21 May 2025
Academic Research Consortium initiative on left atrial appendage closure – standardising definitions and endpoints to move forward
Philippe Garot describes the EuroPCR 2025 session on left atrial appendage closure (LAAC), which offers a preview of the upcoming new consensus document developed by the Academic Research Consortium.
"Over the past 20 years, evidence has accumulated on LAAC as an alternative or complementary approach to reduce the risk of stroke or systemic embolism in patients with non-valvular atrial fibrillation.¹
In 2017, the Munich consensus document on definitions, endpoints and data collection requirements was published in order to achieve a consistent approach for clinical studies on LAAC.² This area has evolved considerably since then, and an Academic Research Consortium initiative was established last year to provide a timely update. Key stakeholders in the LAAC field were involved in these discussions, including not only physicians and trialists, but also large device manufacturers, personnel from smaller start-ups innovating new devices and pharma companies developing new anticoagulants, all of whom were interested in the standardisation of trial designs.
The new consensus document, which will be published very soon, covers a range of contemporary issues related to the conduct of trials on LAAC. Notably, the paper discusses the use and components of combined endpoints, which have varied in recent trials and have made indirect device–device and device–drug comparisons difficult. In addition, the document discusses the most appropriate time to report certain outcomes, which again have differed widely. Safety endpoints and complications, such as peri-device leaks and device-related thrombus, are also considered.
At this session, Jacqueline Saw explained more about the rationale behind the Academic Research Consortium’s LAAC initiative. Megan Coylewright and Horst Sievert presented the top 10 key takeaways from the project and then Davide Capodanno discussed incorporating the newly proposed nomenclature into clinical trials. Even if LAAC is not your field, the session provides interesting insights into how to streamline standardised endpoints for randomised controlled trials and how to develop homogeneous definitions through collaborative work. And if LAAC is one of your specialties, be well informed by the authors ahead of the publication’s release."
Replay available soon on PCRonline.
References
- Holmes DR, et al. EuroIntervention. 2023;18:e1038–1165.
- Tzikas A, et al. Europace. 2017;19:4–15.
