{"id":"ca826f4dc6b8","type":"article","url":"https://hartvaat.nl/2022/01/04/4-jaars-laa-sluiting-versus-niet-warfarine-oac-bij-af/","title":"4-jaars LAA-sluiting versus niet-warfarine OAC bij AF","title_en":"4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2021.10.023","source_url":"https://doi.org/10.1016/j.jacc.2021.10.023","authors":["Pavel Osmancik","Dalibor Herman","Petr Neuzil","Pavel Hala","Milos Taborsky","Petr Kala","Martin Poloczek","Josef Stasek","Ludek Haman","Marian Branny","Jan Chovancik","Pavel Cervinka","Jiri Holy","Tomas Kovarnik","David Zemanek","Stepan Havranek","Vlastimil Vancura","Petr Peichl","Petr Tousek","Veronika Lekesova","Jiri Jarkovsky","Martina Novackova","Klara Benesova","Petr Widimsky","Vivek Y Reddy"],"significance":7,"published":"2022-01-04","source_date":"2022-01-04","image":"","kennis":[],"congress":"","summary_en":"Four-year PRAGUE-17 results confirmed that left atrial appendage closure is noninferior to DOAC therapy for AF-related stroke prevention, providing the longest-term randomized comparison of structural versus pharmacological stroke prevention using contemporary anticoagulants.","created":"2026-07-03T10:29:35Z","updated":"2026-07-03T13:28:42Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"4-jaarsresultaten van linker-hartoorsluiting versus niet-warfarine OAC bij AF.","abstract_original":"BACKGROUND: The PRAGUE-17 (Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) was noninferior to nonwarfarin direct oral anticoagulants (DOACs) for preventing major neurological, cardiovascular, or bleeding events in patients with atrial fibrillation (AF) who were at high risk. OBJECTIVES: This study sought to assess the prespecified long-term (4-year) outcomes in PRAGUE-17. METHODS: PRAGUE-17 was a randomized noninferiority trial comparing percutaneous LAAC (Watchman or Amulet) with DOACs (95% apixaban) in patients with nonvalvular AF and with a history of cardioembolism, clinically-relevant bleeding, or both CHA2DS2-VASc ≥3 and HASBLED ≥2. The primary endpoint was a composite of cardioembolic events (stroke, transient ischemic attack, or systemic embolism), cardiovascular death, clinically relevant bleeding, or procedure-/device-related complications (LAAC group only). The primary analysis was modified intention-to-treat. RESULTS: This study randomized 402 patients with AF (201 per group, age 73.3 ± 7.0 years, 65.7% male, CHA2DS2-VASc 4.7 ±1.5, HASBLED 3.1 ± 0.9). After 3.5 years median follow-up (1,354 patient-years), LAAC was noninferior to DOACs for the primary endpoint by modified intention-to-treat (subdistribution HR [sHR]: 0.81; 95% CI: 0.56-1.18; P = 0.27; P for noninferiority = 0.006). For the components of the composite endpoint, the corresponding sHRs were 0.68 (95% CI: 0.39-1.20; P = 0.19) for cardiovascular death, 1.14 (95% CI: 0.56-2.30; P = 0.72) for all-stroke/transient ischemic attack, 0.75 (95% CI: 0.44-1.27; P = 0.28) for clinically relevant bleeding, and 0.55 (95% CI: 0.31-0.97; P = 0.039) for nonprocedural clinically relevant bleeding. The primary endpoint outcomes were similar in the per-protocol (sHR: 0.80; 95% CI: 0.54-1.18; P = 0.25) and on-treatment (sHR: 0.82; 95% CI: 0.56-1.20; P = 0.30) analyses. CONCLUSIONS: In long-term follow-up of PRAGUE-17, LAAC remains noninferior to DOACs for preventing major cardiovascular, neurological, or bleeding events. Furthermore, nonprocedural bleeding was significantly reduced with LAAC. (PRAGUE-17 [Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation]; NCT02426944)."}