What was the follow-up duration and what inclusion/exclusion criteria were used in the Cardamyst (Etripamil) RAPID trial for adults with supraventricular tachycardia (SVT)?

RAPID Trial Follow-Up Duration and Inclusion/Exclusion Criteria

Follow-Up Duration

The RAPID trial monitored patients for 5 hours after etripamil self-administration using a self-applied cardiac monitoring system, with the primary efficacy endpoint assessed within 30 minutes of the first dose. 1

• The trial design specified continuous electrocardiographic monitoring for 5 hours post-administration to capture conversion events and safety data 1
• The primary endpoint focused on conversion to sinus rhythm for at least 30 seconds within 30 minutes after the first dose, reflecting etripamil's rapid onset and short duration of action 1, 2
• The median time to conversion in the etripamil group was 17.2 minutes (95% CI 13.4-26.5) versus 53.5 minutes (38.7-87.3) with placebo 1

Inclusion/Exclusion Criteria Limiting Generalizability

Key Inclusion Criteria

Eligible patients were required to be at least 18 years old with documented history of paroxysmal supraventricular tachycardia with sustained, symptomatic episodes lasting at least 20 minutes as confirmed by electrocardiogram. 1

• Patients had to successfully tolerate two test doses of intranasal etripamil (each 70 mg, 10 minutes apart) during sinus rhythm before randomization 1
• Only atrioventricular-nodal-dependent PSVT episodes were included in the primary efficacy analysis 1

Generalizability Limitations

The requirement for sustained episodes of at least 20 minutes excludes patients with brief, self-terminating PSVT episodes who may still benefit from treatment. 1

• The mandatory test-dose tolerance requirement during sinus rhythm excludes patients who cannot tolerate etripamil's nasal side effects (nasal discomfort, congestion, rhinorrhea), which occurred in 23%, 13%, and 9% of patients respectively 1
• The trial specifically focused on atrioventricular-nodal-dependent PSVT, excluding other SVT mechanisms such as pre-excited atrial fibrillation where calcium channel blockers are contraindicated 3, 4
• Patients needed to be capable of self-administering intranasal medication and operating a cardiac monitoring system, excluding those with cognitive impairment, severe nasal pathology, or inability to use the delivery system 1
• The trial excluded hemodynamically unstable patients, who would require immediate synchronized cardioversion rather than pharmacological therapy 3, 5

These criteria may limit applicability to real-world populations including elderly patients with cognitive decline, those with brief self-terminating episodes, patients with nasal abnormalities preventing intranasal administration, and those unable to operate monitoring equipment independently. 1