Journal article
Nonprocedural bleeding after left atrial appendage closure versus direct oral anticoagulants: A subanalysis of the randomized PRAGUE-17 trial
Journal of cardiovascular electrophysiology, Vol.34(9), pp.1885-1895
09/01/2023
DOI: 10.1111/jce.16029
PMID: 37529864
Abstract
IntroductionObservational studies have shown low bleeding rates in patients with atrial fibrillation (AF) treated by left atrial appendage closure (LAAC); however, data from randomized studies are lacking. This study compared bleeding events among patients with AF treated by LAAC and nonvitamin K anticoagulants (NOAC). MethodsThe Prague-17 trial was a prospective, multicenter, randomized trial that compared LAAC to NOAC in high-risk AF patients. The primary endpoint was a composite of a cardioembolic event, cardiovascular death, and major and clinically relevant nonmajor bleeding (CRNMB) defined according to the International Society on Thrombosis and Hemostasis (ISTH). ResultsThe trial enrolled 402 patients (201 per arm), and the median follow-up was 3.5 (IQR 2.6-4.2) years. Bleeding occurred in 24 patients (29 events) and 32 patients (40 events) in the LAAC and NOAC groups, respectively. Six of the LAAC bleeding events were procedure/device-related. In the primary intention-to-treat analysis, LAAC was associated with similar rates of ISTH major or CRNMB (sHR 0.75, 95% CI 0.44-1.27, p = 0.28), but with a reduction in nonprocedural major or CRNMB (sHR 0.55, 95% CI 0.31-0.97, p = 0.039). This reduction for nonprocedural bleeding with LAAC was mainly driven by a reduced rate of CRNMB (sHR for major bleeding 0.69, 95% CI 0.34-1.39, p = .30; sHR for CRNMB 0.43, 95% CI 0.18-1.03, p = 0.059). History of bleeding was a predictor of bleeding during follow-up. Gastrointestinal bleeding was the most common bleeding site in both groups. ConclusionDuring the 4-year follow-up, LAAC was associated with less nonprocedural bleeding. The reduction is mainly driven by a decrease in CRNMB.
Details
- Title: Subtitle
- Nonprocedural bleeding after left atrial appendage closure versus direct oral anticoagulants: A subanalysis of the randomized PRAGUE-17 trial
- Creators
- Marian Branny - University Hospital OstravaPavel Osmancik - University Hospital Kralovske VinohradyPetr Kala - Masaryk UniversityMartin Poloczek - Masaryk UniversityDalibor Herman - University Hospital Kralovske VinohradyPetr Neuzil - Na Homolce HospitalPavel Hala - Na Homolce HospitalMilos Taborsky - University Hospital OlomoucJosef Stasek - Charles UniversityLudek Haman - Charles UniversityJan Chovancik - Nemocnice PodlesíPavel Cervinka - Krajská ZdravotníJiri Holy - Krajská ZdravotníTomas Kovarnik - Charles UniversityDavid Zemanek - Charles UniversityStepan Havranek - Charles UniversityVlastimil Vancura - Univ Hosp, Dept Cardiol, Plzen, Czech RepublicPetr Peichl - Institute of Clinical and Experimental MedicinePetr Tousek - Charles UniversityMarek Hozman - University Hospital Kralovske VinohradyVeronika Lekesova - Na Homolce HospitalJiri Jarkovsky - Masaryk UniversityMartina Novackova - Masaryk UniversityKlara Benesova - Masaryk UniversityPetr Y. Widimsky - Charles UniversityVivek Reddy - Na Homolce HospitalPRAGUE 17 Trial Investigators
- Resource Type
- Journal article
- Publication Details
- Journal of cardiovascular electrophysiology, Vol.34(9), pp.1885-1895
- Publisher
- Wiley
- DOI
- 10.1111/jce.16029
- PMID
- 37529864
- ISSN
- 1045-3873
- eISSN
- 1540-8167
- Number of pages
- 11
- Grant note
- AZV 15-29565A; NU21-02-00388 / Ministry of Health, Czech Republic; Czech Republic Government
- Language
- English
- Date published
- 09/01/2023
- Academic Unit
- Electrical and Computer Engineering
- Record Identifier
- 9984627208002771
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