Arrhythmias & electrophysiology
Multicenter, Phase 2, Randomized Controlled Study of the Efficacy and Safety of Etripamil Nasal Spray for the Acute Reduction of Rapid Ventricular Rate in Patients With Symptomatic Atrial Fibrillation (ReVeRA-201)
Primary result · Mean maximum reduction in VR, adjusted for baseline VRResult — go to the resultDifference of mean maximum reductions −29.91 bpm 95% CI −40.31 to −19.52Authors' conclusion
Intranasal etripamil 70 mg reduced VR and improved symptom relief and treatment satisfaction.
Study context
- Population
- Patients presenting urgently with atrial fibrillation (AF) with rapid ventricular rate (VR ≥110 bpm)56 dosed
- Participants
- 69 patients
- Comparison
- Etripamil nasal spray 70 mg vs placebo nasal spray
- Etripamiln = 27
- Placebon = 29reference
- Primary endpoint
- Effectiveness of etripamil in reducing VR in AF-RVR
- Follow-up
- Within 60 minutes of treatment
Methodological detailsdouble-blind, placebo-controlled, multicentre, Canada and the Netherlands
- Double-blind
- Placebo-controlled
- Multicentre
- Canada and the Netherlands
Primary result
As reported in the abstract
Mean maximum reduction in VR, adjusted for baseline VR · over 60 minutes
Difference of mean maximum reductions
−29.91 bpm
95% CI −40.31 to −19.52
P < 0.0001
Etripamilvs Placebo
difference of mean maximum reductions −29.91 bpm (95% CI −40.31 to −19.52); P < 0.0001
Secondary outcomes
| Outcome | Etripamil | Placebo |
|---|---|---|
| VR reduction ≥20% | 66.7% | 0 events |
VR <100 bpm, VR reduction ≥10% or ≥20%
- Significantly greater proportions with etripamil vs placebo (longer median duration <100 bpm)
Duration of VR reduction
- VR reductions persisted up to 150 minutes
Treatment satisfaction (TSQM-9): symptom relief and treatment effectiveness
- Significant improvement with etripamil vs placebo
Safety
- Serious adverse events — Etripamil
- 1 events
Serious adverse events
- Serious adverse events were rare; 1 etripamil patient had transient severe bradycardia and syncope, assessed as due to hypervagotonia
Original publication
Multicenter, Phase 2, Randomized Controlled Study of the Efficacy and Safety of Etripamil Nasal Spray for the Acute Reduction of Rapid Ventricular Rate in Patients With Symptomatic Atrial Fibrillation (ReVeRA-201). Circ Arrhythm Electrophysiol. Published 11 November 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →