Clinical outcomes in patients with atrial fibrillation and frailty: insights from the ENGAGE AF-TIMI 48 trial

Table 3 The association between oral anticoagulation and outcomes, stratified by frailty category

Unadjusted hazard ratio (95% confidence interval) compared to warfarin (ref), within each frailty category
Fit		Pre-frail		Mild-moderate frailty		Severe frailty
Edoxaban 30 mg	Edoxaban 60 mg	Edoxaban 30 mg	Edoxaban 60 mg	Edoxaban 30 mg	Edoxaban 60 mg	Edoxaban 30 mg	Edoxaban 60 mg
Primary endpoints
Time to first adjudicated stroke or systemic embolism
1.04 (0.71–1.50)	1.03 (0.71–1.49)	1.18 (0.97–1.43)	0.82 (0.66–1.01)	1.17 (0.87–1.56)	0.84 (0.61–1.15)	0.30 (0.08–1.11)	0.54 (0.20–1.50)
Time to adjudicated major bleeding during treatment
0.42 (0.28–0.62)	0.96 (0.71–1.30)	0.46 (0.38–0.56)	0.76 (0.64–0.90)	0.47 (0.35–0.64)	0.75 (0.57–0.98)	0.74 (0.36–1.52)	0.60 (0.29–1.26)
Composite net clinical endpoints
1. Stroke, systemic embolic event, major bleeding, or death
0.90 (0.74–1.10)	1.11 (0.92–1.34)	0.83 (0.75–0.92)	0.84 (0.76–0.93)	0.81 (0.70–0.93)	0.90 (0.78–1.03)	0.82 (0.54–1.23)	0.75 (0.50–1.12)
2. Disabling stroke, life-threatening bleeding, or death
1.01 (0.79–1.30)	1.11 (0.87–1.41)	0.83 (0.74–0.95)	0.86 (0.76–0.97)	0.79 (0.66–0.94)	0.88 (0.74–1.04)	0.66 (0.41–1.07)	0.62 (0.39–0.99)
3. Stroke, systemic embolic event, life-threatening bleeding, or death
1.03 (0.82–1.30)	1.14 (0.91–1.42)	0.89 (0.79–1.00)	0.83 (0.74–0.93)	0.85 (0.72–1.00)	0.88 (0.75–1.04)	0.64 (0.40–1.02)	0.66 (0.42–1.03)
Death
1.08 (0.83–1.42)	1.20 (0.92–1.56)	0.89 (0.78–1.02)	0.88 (0.77–1.01)	0.83 (0.69–1.00)	0.89 (0.75–1.07)	0.67 (0.41–1.12)	0.69 (0.43–1.12)

ISSN: 1741-7015