Serveur d'exploration sur les relations entre la France et l'Australie

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Clopidogrel Plus Aspirin Versus Warfarin in Patients With Stroke and Aortic Arch Plaques

Identifieur interne : 004246 ( Main/Exploration ); précédent : 004245; suivant : 004247

Clopidogrel Plus Aspirin Versus Warfarin in Patients With Stroke and Aortic Arch Plaques

Auteurs : Pierre Amarenco [France] ; Stephen Davis [Australie] ; Elizabeth F. Jones [Australie] ; Ariel A. Cohen [France] ; Wolf-Dieter Heiss [Allemagne] ; Markku Kaste [Finlande] ; Cédric Laouenan [France] ; Dennis Young [Australie] ; Malcolm Macleod [Australie, Royaume-Uni] ; Geoffrey A. Donnan [Australie]

Source :

RBID : Pascal:14-0165941

Descripteurs français

English descriptors

Abstract

Background and Purpose-Severe atherosclerosis in the aortic arch is associated with a high risk of recurrent vascular events, but the optimal antithrombotic strategy is unclear. Methods-This prospective randomized controlled, open-labeled trial, with blinded end point evaluation (PROBE design) tested superiority of aspirin 75 to 150 mg/d plus clopidogrel 75 mg/d (A+C) over warfarin therapy (international normalized ratio 2-3) in patients with ischemic stroke, transient ischemic attack, or peripheral embolism with plaque in the thoracic aorta >4 mm and no other identified embolic source. The primary end point included cerebral infarction, myocardial infarction, peripheral embolism, vascular death, or intracranial hemorrhage. Follow-up visits occurred at 1 month and then every 4 months post randomization. Results-The trial was stopped after 349 patients were randomized during a period of 8 years and 3 months. After a median follow-up of 3.4 years, the primary end point occurred in 7.6% (13/172) and 11.3% (20/177) of patients on A+C and on warfarin, respectively (log-rank, P=0.2). The adjusted hazard ratio was 0.76 (95% confidence interval, 0.36-1.61; P=0.5). Major hemorrhages including intracranial hemorrhages occurred in 4 and 6 patients in the A+C and warfarin groups, respectively. Vascular deaths occurred in 0 patients in A+C arm compared with 6 (3.4%) patients in the warfarin arm (log-rank, P=0.013). Time in therapeutic range (67% of the time for international normalized ratio 2-3) analysis by tertiles showed no significant differences across groups. Conclusions-Because of lack of power, this trial was inconclusive and results should be taken as hypothesis generating.


