Rationale and design of the randomized COmparison of Methods for Pulmonary blood flow Augmentation: Shunt versus...

Area of Science:

• Pediatric Cardiology
• Interventional Cardiology
• Congenital Heart Disease Research

Background:

• Neonates with congenital heart disease (CHD) and ductal-dependent pulmonary blood flow (DD-PBF) require timely intervention.
• Historically, surgical systemic-to-pulmonary shunts (SPS) were the standard; however, transcatheter ductal artery stenting (DAS) has emerged as an alternative.
• Existing comparative data between DAS and SPS are limited, primarily from small, single-center studies or retrospective analyses with limitations.

Purpose of the Study:

• To compare the clinical outcomes of transcatheter ductal artery stenting (DAS) versus surgical systemic-to-pulmonary shunts (SPS) in neonates with DD-PBF.
• To assess the therapeutic superiority of DAS compared to SPS in the first year of life.
• To provide high-quality evidence through a multicenter, randomized controlled trial.

Main Methods:

• The COMPASS Trial (NCT05268094) is a prospective, multicenter randomized controlled trial.
• Approximately 236 neonates with DD-PBF will be randomized to receive either DAS or SPS.
• The trial will enroll participants across approximately 27 pediatric centers in North America.

Main Results:

• This section will report the primary and secondary clinical outcomes comparing DAS and SPS at one year of life.
• Data will be analyzed to determine differences in survival, reinterventions, and other relevant clinical endpoints.
• Results will be based on a cohort balanced by randomization to minimize bias.

Conclusions:

• The COMPASS Trial is designed to provide definitive evidence on the comparative effectiveness of DAS versus SPS for neonates with DD-PBF.
• Findings will inform clinical decision-making regarding the optimal palliative strategy for this vulnerable population.
• The study aims to establish whether DAS offers similar or superior outcomes to the traditional surgical approach.