Arrhythmias & electrophysiologyRandomised controlled trial
Self-administered intranasal etripamil using a symptom-prompted, repeat-dose regimen for atrioventricular-nodal-dependent supraventricular tachycardia (RAPID): a multicentre, randomised trial
- Randomised controlled trial
- multicentre
- placebo-controlled
- event-driven
- 160 sites in North America and Europe
- part 2 of the NODE-301 study
Authors' conclusion
Using a symptom-prompted, self-administered, initial and optional-repeat-dosing regimen, intranasal etripamil was well tolerated, safe, and superior to placebo for the rapid conversion of atrioventricular-nodal-dependent paroxysmal supraventricular tachycardia to sinus rhythm.
Study context
- Population
- Adults with a history of ECG-documented paroxysmal supraventricular tachycardia with sustained, symptomatic episodes (≥20 min) who tolerated two etripamil test doses184 treated a confirmed event
- Participants
- 692 adults
- Comparison
- Self-administered intranasal etripamil 70 mg vs placebo
- Etripamiln = 99
- Placebon = 85reference
- Primary endpoint
- Time to conversion of atrioventricular-nodal-dependent paroxysmal supraventricular tachycardia to sinus rhythm for at least 30 s
- Follow-up
- Within 30 min after the first dose
Primary result
As reported in the abstract
Conversion to sinus rhythm by 30 min (Kaplan-Meier) · 30 min
Hazard ratio
2.62
95% CI 1.66–4.15
P < 0.0001
Events by treatment group
Etripamil vs Placebo
HR 2.62 (95% CI 1.66–4.15); P < 0.0001
Safety
Treatment-emergent adverse events
Nasal discomfort Etripamil 23%
Nasal congestion Etripamil 13%
Rhinorrhea Etripamil 9%
- Treatment-emergent adverse events — Serious etripamil-related adverse events or deaths
- 0
- Treatment-emergent adverse events: mostly administration-site, mild or moderate; all transient and resolved without intervention
Original publication
Self-administered intranasal etripamil using a symptom-prompted, repeat-dose regimen for atrioventricular-nodal-dependent supraventricular tachycardia (RAPID): a multicentre, randomised trial. Lancet. Published 15 June 2023. doi:10.1016/s0140-6736(23)00776-6
Summarised from the published abstract; every number is checked against it