AustralieFrV1, Main, Exploration, bibRecord, 004087

Intracranial Hemorrhage Among Patients With Atrial Fibrillation Anticoagulated With Warfarin or Rivaroxaban: The Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation

Identifieur interne : 004087 ( Main/Exploration ); précédent : 004086; suivant : 004088

Intracranial Hemorrhage Among Patients With Atrial Fibrillation Anticoagulated With Warfarin or Rivaroxaban: The Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation

Auteurs : Graeme J. Hankey [Australie] ; Susanna R. Stevens [États-Unis] ; Jonathan P. Piccini [États-Unis] ; Yuliya Lokhnygina [États-Unis] ; Kenneth W. Mahaffey [États-Unis] ; Jonathan L. Halperin [États-Unis] ; Manesh R. Patel [États-Unis] ; Günter Breithardt [Allemagne] ; Daniel E. Singer [États-Unis] ; Richard C. Becker [États-Unis] ; Scott D. Berkowitz [États-Unis] ; John F. Paolini [France] ; Christopher C. Nessel [États-Unis] ; Werner Hacke [Allemagne] ; Keith A. A. Fox [Royaume-Uni] ; Robert M. Califf [États-Unis]

Source :

Stroke : (1970) [ 0039-2499 ] ; 2014.

RBID : Pascal:14-0165951

Descripteurs français

Pascal (Inist)
- Hémorragie intracrânienne, Fibrillation auriculaire, Accident cérébrovasculaire, Warfarine, Rivaroxaban, Homme, Voie orale, Vitamine K, Prévention, Embolie, Facteur risque, Pathologie du système nerveux, Pathologie cérébrovasculaire, Anticoagulant, Antithrombotique.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Anticoagulant, Antithrombotic agent, Atrial fibrillation, Cerebrovascular disease, Embolism, Human, Intracranial hemorrhage, Nervous system diseases, Oral administration, Prevention, Risk factor, Rivaroxaban, Stroke, Vitamin K, Warfarin.

Abstract

Background and Purpose-Intracranial hemorrhage (ICH) is a life-threatening complication of anticoagulation. Methods-We investigated the rate, outcomes, and predictors of ICH in 14264 patients with atrial fibrillation from Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Cox proportional hazards modeling was used. Results-During 1.94 years (median) of follow-up, 172 patients (1.2%) experienced 175 ICH events at a rate of 0.67% per year. The significant, independent predictors of ICH were race (Asian: hazard ratio, 2.02; 95% CI, 1.39-2.94; black: hazard ratio, 3.25; 95% CI, 1.43-7.41), age (1.35; 1.13-1.63 per 10-year increase), reduced serum albumin (1.39; 1.12-1.73 per 0.5 g/dL decrease), reduced platelet count below 210×10⁹/L (1.08; 1.02-1.13 per 10×10⁹/L decrease), previous stroke or transient ischemic attack (1.42; 1.02-1.96), and increased diastolic blood pressure (1.17; 1.01-1.36 per 10 mmHg increase). Predictors of a reduced risk of ICH were randomization to rivaroxaban (0.60; 0.44-0.82) and history of congestive heart failure (0.65; 0.47-0.89). The ability of the model to discriminate individuals with and without ICH was good (C-index, 0.69; 95% CI, 0.64-0.73). Conclusions-Among patients with atrial fibrillation treated with anticoagulation, the risk of ICH was higher among Asians, blacks, the elderly, and in those with previous stroke or transient ischemic attack, increased diastolic blood pressure, and reduced platelet count or serum albumin at baseline. The risk of ICH was significantly lower in patients with heart failure and in those who were randomized to rivaroxaban instead of warfarin. The external validity of these findings requires testing in other atrial fibrillation populations.

Affiliations:

Links toward previous steps (curation, corpus...)

