Key result
Left atrial appendage closure was non-inferior to NOACs for preventing major cardiovascular, neurological or bleeding events (sHR 0.81; 95% CI 0.56-1.18; p=0.006 for non-inferiority).
Why the study?
To assess the pre-specified long-term 4-year outcomes of left atrial appendage closure compared with non-warfarin oral anticoagulants in high-risk patients with atrial fibrillation.
Does percutaneous left atrial appendage closure prevent major neurological, cardiovascular or bleeding events compared to non-warfarin oral anticoagulants in high-risk patients with non-valvular atrial fibrillation?
RCT (n=402)
randomized
Does percutaneous left atrial appendage closure prevent major neurological, cardiovascular or bleeding events compared to non-warfarin oral anticoagulants in high-risk patients with non-valvular atrial fibrillation?
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Given the observed trend of significantly increased nonprocedural clinically relevant bleeding in the NOAC arm, it is likely that late bleeding events will increasingly favor LAAC over time.”
“We didn't do any medication look among the patients, but I don't think that the number of patients who stopped the NOAC treatment was too high because the rate of strokes was very similar to that in the NOAC trials.”
At 3.5 years median follow-up, left atrial appendage closure remained non-inferior to NOACs for preventing major cardiovascular, neurological, or bleeding events in high-risk AF patients, with a significant reduction in non-procedural bleeding.
BACKGROUND The PRAGUE-17 trial demonstrated that left atrial appendage closure (LAAC) was non-inferior to non-warfarin oral anticoagulants (NOAC) for preventing major neurological, cardiovascular or bleeding events in high-risk patients with atrial fibrillation (AF). OBJECTIVE To assess the pre-specified long-term (4-year) outcomes in PRAGUE-17. METHODS PRAGUE-17 was a randomized non-inferiority trial comparing percutaneous LAAC (Watchman or Amulet) with NOACs (95% apixaban) in non-valvular AF patients with a history of cardioembolism, clinically-relevant bleeding, or both CHA2DS2-VASc > 3 and HASBLED > 2. The primary endpoint was a composite of cardioembolic events (stroke, transient ischemic attack, or systemic embolism), cardiovascular death, clinically-relevant bleeding, or procedure/device-related complications (LAAC group only). The primary analysis was modified intention-to-treat (mITT). RESULTS We randomized 402 AF patients (201 per group, age 73.3±7.0 years, 65.7% male, CHA2DS2-VASc 4.7+1.5, HASBLED 3.1+0.9). After 3.5 years median follow-up (1,354 patients-years), LAAC was non-inferior to NOAC for the primary endpoint by mITT (subdistribution hazard ratio[sHR] 0.81, 95% CI 0.56-1.18; p=0.27; p for non-inferiority=0.006). For the components of the composite endpoint, the corresponding sHRs (and 95% CIs) were 0.68 (0.39-1.20; p=0.19) for cardiovascular death, 1.14 (0.56-2.30; p=0.72) for all-stroke/TIA, 0.75 (0.44-1.27; p=0.28) for clinically-relevant bleeding, and 0.55 (0.31-0.97; p=0.039) for non-procedural clinically-relevant bleeding. The primary endpoint outcomes were similar in the per-protocol [sHR 0.80 (95% CI 0.54-1.18), p=0.25] and on-treatment [sHR 0.82 (95% CI 0.56-1.20), p=0.30] analyses. CONCLUSION In long-term follow-up of PRAGUE-17, LAAC remains non-inferior to NOACs for preventing major cardiovascular, neurological or bleeding events. Furthermore, non-procedural bleeding was significantly reduced with LAAC.
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Osmančík et al. (2021) conducted an RCT in Atrial fibrillation (n=402). Percutaneous left atrial appendage closure (Watchman or Amulet) vs. NOACs (95% apixaban) was evaluated on Composite of cardioembolic events (stroke, transient ischemic attack, or systemic embolism), cardiovascular death, clinically-relevant bleeding, or procedure/device-related complications (sHR 0.81, 95% CI 0.56-1.18, p=0.27; p for non-inferiority=0.006). Left atrial appendage closure was non-inferior to NOACs for preventing major cardiovascular, neurological or bleeding events (sHR 0.81; 95% CI 0.56-1.18; p=0.006 for non-inferiority).
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