Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation
| Autor: | Tomas Kovarnik, Jiri Holy, Ludek Haman, Klára Benešová, Jan Opatrny, Petr Neuzil, Petr Peichl, Prague Trial Investigators, Milos Taborsky, Martina Novackova, Pavel Červinka, Jiri Jarkovsky, Veronika Lekesova, Petr Kala, Dalibor Herman, Stepan Havranek, Pavel Osmancik, Vlastimil Vančura, Marian Branny, Pavel Hala, Martin Poloczek, Petr Widimsky, Petr Tousek, Josef Stasek, David Zemánek, Vivek Y. Reddy, Jan Chovančík |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Percutaneous Hemorrhage 030204 cardiovascular system & hematology Prosthesis Implantation 03 medical and health sciences 0302 clinical medicine Left atrial Internal medicine Atrial Fibrillation medicine Humans Atrial Appendage 030212 general & internal medicine Cardiac Surgical Procedures Stroke Aged Intention-to-treat analysis business.industry Atrial fibrillation medicine.disease Confidence interval 3. Good health Outcome and Process Assessment Health Care Cohort Cardiology Apixaban Female Cardiology and Cardiovascular Medicine business medicine.drug Factor Xa Inhibitors |
| Zdroj: | Journal of the American College of Cardiology. 75(25) |
| ISSN: | 1558-3597 |
| Popis: | 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 ) |
| Databáze: | OpenAIRE |
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