Analysis of Healthcare Resource Utilization in the NODE-303 Clinical Trial to Terminate Paroxysmal Supraventricular Tachycardia Episodes

Speaker(s)

Ip JE1, Coutu B2, Ip J3, Noseworthy PA4, Parody ML5, Rafii F6, Sears SF7, Singh N8, Stambler BS9, Tahirkheli N10, Agudelo-Uribe JF11, Omodele S12, Shardonofsky S12, Bharucha DB13, Camm AJ14
1Weill Cornell Medical Center, New York Presbyterian Hospital, New York, NY, USA, 2Montreal University Hospital Center, Montreal, QC, Canada, 3Edward W. Sparrow Hospital Association, Sparrow Thoracic and Cardiovascular Institute, Lansing, MI, USA, 4Mayo Clinic, Rochester, MN, USA, 5Hospital San Roque, San Roque, Córdoba, Argentina, 6lnterventional Cardiology Medical Group, West Hills, CA, USA, 7East Carolina University, Psychology and Cardiovascular Sciences, Greenville, NC, USA, 8NSC Research Center, atlanta, GA, USA, 9Piedmont Heart Institute, Atlanta, GA, USA, 10Oklahoma Heart Hospital, Oklahoma City, OK, USA, 11Clinica CardioVID, Medellin, Colombia, 12Milestone Pharmaceuticals, Montreal, QC, Canada, 13Milestone Pharmaceuticals, Charlotte, NC, USA, 14St George's University of London, London, London, UK

Presentation Documents

OBJECTIVES: Paroxysmal supraventricular tachycardia (PSVT) is a reentrant arrhythmia that creates a substantial burden on the healthcare system, with many patients requiring medical assistance in a clinical setting. Etripamil is a novel fast-acting non-dihydropyridine calcium channel blocker currently under investigation for intranasal self-administration to terminate episodes of PSVT. Etripamil was studied previously in NODE-301 Part 1 and RAPID to assess the safety and efficacy in patients who self-administered this treatment outside the healthcare setting. The objective of present analysis is to characterize healthcare resource utilization (HCRU) among patients in the NODE-303 study.

METHODS: NODE-303 was an open-label study conducted at 148 clinical study sites in the United States, Canada, and Latin America from June 21, 2019 to February 24, 2023. Adult patients (≥18 years) were eligible for the study if they had been diagnosed with at least 1 episode of AV-nodal dependent PSVT prior to enrollment. Any patient who received at least 1 dose of etripamil was included in the safety population and in this analysis. Descriptive statistics were used to characterize HCRU, including emergency department (ED) visits and medical interventions (defined as patients who received oral or intravenous treatment following study drug administration).

RESULTS: Etripamil was self-administered by 503/1,116 patients for ≥1 symptomatic episode of perceived PSVT, with 60% conversion at 30 min and 70% conversion by 60 min in the efficacy population. Additional medical interventions needed to resolve confirmed PSVT episodes included administration of concomitant oral medications (10.1%, 51/503), ED visits (12.3%, 62/503), and hospital visits/admissions (4.0%, 20/503). Intravenous medication (n=225/265; 84.9%) was most commonly used to treat PSVT in the ED or hospital.

CONCLUSIONS: Patients reported visiting an ED or hospital (~12%) at similar rates to the etripamil arms in the randomized NODE-301 Part 1 (13%) and RAPID (14%) clinical trials in patients with confirmed PSVT episodes.

Code

CO61

Topic

Clinical Outcomes

Topic Subcategory

Clinical Outcomes Assessment

Disease

No Additional Disease & Conditions/Specialized Treatment Areas