Trial DesignInterventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study)
Section snippets
Introduction and the rationale for the study
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. Its prevalence is 1% to 2% in the general population; in addition, the incidence increases with age.1 Among those 75 years and older, the incidence of AF is 12%.2 Atrial fibrillation is associated with a 5-fold risk of a cardioembolic events; approximately 20% of all strokes are due to AF.3 The annual average risk of stroke is 5% to 6% in AF patients without antithrombotic treatment. Moreover, strokes due to AF are
Trial design
This is an investigator-initiated, multicenter, prospective, randomized noninferiority trial comparing 2 treatment strategies in moderate- to high-risk AF patients. The study flowchart is show in Figure.
Left atrial appendage occlusion arm (group A, LAAO group)
For those randomized to group A, an interventional LAA occlusion will be performed. The type of LAA occlusion system will be left to the discretion of the implant center; however, only Amulet device (St Jude Medical) and the Watchman device (Boston Scientific, Natick, MA) are available for use in this study. The goal will be to achieve approximately half of patients implanted with the Watchman system (Boston Scientific) and the other half implanted with the Amulet system (St Jude Medical). The
Conclusion
The PRAGUE-17 trial is a multicenter, prospective, randomized trial designed to evaluate the efficacy and safety of LAA occlusion in moderate- to high-risk AF patients, who are indicated for long-term anticoagulation, and compare this treatment strategy with treatment using NOAC. The incidence of AF has been increasing with the increasing average age of the population. CHA2DS2-VASc scores also rise with increasing patient age, which means that the risks of cardioembolic and bleeding events also
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Cited by (50)
Embolization of percutaneous left atrial appendage closure devices: timing, management and clinical outcomes
2024, Cardiovascular Revascularization MedicineDirect oral anticoagulants versus percutaneous left atrial appendage occlusion in atrial fibrillation: 5-year outcomes
2023, International Journal of Cardiology4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation
2022, Journal of the American College of CardiologyCitation Excerpt :The protocol and results of the PRAGUE-17 trial have been described previously (3,4).
Non-vitamin K antagonist oral anticoagulation versus left atrial appendage occlusion for primary and secondary stroke prevention after cardioembolic stroke
2021, Revista Portuguesa de CardiologiaCitation Excerpt :Importantly, bleeding events often occur on both warfarin and NOAC. In randomized trials comparing NOAC and warfarin, bleeding varied between 1.9 and 3.6% per year for patients on NOAC and 3.1 and 4.2% per year for those on warfarin.2,13 Furthermore, if clinically relevant bleeds are considered, the annual bleeding risk on NOAC could reach 15%.14,15,16
Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation
2020, Journal of the American College of CardiologyCitation Excerpt :The PRAGUE-17 (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation; NCT02426944) trial was an investigator-initiated, multicenter, prospective, open-label, randomized, noninferiority trial conducted at 10 cardiac centers in the Czech Republic (8).
Should left atrial appendage closure be considered in resistant left atrial appendage thrombus cases? ‘Former Foe, New Ally’
2024, PACE - Pacing and Clinical Electrophysiology
RCT No: NCT02426944.
Financial support: Research grant from the Ministry of Health Czech Republic (AZV 15-29565A).
Conflicts of interests: None.