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) |