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Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation.
J Am Coll Cardiol. 2020 Jun 30; 75(25):3122-3135.JACC

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).

Authors+Show Affiliations

Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic. Electronic address: pavel.osmancik@gmail.com.Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.Cardiocenter, Department of Cardiology, University Hospital Olomouc, Olomouc, Czech Republic.Clinic of Cardiology, Masaryk University and University Hospital Brno, Brno, Czech Republic.Clinic of Cardiology, Masaryk University and University Hospital Brno, Brno, Czech Republic.First Department of Internal Medicine, Faculty of Medicine, University Hospital Hradec Kralove, Charles University Prague, Prague, Czech Republic.First Department of Internal Medicine, Faculty of Medicine, University Hospital Hradec Kralove, Charles University Prague, Prague, Czech Republic.Department of Cardiology, Cardiocenter, Hospital Podlesí a.s., Trinec, Czech Republic.Department of Cardiology, Cardiocenter, Hospital Podlesí a.s., Trinec, Czech Republic.Department of Cardiology, Krajská zdravotni a.s., Masaryk Hospital and J.E.Purkyne University, Usti nad Labem, Czech Republic.Department of Cardiology, Krajská zdravotni a.s., Masaryk Hospital and J.E.Purkyne University, Usti nad Labem, Czech Republic.Cardiocenter, Second Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Czech Republic.Cardiocenter, Second Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Czech Republic.Cardiocenter, Second Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Czech Republic.Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic.Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic.Cardiocenter, Institute of Clinical and Experimental Medicine, Prague, Czech Republic.Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.Masaryk University, Institute of Biostatistics and Analyses, Brno, Czech Republic.Masaryk University, Institute of Biostatistics and Analyses, Brno, Czech Republic.Masaryk University, Institute of Biostatistics and Analyses, Brno, Czech Republic.Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.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.No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32586585

Citation

Osmancik, Pavel, et al. "Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation." Journal of the American College of Cardiology, vol. 75, no. 25, 2020, pp. 3122-3135.
Osmancik P, Herman D, Neuzil P, et al. Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation. J Am Coll Cardiol. 2020;75(25):3122-3135.
Osmancik, P., Herman, D., Neuzil, P., Hala, P., Taborsky, M., Kala, P., Poloczek, M., Stasek, J., Haman, L., Branny, M., Chovancik, J., Cervinka, P., Holy, J., Kovarnik, T., Zemanek, D., Havranek, S., Vancura, V., Opatrny, J., Peichl, P., ... Reddy, V. Y. (2020). Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation. Journal of the American College of Cardiology, 75(25), 3122-3135. https://doi.org/10.1016/j.jacc.2020.04.067
Osmancik P, et al. Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation. J Am Coll Cardiol. 2020 Jun 30;75(25):3122-3135. PubMed PMID: 32586585.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation. AU - Osmancik,Pavel, AU - Herman,Dalibor, AU - Neuzil,Petr, AU - Hala,Pavel, AU - Taborsky,Milos, AU - Kala,Petr, AU - Poloczek,Martin, AU - Stasek,Josef, AU - Haman,Ludek, AU - Branny,Marian, AU - Chovancik,Jan, AU - Cervinka,Pavel, AU - Holy,Jiri, AU - Kovarnik,Tomas, AU - Zemanek,David, AU - Havranek,Stepan, AU - Vancura,Vlastimil, AU - Opatrny,Jan, AU - Peichl,Petr, AU - Tousek,Petr, AU - Lekesova,Veronika, AU - Jarkovsky,Jiri, AU - Novackova,Martina, AU - Benesova,Klara, AU - Widimsky,Petr, AU - Reddy,Vivek Y, AU - ,, PY - 2020/01/30/received PY - 2020/04/20/revised PY - 2020/04/20/accepted PY - 2020/6/27/entrez KW - atrial fibrillation KW - cardioembolic event KW - direct oral anticoagulant KW - left atrial appendage KW - stroke SP - 3122 EP - 3135 JF - Journal of the American College of Cardiology JO - J. Am. Coll. Cardiol. VL - 75 IS - 25 N2 - 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). SN - 1558-3597 UR - https://www.unboundmedicine.com/medline/citation/32586585/Left_Atrial_Appendage_Closure_Versus_Direct_Oral_Anticoagulants_in_High-Risk_Patients_With_Atrial_Fibrillation L2 - https://linkinghub.elsevier.com/retrieve/pii/S0735-1097(20)35175-5 DB - PRIME DP - Unbound Medicine ER -
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