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)
BACKGROUND 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...
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| creator | Rost, Natalia S Giugliano, Robert P Ruff, Christian T Murphy, Sabina A Crompton, Andrea E Norden, Andrew D Silverman, Scott Singhal, Aneesh B Nicolau, José C SomaRaju, Bhupathi Mercuri, Michele F Antman, Elliott M Braunwald, Eugene |
| description | BACKGROUND 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 CHADS2 (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 |
| doi_str_mv | 10.1161/STROKEAHA.116.013540 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1807280542</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1807280542</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3050-d593ebba7e1b1206fa9f6c0a0d99eb320af5ec8ef8be835257ccbd7121565cd13</originalsourceid><addsrcrecordid>eNp9kd9u0zAUxiMEYmXwBgj5crvIsJ24cbiLqqSr2NYJyp-7yHZOVkMaD9vp1ufmBXBI2SWSJevYv-98x_6i6C3BF4TMyfvPm0_rj2VxWYzlBSYJS_GzaEYYTeN0TvnzaIZxksc0zfOT6JVzPzDGNOHsZXRCs4RneZ7Oot_rwSuzA4e-ab9FZWMehRQ9-grWDeFQ2FZY3aOwboXX0PsjeWthr01AFmBBWrMXTg2dsKjcj9AHVOm-0f2dQ5U1O1TeLItliYoq3qyuVyjl6KxsW1Be7wEVvdfKiLug99r0k0EllDcWfRfoBh49WkIPdroOsxTeatEFD2l1N6nizTYYSdMdnHYjc30wSthm5FZ9eIX6K075-evoRSs6B2-O-2n0pSo3i8v4ar1cLYqrWCWY4bhheQJSigyIJBTPW5G3c4UFbvIcZEKxaBkoDi2XwBNGWaaUbDJCCZsz1ZDkNDqb-t5b82sA5-uddgrCvD2En6sJxxnlmKU0oOmEKmucs9DW91bvhD3UBNdj3PVT3GNZT3EH2bujwyB30DyJ_uUbAD4BD6bzIdKf3fAAtt6C6Pz2_73_AJNsvN0</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1807280542</pqid></control><display><type>article</type><title>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)</title><source>MEDLINE</source><source>American Heart Association Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Journals@Ovid Complete</source><source>Alma/SFX Local Collection</source><creator>Rost, Natalia S ; Giugliano, Robert P ; Ruff, Christian T ; Murphy, Sabina A ; Crompton, Andrea E ; Norden, Andrew D ; Silverman, Scott ; Singhal, Aneesh B ; Nicolau, José C ; SomaRaju, Bhupathi ; Mercuri, Michele F ; Antman, Elliott M ; Braunwald, Eugene</creator><creatorcontrib>Rost, Natalia S ; Giugliano, Robert P ; Ruff, Christian T ; Murphy, Sabina A ; Crompton, Andrea E ; Norden, Andrew D ; Silverman, Scott ; Singhal, Aneesh B ; Nicolau, José C ; SomaRaju, Bhupathi ; Mercuri, Michele F ; Antman, Elliott M ; Braunwald, Eugene ; ENGAGE AF-TIMI 48 Investigators</creatorcontrib><description>BACKGROUND 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 CHADS2 (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.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT00781391.</description><identifier>ISSN: 0039-2499</identifier><identifier>EISSN: 1524-4628</identifier><identifier>DOI: 10.1161/STROKEAHA.116.013540</identifier><identifier>PMID: 27387994</identifier><language>eng</language><publisher>United States: American Heart Association, Inc</publisher><subject>Aged ; Anticoagulants - therapeutic use ; Atrial Fibrillation - drug therapy ; Atrial Fibrillation - prevention & control ; Brain Ischemia - drug therapy ; Brain Ischemia - prevention & control ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Pyridines - therapeutic use ; Recurrence ; Secondary Prevention ; Stroke - drug therapy ; Stroke - prevention & control ; Thiazoles - therapeutic use ; Treatment Outcome ; Warfarin - therapeutic use</subject><ispartof>Stroke (1970), 2016-08, Vol.47 (8), p.2075-2082</ispartof><rights>2016 American Heart