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Updated: Oct 14, 2025
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation
Pavel Osmancik1, Dalibor Herman1, Petr Neuzil2
1Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.
Insights
Left atrial appendage closure (LAAC) is noninferior to direct oral anticoagulants (DOACs) for preventing major events in atrial fibrillation patients. Long-term results show LAAC significantly reduces nonprocedural bleeding.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Atrial fibrillation (AF) poses a high risk for stroke and bleeding.
- Left atrial appendage closure (LAAC) and direct oral anticoagulants (DOACs) are key treatments for stroke prevention in AF.
- The PRAGUE-17 trial initially compared LAAC with DOACs in high-risk AF patients.
Purpose of the Study:
- To evaluate the long-term (4-year) outcomes of the PRAGUE-17 trial.
- To compare the efficacy and safety of LAAC versus DOACs in patients with nonvalvular AF at high risk for stroke or bleeding.
Main Methods:
- A randomized noninferiority trial (PRAGUE-17) comparing percutaneous LAAC (Watchman or Amulet) with DOACs (primarily apixaban).
- Inclusion criteria: nonvalvular AF with prior cardioembolism or bleeding, CHA 2 DS 2 -VASc ≥3 , and HASBLED ≥2 .
- Primary endpoint: composite of cardioembolic events, cardiovascular death, relevant bleeding, or procedure/device complications; analyzed by modified intention-to-treat.
Main Results:
- After a median 3.5-year follow-up, LAAC was noninferior to DOACs for the primary composite endpoint (sHR: 0.81; P=0.27).
- Nonprocedural clinically relevant bleeding was significantly reduced in the LAAC group (sHR: 0.55; P=0.039).
- Secondary analyses (per-protocol, on-treatment) confirmed the primary findings.
Conclusions:
- Long-term follow-up of the PRAGUE-17 trial confirms LAAC is noninferior to DOACs in preventing major neurological, cardiovascular, or bleeding events.
- LAAC offers a significant reduction in nonprocedural bleeding compared to DOACs in high-risk AF patients.
Background:
The PRAGUE-17 (Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) was noninferior to nonwarfarin direct oral anticoagulants (DOACs) for preventing major neurological, cardiovascular, or bleeding events in patients with atrial fibrillation (AF) who were at high risk.
Objectives:
This study sought to assess the prespecified long-term (4-year) outcomes in PRAGUE-17.
Methods:
PRAGUE-17 was a randomized noninferiority trial comparing percutaneous LAAC (Watchman or Amulet) with DOACs (95% apixaban) in patients with nonvalvular AF and 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.
Results:
This study randomized 402 patients with AF (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 patient-years), LAAC was noninferior to DOACs for the primary endpoint by modified intention-to-treat (subdistribution HR [sHR]: 0.81; 95% CI: 0.56-1.18; P = 0.27; P for noninferiority = 0.006). For the components of the composite endpoint, the corresponding sHRs were 0.68 (95% CI: 0.39-1.20; P = 0.19) for cardiovascular death, 1.14 (95% CI: 0.56-2.30; P = 0.72) for all-stroke/transient ischemic attack, 0.75 (95% CI: 0.44-1.27; P = 0.28) for clinically relevant bleeding, and 0.55 (95% CI: 0.31-0.97; P = 0.039) for nonprocedural 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.
Conclusions:
In long-term follow-up of PRAGUE-17, LAAC remains noninferior to DOACs for preventing major cardiovascular, neurological, or bleeding events. Furthermore, nonprocedural bleeding was significantly reduced with LAAC. (PRAGUE-17 [Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation]; NCT02426944).
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