Neonates with congenital heart disease (CHD) and ductal-dependent pulmonary blood flow (DD-PBF) require early intervention. Historically, this intervention was most often a surgical systemic-to-pulmonary shunt (SPS; e.g., Blalock–Thomas–Taussig shunt). However, over the past two decades an alternative to SPS has emerged in the form of transcatheter ductal artery stenting (DAS). While many reports have indicated safety and durability of the DAS approach, few studies compare outcomes between DAS and SPS. The reports that do exist are comprised primarily of small-cohort single-center reviews. Two multicenter retrospective studies suggest that DAS is associated with similar or superior survival compared to SPS. These studies offer the best evidence to-date, and yet both have important limitations. The authors describe herein the rationale and design of the COMPASS (COmparison of Methods for Pulmonary blood flow Augmentation: Shunt vs. Stent) Trial (NCT05268094, IDE G210212). The COMPASS Trial aims to randomize 236 neonates with DD-PBF to either DAS or SPS across approximately 27 pediatric centers in North America. The goal of this trial is to compare important clinical outcomes between DAS and SPS over the first year of life in a cohort of neonates balanced by randomization to assess whether one method of palliation demonstrates therapeutic superiority.

中文翻译：

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肺血流增强方法随机会议的基本原理和设计：分流与支架 （COMPASS） 试验：一项儿科心脏网络研究


患有先天性心脏病 （CHD） 和导管依赖性肺血流 （DD-PBF） 的新生儿需要早期干预。从历史上看，这种干预最常见的是外科体肺分流术 （SPS;例如，Blalock-Thomas-Taussig 分流术）。然而，在过去的二十年里，出现了 SPS 的替代方案，即经导管导管动脉支架置入术 （DAS）。虽然许多报告表明 DAS 方法的安全性和持久性，但很少有研究比较 DAS 和 SPS 之间的结果。确实存在的报告主要由小群体单中心综述组成。两项多中心回顾性研究表明，与 SPS 相比，DAS 的生存率相似或更高。这些研究提供了迄今为止最好的证据，但两者都有重要的局限性。作者在此描述了 COMPASS （肺血流增强方法指南：分流与支架） 试验 （NCT05268094， IDE G210212） 的基本原理和设计。COMPASS 试验旨在将北美约 27 个儿科中心的 236 名患有 DD-PBF 的新生儿随机分配到 DAS 或 SPS。本试验的目的是在通过随机平衡的新生儿队列中比较 DAS 和 SPS 在出生后第一年的重要临床结果，以评估一种姑息治疗方法是否显示出治疗优势。