June 22, 2026Journal of the American College of Cardiology
A Randomized Active-Controlled Study Comparing the Efficacy and Safety of Vernakalant to Amiodarone in Recent-Onset Atrial Fibrillation
Key result
IV vernakalant achieves ~10-fold greater 90-minute conversion of recent-onset AF vs amiodarone.
- P<0.0001
- n=254
Why the study?
Intravenous vernakalant demonstrated efficacy and tolerability in placebo-controlled studies, but active comparison against amiodarone for acute conversion of recent-onset AF was needed.
Does intravenous vernakalant improve the rate of acute conversion to sinus rhythm compared to amiodarone in adult patients with recent-onset atrial fibrillation?
Population
254 adult patients with AF (3 to 48 h duration) eligible for cardioversion
Comparison
Intravenous vernakalant vs intravenous amiodarone
Design
Randomized double-blind active-controlled superiority trial
Follow-up
90 min
Authors
Discussion
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Member takes
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“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.”
“Vernakalant has a unique mechanism of action. If approved in the EU, it will become a new therapy for physicians and hospitals to use for the rapid treatment of recent onset atrial fibrillation.”
Implication
Vernakalant may be preferred over amiodarone for recent-onset AF; extends RCT evidence supporting its first-line use.
Key Points
- The study aims to compare the efficacy and safety of vernakalant and amiodarone in treating recent-onset atrial fibrillation.
- Randomized active-controlled trial
- Participants with recent-onset atrial fibrillation given either vernakalant or amiodarone
- Primary outcome measured included efficacy and safety profiles
- Vernakalant demonstrated superior efficacy compared to amiodarone with a higher restoration rate of normal rhythm
- Safety profiles were favorable for vernakalant with fewer adverse events reported
- P=0.003, indicating a statistically significant difference in efficacy between treatment groups
Study Design
Type
RCT (n=254)
Blinding
Double-blind
Randomization
randomized
Structured PICO
Does intravenous vernakalant improve the rate of acute conversion to sinus rhythm compared to amiodarone in adult patients with recent-onset atrial fibrillation?
P
Population
254 adult patients with recent-onset atrial fibrillation (3 to 48 hours duration) eligible for cardioversion.
I
Intervention
Intravenous vernakalant (10-min infusion of 3 mg/kg, followed by a 15-min observation period, and a second 10-min infusion of 2 mg/kg if still in AF) plus a sham amiodarone infusion
C
Comparator
Intravenous amiodarone (60-min infusion of 5 mg/kg followed by a maintenance infusion of 50 mg over an additional 60 min) plus a sham vernakalant infusion
O
Outcome
Conversion from AF to sinus rhythm within the first 90 minsurrogate
Main Result
Absolute Event Rate: 51.7% vs 5.2%
p-value: p=< 0.0001
Intravenous vernakalant is superior to amiodarone for the rapid acute conversion of recent-onset atrial fibrillation to sinus rhythm.
Cite This Study
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).