TY - JOUR
T1 - Comparison of anticoagulation with left atrial appendage closure after atrial fibrillation ablation
T2 - Rationale and design of the OPTION randomized trial
AU - Wazni, Oussama M.
AU - Boersma, Lucas
AU - Healey, Jeff S.
AU - Mansour, Moussa
AU - Tondo, Claudio
AU - Phillips, Karen
AU - Doshi, Rahul
AU - Jaber, Wael
AU - Hynes, Erin
AU - Allocco, Dominic J.
AU - Reddy, Vivek Y.
N1 - Funding Information: OPTION is funded by Boston Scientific. The study was designed by the Steering Committee (OW, WJ, MM, CT, JH, KP, LB, RD, VR), in collaboration with the sponsor and with approval by the US Federal Drug Administration. No extramural funding will be used to support this work. The authors are responsible for the design and conduct of this study, the drafting and editing of this manuscript, and its final contents. Publisher Copyright: © 2022
PY - 2022/9/1
Y1 - 2022/9/1
N2 - Background: For patients with symptomatic atrial fibrillation (AF), physicians typically offer AF ablation for symptom relief; however, patients often anticipate/expect a life free from anticoagulation. This belief puts patients at increased risk of stroke due to the potential for asymptomatic AF postablation if anticoagulation is ceased contrary to clinical guidelines. Although the WATCHMAN device has been FDA-approved to decrease the risk of thromboembolism from the left atrial appendage (LAA) in patients with an appropriate rationale to avoid oral anticoagulation, it has not been well-studied following AF ablation. Additionally, there are limited data comparing the WATCHMAN device to direct oral anticoagulants. The OPTION study will investigate whether LAA closure with the WATCHMAN FLX device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for nonvalvular AF. Trial design: OPTION is a multinational, multicenter, prospective randomized clinical trial. Patients with a CHA2DS2-VASc of ≥2 in men or ≥3 in women and who underwent a AF catheter ablation procedure between 90 and 180 days prior to randomization (sequential) or are planning to have catheter ablation within 10 days of randomization (concomitant) will be randomized in a 1:1 allocation of WATCHMAN FLX vs control. Control patients will start or continue market-approved oral anticoagulation for the duration of the trial. A total of 1600 patients were randomized from 130 global investigational sites. Follow-up for both device and control patients will occur at 3, 12, 24, and 36 months. The primary effectiveness noninferiority endpoint is stroke (ischemic or hemorrhagic), all-cause death, or systemic embolism at 36 months. The primary safety superiority endpoint is nonprocedural bleeding through 36 months (International Society on Thrombosis and Haemostasis [ISTH] major bleeding or clinically relevant nonmajor bleeding). The secondary noninferiority endpoint is ISTH major bleeding through 36 months (including procedural bleeding). Conclusions: This trial will assess the safety and efficacy of WATCHMAN FLX in a postablation contemporary clinical AF patient population at risk of stroke.
AB - Background: For patients with symptomatic atrial fibrillation (AF), physicians typically offer AF ablation for symptom relief; however, patients often anticipate/expect a life free from anticoagulation. This belief puts patients at increased risk of stroke due to the potential for asymptomatic AF postablation if anticoagulation is ceased contrary to clinical guidelines. Although the WATCHMAN device has been FDA-approved to decrease the risk of thromboembolism from the left atrial appendage (LAA) in patients with an appropriate rationale to avoid oral anticoagulation, it has not been well-studied following AF ablation. Additionally, there are limited data comparing the WATCHMAN device to direct oral anticoagulants. The OPTION study will investigate whether LAA closure with the WATCHMAN FLX device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for nonvalvular AF. Trial design: OPTION is a multinational, multicenter, prospective randomized clinical trial. Patients with a CHA2DS2-VASc of ≥2 in men or ≥3 in women and who underwent a AF catheter ablation procedure between 90 and 180 days prior to randomization (sequential) or are planning to have catheter ablation within 10 days of randomization (concomitant) will be randomized in a 1:1 allocation of WATCHMAN FLX vs control. Control patients will start or continue market-approved oral anticoagulation for the duration of the trial. A total of 1600 patients were randomized from 130 global investigational sites. Follow-up for both device and control patients will occur at 3, 12, 24, and 36 months. The primary effectiveness noninferiority endpoint is stroke (ischemic or hemorrhagic), all-cause death, or systemic embolism at 36 months. The primary safety superiority endpoint is nonprocedural bleeding through 36 months (International Society on Thrombosis and Haemostasis [ISTH] major bleeding or clinically relevant nonmajor bleeding). The secondary noninferiority endpoint is ISTH major bleeding through 36 months (including procedural bleeding). Conclusions: This trial will assess the safety and efficacy of WATCHMAN FLX in a postablation contemporary clinical AF patient population at risk of stroke.
UR - http://www.scopus.com/inward/record.url?scp=85132720885&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ahj.2022.05.003
DO - https://doi.org/10.1016/j.ahj.2022.05.003
M3 - Article
C2 - 35526570
SN - 0002-8703
VL - 251
SP - 35
EP - 42
JO - American Heart Journal
JF - American Heart Journal
ER -