Abstract | OBJECTIVES: The evaluation of the "net clinical benefit" allows an integrated assessment of both the anti-ischemic and the prohemorrhagic effects of non- vitamin K antagonist oral anticoagulants compared with warfarin, and—in the absence of direct comparisons—may inform clinical decisions. We estimated the net clinical benefit of non- vitamin K antagonist oral anticoagulants versus warfarin across the 4 phase III clinical trials performed in patients with atrial fibrillation. METHODS: We considered various composites of the main ischemic and hemorrhagic events, estimating the rate ratio of all treatment groups versus warfarin for each composite outcome. Because the clinical relevance of the various ischemic or hemorrhagic events is not identical, we then attributed to each of them a weight, according to its impact on death, as derived from previous studies. We evaluated a weighed net clinical benefit of each non- vitamin K antagonist oral anticoagulant compared with warfarin in the 4 trials. RESULTS: CONCLUSIONS:
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Authors | Giulia Renda, Marta di Nicola, Raffaele De Caterina |
Journal | The American journal of medicine
(Am J Med)
Vol. 128
Issue 9
Pg. 1007-14.e2
(Sep 2015)
ISSN: 1555-7162 [Electronic] United States |
PMID | 25910790
(Publication Type: Clinical Trial, Phase III, Journal Article)
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Copyright | Copyright © 2015 Elsevier Inc. All rights reserved. |
Chemical References |
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Topics |
- Administration, Oral
- Aged
- Anticoagulants
(therapeutic use)
- Atrial Fibrillation
(complications)
- Brain Ischemia
(prevention & control)
- Female
- Humans
- Intracranial Hemorrhages
(prevention & control)
- Male
- Middle Aged
- Myocardial Infarction
(prevention & control)
- Risk Factors
- Stroke
(prevention & control)
- Thromboembolism
(prevention & control)
- Treatment Outcome
- Warfarin
(therapeutic use)
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