Intravenous vernakalant demonstrated superior efficacy to amiodarone for acute conversion of recent-onset atrial fibrillation within 90 minutes (51.7% vs 5.2%; p<0.0001).
RCT (n=254)
Double-blind
randomized
Does intravenous vernakalant improve the rate of acute conversion to sinus rhythm compared to amiodarone in adult patients with recent-onset atrial fibrillation?
Intravenous vernakalant is superior to amiodarone for the rapid acute conversion of recent-onset atrial fibrillation to sinus rhythm.
Absolute Event Rate: 51.7% vs 5.2%
p-value: p=< 0.0001
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).
“Atrial fibrillation is the most common abnormal heart rhythm and its prevalence has increased over the past 20 years. It is important to have therapies that convert patients back to a normal heart rhythm as quickly as possible. The efficacy and safety results of vernakalant in this study are encouraging.”
Camm et al. (2011) conducted an RCT in Recent-onset atrial fibrillation (n=254). Vernakalant vs. Amiodarone was evaluated on Conversion from AF to sinus rhythm within the first 90 min (p=< 0.0001). Intravenous vernakalant demonstrated superior efficacy to amiodarone for acute conversion of recent-onset atrial fibrillation within 90 minutes (51.7% vs 5.2%; p<0.0001).