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   association of intracranial hemorrhage risk with non-vitamin k antagonist oral anticoagulant use vs aspirin use: a systematic review and meta-analysis  
   
نویسنده huang w.-y. ,singer d.e. ,wu y.-l. ,chiang c.-e. ,weng h.-h. ,lee m. ,ovbiagele b.
منبع jama neurology - 2018 - دوره : 75 - شماره : 12 - صفحه:1511 -1518
چکیده    Importance: non-vitamin k antagonist oral anticoagulants (noacs) might be an attractive choice for stroke prevention in people without atrial fibrillation who may harbor a potential source of cardiac emboli, but not if certain individual noacs carry risks of intracranial hemorrhage that are heightened relative to aspirin. objective: to conduct a systematic review and meta-analysis of randomized clinical trials to assess the risk of intracranial hemorrhage with individual noacs vs aspirin across all indications. data sources: we searched pubmed, embase, central, and clinicaltrials.gov from inception to may 28, 2018, with the terms novel oral anticoagulants, non-vitamin k antagonist oral anticoagulants, direct oral anticoagulants, dabigatran, rivaroxaban, apixaban, edoxaban, warfarin, coumadin, vitamin k antagonist, aspirin, acetylsalicylic acid, or asa, and major bleeding, fatal bleeding, or intracranial hemorrhage. we restricted our search to clinical trials on humans. there were no language restrictions. study selection: randomized clinical trials of 3 months or longer that included a comparison of the outcomes of noac use vs use of aspirin. data extraction and synthesis: two investigators independently abstracted data from eligible studies. we computed a fixed-effect estimate based on the mantel-haenszel method. main outcomes and measures: odds ratios (ors) with 95% ci were used as a measure of the association of individual noac vs aspirin with the risk of intracranial hemorrhage. the hypothesis that intracranial hemorrhage risk would be higher with noacs than aspirin was formulated during data collection. results: our principal analysis included 5 randomized clinical trials comparing 1 or more noacs with aspirin, with 39398 individuals enrolled. pooling the results from the fixed-effects model showed that a dose of 15 to 20 mg of rivaroxaban once daily was associated with an increased risk of intracranial hemorrhage (2 trials; or, 3.31 [95% ci, 1.42 to 7.72]) compared with aspirin, while a 10-mg dose of rivaroxaban once daily or a 5-mg dose twice daily (3 trials; or, 1.43 [95% ci, 0.93 to 2.21]) and a 5-mg dose of apixaban twice daily (1 trial; or, 0.84 [95% ci, 0.38 to 1.88]) were not. conclusions and relevance: a 15-mg to 20-mg dose of rivaroxaban once daily is associated with substantially increased risks of intracranial hemorrhage, while smaller daily doses of rivaroxaban and apixaban were not, implying that risk increase is dose dependent. it may be worthwhile to conduct randomized clinical trials comparing specific noacs in specific doses (eg, apixaban, 5 mg twice daily) and aspirin in patients without atrial fibrillation, but with potential sources of cardiac emboli that could cause stroke.
آدرس chang gung university college of medicine, keelung branch, chang gung memorial hospital, department of neurology, taiwan, harvard medical school, harvard medical school, division of general internal medicine, usa, national health research institutes, institute of population health sciences, taiwan, national yang-ming university, general clinical research center, taipei veterans general hospital, taipei veterans general hospital, division of cardiology, taiwan, chang gung university college of medicine, chiayi branch, chang gung memorial hospital, department of radiology, taiwan, chang gung university college of medicine, chiayi branch, chang gung memorial hospital, department of neurology, taiwan, university of california, now with department of neurology, usa. medical university of south carolina, department of neurology, usa
 
     
   
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