Nonprocedural bleeding after left atrial appendage closure versus direct oral anticoagulants: A subanalysis of the randomized PRAGUE-17 trial |
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| Authors: | Marian Branny MD PhD Pavel Osmancik MD PhD Petr Kala MD PhD Martin Poloczek MD Dalibor Herman MD PhD Petr Neuzil MD CSc Pavel Hala MD Milos Taborsky MD CSc Josef Stasek MD PhD Ludek Haman MD PhD Jan Chovancik MD Pavel Cervinka MD PhD Jiri Holy MD Tomas Kovarnik MD PhD David Zemanek MD PhD Stepan Havranek MD PhD Vlastimil Vancura MD PhD Petr Peichl MD PhD Petr Tousek MD PhD Marek Hozman MD Veronika Lekesova MD Jiri Jarkovsky RNDr PhD Martina Novackova Mgr. Klara Benesova Mgr Petr Widimsky MD DrSc Vivek Y. Reddy MD the PRAGUE-17 Trial Investigators |
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| Affiliation: | 1. Department of Cardiology, Cardiocenter, Hospital Podlesí a.s., Trinec, Czech Republic;2. Department of Cardiology, Third Faculty of Medicine, University Hospital Kralovske Vinohrady, Charles University, Prague, Czech Republic;3. Department of Internal Medicine and Cardiology, University Hospital Brno and Medical Faculty of Masaryk University, Brno, Czech Republic;4. Department of Cardiology, Cardiocenter, Na Homolce Hospital, Prague, Czech Republic;5. Department of Cardiology, Cardiocenter, University Hospital Olomouc, Olomouc, Czech Republic;6. 1st Department of Internal Medicine, Faculty of Medicine, University Hospital Hradec Kralove, Charles University Prague, Prague, Czech Republic;7. Department of Cardiology, Krajská zdravotni a.s., Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic;8. Cardiocenter, 2nd Internal Clinic—Cardiology and Angiology, General Faculty Hospital, Charles University, Prague, Czech Republic;9. Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic;10. Cardiocenter, Institute of Clinical and Experimental Medicine, Prague, Czech Republic;11. Institute of Biostatistics and Analyses, Masaryk University, Brno, Czech Republic |
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| Abstract: | Introduction Observational 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). Methods The 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). Results The 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. Conclusion During the 4-year follow-up, LAAC was associated with less nonprocedural bleeding. The reduction is mainly driven by a decrease in CRNMB. |
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| Keywords: | atrial fibrillation bleeding gastrointestinal bleeding left atrial appendage closure major bleeding nonvitamin K anticoagulants |
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