The Left Atrial Appendage Closure by Surgery-2 (LAACS-2) trial protocol Rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk

Christoffer Læssøe Madsen, Jesper Park-Hansen, Akhmadjon Irmukhamedov, Christian Lildal Carranza, Sulman Rafiq, Rafael Rodríguez Lecoq, Neiser Palmer Camino, Ivy Susanne Modrau, Emma C Hansson, Anders Jeppsson, Rakin Hadad, Angel Moya-Mitjans, Anders Møller Greve, Robin Christensen, Helle Gervig Carstensen, Nis Baun Høst, Ulrik Dixen, Christian Torp-Pedersen, Lars Køber, Ismail GögenurThomas Clement Truelsen, Christina Kruuse, Ahmad Sajadieh, Helena Domínguez*

*Corresponding author af dette arbejde

Abstract

BACKGROUND: Current recommendations regarding the use of surgical left atrial appendage (LAA) closure to prevent thromboembolisms lack high-level evidence. Patients undergoing open-heart surgery often have several cardiovascular risk factors and a high occurrence of postoperative atrial fibrillation (AF)-with a high recurrence rate-and are thus at a high risk of stroke. Therefore, we hypothesized that concomitant LAA closure during open-heart surgery will reduce mid-term risk of stroke independently of preoperative AF status and CHA2DS2-VASc score.

METHODS: This protocol describes a randomized multicenter trial. Consecutive participants ≥18 years scheduled for first-time planned open-heart surgery from cardiac surgery centers in Denmark, Spain, and Sweden are included. Both patients with a previous diagnosis of paroxysmal or chronic AF, as well as those without AF, are eligible to participate, irrespective of their CHA2DS2-VASc score. Patients already planned for ablation or LAA closure during surgery, with current endocarditis, or where follow-up is not possible are considered noneligible. Patients are stratified by site, surgery type, and preoperative or planned oral anticoagulation treatment. Subsequently, patients are randomized 1:1 to either concomitant LAA closure or standard care (ie, open LAA). The primary outcome is stroke, including transient ischemic attack, as assigned by 2 independent neurologists blinded to the treatment allocation. To recognize a 60% relative risk reduction of the primary outcome with LAA closure, 1,500 patients are randomized and followed for 2 years (significance level of 0.05 and power of 90%).

CONCLUSIONS: The LAACS-2 trial is likely to impact the LAA closure approach in most patients undergoing open-heart surgery.

TRIAL REGISTRATION: NCT03724318.

OriginalsprogEngelsk
TidsskriftAmerican Heart Journal
Vol/bind264
Sider (fra-til)133-142
Antal sider10
ISSN0002-8703
DOI
StatusUdgivet - 2023

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