Abstract
Background
Methods
Results
Conclusions
Notes
Author contributions
Conceptualization: SHK, SSH; Data curation: SHK, SSH; Formal analysis: SHK, SSH; Funding acquisition: SHK, SSH; Investigation: SHK, SSH; Methodology: SHK, SSH; Project administration: SHK, SSH; Resources: SHK, SSH; Software: SHK, SSH; Supervision: SHK, SSH; Validation: SHK, SSH; Visualization: SHK, SSH; Writing – original draft: SHK, SYP, SSH; Writing – review & editing: SHK, SSH, SYP. All authors read and approved the final manuscript.
REFERENCES
Table 1.
Variable | RE-LYa) (n=12,098) | ROCKET-AF (n=14,264) | ARISTOTLE (n=18,201) | PROTECT AF (n=707) |
---|---|---|---|---|
Key inclusion criteria | Nonvalvular AF, CHADS2 ≥1 | Nonvalvular AF, CHADS2 ≥2 | Nonvalvular AF, CHADS2 ≥1 | Nonvalvular AF, CHADS2 ≥1 |
Study group | Dabigatran (150 mg twice daily) | Rivaroxaban (20 mg daily) | Apixaban (5 mg twice daily) | LAAO (Watchman) |
Control group (TTR) | Warfarin (64%) | Warfarin (55%) | Warfarin (66%) | Warfarin (66%) |
Follow-up (yr), median | 2.4 | 1.9 | 1.8 | 2.3 |
RE-LY, randomized evaluation of long-term anticoagulation therapy; ROCKET-AF, rivaroxaban once daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation; ARISTOTLE, apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation; PROTECT AF, Watchman left atrial appendage system for embolic protection in patients with atrial fibrillation; AF, atrial fibrillation; CHADS2, congestive heart failure, hypertension, age ≥75years, diabetes mellitus, stroke (2 points); LAAO, left atrial appendage occlusion; TTR, time in therapeutic range.
Table 2.
Baseline characteristic | RE-LYa) (n=12,098) | ROCKET-AF (n=14,264) | ARISTOTLE (n=18,201) | PROTECT AF (n=707) |
---|---|---|---|---|
Age (yr) | 71.5±8.7 | 73 (65–78) | 70 (63–76) | 72.0±8.9 |
Male sex (%) | 63.2 | 60.3 | 64.8 | 70.3 |
CHADS2, mean | 2.2 | 3.5 | 2.1 | 2.2 |
CHADS2 score (%) | ||||
0–1 | 31.6 | 0 | 34.0 | 31.5 |
2 | 36.1 | 13.0 | 35.8 | 34.8 |
3–6 | 32.4 | 87.0 | 30.2 | 33.7 |
Prior stroke, TIA, systemic embolism (%) | 20.1 | 54.9 | 19.4 | 18.5 |
Heart failure (%) | 31.9 | 62.6 | 35.4 | 26.9 |
Prior myocardial infarction (%) | 16.5 | 16.6 | 14.2 | |
Diabetes mellitus (%) | 23.2 | 40.4 | 25.0 | 26.2 |
Hypertension (%) | 78.9 | 90.3 | 87.5 | 89.5 |
Paroxysmal AF (%) | 33.2 | 17.5 | 15.3 | 42.3 |
Use of warfarin (%) | 49.4 | 62.3 | 57.2 | 98.7 |
Race/ethnicity (%) | ||||
Asian | 15.3 | 12.6 | 16.0 | 0.7 |
Black | NA | 1.3 | NA | 1.6 |
White | NA | 83.2 | NA | 91.5 |
Other | NA | 3.0 | NA | 6.2 |
Values are presented as mean±standard deviation, median (range), or number. RE-LY, randomized evaluation of long-term anticoagulation therapy; ROCKET-AF, rivaroxaban once daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation; ARISTOTLE, apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation; PROTECT AF, Watchman left atrial appendage system for embolic protection in patients with atrial fibrillation; CHADS2, congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke (double weight); TIA, transient ischemic attack; AF, atrial fibrillation; NA, not available.
Table 3.
Variable | RE-LYa) (n=12,098) | ROCKET-AF (n=14,264) | ARISTOTLE (n=18,201) | PROTECT AF (n=707) |
---|---|---|---|---|
Stroke and systemic embolism | 0.66 (0.53–0.82) | 0.79 (0.66–0.96) | 0.79 (0.66–0.95) | 1.51 (0.65–0.92) |
Major bleeding and procedure-related complicationsb) | 0.93 (0.81–1.07) | 1.04 (0.90–1.20) | 0.69 (0.60–0.80) | 1.53 (0.95–2.70) |
Cardiovascular death | 0.85 (0.72–0.99) | 0.86 (0.74–0.99) | 0.89 (0.76–1.04) | 0.38 (0.18–0.85) |
All-cause death | 0.88 (0.77–1.00) | 0.92 (0.82–1.03) | 0.89 (0.80–0.99) | 0.71 (0.46–1.28) |
Values are presented as number (range). In the RE-LY trial, NOAC showed preventive effect on the occurrence of stoke and systemic embolism with HR 0.66 (0.53–0.82).
RE-LY, randomized evaluation of long-term anticoagulation therapy; ROCKET-AF, rivaroxaban once daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation; ARISTOTLE, apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation; PROTECT AF, Watchman left atrial appendage system for embolic protection in patients with atrial fibrillation.