Dr Bruce Stambler (Piedmont Heart Institute, GA, USA) reiterated the results of the phase 3 NODE-301 trial (NCT03464019), which were previously shared at the 2020 Heart Rhythm Society meeting. The multicentre NODE-301 study evaluated etripamil’s ability to terminate episodes of PSVT effectively and safely.
Participants with a history of ECG-documented PSVT were randomised in a 2:1 fashion to self-administer either intranasal etripamil (n=107) or placebo (n=49) during an episode of PSVT. The study population had a median age of 55 years and had a high burden and frequency of PSVT episodes over the past year, ranging from 7.4 episodes in the etripamil group to 11.3 in the placebo group. NODE-301 failed to meet its primary efficacy endpoint of superiority of a single, 70 mg dose of etripamil over placebo for a conversion of an episode of PVST over 5 hours (HR 1.09; 95% CI 0.73–1.62; P=0.12). A post-hoc secondary analysis was also performed, which considered the known pharmacology of etripamil with a rapid onset of action (within 5-10 minutes) and short duration of action (30-45 minutes). This analysis demonstrated a clinically meaningful early treatment effect with etripamil as compared with placebo; etripamil was significantly more effective than placebo at converting PSVT over the first 45 minutes after administration of the nasal spray (HR 1.67; 95% CI 1.03–2.7; P=0.02). Etripamil had an acceptable and favourable safety profile.
At ACC 2021, Dr Stambler discussed the secondary clinical endpoints of the NODE-301 trial, namely:
- the relief of PSVT-specific symptoms (such as heart palpitations, rapid pulse, chest pain, anxiety, shortness of breath, dizziness, and fainting);
- patient-reported satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM-9);
- the need for any emergency interventions; and
- the need for any additional rescue medication therapy.
Etripamil was more effective than placebo at relieving PSVT specific symptoms. TSQM-9 scores for global satisfaction with treatment and treatment effectiveness were both significantly higher in the etripamil group than in the placebo group. In the etripamil group, 14% of participants sought additional medical therapy compared with 26.5% in the placebo group; most commonly, this consisted of intravenous adenosine administered in the emergency room. During the 5-hour observation period after administration of etripamil, 28 participants sought additional rescue medication intervention; 25 of these presented to the emergency room, and 5 self-administered oral rescue medications for PSVT. The time to emergency room intervention was longer in the etripamil group than in the placebo group (116±14 vs 79±10 minutes; P<0.05).
The researchers concluded that further development of etripamil nasal spray for the treatment of PSVT is supported by these favourable data.
- Stambler BS. Etripamil Nasal Spray Relieves Symptoms and Reduces Emergency Room Interventions in Patients with Paroxysmal Supraventricular Tachycardia (PSVT). ACC 2021 Scientific Session, 15–17 May.
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Table of Contents: ACC 2021
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Electrophysiology
Favourable outcomes with transcatheter atrial appendage occlusion
Etripamil nasal spray significantly improves PSVT-related symptoms
Ablation-based rhythm control as effective as rate control in AF and HF
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Heart Failure and Cardiomyopathy
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Older adults with heart failure benefit from rehabilitation programme
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Sacubitril/valsartan does not reduce NT-proBNP versus valsartan alone in HFrEF
Novel use of ivabradine in reversible cardiomyopathy
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Interventional and Structural Cardiology
Men and women benefit equally from early aspirin withdrawal following PCI
Similar outcomes with fractional flow reserve and angiography-guided revascularisation
TALOS-AMI: Exploring outcomes after switching to clopidogrel versus ticagrelor at 1 month from MI
Clopidogrel monotherapy associated with better net outcomes relative to aspirin monotherapy 6-18 months after PCI
Ischaemic Heart Disease
No difference in ischaemic risk or bleeding with low vs high-dose aspirin for secondary prevention: Lessons and questions from the ADAPTABLE trial
Rivaroxaban reduces total ischaemic events after peripheral artery revascularisation
Moderate hypothermia not superior to mild hypothermia following out-of-hospital cardiac arrest
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Valvular Heart Disease
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