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 - Lecoq, Rafael Rodríguez
AU - Camino, Neiser Palmer
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
N1 - Copyright © 2023 Elsevier Inc. All rights reserved.
PY - 2023/10
Y1 - 2023/10
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 CHA
2DS
2-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 CHA
2DS
2-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 CHA
2DS
2-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 CHA
2DS
2-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.
KW - Atrial Appendage/surgery
KW - Atrial Fibrillation/complications
KW - Cardiac Surgical Procedures/methods
KW - Humans
KW - Multicenter Studies as Topic
KW - Randomized Controlled Trials as Topic
KW - Stroke/epidemiology
KW - Treatment Outcome
U2 - 10.1016/j.ahj.2023.06.003
DO - 10.1016/j.ahj.2023.06.003
M3 - Article
C2 - 37302738
SN - 0002-8703
VL - 264
SP - 133
EP - 142
JO - American heart journal
JF - American heart journal
ER -