ATHENA Trial (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) Presented at Heart Rhythm 2008 in San Francisco, USA Presented by Stefan H. Hohnloser, MD ATHENA Trial Copyleft Clinical Trial Results. You Must Redistribute Slides
Atrial fibrillation (AF) impairs patients’ lives, leading to increased risks of cardiovascular complications.
Over the course of 20 years of clinical drug trials in AF no drug has demonstrated a significant reduction in the risk of cardiac death.
ATHENA set out to evaluate the effect of Multaq ® (dronedarone), a multi-channel blocker with anti-adrenergic properties, on a composite primary endpoint of all-cause mortality and cardiovascular hospitalization in patients with AF.
Primary Endpoint: composite of all-cause mortality combined with cardiovascular hospitalization
Secondary Endpoint: death from any cause, cardiovascular death, hospitalization for cardiovascular reasons
Multaq ® (dronedarone) 400 mg BID Placebo 4,628 patients > 75 years with atrial fibrillation or 70-75 years with atrial fibrillation and at least one additional cardiovascular risk factor prior to randomization. Double blind. Randomized. Placebo controlled. International multicenter. Mean follow-up 21 months. JCE 2008; 19.1/Heart Rhythm 2008 R 12-30 mos. follow-up Copyleft Clinical Trial Results. You Must Redistribute Slides
≥ 70 yrs with at least one of the following risk factors: arterial hypertension (ongoing therapy with at least two antihypertensive drugs of different classes), diabetes mellitus, prior stroke or transient ischemic attack or systemic embolism, left atrium diameter ≥ 50 mm by M-mode echocardiography, LVEF < 0.40 by 2D-echocardiography.
JCE 2008; 19.1/Heart Rhythm 2008 Copyleft Clinical Trial Results. You Must Redistribute Slides
A calculated GFR at baseline < 10mL/min using the Cockroft Gault formula
Potassium level < 3.5 mmol/L if not corrected
Need for concomitant medication prohibited within ATHENA (i.e., other antiarrhythmic drugs of Vaughan-Williams class I or III)
Copyleft Clinical Trial Results. You Must Redistribute Slides JCE 2008; 19.1/Heart Rhythm 2008
ATHENA Trial: Baseline Characteristics JCE 2008; 19.1 /Heart Rhythm 2008 Copyleft Clinical Trial Results. You Must Redistribute Slides *AF at baseline: according to the stratification factor at randomization. Characteristic Incidence/Mean Value Patient age <65 years 19% 65-74 years 40% ≥ 75 years 42% Female gender 47% Hypertension 86% Mean systolic blood pressure 134 mmHg AF at baseline* 25% History of cardioversion 34%