Titre du document / Document title

Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the atrial fibrillation clopidogrel trial with irbesartan for prevention of vascular events (ACTIVE W) : a randomised controlled trial. Commentary

Auteur(s) / Author(s)

ACTIVE Investigators
VERHEUQT Freek W. A. (Commentateur (texte écrit)) ⁽¹⁾ ; CONNOLLY Stuart J. ⁽²⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Department of Cardiology, Heartcentre, University Medical Centre St Radboud, Nijmegen 6500-HB, PAYS-BAS
⁽²⁾ Hamilton Health Sciences Corporation, Hamilton General Site, 237 Barton Street East, Hamilton, ON L8L 2X2, CANADA

Résumé / Abstract

Background Oral anticoagulation therapy reduces risk of vascular events in patients with atrial fibrillation. However, long-term monitoring is necessary and many patients cannot achieve optimum anticoagulation. We assessed whether clopidogrel plus aspirin was non-inferior to oral anticoagulation therapy for prevention of vascular events. Methods Patients were enrolled if they had atrial fibrillation plus one or more risk factor for stroke, and were randomly allocated to receive oral anticoagulation therapy (target international normalised ratio of 2·0-3·0; n=3371) or clopidogrel (75 mg per day) plus aspirin (75-100 mg per day recommended; n=3335). Outcome events were adjudicated by a blinded committee. Primary outcome was first occurrence of stroke, non-CNS systemic embolus, myocardial infarction, or vascular death. Analyses were by intention-to-treat. This study is registered with ClinicalTrials.gov, number NCT00243178. Results The study was stopped early because of clear evidence of superiority of oral anticoagulation therapy. There were 165 primary events in patients on oral anticoagulation therapy (annual risk 3·93%) and 234 in those on clopidogrel plus aspirin (annual risk 5·60%;relative risk 1·44 (1·18-1.76; p=0.0003). Patients on oral anticoagulation therapy who were already receiving this treatment at study entry had a trend towards a greater reduction in vascular events (relative risk 1·50, 95% CI 1·19-1·80) and a significantly (p=0·03 for interaction) lower risk of major bleeding with oral anticoagulation therapy (1.30; 0.94-1.79) than patients not on this treatment at study entry (1·27,0·85-1·89 and 0·59, 0·32-1·08, respectively). Conclusion Oral anticoagulation therapy is superior to clopidogrel plus aspirin for prevention of vascular events in patients with atrial fibrillation at high risk of stroke, especially in those already taking oral anticoagulation therapy.

Revue / Journal Title

Lancet   ISSN 0140-6736   CODEN LANCAO 

Source / Source

2006, vol. 367, n^o9526, [Note(s): 1877-1878,1903-1912 [12 p.]] (33 ref.)

Langue / Language

Anglais

Editeur / Publisher

Lancet, London, ROYAUME-UNI  (1823) (Revue)

Mots-clés anglais / English Keywords

Octapeptide ; Peptide hormone ; Renin angiotensin system ; Circulatory system ; Tetrazole derivatives ; AT1 angiotensin receptor ; Biphenyl derivatives ; Angiotensin antagonist ; Angiotensin II ; Arrhythmia ; Excitability disorder ; Heart disease ; Cardiovascular disease ; Salicylates ; Enzyme ; Oxidoreductases ; Prostaglandin-endoperoxide synthase ; Enzyme inhibitor ; Thienopyridine derivative ; Randomised controlled trial ; Antihypertensive agent ; Non steroidal antiinflammatory agent ; Analgesic ; Antipyretic ; Medicine ; Critical study ; Blood vessel ; Prevention ; Clinical trial ; Irbesartan ; Treatment ; Anticoagulant ; Atrial fibrillation ; Oral administration ; Comparative study ; Acetylsalicylic acid ; Drug combination ; Antiplatelet agent ; Clopidogrel ;

Mots-clés français / French Keywords

Sartan dérivé ; Octapeptide ; Hormone peptide ; Système renin angiotensine ; Appareil circulatoire ; Tétrazole dérivé ; Récepteur angiotensine AT1 ; Biphényle dérivé ; Antagoniste angiotensine ; Angiotensine II ; Trouble rythme cardiaque ; Trouble excitabilité ; Cardiopathie ; Appareil circulatoire pathologie ; Salicylés ; Enzyme ; Oxidoreductases ; Prostaglandin-endoperoxide synthase ; Inhibiteur enzyme ; Thiénopyridine dérivé ; Essai randomisé contrôlé ; Antihypertenseur ; Antiinflammatoire non stéroïde ; Analgésique ; Antipyrétique ; Médecine ; Etude critique ; Vaisseau sanguin ; Prévention ; Essai clinique ; Irbésartan ; Traitement ; Anticoagulant ; Fibrillation auriculaire ; Voie orale ; Etude comparative ; Acétylsalicylique acide ; Association médicamenteuse ; Inhibiteur thromboagrégation ; Clopidogrel ;

Mots-clés espagnols / Spanish Keywords

Octapéptido ; Hormona péptido ; Sistema renin angiotensina ; Aparato circulatorio ; Tetrazol derivado ; Receptor angiotensina AT1 ; Bifenilo derivado ; Antagonista angiotensina ; Angiotensina II ; Arritmia ; Trastorno excitabilidad ; Cardiopatía ; Aparato circulatorio patología ; Salicilatos ; Enzima ; Oxidoreductases ; Prostaglandin-endoperoxide synthase ; Inhibidor enzima ; Thienopyridin derivado ; Ensayo clínico aleatorio ; Antihipertensivo ; Antiinflamatorio no esteroide ; Analgésico ; Antipirético ; Medicina ; Estudio crítico ; Vaso sanguíneo ; Prevención ; Ensayo clínico ; Irbesartán ; Tratamiento ; Anticoagulante ; Fibrilación auricular ; Vía oral ; Estudio comparativo ; Acetilsalicilico ácido ; Asociación medicamentosa ; Inhibidor tromboagregación ; Clopidogrel ;

Localisation / Location

INIST-CNRS, Cote INIST : 5004, 35400015309280.0100