2017
DOI: 10.1161/strokeaha.117.017549
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Real-World Setting Comparison of Nonvitamin-K Antagonist Oral Anticoagulants Versus Vitamin-K Antagonists for Stroke Prevention in Atrial Fibrillation

Abstract: This meta-analysis confirms the main findings of the randomized controlled trials of dabigatran, rivaroxaban, and apixaban in the real-world setting and, hence, strengthens their validity.

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Cited by 202 publications
(168 citation statements)
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“…In phase III trials, all were at least non-inferior to warfarin for preventing stroke and systemic embolism, with about half the rate of intracranial haemorrhage 81–84. These clinical trial data are strongly supported by data from observational studies in ‘real world’ populations 85. Our practice, supported by European guidelines,8 is to recommend a DOAC to all patients without a specific indication for a vitamin K antagonist (eg, a mechanical prosthetic heart valve or significant mitral stenosis)86 (box 1).…”
Section: Starting An Anticoagulantmentioning
confidence: 90%
“…In phase III trials, all were at least non-inferior to warfarin for preventing stroke and systemic embolism, with about half the rate of intracranial haemorrhage 81–84. These clinical trial data are strongly supported by data from observational studies in ‘real world’ populations 85. Our practice, supported by European guidelines,8 is to recommend a DOAC to all patients without a specific indication for a vitamin K antagonist (eg, a mechanical prosthetic heart valve or significant mitral stenosis)86 (box 1).…”
Section: Starting An Anticoagulantmentioning
confidence: 90%
“…23,24 Clinical trials and real-world setting data provide consistent observations of a lower incidence of intracranial bleeding with DOACs; however, there is a higher risk of gastrointestinal hemorrhage when compared with VKAs. 25,26 Data from dabigatran registry (Global Registry on Long-term Oral Anti-thrombotic Treatment in Patients with Atrial Fibrillation) and real-world data show that the majority of major bleeding events in dabigatran occur during the first 12 months of therapy. 27,28 In our study, one patient on dabigatran developed gastrointestinal bleeding with hemopericardium that required reversal with the antidote.…”
Section: Discussionmentioning
confidence: 99%
“…2 Nevertheless, the high proportion is concerning considering the extensive use of the Danish population-based health care registers in the evaluation of safety and effectiveness of real-world DOAC use. 3 In such studies, safety and effectiveness are usually explored in the context of a specific treatment indication defined by the presence of a specific hospital-based diagnosis, such as AF. However, with this approach, many DOAC users potentially treated for the indication of interest, but without a registered diagnosis, will not be included.…”
Section: Cohort Selection In Register-based Studies Of Direct Oral Anmentioning
confidence: 99%