibrillation in real-use conditions. METHODS: We used a population-based retrospective cohort study. Information emerges from SIDIAP, a database containing anonymized information from electronic health records from 274 primary healthcare centres of the Catalan Health Institute, Catalonia (Spain), with a reference population of 5 835 000 people. Population includes all adults with a new diagnosis of non-valvular atrial fibrillation registered in SIDIAP from 2007 to 2012. The main outcome of antithrombotics' effectiveness was stroke. The main outcomes of safety were cerebral and gastrointestinal haemorrhages. We also estimated all-cause mortality. We used multivariable Cox proportional hazard models to examine association between antithrombotic treatment and main outcomes. RESULTS: We included 22 205 subjects with non-valvular atrial fibrillation; 40.8% initiated on vitamin K antagonists (VKA), 33.4% on antiplatelets and 25.8% untreated. We found stroke-risk reduction with VKA, hazard ratio (HR) 0.72 (95% confidence interval (CI), 0.58-0.91), also seen in patients with CHADS2 ≥ 2, HR 0.65 (95%CI, 0.49-0.86), and CHA2 DS2 -VASc ≥ 2, HR 0.66 (95%CI, 0.52-0.84). We observed a higher risk of digestive bleeding with antiplatelets, HR 1.32 (95%CI, 1.01-1.73). Both VKA and antiplatelets were associated with reduction of all-cause mortality risk; HR 0.55 (95%CI, 0.49-0.62) and HR 0.89 (95%CI, 0.80-0.97), respectively. CONCLUSIONS: This study found a stroke-risk reduction associated with VKA and an increased risk of gastrointestinal bleeding associated with platelet-aggregation inhibitors in comparison with untreated patients. Both antithrombotic groups showed a reduction in all-cause mortality.
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