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Le document en format XML

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<author><name sortKey="Fox, Keith A A" sort="Fox, Keith A A" uniqKey="Fox K" first="Keith A. A." last="Fox">Keith A. A. Fox</name>
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<author><name sortKey="Califf, Robert M" sort="Califf, Robert M" uniqKey="Califf R" first="Robert M." last="Califf">Robert M. Califf</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Intracranial Hemorrhage Among Patients With Atrial Fibrillation Anticoagulated With Warfarin or Rivaroxaban: The Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation</title>
<author><name sortKey="Hankey, Graeme J" sort="Hankey, Graeme J" uniqKey="Hankey G" first="Graeme J." last="Hankey">Graeme J. Hankey</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>School of Medicine and Pharmacology, The University of Western Australia</s1>
<s2>Perth</s2>
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<country>Australie</country>
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<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Neurology, Sir Charles Gairdner Hospital</s1>
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<author><name sortKey="Stevens, Susanna R" sort="Stevens, Susanna R" uniqKey="Stevens S" first="Susanna R." last="Stevens">Susanna R. Stevens</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Duke Clinical Research Institute, Duke University Medical Center</s1>
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<author><name sortKey="Piccini, Jonathan P" sort="Piccini, Jonathan P" uniqKey="Piccini J" first="Jonathan P." last="Piccini">Jonathan P. Piccini</name>
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<author><name sortKey="Lokhnygina, Yuliya" sort="Lokhnygina, Yuliya" uniqKey="Lokhnygina Y" first="Yuliya" last="Lokhnygina">Yuliya Lokhnygina</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Duke Clinical Research Institute, Duke University Medical Center</s1>
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<author><name sortKey="Mahaffey, Kenneth W" sort="Mahaffey, Kenneth W" uniqKey="Mahaffey K" first="Kenneth W." last="Mahaffey">Kenneth W. Mahaffey</name>
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<author><name sortKey="Halperin, Jonathan L" sort="Halperin, Jonathan L" uniqKey="Halperin J" first="Jonathan L." last="Halperin">Jonathan L. Halperin</name>
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<author><name sortKey="Patel, Manesh R" sort="Patel, Manesh R" uniqKey="Patel M" first="Manesh R." last="Patel">Manesh R. Patel</name>
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<author><name sortKey="Breithardt, Gunter" sort="Breithardt, Gunter" uniqKey="Breithardt G" first="Günter" last="Breithardt">Günter Breithardt</name>
<affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Department of Cardiovascular Medicine, Hospital of the University of Münster</s1>
<s2>Münster</s2>
<s3>DEU</s3>
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</inist:fA14>
<country>Allemagne</country>
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<author><name sortKey="Singer, Daniel E" sort="Singer, Daniel E" uniqKey="Singer D" first="Daniel E." last="Singer">Daniel E. Singer</name>
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<author><name sortKey="Becker, Richard C" sort="Becker, Richard C" uniqKey="Becker R" first="Richard C." last="Becker">Richard C. Becker</name>
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<author><name sortKey="Berkowitz, Scott D" sort="Berkowitz, Scott D" uniqKey="Berkowitz S" first="Scott D." last="Berkowitz">Scott D. Berkowitz</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Global Clinical Development, Bayer HealthCare Pharmaceuticals</s1>
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<wicri:noRegion>Whippany, NJ</wicri:noRegion>
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<author><name sortKey="Paolini, John F" sort="Paolini, John F" uniqKey="Paolini J" first="John F." last="Paolini">John F. Paolini</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Cerenis Therapeutics</s1>
<s2>Labege</s2>
