This Article Full Text Full Text (PDF) All Versions of this Article: 120/13/1174    most recent CIRCULATIONAHA.109.875252v1 Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Google Scholar Articles by Connolly, S. J. PubMed PubMed Citation Articles by Connolly, S. J. Pubmed/NCBI databases Compound via MeSH Substance via MeSH Hazardous Substances DB AMIODARONE HYDROCHLORIDE Medline Plus Health Information Atrial Fibrillation Stroke Related Collections Arrhythmias, clinical electrophysiology, drugs Embolic stroke Other Stroke Treatment - Medical Related Articles

(Circulation. 2009;120:1174-1180.)
© 2009 American Heart Association, Inc.

Arrhythmia/Electrophysiology

Analysis of Stroke in ATHENA: A Placebo-Controlled, Double-Blind, Parallel-Arm Trial to Assess the Efficacy of Dronedarone 400 mg BID for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation/Atrial Flutter

Stuart J. Connolly, MD; Harry J.G.M. Crijns, MD; Christian Torp-Pedersen, MD; Martin van Eickels, MD; Christophe Gaudin, MD; Richard L. Page, MD; Stefan H. Hohnloser, MD, for the ATHENA Investigators

From the Population Health Research Institute (S.J.C.), McMaster University, Hamilton, Ontario, Canada; Department of Cardiology (H.J.G.M.C.), University Hospital Maastricht, Maastricht, Netherlands; Department of Cardiology (C.T.-P.), Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; sanofi-aventis (M.v.E., C.G.), Research and Development, Frankfurt, Germany; Department of Cardiology (R.L.P.), University of Washington, Seattle, Wash; and Department of Cardiology (S.H.H.), J.W. Goethe University, Frankfurt, Germany.

Correspondence to Stuart J. Connolly, MD, FRCPC, Division of Cardiology, Hamilton Health Sciences, General Site, 502-237 Barton St E, Hamilton, Ontario L8L 2X2, Canada. E-mail connostu{at}phri.ca

Received April 28, 2009; accepted July 13, 2009.

Background— Many patients with atrial fibrillation are at high risk for stroke and require antithrombotic therapy. Antiarrhythmic drugs have not previously been shown to reduce the risk of stroke in atrial fibrillation. The effect of dronedarone, a new multichannel-blocking antiarrhythmic drug, on stroke has been evaluated in a randomized, double-blind clinical trial, ATHENA (A placebo-controlled, double-blind, parallel-arm Trial to assess the efficacy of dronedarone 400 mg BID for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter).

Methods and Results— Patients with persistent or paroxysmal atrial fibrillation and at least 1 risk factor for cardiovascular hospitalization were randomized to receive dronedarone (400 mg BID) or double-blind matching placebo and followed up for a minimum of 1 year to a common termination at 30 months. All strokes that occurred during the study were included in the present post hoc analysis. There were 4628 patients randomized to placebo or dronedarone. The baseline risk factors for stroke were well balanced between the 2 groups, and the baseline mean CHADS₂ score was 2. The baseline use of either oral anticoagulant therapy or antiplatelet agent alone was 60%. Dronedarone reduced the risk of stroke from 1.8% per year to 1.2% per year (hazard ratio 0.66, 95% confidence interval 0.46 to 0.96, P=0.027). The effect of dronedarone was similar whether or not patients were receiving oral anticoagulant therapy, and there was a significantly greater effect of dronedarone in patients with higher CHADS₂ scores.

Conclusions— In this post hoc analysis, a reduction in stroke was observed in patients with atrial fibrillation who were receiving usual care, which included antithrombotic therapy and heart rate control, who were randomized to dronedarone. Further studies to investigate the effect of dronedarone and other antiarrhythmic agents on stroke are indicated.

---

 

CLINICAL PERSPECTIVE

Related Articles:

Clinical Summaries
Circulation 2009 120: 1165-1167. [Extract] [Full Text]

Reducing Stroke Rates in Patients With Atrial Fibrillation: How Low Can We Go?

Michael D. Ezekowitz, Meghashyam J. Koti, and Brian Fulton
Circulation 2009 120: 1169-1170. [Extract] [Full Text]

This article has been cited by other articles:

				M. D. Ezekowitz, M. J. Koti, and B. Fulton Reducing Stroke Rates in Patients With Atrial Fibrillation: How Low Can We Go? Circulation, September 29, 2009; 120(13): 1169 - 1170. [Full Text] [PDF]