October 1, 1996Circulation
Efficacy and Safety of Repeated Intravenous Doses of Ibutilide for Rapid Conversion of Atrial Flutter or Fibrillation
Why the study?
Does intravenous ibutilide improve the conversion rate in patients with sustained atrial fibrillation or flutter?
Population
266 patients with sustained atrial fibrillation or flutter, with an arrhythmia duration of 3 hours to 45 days
Comparison
Intravenous ibutilide, up to two 10-minute… vs Placebo
Design
RCT, randomized
Follow-up
acute (mean 27 minutes after infusion)
Authors
Discussion
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Implication
Supports ibutilide for acute AF/flutter conversion; confirms high efficacy versus placebo in this RCT.
Key Points
- The study aims to evaluate the efficacy and safety of repeated intravenous ibutilide doses for terminating atrial flutter or fibrillation.
- Multicenter randomized trial involving 266 patients with sustained atrial fibrillation or flutter.
- Patients received up to two 10-minute infusions of ibutilide or placebo.
- Conversion rates were assessed comparing ibutilide to placebo and among dosing regimens.
- Conversion rate after ibutilide was 47% versus 2% with placebo (P < .0001).
- Efficacy of ibutilide was greater for atrial flutter (63%) than for fibrillation (31%) (P < .0001).
- Polymorphic ventricular tachycardia occurred in 8.3% of ibutilide-treated patients, with 1.7% requiring cardioversion.
Structured PICO
Does intravenous ibutilide improve the conversion rate in patients with sustained atrial fibrillation or flutter?
P
Population
266 patients with sustained atrial fibrillation (n = 133) or flutter (n = 133), with an arrhythmia duration of 3 hours to 45 days
I
Intervention
Intravenous ibutilide, up to two 10-minute infusions separated by 10 minutes (1.0 and 0.5 mg or 1.0 and 1.0 mg)
C
Comparator
Placebo
O
Outcome
Conversion rate of atrial fibrillation or flutter
Repeated intravenous doses of ibutilide are highly effective for the rapid conversion of atrial flutter and fibrillation, though associated with an 8.3% risk of polymorphic ventricular tachycardia.
Cite This Study
Stambler et al. (1996) studied this question.