Journal of cardiovascular electrophysiology · 2026
Self-Administered Etripamil Nasal Spray Slows Ventricular Rate in Patients With Atrial Fibrillation: A Post Hoc Analysis of the NODE-303 Study.
СтатьяМногоцентровое исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Dorian Paul, Alings Marco, Coutu Benoit, Ip James E, Martinez Felipe A, Piccini Jonathan P, Stambler Bruce S, Sheikh Muhammad, Shardonofsky Silvia, Bharucha David B, Camm A John
Аннотация
INTRODUCTION: Currently, there are no available fast-acting agents to control the ventricular rate (VR) during atrial fibrillation (AF) episodes that can be self-administered by patients on an as-needed basis without medical supervision. Here, we aim to evaluate the effect of intranasal etripamil on VR in patients treating presumed paroxysmal supraventricular tachycardia (PSVT) episodes later identified as AF.
METHODS: NODE-303 is a phase 3, multicenter, open-label study to evaluate the safety and efficacy of self-administered intranasal etripamil. The study enrolled adult (≥ 18 years) patients with prior documented PSVT. Patients self-administered 70 mg of intranasal etripamil after applying an ECG monitor and performing a vagal maneuver. An optional second 70 mg dose was permitted if symptoms persisted after 10 min. This post hoc analysis specifically focused on AF patients (those with presumed PSVT episodes subsequently identified as AF) and evaluated the change from baseline VR (beats per minute, bpm), calculated using patient ECG data that was recorded through 60 min after drug administration, during an etripamil-treated AF episode.
RESULTS: Of 1116 total enrolled patients, 503 self-administered ≥ 1 dose of etripamil for presumed PSVT, and 18 had ≥ 1 episode(s) later identified as AF with adequate ECG data. AF episode baseline median VR (range) was 127 bpm (79, 164), and the average maximum reduction in VR was 27.4 bpm ± 6.1 at 22 min. VR reduction was sustained for at least 30 to 60 min (median VR reduction -22 and -18 bpm, respectively). No serious adverse events or adverse events of special interest were observed, including bradyarrhythmias, AV block, or sinus pauses ≥ 3 s, and treatment-emergent adverse events were mild to moderate, transient, and related to the nasal administration route.
DISCUSSION: In this post hoc subgroup analysis of the open-label NODE-303 trial, self-administered etripamil nasal spray led to a clinically significant and sustained VR reduction in patients with symptomatic AF. Further studies are needed to confirm efficacy in a broader AF population.
CONCLUSION: Self-administered etripamil may help to acutely control symptomatic AF-RVR episodes outside of the healthcare setting.
CLINICAL TRIAL REGISTRATION: NCT04072835.
METHODS: NODE-303 is a phase 3, multicenter, open-label study to evaluate the safety and efficacy of self-administered intranasal etripamil. The study enrolled adult (≥ 18 years) patients with prior documented PSVT. Patients self-administered 70 mg of intranasal etripamil after applying an ECG monitor and performing a vagal maneuver. An optional second 70 mg dose was permitted if symptoms persisted after 10 min. This post hoc analysis specifically focused on AF patients (those with presumed PSVT episodes subsequently identified as AF) and evaluated the change from baseline VR (beats per minute, bpm), calculated using patient ECG data that was recorded through 60 min after drug administration, during an etripamil-treated AF episode.
RESULTS: Of 1116 total enrolled patients, 503 self-administered ≥ 1 dose of etripamil for presumed PSVT, and 18 had ≥ 1 episode(s) later identified as AF with adequate ECG data. AF episode baseline median VR (range) was 127 bpm (79, 164), and the average maximum reduction in VR was 27.4 bpm ± 6.1 at 22 min. VR reduction was sustained for at least 30 to 60 min (median VR reduction -22 and -18 bpm, respectively). No serious adverse events or adverse events of special interest were observed, including bradyarrhythmias, AV block, or sinus pauses ≥ 3 s, and treatment-emergent adverse events were mild to moderate, transient, and related to the nasal administration route.
DISCUSSION: In this post hoc subgroup analysis of the open-label NODE-303 trial, self-administered etripamil nasal spray led to a clinically significant and sustained VR reduction in patients with symptomatic AF. Further studies are needed to confirm efficacy in a broader AF population.
CONCLUSION: Self-administered etripamil may help to acutely control symptomatic AF-RVR episodes outside of the healthcare setting.
CLINICAL TRIAL REGISTRATION: NCT04072835.