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PALLAS TRIAL |
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| Problem | High-risk permanent AF |
| Format | Double-blinded multi-center RCT |
| Treatment | Dronedarone |
| Control | Placebo |
| Population | 3236 patients |
| Inclusion criteria | Permanent atrial fibrillation or flutter, as documented on electrocardiography performed both within 14 days before randomization and 6 or more months beforehand, who had no evidence of intervening sinus rhythm and for whom there was no plan to restore sinus rhythm Aged >65 years with at least one of: Coronary artery disease Previous stroke or transient ischemic attack Symptomatic heart failure, which was defined as current New York Heart Association class II or III symptoms and admission to the hospital for heart failure in the previous year (but not in the most recent month) Left ventricular ejection fraction of 40% or less Peripheral arterial disease OR the combination of an age of 75 years or older, hypertension, and diabetes. |
| Exclusion criteria | Paroxysmal or persistent atrial fibrillation Use of an implantable cardioverter–defibrillator Sustained daytime bradycardia of less than 50 beats per minute QT interval corrected for heart rate of more than 500 msec (or >530 msec for patients with a paced ventricular rhythm). |
| Follow-up | STOPPED EARLY - Median 3.5 months |
| Primary endpoint | 2 Coprimary outcomes 1) Stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes 2) Unplanned hospitalization for a cardiovascular cause or death. |
| Secondary endpoint(s) | Death from cardiovascular causes Death from arrhythmia Recurrent hospitalization for cardiovascular causes Total nights in the hospital for cardiovascular reasons Acute coronary syndrome Stroke or systemic embolism Hospitalization for heart failure or heart-failure episode without hospitalization Death from any cause. |
| Details | N.B. STOPPED EARLY Patients who were at least 65 years of age with at least a 6-month history of permanent atrial fibrillation and risk factors for major vascular events |
| Brief summary: | Followed ATHENA; showed dronedarone kills high risk AF patients |
| PAPER: Dronedarone in High-Risk Permanent Atrial Fibrillation | |
|---|---|
| Date | 14 Nov 2011 |
| Journal | N Engl J Med. 2011 Nov 14. [Epub ahead of print] |
| Information | N.B. STOPPED EARLY Increased rates of -Heart failure -Stroke -Death from cardiovascular causes |