Efficacy and Safety of Etripamil for Termination of Spontaneous PSVT - NODE-301

May 15, 2021
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Milestone Pharmaceuticals, Medpace
Date Presented:
05/15/2021
Date Updated:
05/15/2021
Original Posted Date:
05/15/2021
References

Contribution To Literature:

The NODE-301 trial failed to show that etripamil improved conversion from paroxysmal supraventricular tachycardia. 

Description:

The goal of the trial was to evaluate etripamil, a novel L-type calcium channel blocker, compared with placebo among outpatients with paroxysmal supraventricular tachycardia. Etripamil is a self-administered nasal spray.

Study Design

  • Randomized
  • Parallel
  • Placebo

Patients with documented paroxysmal supraventricular tachycardia were randomized to etripamil (n = 138) versus placebo (n = 60).

  • Total number of enrollees: 198
  • Mean patient age: 56 years
  • Percentage female: 68%
  • Percentage with diabetes: 32%

Inclusion criteria:

  • Paroxysmal supraventricular tachycardia lasting ≥20 minutes

Interpretation:

The primary outcome, time to conversion of paroxysmal supraventricular tachycardia over 5 hours, was similar between the treatment groups (hazard ratio 1.09, 95% confidence interval 0.73-1.62, p = 0.12).

Secondary outcomes:

  • Relief of palpitations (higher score correlates with improved symptom satisfaction): 4.3 with etripamil vs. 2.7 with placebo (p = 0.0001)
  • Relief of dizziness (higher score correlates with improved symptom satisfaction): 4.7 with etripamil vs. 3.2 with placebo (p = 0.01)
  • Need for emergency department intervention to treat paroxysmal supraventricular tachycardia: 12.1% with etripamil vs. 24.5% with placebo (p = 0.051)

References:

Presented by Dr. Bruce Sheldon Stambler at the American College of Cardiology Virtual Annual Scientific Session (ACC 2021), May 15, 2021.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: ACC21, ACC Annual Scientific Session, Arrhythmias, Cardiac, Dizziness, Emergency Service, Hospital, Nasal Sprays, Outpatients, Tachycardia, Paroxysmal, Tachycardia, Ventricular, Tachycardia, Supraventricular


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