TY - JOUR
T1 - COMPARE LAAO
T2 - Rationale and design of the randomized controlled trial “COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy”
AU - Huijboom, Marina
AU - Maarse, Moniek
AU - Aarnink, Errol
AU - van Dijk, Vincent
AU - Swaans, Martin
AU - van der Heijden, Jeroen
AU - IJsselmuiden, Sander
AU - Folkeringa, Richard
AU - Blaauw, Yuri
AU - Elvan, Arif
AU - Stevenhagen, Jeroen
AU - Vlachojannis, George
AU - van der Voort, Pepijn
AU - Westra, Sjoerd
AU - Chaldoupi, Marisevi
AU - Khan, Muchtiar
AU - de Groot, Joris
AU - van der Kley, Frank
AU - van Mieghem, Nicolas
AU - van Dijk, Ewoud
AU - Dijkgraaf, Marcel
AU - Tijssen, Jan
AU - Boersma, Lucas
N1 - Publisher Copyright: © 2022 The Authors
PY - 2022/8/1
Y1 - 2022/8/1
N2 - Background: Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking. Study objectives: To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications. Study design: This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands. The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use.
AB - Background: Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking. Study objectives: To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications. Study design: This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands. The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use.
UR - http://www.scopus.com/inward/record.url?scp=85131352980&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ahj.2022.05.001
DO - https://doi.org/10.1016/j.ahj.2022.05.001
M3 - Article
C2 - 35537503
SN - 0002-8703
VL - 250
SP - 45
EP - 56
JO - American Heart Journal
JF - American Heart Journal
ER -