Outcomes With Edoxaban Versus Warfarin in Patients With Previous Cerebrovascular Events Findings From ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48)

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dc.contributor.authorRost, Natalia S.
dc.contributor.authorGiugliano, Robert P.
dc.contributor.authorRuff, Christian T.
dc.contributor.authorMurphy, Sabina A.
dc.contributor.authorCrompton, Andrea E.
dc.contributor.authorNorden, Andrew D.
dc.contributor.authorSilverman, Scott
dc.date.accessioned2024-02-23T14:26:44Z
dc.date.available2024-02-23T14:26:44Z
dc.date.issued2016
dc.departmentNEÜen_US
dc.description.abstractBackground and Purpose-Patients with atrial fibrillation and previous ischemic stroke (IS)/transient ischemic attack (TIA) are at high risk of recurrent cerebrovascular events despite anticoagulation. In this prespecified subgroup analysis, we compared warfarin with edoxaban in patients with versus without previous IS/TIA. Methods-ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) was a double-blind trial of 21 105 patients with atrial fibrillation randomized to warfarin (international normalized ratio, 2.0-3.0; median time-in-therapeutic range, 68.4%) versus once-daily edoxaban (higher-dose edoxaban regimen [HDER], 60/30 mg; lower-dose edoxaban regimen, 30/15 mg) with 2.8-year median follow-up. Primary end points included all stroke/systemic embolic events (efficacy) and major bleeding (safety). Because only HDER is approved, we focused on the comparison of HDER versus warfarin. Results-Of 5973 (28.3%) patients with previous IS/TIA, 67% had CHADS 2 (congestive heart failure, hypertension, age, diabetes, prior stroke/transient ischemic attack) > 3 and 36% were >= 75 years. Compared with 15 132 without previous IS/TIA, patients with previous IS/TIA were at higher risk of both thromboembolism and bleeding (stroke/systemic embolic events 2.83% versus 1.42% per year; P<0.001; major bleeding 3.03% versus 2.64% per year; P<0.001; intracranial hemorrhage, 0.70% versus 0.40% per year; P<0.001). Among patients with previous IS/TIA, annualized intracranial hemorrhage rates were lower with HDER than with warfarin (0.62% versus 1.09%; absolute risk difference, 47 [8-85] per 10 000 patient-years; hazard ratio, 0.57; 95% confidence interval, 0.36-0.92; P=0.02). No treatment subgroup interactions were found for primary efficacy (P=0.86) or for intracranial hemorrhage (P=0.28). Conclusions-Patients with atrial fibrillation with previous IS/TIA are at high risk of recurrent thromboembolism and bleeding. HDER is at least as effective and is safer than warfarin, regardless of the presence or the absence of previous IS or TIA.en_US
dc.description.sponsorshipDaiichi-Sankyo Pharma Development, Edison, NJen_US
dc.description.sponsorshipThis study was supported by Daiichi-Sankyo Pharma Development, Edison, NJ.en_US
dc.identifier.doi10.1161/STROKEAHA.116.013540
dc.identifier.endpage2082en_US
dc.identifier.issn0039-2499
dc.identifier.issn1524-4628
dc.identifier.issue8en_US
dc.identifier.pmid27387994en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage2075en_US
dc.identifier.urihttps://doi.org/10.1161/STROKEAHA.116.013540
dc.identifier.urihttps://hdl.handle.net/20.500.12452/14313
dc.identifier.volume47en_US
dc.identifier.wosWOS:000380808400028en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherLippincott Williams & Wilkinsen_US
dc.relation.ispartofStrokeen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectAtrial Fibrillationen_US
dc.subjectClinical Trialen_US
dc.subjectHemorrhageen_US
dc.subjectRisk Factorsen_US
dc.subjectStrokeen_US
dc.titleOutcomes With Edoxaban Versus Warfarin in Patients With Previous Cerebrovascular Events Findings From ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48)en_US
dc.typeArticleen_US

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