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dc.contributor.authorKato, Eri Todaen_US
dc.contributor.authorGiugliano, Robert P.en_US
dc.contributor.authorRuff, Christian T.en_US
dc.contributor.authorKoretsune, Yukihiroen_US
dc.contributor.authorYamashita, Takeshien_US
dc.contributor.authorKiss, Robert Gaboren_US
dc.contributor.authorNordio, Francescoen_US
dc.contributor.authorMurphy, Sabina A.en_US
dc.contributor.authorKimura, Tetsuyaen_US
dc.contributor.authorJin, Jamesen_US
dc.contributor.authorLanz, Hansen_US
dc.contributor.authorMercuri, Micheleen_US
dc.contributor.authorBraunwald, Eugeneen_US
dc.contributor.authorAntman, Elliott M.en_US
dc.date.accessioned2016-07-14T19:20:25Z
dc.date.issued2016en_US
dc.identifier.citationKato, E. T., R. P. Giugliano, C. T. Ruff, Y. Koretsune, T. Yamashita, R. G. Kiss, F. Nordio, et al. 2016. “Efficacy and Safety of Edoxaban in Elderly Patients With Atrial Fibrillation in the ENGAGE AF–TIMI 48 Trial.” Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease 5 (5): e003432. doi:10.1161/JAHA.116.003432. http://dx.doi.org/10.1161/JAHA.116.003432.en
dc.identifier.issn2047-9980en
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:27662313
dc.description.abstractBackground: Elderly patients with atrial fibrillation are at higher risk of both ischemic and bleeding events compared to younger patients. In a prespecified analysis from the ENGAGE AF‐TIMI 48 trial, we evaluate clinical outcomes with edoxaban versus warfarin according to age. Methods and Results: Twenty‐one thousand one‐hundred and five patients enrolled in the ENGAGE AF‐TIMI 48 trial were stratified into 3 prespecified age groups: <65 (n=5497), 65 to 74 (n=7134), and ≥75 (n=8474) years. Older patients were more likely to be female, with lower body weight and reduced creatinine clearance, leading to higher rates of edoxaban dose reduction (10%, 18%, and 41% for the 3 age groups, P<0.001). Stroke or systemic embolic event (1.1%, 1.8%, and 2.3%) and major bleeding (1.8%, 3.3%, and 4.8%) rates with warfarin increased across age groups (P trend<0.001 for both). There were no interactions between age group and randomized treatment in the primary efficacy and safety outcomes. In the elderly (≥75 years), the rates of stroke/systemic embolic event were similar with edoxaban versus warfarin (hazard ratio 0.83 [0.66–1.04]), while major bleeding was significantly reduced with edoxaban (hazard ratio 0.83 [0.70–0.99]). The absolute risk difference in major bleeding (−82 events/10 000 pt‐yrs) and in intracranial hemorrhage (−73 events/10 000 pt‐yrs) both favored edoxaban over warfarin in older patients. Conclusions: Age has a greater influence on major bleeding than thromboembolic risk in patients with atrial fibrillation. Given the higher rates of bleeding and death with increasing age, treatment of elderly patients with edoxaban provides an even greater absolute reduction in safety events over warfarin, compared to treatment with edoxaban versus warfarin in younger patients. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00781391.en
dc.language.isoen_USen
dc.publisherJohn Wiley and Sons Inc.en
dc.relation.isversionofdoi:10.1161/JAHA.116.003432en
dc.relation.hasversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC4889207/pdf/en
dash.licenseLAAen_US
dc.subjectantithromboticen
dc.subjectbleedingen
dc.subjectdeathen
dc.subjectelderlyen
dc.subjectstrokeen
dc.subjectAtrial Fibrillationen
dc.subjectIntracranial Hemorrhageen
dc.subjectIschemic Strokeen
dc.subjectComplicationsen
dc.subjectMortality/Survivalen
dc.titleEfficacy and Safety of Edoxaban in Elderly Patients With Atrial Fibrillation in the ENGAGE AF–TIMI 48 Trialen
dc.typeJournal Articleen_US
dc.description.versionVersion of Recorden
dc.relation.journalJournal of the American Heart Association: Cardiovascular and Cerebrovascular Diseaseen
dash.depositing.authorKato, Eri Todaen_US
dc.date.available2016-07-14T19:20:25Z
dc.identifier.doi10.1161/JAHA.116.003432*
dash.authorsorderedfalse
dash.contributor.affiliatedKato, Eri Toda
dash.contributor.affiliatedRuff, Christian
dash.contributor.affiliatedNordio, Francesco
dash.contributor.affiliatedGiugliano, Robert
dash.contributor.affiliatedAntman, Elliott
dash.contributor.affiliatedBraunwald, Eugene


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