{"id":"7ecee3169960","type":"article","url":"https://hartvaat.nl/2020/06/30/laa-sluiting-versus-doac-bij-hoogrisico-af-vergelijkende-analyse/","title":"LAA-sluiting versus DOAC bij hoogrisico AF: vergelijkende analyse","title_en":"Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2020.04.067","source_url":"https://doi.org/10.1016/j.jacc.2020.04.067","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","Jan Opatrny","Petr Peichl","Petr Tousek","Veronika Lekesova","Jiri Jarkovsky","Martina Novackova","Klara Benesova","Petr Widimsky","Vivek Y Reddy"],"significance":7,"published":"2020-06-30","source_date":"2020-06-30","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/","https://hartvaat.nl/kennis/atriumfibrilleren/af-bij-ouderen/"],"congress":"","summary_en":"This comparative analysis of left atrial appendage closure versus DOACs in high-risk AF patients evaluated the evolving position of structural stroke prevention in the era of highly effective oral anticoagulation.","created":"2026-07-03T10:28:38Z","updated":"2026-07-03T13:27:48Z","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":"Vergelijkende analyse van linker-hartoorsluiting versus DOAC bij hoogrisico AF-patiënten.","abstract_original":"BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown. OBJECTIVES: This study sought to compare DOACs with LAAC in high-risk patients with AF. METHODS: Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA2DS2-VASc of ≥3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat. RESULTS: A high-risk patient cohort (CHA2DS2-VASc: 4.7 ± 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients. CONCLUSIONS: Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944)."}