Details

Autor(en) / Beteiligte

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

Titel

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

Ist Teil von

• The American heart journal, 2023-10, Vol.264, p.133-142

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2023

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• 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. 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%). The LAACS-2 trial is likely to impact the LAA closure approach in most patients undergoing open-heart surgery. Trial registration: NCT03724318. [Display omitted]