4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation
Language English Country United States Media print-electronic
Document type Equivalence Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't
PubMed
34748929
DOI
10.1016/j.jacc.2021.10.023
PII: S0735-1097(21)07895-5
Knihovny.cz E-resources
- Keywords
- atrial fibrillation, cardioembolism, dire oral anticoagulant, left atrial appendage closure, oral anticoagulation,
- MeSH
- Stroke epidemiology prevention & control MeSH
- Atrial Fibrillation therapy MeSH
- Factor Xa Inhibitors therapeutic use MeSH
- Hemorrhage epidemiology MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Prospective Studies MeSH
- Aged MeSH
- Atrial Appendage surgery MeSH
- Ischemic Attack, Transient epidemiology prevention & control MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Equivalence Trial MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Names of Substances
- Factor Xa Inhibitors MeSH
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).
Cardiocenter Department of Cardiology Na Homolce Hospital Prague Czech Republic
Cardiocenter Department of Cardiology University Hospital Olomouc Olomouc Czech Republic
Cardiocenter Institute of Clinical and Experimental Medicine Prague Czech Republic
Clinic of Cardiology Masaryk University and University Hospital Brno Brno Czech Republic
Department of Cardiology Cardiocenter Hospital Podlesí a s Trinec Czech Republic
Department of Cardiology University Hospital and Faculty of Medicine Pilsen Pilsen Czech Republic
Institute of Biostatistics and Analysis Faculty of Medicine Masaryk University Brno Czech Republic
References provided by Crossref.org
ClinicalTrials.gov
NCT02426944
