Elsevier

American Heart Journal

Volume 183, January 2017, Pages 108-114
American Heart Journal

Trial Design
Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study)

https://doi.org/10.1016/j.ahj.2016.10.003Get rights and content

Background

Atrial fibrillation (AF), with a prevalence of 1% to 2%, is the most common cardiac arrhythmia. Without antithrombotic treatment, the annual risk of a cardioembolic event is 5% to 6%. The source of a cardioembolic event is a thrombus, which is usually formed in the left atrial appendage (LAA). Prevention of cardioembolic events involves treatment with anticoagulant drugs: either vitamin K antagonists or, recently, novel oral anticoagulants (NOAC). The other (nonpharmacologic) option for the prevention of a cardioembolic event involves interventional occlusion of the LAA.

Objective

To determine whether percutaneous LAA occlusion is noninferior to treatment with NOAC in AF patients indicated for long-term systemic anticoagulation.

Study design

The trial will be a prospective, multicenter, randomized noninferiority trial comparing 2 treatment strategies in moderate to high-risk AF patients (ie, patients with history of significant bleeding, or history of cardiovascular event(s), or a with CHA2DS2VASc ≥3 and HAS-BLED score ≥2). Patients will be randomized into a percutaneous LAA occlusion (group A) or a NOAC treatment (group B) in a 1:1 ratio; the randomization was done using Web-based randomization software. A total of 396 study participants (198 patients in each group) will be enrolled in the study. The primary end point will be the occurrence of any of the following events within 24 months after randomization: stroke or transient ischemic attack (any type), systemic cardioembolic event, clinically significant bleeding, cardiovascular death, or a significant periprocedural or device-related complications.

Conclusion

The PRAGUE-17 trial will determine if LAA occlusion is noninferior to treatment with NOAC in moderate- to high-risk AF patients.

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

References (19)

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RCT No: NCT02426944.

Financial support: Research grant from the Ministry of Health Czech Republic (AZV 15-29565A).

Conflicts of interests: None.

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