A randomized active-controlled study comparing the efficacy and safety of
vernakalant to amiodarone in recent-onset atrial fibrillation.
Author(s): Camm AJ, Capucci A, Hohnloser SH, Torp-Pedersen C, Van Gelder IC, Mangal B,
Beatch G; AVRO Investigators.
Affiliation(s): St. George's University of London, United Kingdom. jcamm@sgul.ac.uk
Publication date & source: 2011, J Am Coll Cardiol. , 57(3):313-21
OBJECTIVES: This randomized double-blind study compared the efficacy and safety
of intravenous vernakalant and amiodarone for the acute conversion of
recent-onset atrial fibrillation (AF).
BACKGROUND: Intravenous vernakalant has effectively converted recent-onset AF and
was well tolerated in placebo-controlled studies.
METHODS: A total of 254 adult patients with AF (3 to 48 h duration) eligible for
cardioversion were enrolled in the study. Patients received either a 10-min
infusion of vernakalant (3 mg/kg) followed by a 15-min observation period and a
second 10-min infusion (2 mg/kg) if still in AF, plus a sham amiodarone infusion,
or a 60-min infusion of amiodarone (5 mg/kg) followed by a maintenance infusion
(50 mg) over an additional 60 min, plus a sham vernakalant infusion.
RESULTS: Conversion from AF to sinus rhythm within the first 90 min (primary end
point) was achieved in 60 of 116 (51.7%) vernakalant patients compared with 6 of
116 (5.2%) amiodarone patients (p < 0.0001). Vernakalant resulted in rapid
conversion (median time of 11 min in responders) and was associated with a higher
rate of symptom relief compared with amiodarone (53.4% of vernakalant patients
reported no AF symptoms at 90 min compared with 32.8% of amiodarone patients; p =
0.0012). Serious adverse events or events leading to discontinuation of study
drug were uncommon. There were no cases of torsades de pointes, ventricular
fibrillation, or polymorphic or sustained ventricular tachycardia.
CONCLUSIONS: Vernakalant demonstrated efficacy superior to amiodarone for acute
conversion of recent-onset AF. Both vernakalant and amiodarone were safe and well
tolerated in this study. (A Phase III Superiority Study of Vernakalant vs
Amiodarone in Subjects With Recent Onset Atrial Fibrillation [AVRO];
NCT00668759).
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