Key result
In a prospective Spanish cohort of 1,443 patients with atrial fibrillation, DOAC use resulted in stroke, major bleeding, and intracranial bleeding rates of 0.7, 1.3, and 0.2 events/100 patient-years.
Why the study?
The study was conducted to analyze the effectiveness and safety of direct oral anticoagulants in atrial fibrillation patients treated in real-world clinical practice.
Observational (n=1,443)
In a real-world Spanish cohort of patients with nonvalvular atrial fibrillation, DOACs demonstrated effectiveness and safety profiles consistent with pivotal clinical trials.
Answers are grounded in this paper and cite their sources.
Supports DOAC consistency with trials in real-world Spanish AF; extends evidence observationally but leaves practice change open.
Aim: To analyze the effectiveness and safety of direct oral anticoagulants (DOACs) in atrial fibrillation (AF) patients attended in clinical practice. Methods: Observational and prospective study of AF patients that started treatment with DOACs. Results: 1443 patients (age 77.2 ± 9.7 years, CHA 2 DS 2 -VASc = 4.1 ± 1.5) were included. 46.0% were taking rivaroxaban, 24.4% dabigatran, 22.5% apixaban and 7.1% edoxaban. Patients taking dabigatran were younger, had lower CHA 2 DS 2 -VASc and lesser renal insufficiency. Patients taking apixaban had higher CHA 2 DS 2 -VASc and more renal insufficiency. Rates of stroke/major bleeding/intracranial bleeding were 0.7/1.3/0.2 events/100 patient-years, respectively. Conclusion: This was the first prospective study that analyzed the use of all DOACs in AF patients in Spain, showing a good profile in terms of safety and effectiveness in accordance with pivotal studies.
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Cerdá et al. (2019) conducted an observational in atrial fibrillation (n=1,443). Direct oral anticoagulants (DOACs) was evaluated on stroke / major bleeding / intracranial bleeding. In a prospective Spanish cohort of 1,443 patients with atrial fibrillation, DOAC use resulted in stroke, major bleeding, and intracranial bleeding rates of 0.7, 1.3, and 0.2 events/100 patient-years.
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