<s3>FRA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>Labege</wicri:noRegion>
<wicri:noRegion>Cerenis Therapeutics</wicri:noRegion>
<wicri:noRegion>Cerenis Therapeutics</wicri:noRegion>
</affiliation>
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<author><name sortKey="Nessel, Christopher C" sort="Nessel, Christopher C" uniqKey="Nessel C" first="Christopher C." last="Nessel">Christopher C. Nessel</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Janssen Research and Development</s1>
<s2>Raritan, NJ</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Janssen Research and Development</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hacke, Werner" sort="Hacke, Werner" uniqKey="Hacke W" first="Werner" last="Hacke">Werner Hacke</name>
<affiliation wicri:level="3"><inist:fA14 i1="13"><s1>Ruprecht-Karls-University</s1>
<s2>Heidelberg</s2>
<s3>DEU</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Karlsruhe</region>
<settlement type="city">Heidelberg</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Fox, Keith A A" sort="Fox, Keith A A" uniqKey="Fox K" first="Keith A. A." last="Fox">Keith A. A. Fox</name>
<affiliation wicri:level="3"><inist:fA14 i1="14"><s1>University of Edinburgh and Royal Infirmary of Edinburgh</s1>
<s2>Edinburgh</s2>
<s3>GBR</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<placeName><settlement type="city">Édimbourg</settlement>
<region type="country">Écosse</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Califf, Robert M" sort="Califf, Robert M" uniqKey="Califf R" first="Robert M." last="Califf">Robert M. Califf</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Duke Translational Medicine Institute, Duke University Medical Center</s1>
<s2>Durham, NC</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Durham, NC</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Stroke : (1970)</title>
<title level="j" type="abbreviated">Stroke : (1970)</title>
<idno type="ISSN">0039-2499</idno>
<imprint><date when="2014">2014</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Stroke : (1970)</title>
<title level="j" type="abbreviated">Stroke : (1970)</title>
<idno type="ISSN">0039-2499</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Anticoagulant</term>
<term>Antithrombotic agent</term>
<term>Atrial fibrillation</term>
<term>Cerebrovascular disease</term>
<term>Embolism</term>
<term>Human</term>
<term>Intracranial hemorrhage</term>
<term>Nervous system diseases</term>
<term>Oral administration</term>
<term>Prevention</term>
<term>Risk factor</term>
<term>Rivaroxaban</term>
<term>Stroke</term>
<term>Vitamin K</term>
<term>Warfarin</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Hémorragie intracrânienne</term>
<term>Fibrillation auriculaire</term>
<term>Accident cérébrovasculaire</term>
<term>Warfarine</term>
<term>Rivaroxaban</term>
<term>Homme</term>
<term>Voie orale</term>
<term>Vitamine K</term>
<term>Prévention</term>
<term>Embolie</term>
<term>Facteur risque</term>
<term>Pathologie du   système nerveux</term>
<term>Pathologie cérébrovasculaire</term>
<term>Anticoagulant</term>
<term>Antithrombotique</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Background and Purpose-Intracranial hemorrhage (ICH) is a life-threatening complication of anticoagulation. Methods-We investigated the rate, outcomes, and predictors of ICH in 14264 patients with atrial fibrillation from Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Cox proportional hazards modeling was used. Results-During 1.94 years (median) of follow-up, 172 patients (1.2%) experienced 175 ICH events at a rate of 0.67% per year. The significant, independent predictors of ICH were race (Asian: hazard ratio, 2.02; 95% CI, 1.39-2.94; black: hazard ratio, 3.25; 95% CI, 1.43-7.41), age (1.35; 1.13-1.63 per 10-year increase), reduced serum albumin (1.39; 1.12-1.73 per 0.5 g/dL decrease), reduced platelet count below 210×10<sup>9</sup>
/L (1.08; 1.02-1.13 per 10×10<sup>9</sup>
