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4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation

P. Osmancik, D. Herman, P. Neuzil, P. Hala, M. Taborsky, P. Kala, M. Poloczek, J. Stasek, L. Haman, M. Branny, J. Chovancik, P. Cervinka, J. Holy, T. Kovarnik, D. Zemanek, S. Havranek, V. Vancura, P. Peichl, P. Tousek, V. Lekesova, J. Jarkovsky,...

. 2022 ; 79 (1) : 1-14. [pub] 20211105

Jazyk angličtina Země Spojené státy americké

Typ dokumentu hodnocení ekvivalence, časopisecké články, multicentrická studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc22011399

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).

Citace poskytuje Crossref.org

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$a 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).
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$a Herman, Dalibor $u Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic
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$a Neuzil, Petr $u Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic
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$a Hala, Pavel $u Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic
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$a Taborsky, Milos $u Cardiocenter, Department of Cardiology, University Hospital Olomouc, Olomouc, Czech Republic
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$a Kala, Petr $u Clinic of Cardiology, Masaryk University and University Hospital Brno, Brno, Czech Republic
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$a Poloczek, Martin $u Clinic of Cardiology, Masaryk University and University Hospital Brno, Brno, Czech Republic
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$a Stasek, Josef $u First Department of Internal Medicine, Faculty of Medicine, University Hospital Hradec Kralove, Charles University Prague, Prague, Czech Republic
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$a Haman, Ludek $u First Department of Internal Medicine, Faculty of Medicine, University Hospital Hradec Kralove, Charles University Prague, Prague, Czech Republic
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$a Branny, Marian $u Department of Cardiology, Cardiocenter, Hospital Podlesí a.s., Trinec, Czech Republic
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$a Chovancik, Jan $u Department of Cardiology, Cardiocenter, Hospital Podlesí a.s., Trinec, Czech Republic
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$a Cervinka, Pavel $u Department of Cardiology, Krajská zdravotni a.s., Masaryk Hospital and Jan Evangelista Purkyně University, Usti nad Labem, Czech Republic
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$a Holy, Jiri $u Department of Cardiology, Krajská zdravotni a.s., Masaryk Hospital and Jan Evangelista Purkyně University, Usti nad Labem, Czech Republic
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$a Havranek, Stepan $u Cardiocenter, Second Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Czech Republic
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$a Vancura, Vlastimil $u Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic
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$a Peichl, Petr $u Cardiocenter, Institute of Clinical and Experimental Medicine, Prague, Czech Republic
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$a Tousek, Petr $u Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic
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$a Lekesova, Veronika $u Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic
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$a Jarkovsky, Jiri $u Institute of Biostatistics and Analysis, Faculty of Medicine, Masaryk University, Brno, Czech Republic
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$a Novackova, Martina $u Institute of Biostatistics and Analysis, Faculty of Medicine, Masaryk University, Brno, Czech Republic
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$a Widimsky, Petr $u Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic
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