May 14, 2010
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AVRO: Vernakalant superior to amiodarone for acute recent-onset AF conversion

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Heart Rhythm Society 31st Annual Scientific Sessions

Vernakalant was more efficacious than amiodarone at the rapid conversion of patients with symptomatic recent onset AF to sinus rhythm, results from the AVRO study suggested.

Researchers for the phase III trial enrolled 254 adult patients with symptomatic AF of three to 48 hours duration. Patients were randomly assigned at 1:1 to either a 10-minute infusion of 3 mg/kg vernakalant followed by a 10-minute infusion of 2 mg/kg vernakalant (Cardiome, n=128) or to a 60-minute infusion of 5 mg/kg amiodarone followed by a 60-minute maintenance infusion of 50 mg amiodarone (n=126). The primary endpoint was the proportion of patient achieving sinus rhythm at 90 minutes.

According to the researchers, 116 patients in each group received at least one dose of the study drug. Conversion from AF to sinus rhythm was achieved in 60 of 116 patients receiving vernakalant vs. six of 116 receiving amiodarone (51.7% vs. 5.2%, P<.0001). Higher rates of symptom AF relief were associated with vernakalant at 90 minutes when compared with amiodarone (53.4% vs. 3.8%, P<.0012). Adverse events or events leading to discontinuation of study drugs were uncommon, according to the researchers, and there were no cases of torsades du pointes, ventricular fibrillation or polymorphic or sustained ventricular tachycardia.

“Vernakalant was more effective in the rapid conversion of AF to sinus rhythm than was amiodarone, and vernakalant was associated with a higher rate of symptom relief than treatment with amiodarone,” John A. Camm, MD, a cardiologist at St. George’s Hospital Medical School in London, said in his presentation. “Vernakalant was associated with more significant improvement in patient quality of life compared with amiodarone and was safe and well-tolerated.”

The AVRO study was funded by Cardiome Pharma Corp. – by Eric Raible

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