Net clinical benefit of non-vitamin K antagonist oral anticoagulants versus warfarin in phase III atrial fibrillation trials.
Am J Med. 2015 Apr 21;
Authors: Renda G, di Nicola M, De Caterina R
Abstract
AIMS: The evaluation of the "net clinical benefit" allows an integrated assessment of both the anti-ischemic and the pro-hemorrhagic effects of non-vitamin K antagonist oral anticoagulants (NOACs) compared with warfarin, and-in the absence of direct comparisons-may inform clinical decisions. We estimated the net clinical benefit of NOACs vs warfarin across the 4 phase III clinical trials performed in atrial fibrillation.
METHODS AND RESULTS: We considered various composites of the main ischemic and hemorrhagic events, estimating the rate ratio (RR) of all treatment groups vs warfarin for each composite outcome. Since however 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 thus evaluated a weighed net clinical benefit of each NOAC compared with warfarin in the 4 trials. The composite outcome of ischemic+hemorrhagic stroke was reduced by dabigatran 150 mg and apixaban. The composite of disabling stroke+life-threatening bleeding was reduced by all NOACs. The composite of ischemic stroke+systemic embolism+myocardial infarction+hemorrhagic stroke+major bleeding was reduced by apixaban and edoxaban at both doses. By attributing weights to these events according to their impact on mortality, all NOACs featured a favorable net clinical benefit compared with warfarin, albeit to a quantitatively different extent.
CONCLUSIONS: The choice of the proper antithrombotic treatment in atrial fibrillation has to consider the net clinical benefit of each drug.All NOACs however have a better compounded efficacy/safety profile than warfarin in patients with atrial fibrillation.
PMID: 25910790 [PubMed - as supplied by publisher]