Association, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3050-d593ebba7e1b1206fa9f6c0a0d99eb320af5ec8ef8be835257ccbd7121565cd13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,3674,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27387994$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rost, Natalia S</creatorcontrib><creatorcontrib>Giugliano, Robert P</creatorcontrib><creatorcontrib>Ruff, Christian T</creatorcontrib><creatorcontrib>Murphy, Sabina A</creatorcontrib><creatorcontrib>Crompton, Andrea E</creatorcontrib><creatorcontrib>Norden, Andrew D</creatorcontrib><creatorcontrib>Silverman, Scott</creatorcontrib><creatorcontrib>Singhal, Aneesh B</creatorcontrib><creatorcontrib>Nicolau, José C</creatorcontrib><creatorcontrib>SomaRaju, Bhupathi</creatorcontrib><creatorcontrib>Mercuri, Michele F</creatorcontrib><creatorcontrib>Antman, Elliott M</creatorcontrib><creatorcontrib>Braunwald, Eugene</creatorcontrib><creatorcontrib>ENGAGE AF-TIMI 48 Investigators</creatorcontrib><title>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)</title><title>Stroke (1970)</title><addtitle>Stroke</addtitle><description>BACKGROUND 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 CHADS2 (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.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT00781391.</description><subject>Aged</subject><subject>Anticoagulants - therapeutic use</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Atrial Fibrillation - prevention & control</subject><subject>Brain Ischemia - drug therapy</subject><subject>Brain Ischemia - prevention & control</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pyridines - therapeutic use</subject><subject>Recurrence</subject><subject>Secondary Prevention</subject><subject>Stroke - drug therapy</subject><subject>Stroke - prevention & control</subject><subject>Thiazoles - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Warfarin - therapeutic use</subject><issn>0039-2499</issn><issn>1524-4628</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kd9u0zAUxiMEYmXwBgj5crvIsJ24cbiLqqSr2NYJyp-7yHZOVkMaD9vp1ufmBXBI2SWSJevYv-98x_6i6C3BF4TMyfvPm0_rj2VxWYzlBSYJS_GzaEYYTeN0TvnzaIZxksc0zfOT6JVzPzDGNOHsZXRCs4RneZ7Oot_rwSuzA4e-ab9FZWMehRQ9-grWDeFQ2FZY3aOwboXX0PsjeWthr01AFmBBWrMXTg2dsKjcj9AHVOm-0f2dQ5U1O1TeLItliYoq3qyuVyjl6KxsW1Be7wEVvdfKiLug99r0k0EllDcWfRfoBh49WkIPdroOsxTeatEFD2l1N6nizTYYSdMdnHYjc30wSthm5FZ9eIX6K075-evoRSs6B2-O-2n0pSo3i8v4ar1cLYqrWCWY4bhheQJSigyIJBTPW5G3c4UFbvIcZEKxaBkoDi2XwBNGWaaUbDJCCZsz1ZDkNDqb-t5b82sA5-uddgrCvD2En6sJxxnlmKU0oOmEKmucs9DW91bvhD3UBNdj3PVT3GNZT3EH2bujwyB30DyJ_uUbAD4BD6bzIdKf3fAAtt6C6Pz2_73_AJNsvN0</recordid><startdate>201608</startdate><enddate>201608</enddate><creator>Rost, Natalia S</creator><creator>Giugliano, Robert P</creator><creator>Ruff, Christian T</creator><creator>Murphy, Sabina A</creator><creator>Crompton, Andrea E</creator><creator>Norden, Andrew D</creator><creator>Silverman, Scott</creator><creator>Singhal, Aneesh B</creator><creator>Nicolau, José C</creator><creator>SomaRaju, Bhupathi</creator><creator>Mercuri, Michele F</creator><creator>Antman, Elliott M</creator><creator>Braunwald, Eugene</creator><general>American Heart Association, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201608</creationdate><title>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)</title><author>Rost, Natalia S ; Giugliano, Robert P ; Ruff, Christian T ; Murphy, Sabina A ; Crompton, Andrea E ; Norden, Andrew D ; Silverman, Scott ; Singhal, Aneesh B ; Nicolau, José C ; SomaRaju, Bhupathi ; Mercuri, Michele F ; Antman, Elliott M ; Braunwald, Eugene</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3050-d593ebba7e1b1206fa9f6c0a0d99eb320af5ec8ef8be835257ccbd7121565cd13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Aged</topic><topic>Anticoagulants - therapeutic use</topic><topic>Atrial Fibrillation - drug therapy</topic><topic>Atrial Fibrillation - prevention & control</topic><topic>Brain Ischemia - drug therapy</topic><topic>Brain Ischemia - prevention & control</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pyridines - therapeutic use</topic><topic>Recurrence</topic><topic>Secondary Prevention</topic><topic>Stroke - drug therapy</topic><topic>Stroke - prevention & control</topic><topic>Thiazoles - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Warfarin - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rost, Natalia S</creatorcontrib><creatorcontrib>Giugliano, Robert P</creatorcontrib><creatorcontrib>Ruff, Christian T</creatorcontrib><creatorcontrib>Murphy, Sabina A</creatorcontrib><creatorcontrib>Crompton, Andrea E</creatorcontrib><creatorcontrib>Norden, Andrew D</creatorcontrib><creatorcontrib>Silverman, Scott</creatorcontrib><creatorcontrib>Singhal, Aneesh B</creatorcontrib><creatorcontrib>Nicolau, José C</creatorcontrib><creatorcontrib>SomaRaju, Bhupathi</creatorcontrib><creatorcontrib>Mercuri, Michele F</creatorcontrib><creatorcontrib>Antman, Elliott M</creatorcontrib><creatorcontrib>Braunwald, Eugene</creatorcontrib><creatorcontrib>ENGAGE AF-TIMI 48 Investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Stroke (1970)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rost, Natalia S</au><au>Giugliano, Robert P</au><au>Ruff, Christian T</au><au>Murphy, Sabina A</au><au>Crompton, Andrea E</au><au>Norden, Andrew D</au><au>Silverman, Scott</au><au>Singhal, Aneesh B</au><au>Nicolau, José C</au><au>SomaRaju, Bhupathi</au><au>Mercuri, Michele F</au><au>Antman, Elliott M</au><au>Braunwald, Eugene</au><aucorp>ENGAGE AF-TIMI 48 Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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)</atitle><jtitle>Stroke (1970)</jtitle><addtitle>Stroke</addtitle><date>2016-08</date><risdate>2016</risdate><volume>47</volume><issue>8</issue><spage>2075</spage><epage>2082</epage><pages>2075-2082</pages><issn>0039-2499</issn><eissn>1524-4628</eissn><abstract>BACKGROUND 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 CHADS2 (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.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT00781391.</abstract><cop>United States</cop><pub>American Heart Association, Inc</pub><pmid>27387994</pmid><doi>10.1161/STROKEAHA.116.013540</doi><tpages>8</tpages></addata></record> |
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| source | MEDLINE; American Heart Association Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Journals@Ovid Complete; Alma/SFX Local Collection |
| subjects | Aged Anticoagulants - therapeutic use Atrial Fibrillation - drug therapy Atrial Fibrillation - prevention & control Brain Ischemia - drug therapy Brain Ischemia - prevention & control Double-Blind Method Female Humans Male Middle Aged Pyridines - therapeutic use Recurrence Secondary Prevention Stroke - drug therapy Stroke - prevention & control Thiazoles - therapeutic use Treatment Outcome Warfarin - therapeutic use |
| title | 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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