Outcomes With Edoxaban Versus Warfarin in Patients With Previous Cerebrovascular Events

DOI Web Site 被引用文献2件
  • Natalia S. Rost
    From the Massachusetts General Hospital, Boston (N.S.R., S.S., A.B.S.); TIMI Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston MA (R.P.G., C.T.R., S.A.M., A.E.C., A.D.N., E.M.A., E.B.); Heart Institute (InCor), University of São Paulo Medical School, Brazil (J.C.N.); CARE Musheerabad, Hyderabad, India (B.S.); and Daiichi-Sankyo Pharma Development, Edison, NJ (M.F.M.).
  • Robert P. Giugliano
    From the Massachusetts General Hospital, Boston (N.S.R., S.S., A.B.S.); TIMI Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston MA (R.P.G., C.T.R., S.A.M., A.E.C., A.D.N., E.M.A., E.B.); Heart Institute (InCor), University of São Paulo Medical School, Brazil (J.C.N.); CARE Musheerabad, Hyderabad, India (B.S.); and Daiichi-Sankyo Pharma Development, Edison, NJ (M.F.M.).
  • Christian T. Ruff
    From the Massachusetts General Hospital, Boston (N.S.R., S.S., A.B.S.); TIMI Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston MA (R.P.G., C.T.R., S.A.M., A.E.C., A.D.N., E.M.A., E.B.); Heart Institute (InCor), University of São Paulo Medical School, Brazil (J.C.N.); CARE Musheerabad, Hyderabad, India (B.S.); and Daiichi-Sankyo Pharma Development, Edison, NJ (M.F.M.).
  • Sabina A. Murphy
    From the Massachusetts General Hospital, Boston (N.S.R., S.S., A.B.S.); TIMI Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston MA (R.P.G., C.T.R., S.A.M., A.E.C., A.D.N., E.M.A., E.B.); Heart Institute (InCor), University of São Paulo Medical School, Brazil (J.C.N.); CARE Musheerabad, Hyderabad, India (B.S.); and Daiichi-Sankyo Pharma Development, Edison, NJ (M.F.M.).
  • Andrea E. Crompton
    From the Massachusetts General Hospital, Boston (N.S.R., S.S., A.B.S.); TIMI Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston MA (R.P.G., C.T.R., S.A.M., A.E.C., A.D.N., E.M.A., E.B.); Heart Institute (InCor), University of São Paulo Medical School, Brazil (J.C.N.); CARE Musheerabad, Hyderabad, India (B.S.); and Daiichi-Sankyo Pharma Development, Edison, NJ (M.F.M.).
  • Andrew D. Norden
    From the Massachusetts General Hospital, Boston (N.S.R., S.S., A.B.S.); TIMI Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston MA (R.P.G., C.T.R., S.A.M., A.E.C., A.D.N., E.M.A., E.B.); Heart Institute (InCor), University of São Paulo Medical School, Brazil (J.C.N.); CARE Musheerabad, Hyderabad, India (B.S.); and Daiichi-Sankyo Pharma Development, Edison, NJ (M.F.M.).
  • Scott Silverman
    From the Massachusetts General Hospital, Boston (N.S.R., S.S., A.B.S.); TIMI Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston MA (R.P.G., C.T.R., S.A.M., A.E.C., A.D.N., E.M.A., E.B.); Heart Institute (InCor), University of São Paulo Medical School, Brazil (J.C.N.); CARE Musheerabad, Hyderabad, India (B.S.); and Daiichi-Sankyo Pharma Development, Edison, NJ (M.F.M.).
  • Aneesh B. Singhal
    From the Massachusetts General Hospital, Boston (N.S.R., S.S., A.B.S.); TIMI Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston MA (R.P.G., C.T.R., S.A.M., A.E.C., A.D.N., E.M.A., E.B.); Heart Institute (InCor), University of São Paulo Medical School, Brazil (J.C.N.); CARE Musheerabad, Hyderabad, India (B.S.); and Daiichi-Sankyo Pharma Development, Edison, NJ (M.F.M.).
  • José C. Nicolau
    From the Massachusetts General Hospital, Boston (N.S.R., S.S., A.B.S.); TIMI Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston MA (R.P.G., C.T.R., S.A.M., A.E.C., A.D.N., E.M.A., E.B.); Heart Institute (InCor), University of São Paulo Medical School, Brazil (J.C.N.); CARE Musheerabad, Hyderabad, India (B.S.); and Daiichi-Sankyo Pharma Development, Edison, NJ (M.F.M.).
  • Bhupathi SomaRaju
    From the Massachusetts General Hospital, Boston (N.S.R., S.S., A.B.S.); TIMI Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston MA (R.P.G., C.T.R., S.A.M., A.E.C., A.D.N., E.M.A., E.B.); Heart Institute (InCor), University of São Paulo Medical School, Brazil (J.C.N.); CARE Musheerabad, Hyderabad, India (B.S.); and Daiichi-Sankyo Pharma Development, Edison, NJ (M.F.M.).
  • Michele F. Mercuri
    From the Massachusetts General Hospital, Boston (N.S.R., S.S., A.B.S.); TIMI Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston MA (R.P.G., C.T.R., S.A.M., A.E.C., A.D.N., E.M.A., E.B.); Heart Institute (InCor), University of São Paulo Medical School, Brazil (J.C.N.); CARE Musheerabad, Hyderabad, India (B.S.); and Daiichi-Sankyo Pharma Development, Edison, NJ (M.F.M.).
  • Elliott M. Antman
    From the Massachusetts General Hospital, Boston (N.S.R., S.S., A.B.S.); TIMI Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston MA (R.P.G., C.T.R., S.A.M., A.E.C., A.D.N., E.M.A., E.B.); Heart Institute (InCor), University of São Paulo Medical School, Brazil (J.C.N.); CARE Musheerabad, Hyderabad, India (B.S.); and Daiichi-Sankyo Pharma Development, Edison, NJ (M.F.M.).
  • Eugene Braunwald
    From the Massachusetts General Hospital, Boston (N.S.R., S.S., A.B.S.); TIMI Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston MA (R.P.G., C.T.R., S.A.M., A.E.C., A.D.N., E.M.A., E.B.); Heart Institute (InCor), University of São Paulo Medical School, Brazil (J.C.N.); CARE Musheerabad, Hyderabad, India (B.S.); and Daiichi-Sankyo Pharma Development, Edison, NJ (M.F.M.).

書誌事項

タイトル別名
  • Findings From ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48)

抄録

<jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p> Of 5973 (28.3%) patients with previous IS/TIA, 67% had CHADS <jats:sub>2</jats:sub> (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; <jats:italic>P</jats:italic> <0.001; major bleeding 3.03% versus 2.64% per year; <jats:italic>P</jats:italic> <0.001; intracranial hemorrhage, 0.70% versus 0.40% per year; <jats:italic>P</jats:italic> <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; <jats:italic>P</jats:italic> =0.02). No treatment subgroup interactions were found for primary efficacy ( <jats:italic>P</jats:italic> =0.86) or for intracranial hemorrhage ( <jats:italic>P</jats:italic> =0.28). </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT00781391. </jats:p> </jats:sec>

収録刊行物

  • Stroke

    Stroke 47 (8), 2075-2082, 2016-08

    Ovid Technologies (Wolters Kluwer Health)

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