TY - JOUR

T1 - 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

AU - Madsen, Christoffer Læssøe

AU - Park-Hansen, Jesper

AU - Irmukhamedov, Akhmadjon

AU - Carranza, Christian Lildal

AU - Rafiq, Sulman

AU - Rodriguez-Lecoq, Rafael

AU - Palmer-Camino, Neiser

AU - Modrau, Ivy Susanne

AU - Hansson, Emma C.

AU - Jeppsson, Anders

AU - Hadad, Rakin

AU - Moya-Mitjans, Angel

AU - Greve, Anders Møller

AU - Christensen, Robin

AU - Carstensen, Helle Gervig

AU - Høst, Nis Baun

AU - Dixen, Ulrik

AU - Torp-Pedersen, Christian

AU - Køber, Lars

AU - Gögenur, Ismail

AU - Truelsen, Thomas Clement

AU - Kruuse, Christina

AU - Sajadieh, Ahmad

AU - Domínguez, Helena

AU - LAACS-2 trial Investigators

N1 - Publisher Copyright: © 2023 Elsevier Inc.

PY - 2023

Y1 - 2023

N2 - 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.

AB - 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.

U2 - 10.1016/j.ahj.2023.06.003

DO - 10.1016/j.ahj.2023.06.003

M3 - Journal article

C2 - 37302738

AN - SCOPUS:85164342012

VL - 264

SP - 133

EP - 142

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

ER -