/L decrease), previous stroke or transient ischemic attack (1.42; 1.02-1.96), and increased diastolic blood pressure (1.17; 1.01-1.36 per 10 mmHg increase). Predictors of a reduced risk of ICH were randomization to rivaroxaban (0.60; 0.44-0.82) and history of congestive heart failure (0.65; 0.47-0.89). The ability of the model to discriminate individuals with and without ICH was good (C-index, 0.69; 95% CI, 0.64-0.73). Conclusions-Among patients with atrial fibrillation treated with anticoagulation, the risk of ICH was higher among Asians, blacks, the elderly, and in those with previous stroke or transient ischemic attack, increased diastolic blood pressure, and reduced platelet count or serum albumin at baseline. The risk of ICH was significantly lower in patients with heart failure and in those who were randomized to rivaroxaban instead of warfarin. The external validity of these findings requires testing in other atrial fibrillation populations.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>France</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Bade-Wurtemberg</li>
<li>District de Karlsruhe</li>
<li>District de Münster</li>
<li>Massachusetts</li>
<li>Rhénanie-du-Nord-Westphalie</li>
<li>Écosse</li>
<li>État de New York</li>
</region>
<settlement><li>Boston</li>
<li>Heidelberg</li>
<li>Münster</li>
<li>Édimbourg</li>
</settlement>
</list>
<tree><country name="Australie"><noRegion><name sortKey="Hankey, Graeme J" sort="Hankey, Graeme J" uniqKey="Hankey G" first="Graeme J." last="Hankey">Graeme J. Hankey</name>
</noRegion>
<name sortKey="Hankey, Graeme J" sort="Hankey, Graeme J" uniqKey="Hankey G" first="Graeme J." last="Hankey">Graeme J. Hankey</name>
</country>
<country name="États-Unis"><noRegion><name sortKey="Stevens, Susanna R" sort="Stevens, Susanna R" uniqKey="Stevens S" first="Susanna R." last="Stevens">Susanna R. Stevens</name>
</noRegion>
<name sortKey="Becker, Richard C" sort="Becker, Richard C" uniqKey="Becker R" first="Richard C." last="Becker">Richard C. Becker</name>
<name sortKey="Berkowitz, Scott D" sort="Berkowitz, Scott D" uniqKey="Berkowitz S" first="Scott D." last="Berkowitz">Scott D. Berkowitz</name>
<name sortKey="Califf, Robert M" sort="Califf, Robert M" uniqKey="Califf R" first="Robert M." last="Califf">Robert M. Califf</name>
<name sortKey="Halperin, Jonathan L" sort="Halperin, Jonathan L" uniqKey="Halperin J" first="Jonathan L." last="Halperin">Jonathan L. Halperin</name>
<name sortKey="Lokhnygina, Yuliya" sort="Lokhnygina, Yuliya" uniqKey="Lokhnygina Y" first="Yuliya" last="Lokhnygina">Yuliya Lokhnygina</name>
<name sortKey="Mahaffey, Kenneth W" sort="Mahaffey, Kenneth W" uniqKey="Mahaffey K" first="Kenneth W." last="Mahaffey">Kenneth W. Mahaffey</name>
<name sortKey="Nessel, Christopher C" sort="Nessel, Christopher C" uniqKey="Nessel C" first="Christopher C." last="Nessel">Christopher C. Nessel</name>
<name sortKey="Patel, Manesh R" sort="Patel, Manesh R" uniqKey="Patel M" first="Manesh R." last="Patel">Manesh R. Patel</name>
<name sortKey="Piccini, Jonathan P" sort="Piccini, Jonathan P" uniqKey="Piccini J" first="Jonathan P." last="Piccini">Jonathan P. Piccini</name>
<name sortKey="Singer, Daniel E" sort="Singer, Daniel E" uniqKey="Singer D" first="Daniel E." last="Singer">Daniel E. Singer</name>
</country>
<country name="Allemagne"><region name="Rhénanie-du-Nord-Westphalie"><name sortKey="Breithardt, Gunter" sort="Breithardt, Gunter" uniqKey="Breithardt G" first="Günter" last="Breithardt">Günter Breithardt</name>
</region>
<name sortKey="Hacke, Werner" sort="Hacke, Werner" uniqKey="Hacke W" first="Werner" last="Hacke">Werner Hacke</name>
</country>
<country name="France"><noRegion><name sortKey="Paolini, John F" sort="Paolini, John F" uniqKey="Paolini J" first="John F." last="Paolini">John F. Paolini</name>
</noRegion>
</country>
<country name="Royaume-Uni"><region name="Écosse"><name sortKey="Fox, Keith A A" sort="Fox, Keith A A" uniqKey="Fox K" first="Keith A. A." last="Fox">Keith A. A. Fox</name>
</region>
</country>
</tree>
</affiliations>
</record>

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Intracranial Hemorrhage Among Patients With Atrial Fibrillation Anticoagulated With Warfarin or Rivaroxaban: The Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation

Intracranial Hemorrhage Among Patients With Atrial Fibrillation Anticoagulated With Warfarin or Rivaroxaban: The Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation

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