Pavel Osmancik1, Dalibor Herman2, Petr Neuzil3, Pavel Hala3, Milos Taborsky4, Petr Kala5, Martin Poloczek5, Josef Stasek6, Ludek Haman6, Marian Branny7, Jan Chovancik7, Pavel Cervinka8, Jiri Holy8, Tomas Kovarnik9, David Zemanek9, Stepan Havranek9, Vlastimil Vancura10, Jan Opatrny10, Petr Peichl11, Petr Tousek2, Veronika Lekesova3, Jiri Jarkovsky12, Martina Novackova12, Klara Benesova12, Petr Widimsky2, Vivek Y Reddy13. 1. Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic. Electronic address: pavel.osmancik@gmail.com. 2. Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic. 3. Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic. 4. Cardiocenter, Department of Cardiology, University Hospital Olomouc, Olomouc, Czech Republic. 5. Clinic of Cardiology, Masaryk University and University Hospital Brno, Brno, Czech Republic. 6. First Department of Internal Medicine, Faculty of Medicine, University Hospital Hradec Kralove, Charles University Prague, Prague, Czech Republic. 7. Department of Cardiology, Cardiocenter, Hospital Podlesí a.s., Trinec, Czech Republic. 8. Department of Cardiology, Krajská zdravotni a.s., Masaryk Hospital and J.E.Purkyne University, Usti nad Labem, Czech Republic. 9. Cardiocenter, Second Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Czech Republic. 10. Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic. 11. Cardiocenter, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. 12. Masaryk University, Institute of Biostatistics and Analyses, Brno, Czech Republic. 13. Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic; Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: vivek.reddy@mountsinai.org.
Abstract
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).
RCT Entities:
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).
Authors: Robert C Ward; Trevon McGill; Fadi Adel; Shiva Ponamgi; Samuel J Asirvatham; Larry M Baddour; David R Holmes; Daniel C DeSimone; Christopher V DeSimone Journal: Biomed Hub Date: 2021-06-03
Authors: Shinwan Kany; Bruno Reissmann; Andreas Metzner; Paulus Kirchhof; Dawood Darbar; Renate B Schnabel Journal: Cardiovasc Res Date: 2021-06-16 Impact factor: 10.787
Authors: Shadi Yaghi; Nils Henninger; James A Giles; Christopher Leon Guerrero; Eva Mistry; Ava L Liberman; Daniyal Asad; Angela Liu; Muhammad Nagy; Ashutosh Kaushal; Idrees Azher; Brian Mac Grory; Hiba Fakhri; Kiersten Brown Espaillat; Hemanth Pasupuleti; Heather Martin; Jose Tan; Manivannan Veerasamy; Charles Esenwa; Natalie Cheng; Khadean Moncrieffe; Iman Moeini-Naghani; Mithilesh Siddu; Erica Scher; Tushar Trivedi; Karen L Furie; Salah G Keyrouz; Amre Nouh; Adam de Havenon; Muhib Khan; Eric E Smith; M Edip Gurol Journal: J Neurol Neurosurg Psychiatry Date: 2021-04-26 Impact factor: 13.654