A Randomized Active-Controlled Study Comparing the Efficacy and Safety of Vernakalant to Amiodarone in Recent-Onset Atrial Fibrillation

Study Questions:

Is vernakalant more effective than amiodarone for acute conversion of atrial fibrillation (AF)?

Methods:

Two hundred and thirty-two patients (mean age 63 years) with AF lasting 3-48 hours in duration were randomly assigned to one of two intravenous therapies: vernakalant, 3 mg/kg over 10 minutes, then an additional 10-minute infusion of 2 mg/kg if necessary 15 minutes later (n = 116); amiodarone 5 mg/kg over 60 minutes, then 50 mg over an additional 60 minutes (n = 116). The study was double-blinded. The primary endpoint was conversion to sinus rhythm (SR) within 90 minutes of first exposure to the study drug.

Results:

Conversion to SR occurred significantly more often in the vernakalant group (51.7%) than in the amiodarone group (5.2%). The mean time to conversion was 11 minutes with vernakalant. The study drug was discontinued because of a serious adverse event in 2.6% of patients in the vernakalant group compared to 0.9% in the amiodarone group. Torsades de pointes, ventricular fibrillation, polymorphic ventricular tachycardia (VT), or sustained monomorphic VT did not occur in either group.

Conclusions:

Vernakalant is approximately 10 times more effective than amiodarone for the acute conversion of AF, and is well tolerated.

Perspective:

Vernakalant, an investigational agent in the United States, is a multiple ion channel blocker and is novel in that it blocks potassium channels that are present in the atrium and not in the ventricle (e.g., the ultra-rapid delayed rectifier current and the inwardly rectifying, acetylcholine-regulated current). The advantage of its atrial-selective action is a major reduction in the risk of ventricular proarrhythmia associated with other potassium-channel blockers such as ibutilide.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Heart Failure and Cardiomyopathies, Prevention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Lipid Metabolism, Nonstatins, Novel Agents, Statins, Acute Heart Failure, Chronic Heart Failure

Keywords: Stroke, Myocardial Infarction, National Heart, Lung, and Blood Institute (U.S.), Risk Reduction Behavior, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Risk Factors, Peripheral Arterial Disease, Heart Failure, Systolic, Primary Prevention, Lipoproteins, LDL, Renal Dialysis, Dyslipidemias, Lipoproteins, HDL, Risk Assessment


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