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. 2018 Jul 26;48(8):692–704. doi: 10.4070/kcj.2018.0231

Table 1. Major studies for different types of LAAO devices: Watchman.

PROTECT AF10) PREVAIL11) CAP registry13) CAP 2 registry12),14) EWOLUTION15) UK registry16)
Study types Randomized trial Randomized trial Prospective registry Prospective registry Prospective registry Retrospective
Population 463/244 269/138 460 579 1,021 371 (watchman=234, ACP=129, Lariat=6, Coherex Wavecrest =2)
Implantation success rate (%) 91 95.1 95 94.8 98.5 92.5
CHA2DS2-Vasc ≥1* Mean 3.8* Mean 2.4 2.7 4.5 4.2
HAS-BLED score ≥1 in 97% 2.3 3.3
Anticoagulation used Warfarin for 45 days post implantation followed by aspirin and Plavix × 6 months then aspirin alone Warfarin for 45 days post implantation followed by aspirin and Plavix × 6 months then aspirin alone Warfarin for 45 days post implantation followed by aspirin and Plavix × 6 months then aspirin alone Warfarin for 45 days post implantation followed by aspirin and Plavix × 6 months then aspirin alone 27% treated with OAC, 59% on dual antiplatelets, 7% single APT, 6% without any therapy OAC-20%, DAPT 50%, OAC plus single APT-20%, single APT-10%
Ischemic stroke (%) 2.2/1.6 1.9/0.7 - - - 0.1
Hemorrhagic stroke (%) 0.1/1.6 0.4/0 - - - 0.5
Major bleeding (%) 3.5/4.1 0.4/NA 0.7 - 0.7 0.5
Pericardial effusion/tamponade (%) 4.8/0 0.4/0 2.2 2.4 0.5 0.8
Device embolization (%) 0.6/0 0.7/0 0 0 0.2 1.3
Procedure-related stroke (%) 1/0 0.4/0 0 - - -

ACP = Amplatzer Cardiac Plug; APT = antiplatelet therapy; DAPT = dual antiplatelet therapy; LAAO = left atrial appendage occlusion; NA = not available; OAC = oral anticoagulation.

*CHADS2; Randomized studies, n/n=LAAO/warfarin arms.