Table 2.

RCTs of LAAO—main findings.

Trial	Designa and cohort size	Main findings
PROTECT-AF76	Watchman (n = 463) vs. Warfarin (n = 244)	▪The primary efficacy endpointb 3.0 (95% CrI 1.9–4.5) vs. 4.9 (2.8–7.1), RR 0.62 (95% CrI 0.35–1.25) ▪Primary safety events 7.4 (95% CrI 5.5–9.7) vs. 4.4 (2.5–6.7), RR 1.69 (95% CrI 1.01–3.19)
PREVAIL77	Watchman (n = 269) vs. Warfarin (n = 138)	▪First co-primary efficacy endpointb 0.064 vs. 0.063, RR 1.07 (95% CrI 0.57–1.89) ▪Second co-primary efficacy endpointc 0.025 vs. 0.020, risk difference 0.005 (95% CrI −0.019 to 0.027) ▪Adverse events lower than in the PROTECT-AF (4.2% vs. 8.7%, p = 0.004)
PRAGUE-1778	LAAO device (n = 201) vs. DOAC (n = 201)	▪The primary composite outcomed 10.99% vs. 13.42%, sHR 0.84 (95% CI 0.53–1.31), noninferiority P = 0.004 ▪Major LAAO-related complications occurred in 9 patients (4.5%)

PROTECT-AF, WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation; PREVAIL, Evaluation of the WATCHMAN Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long term Warfarin Therapy; PRAGUE, Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation; CrI, Credible Interval; RR, Rate Ratio; sHR, Subdistribution Hazard Ratio; CI, Confidence interval. DOAC = direct oral anticoagulants.

^aAll RCTs were noninferiority trials.

^bStroke, systemic embolism, and cardiovascular/unexplained death.

^cStroke or systemic embolism >7 days after randomization.

^dStroke, transient ischaemic attack, systemic embolism, cardiovascular death, major or non-major clinically relevant bleeding, or procedure/device-related complications.