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
Copyright © 2023 Elsevier Inc. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:264 |
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| Enthalten in: |
American heart journal - 264(2023) vom: 01. Okt., Seite 133-142 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Madsen, Christoffer Læssøe [VerfasserIn] |
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| Links: |
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| Themen: |
Clinical Trial Protocol |
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| Anmerkungen: |
Date Completed 18.09.2023 Date Revised 10.10.2023 published: Print-Electronic ClinicalTrials.gov: NCT03724318 Citation Status MEDLINE |
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| doi: |
10.1016/j.ahj.2023.06.003 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM358044650 |
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| 100 | 1 | |a Madsen, Christoffer Læssøe |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a 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 |
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| 500 | |a Date Revised 10.10.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03724318 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 Elsevier Inc. All rights reserved. | ||
| 520 | |a 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 | ||
| 520 | |a 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%) | ||
| 520 | |a CONCLUSIONS: The LAACS-2 trial is likely to impact the LAA closure approach in most patients undergoing open-heart surgery | ||
| 520 | |a TRIAL REGISTRATION: NCT03724318 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 700 | 1 | |a Park-Hansen, Jesper |e verfasserin |4 aut | |
| 700 | 1 | |a Irmukhamedov, Akhmadjon |e verfasserin |4 aut | |
| 700 | 1 | |a Carranza, Christian Lildal |e verfasserin |4 aut | |
| 700 | 1 | |a Rafiq, Sulman |e verfasserin |4 aut | |
| 700 | 1 | |a Rodriguez-Lecoq, Rafael |e verfasserin |4 aut | |
| 700 | 1 | |a Palmer-Camino, Neiser |e verfasserin |4 aut | |
| 700 | 1 | |a Modrau, Ivy Susanne |e verfasserin |4 aut | |
| 700 | 1 | |a Hansson, Emma C |e verfasserin |4 aut | |
| 700 | 1 | |a Jeppsson, Anders |e verfasserin |4 aut | |
| 700 | 1 | |a Hadad, Rakin |e verfasserin |4 aut | |
| 700 | 1 | |a Moya-Mitjans, Angel |e verfasserin |4 aut | |
| 700 | 1 | |a Greve, Anders Møller |e verfasserin |4 aut | |
| 700 | 1 | |a Christensen, Robin |e verfasserin |4 aut | |
| 700 | 1 | |a Carstensen, Helle Gervig |e verfasserin |4 aut | |
| 700 | 1 | |a Høst, Nis Baun |e verfasserin |4 aut | |
| 700 | 1 | |a Dixen, Ulrik |e verfasserin |4 aut | |
| 700 | 1 | |a Torp-Pedersen, Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Køber, Lars |e verfasserin |4 aut | |
| 700 | 1 | |a Gögenur, Ismail |e verfasserin |4 aut | |
| 700 | 1 | |a Truelsen, Thomas Clement |e verfasserin |4 aut | |
| 700 | 1 | |a Kruuse, Christina |e verfasserin |4 aut | |
| 700 | 1 | |a Sajadieh, Ahmad |e verfasserin |4 aut | |
| 700 | 1 | |a Domínguez, Helena |e verfasserin |4 aut | |
| 700 | 0 | |a LAACS-2 trial Investigators |e verfasserin |4 aut | |
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