Michela Giustozzi1, Maria Cristina Vedovati2, Melina Verso2, Luca Scrucca3, Serenella Conti4, Paolo Verdecchia5, Giulio Bogliari2, Lucia Pierpaoli6, Giancarlo Agnelli2, Cecilia Becattini2. 1. Internal Vascular and Emergency Medicine and Stroke Unit, University of Perugia, Perugia, Italy. Electronic address: michela.giustozzi@unipg.it. 2. Internal Vascular and Emergency Medicine and Stroke Unit, University of Perugia, Perugia, Italy. 3. Statistics Division, Department of Economy, University of Perugia, Perugia, Italy. 4. Division of Cardiology, S. Matteo Degli Infermi Hospital, Spoleto, Italy. 5. Department of Medicine, Hospital of Assisi, Assisi, Italy. 6. Emergency Medicine, S. Maria Delle Croci Hospital, Ravenna, Italy.
Abstract
BACKGROUND: Patients aged 90 years or older are often excluded from or under-represented in clinical trials and cohort studies. The clinical benefit of anticoagulation in nonagenarians with atrial fibrillation (AF) remains undefined. OBJECTIVES: To assess the effectiveness and safety of oral anticoagulants in AF patients aged 90 years or older. METHODS: Non-valvular AF patients aged 90 years or older receiving direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs) were included in this observational multicentre study. The primary outcome was the composite of ischaemic stroke/transient ischemic attack (TIA) and systemic embolism (SE). Major bleeding (MB), anticoagulant discontinuation and all-cause death were also assessed. Results are reported as sub-distribution hazard ratios (SHR) with 95% CI, taking death as competing risk. RESULTS: 546 patients were included (301 VKAs retrospective cohort and 245 DOACs prospective cohort; median follow-up 404 days). The rate of ischaemic stroke/TIA/SE was 2.4% patient-year and that of MB 5.5% patient-year. Previous ischaemic stroke/TIA (SHR 3.47; 95% CI 1.54-7.81) and vascular disease (SHR 2.89; 95% CI 1.27-6.60) were independent predictors of ischaemic stroke/TIA/SE. Previous bleeding (SHR 2.53; 95% CI 1.37-4.64) was an independent predictor of MB. The risk of ischaemic stroke/TIA/SE (SHR 0.78, 95% CI 0.30-2.04) or MB (SHR 1.43, 95% CI 0.77-2.65) was not significantly different with DOACs or VKAs. CONCLUSIONS: In AF nonagenarians receiving anticoagulant treatment, the rate of ischaemic stroke/TIA/SE is relatively low with the drawback of a not negligible rate of MB. DOACs seem a reasonable option for prevention of ischaemic stroke/TIA/SE in this setting. Crown
BACKGROUND:Patients aged 90 years or older are often excluded from or under-represented in clinical trials and cohort studies. The clinical benefit of anticoagulation in nonagenarians with atrial fibrillation (AF) remains undefined. OBJECTIVES: To assess the effectiveness and safety of oral anticoagulants in AFpatients aged 90 years or older. METHODS: Non-valvular AFpatients aged 90 years or older receiving direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs) were included in this observational multicentre study. The primary outcome was the composite of ischaemic stroke/transient ischemic attack (TIA) and systemic embolism (SE). Major bleeding (MB), anticoagulant discontinuation and all-cause death were also assessed. Results are reported as sub-distribution hazard ratios (SHR) with 95% CI, taking death as competing risk. RESULTS: 546 patients were included (301 VKAs retrospective cohort and 245 DOACs prospective cohort; median follow-up 404 days). The rate of ischaemic stroke/TIA/SE was 2.4% patient-year and that of MB 5.5% patient-year. Previous ischaemic stroke/TIA (SHR 3.47; 95% CI 1.54-7.81) and vascular disease (SHR 2.89; 95% CI 1.27-6.60) were independent predictors of ischaemic stroke/TIA/SE. Previous bleeding (SHR 2.53; 95% CI 1.37-4.64) was an independent predictor of MB. The risk of ischaemic stroke/TIA/SE (SHR 0.78, 95% CI 0.30-2.04) or MB (SHR 1.43, 95% CI 0.77-2.65) was not significantly different with DOACs or VKAs. CONCLUSIONS: In AF nonagenarians receiving anticoagulant treatment, the rate of ischaemic stroke/TIA/SE is relatively low with the drawback of a not negligible rate of MB. DOACs seem a reasonable option for prevention of ischaemic stroke/TIA/SE in this setting. Crown