Nonprocedural bleeding after left atrial appendage closure versus direct oral anticoagulants: A subanalysis of the randomized PRAGUE-17 trial

Marian Branny, Pavel Osmancik, Petr Kala, Martin Poloczek, Dalibor Herman, Petr Neuzil, Pavel Hala, Milos Taborsky, Josef Stasek, Ludek Haman, Jan Chovancik, Pavel Cervinka, Jiri Holy, Tomas Kovarnik, David Zemanek, Stepan Havranek, Vlastimil Vancura, Petr Peichl, Petr Tousek, Marek HozmanVeronika Lekesova, Jiri Jarkovsky, Martina Novackova, Klara Benesova, Petr Widimsky, Vivek Y. Reddy

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)1885-1895
Number of pages11
JournalJournal of Cardiovascular Electrophysiology
Volume34
Issue number9
DOIs
StatePublished - Sep 2023

Keywords

  • atrial fibrillation
  • bleeding
  • gastrointestinal bleeding
  • left atrial appendage closure
  • major bleeding
  • nonvitamin K anticoagulants

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