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Le document en format XML

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<country>France</country>
<wicri:noRegion>Hôpital Bichat</wicri:noRegion>
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<name sortKey="Kaste, Markku" sort="Kaste, Markku" uniqKey="Kaste M" first="Markku" last="Kaste">Markku Kaste</name>
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<name sortKey="Laouenan, Cedric" sort="Laouenan, Cedric" uniqKey="Laouenan C" first="Cédric" last="Laouenan">Cédric Laouenan</name>
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<s1>Department of Biostatistics, Paris-Diderot-Sorbonne University, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris</s1>
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<settlement type="city">Paris</settlement>
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<name sortKey="Young, Dennis" sort="Young, Dennis" uniqKey="Young D" first="Dennis" last="Young">Dennis Young</name>
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<settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
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<name sortKey="Macleod, Malcolm" sort="Macleod, Malcolm" uniqKey="Macleod M" first="Malcolm" last="Macleod">Malcolm Macleod</name>
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<region type="état">Victoria (État)</region>
<settlement type="city">Melbourne</settlement>
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<s1>Division of Clinical Neurosciences, University of Edinburgh (SC005336)</s1>
<s2>Scotland</s2>
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<country>Royaume-Uni</country>
<placeName>
<settlement type="city">Édimbourg</settlement>
<region type="country">Écosse</region>
</placeName>
<orgName type="university">Université d'Édimbourg</orgName>
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<name sortKey="Donnan, Geoffrey A" sort="Donnan, Geoffrey A" uniqKey="Donnan G" first="Geoffrey A." last="Donnan">Geoffrey A. Donnan</name>
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<s1>Florey Institute of Neuroscience and Mental Health, University of Melbourne</s1>
<s2>Melbourne</s2>
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<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
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<country>Australie</country>
<placeName>
<settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
<settlement type="city">Melbourne</settlement>
</placeName>
<orgName type="university">Université de Melbourne</orgName>
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<series>
<title level="j" type="main">Stroke : (1970)</title>
<title level="j" type="abbreviated">Stroke : (1970)</title>
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<title level="j" type="main">Stroke : (1970)</title>
<title level="j" type="abbreviated">Stroke : (1970)</title>
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<keywords scheme="KwdEn" xml:lang="en">
<term>Acetylsalicylic acid</term>
<term>Analgesic</term>
<term>Anticoagulant</term>
<term>Antiplatelet agent</term>
<term>Antipyretic</term>
<term>Antithrombotic agent</term>
<term>Aorta</term>
<term>Aortic arch</term>
<term>Atherosclerosis</term>
<term>Cerebral infarction</term>
<term>Cerebrovascular disease</term>
<term>Clopidogrel</term>
<term>Comparative study</term>
<term>Human</term>
<term>Nervous system diseases</term>
<term>Non steroidal antiinflammatory agent</term>
<term>Stroke</term>
<term>Warfarin</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Accident cérébrovasculaire</term>
<term>Athérosclérose</term>
<term>Ramollissement cérébral</term>
<term>Clopidogrel</term>
<term>Acide acétylsalicylique</term>
<term>Warfarine</term>
<term>Etude comparative</term>
<term>Homme</term>
<term>Arc aortique</term>
<term>Aorte</term>
<term>Pathologie du système nerveux</term>
<term>Pathologie cérébrovasculaire</term>
<term>Antithrombotique</term>
<term>Inhibiteur thromboagrégation</term>
<term>Antipyrétique</term>
<term>Analgésique</term>
<term>Antiinflammatoire non stéroïde</term>
<term>Anticoagulant</term>
</keywords>
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<term>Homme</term>
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<front>
<div type="abstract" xml:lang="en">Background and Purpose-Severe atherosclerosis in the aortic arch is associated with a high risk of recurrent vascular events, but the optimal antithrombotic strategy is unclear. Methods-This prospective randomized controlled, open-labeled trial, with blinded end point evaluation (PROBE design) tested superiority of aspirin 75 to 150 mg/d plus clopidogrel 75 mg/d (A+C) over warfarin therapy (international normalized ratio 2-3) in patients with ischemic stroke, transient ischemic attack, or peripheral embolism with plaque in the thoracic aorta >4 mm and no other identified embolic source. The primary end point included cerebral infarction, myocardial infarction, peripheral embolism, vascular death, or intracranial hemorrhage. Follow-up visits occurred at 1 month and then every 4 months post randomization. Results-The trial was stopped after 349 patients were randomized during a period of 8 years and 3 months. After a median follow-up of 3.4 years, the primary end point occurred in 7.6% (13/172) and 11.3% (20/177) of patients on A+C and on warfarin, respectively (log-rank, P=0.2). The adjusted hazard ratio was 0.76 (95% confidence interval, 0.36-1.61; P=0.5). Major hemorrhages including intracranial hemorrhages occurred in 4 and 6 patients in the A+C and warfarin groups, respectively. Vascular deaths occurred in 0 patients in A+C arm compared with 6 (3.4%) patients in the warfarin arm (log-rank, P=0.013). Time in therapeutic range (67% of the time for international normalized ratio 2-3) analysis by tertiles showed no significant differences across groups. Conclusions-Because of lack of power, this trial was inconclusive and results should be taken as hypothesis generating.</div>
</front>
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<li>Australie</li>
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<li>France</li>
<li>Royaume-Uni</li>
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<li>Uusimaa</li>
<li>Victoria (État)</li>
<li>Écosse</li>
<li>Île-de-France</li>
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<settlement>
<li>Helsinki</li>
<li>Melbourne</li>
<li>Paris</li>
<li>Édimbourg</li>
</settlement>
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<li>Université d'Édimbourg</li>
<li>Université de Melbourne</li>
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