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
Key result
Dronedarone reduced the risk of stroke from 1.8% to 1.2% per year compared to placebo in patients with atrial fibrillation (HR 0.66; 95% CI 0.46-0.96; P=0.027).
Why the study?
Does dronedarone reduce the risk of stroke in patients with persistent or paroxysmal atrial fibrillation?
Population
4,628 patients with persistent or paroxysmal atrial fibrillation and at least 1 risk factor for…
Comparison
Dronedarone 400 mg BID added to usual care vs Double-blind matching placebo added to usual care
Design
RCT, randomized, double-blind
Follow-up
minimum of 1 year to a common termination at 30 months
Authors
Discussion
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Implication
Dronedarone offers an additional stroke prevention option in AF; confirms benefit in RCT independent of anticoagulation.
Study Design
Type
RCT (n=4,628)
Blinding
double-blind
Randomization
randomized
Structured PICO
Does dronedarone reduce the risk of stroke in patients with persistent or paroxysmal atrial fibrillation?
P
Population
4,628 patients with persistent or paroxysmal atrial fibrillation and at least 1 risk factor for cardiovascular hospitalization, mean CHADS2 score 2
I
Intervention
Dronedarone 400 mg BID added to usual care (antithrombotic therapy and heart rate control)
C
Comparator
Double-blind matching placebo added to usual care
O
Outcome
Stroke (post hoc analysis)hard clinical
Main Result
Effect estimate: HR 0.66 (95% CI 0.46 to 0.96)
Absolute Event Rate: 1.2% vs 1.8%
p-value: p=0.027
In a post hoc analysis of the ATHENA trial, dronedarone significantly reduced the risk of stroke in patients with atrial fibrillation compared to placebo.
Limitations
- Post hoc analysis
- post hoc analysis
Cite This Study
Connolly et al. (2009) conducted an RCT in Atrial fibrillation/atrial flutter (n=4,628). dronedarone vs. placebo was evaluated on stroke (HR 0.66, 95% CI 0.46 to 0.96, p=0.027). Dronedarone reduced the risk of stroke from 1.8% to 1.2% per year compared to placebo in patients with atrial fibrillation (HR 0.66; 95% CI 0.46-0.96; P=0.027).