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

Madsen, Claus; Park-Hansen, Jesper; Irmukhamedov, Akhmadjon; Carranza, Christian L; Rafiq, Sulman; Lecoq, R; Camino, Neiser Palmer; Modrau, Ivy Susanne; Hansson, Emma C.; Jeppsson, Anders; Hadad, Rakin; Moya-Mitjans, Àngel; Greve, Anders M.; Christensen, Robin; Carstensen, Helena; Høst, Nis; Dixen, Ulrik; Torp‐Pedersen, Christian; Køber, Lars; Gögenür, Ismail; Truelsen, Thomas; Kruuse, Christina; Sajadieh, Ahmad; Dominguez, Helena

doi:10.1016/j.ahj.2023.06.003

Cited by 6 publications

(3 citation statements)

References 43 publications

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“…The trial will enroll 1500 patients to account for deviations in treatment allocation and death. Please see the trial protocol for more details [ 20 ].…”

Section: Study Methodsmentioning

confidence: 99%

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The left atrial appendage closure by surgery 2 trial: statistical analysis plan for a randomized multicenter trial exploring if the closure of the left atrial appendage during open-heart surgery reduces stroke irrespective of patients’ stroke risk and preoperative atrial fibrillation status

Madsen,

Park-Hansen,

Hadad

et al. 2024

Trials

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Background Surgical left atrial appendage (LAA) closure concomitant to open-heart surgery prevents thromboembolism in high-risk patients. Nevertheless, high-level evidence does not exist for LAA closure performed in patients with any CHA2DS2-VASc score and preoperative atrial fibrillation or flutter (AF) status—the current trial attempts to provide such evidence. Methods The study is designed as a randomized, open-label, blinded outcome assessor, multicenter trial of adult patients undergoing first-time elective open-heart surgery. Patients with and without AF and any CHA2DS2-VASc score will be enrolled. The primary exclusion criteria are planned LAA closure, planned AF ablation, or ongoing endocarditis. Before randomization, a three-step stratification process will sort patients by site, surgery type, and preoperative or expected oral anticoagulation treatment. Patients will undergo balanced randomization (1:1) to LAA closure on top of the planned cardiac surgery or standard care. Block sizes vary from 8 to 16. Neurologists blinded to randomization will adjudicate the primary outcome of stroke, including transient ischemic attack (TIA). The secondary outcomes include a composite outcome of stroke, including TIA, and silent cerebral infarcts, an outcome of ischemic stroke, including TIA, and a composite outcome of stroke and all-cause mortality. LAA closure is expected to provide a 60% relative risk reduction. In total, 1500 patients will be randomized and followed for 2 years. Discussion The trial is expected to help form future guidelines within surgical LAA closure. This statistical analysis plan ensures transparency of analyses and limits potential reporting biases. Trial registration Clinicaltrials.gov, NCT03724318. Registered 26 October 2018, https://clinicaltrials.gov/study/NCT03724318. Protocol version https://doi.org/10.1016/j.ahj.2023.06.003.

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“…The trial will enroll 1500 patients to account for deviations in treatment allocation and death. Please see the trial protocol for more details [ 20 ].…”

Section: Study Methodsmentioning

confidence: 99%

“…Please see the protocol for ethics approval, consent, availability of data, funding information, and acknowledgments [ 20 ].…”

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confidence: 99%

The left atrial appendage closure by surgery 2 trial: statistical analysis plan for a randomized multicenter trial exploring if the closure of the left atrial appendage during open-heart surgery reduces stroke irrespective of patients’ stroke risk and preoperative atrial fibrillation status

Madsen,

Park-Hansen,

Hadad

et al. 2024

Trials

Self Cite

View full text Add to dashboard Cite

show abstract

“…It has been also speculated that LAAC may serve as bailout for patients developing postoperative AF (POAF) after cardiac surgery to reduce embolic risk and POAF-related stroke burden. 17 , 18 …”

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confidence: 99%