Table 9.
Primary efficacy endpoint (%/y)a | Primary safety endpoint (%/y)b | |||||||
---|---|---|---|---|---|---|---|---|
RE-LY | ||||||||
eGFR (mL/min) | <50 | 50 to<80 | ≥80 | P (int) | <50 | 50 to <80 | ≥80 | P (int) |
Dabi 150 | 1.53 | 1.25 | 0.71 | 5.50 | 3.35 | 2.04 | ||
Dabi 110 | 2.32 | 1.69 | 0.88 | 5.45 | 2.84 | 1.48 | ||
Warfarin | 2.70 | 1.83 | 1.05 | 5.49 | 3.70 | 2.43 | ||
HR (95% CI) | ||||||||
Dabi 150/W | 0.56 | 0.68 | 0.67 | 0.7522 | 1.01 | 0.91 | 0.84 | 0.6393 |
(0.37–0.85) | (0.50–0.92) | (0.42–1.09) | (0.79–1.30) | (0.75–1.11) | (0.62–1.13) | |||
Dabi 110/W | 0.85 | 0.93 | 0.84 | 0.9108 | 0.99 | 0.76 | 0.61 | 0.0607 |
(0.59–1.24) | (0.70–1.23) | (0.54–1.32) | (0.77–1.28) | (0.62–0.94) | (0.44–0.84 | |||
ROCKET AF | ||||||||
CrCl (mL/min) | 30–49 | ≥50 | 30–49 | ≥50 | ||||
Riva 15 | 2.32 | 17.82 | ||||||
Riva 20 | 1.57 | 14.24 | ||||||
Warfarin | 2.77 | 2.00 | 18.28 | 13.67 | ||||
HR (95% CI) | ||||||||
Riva/W | 0.84 (0.57–1.23) | 0.78 | 0.76 | 0.98 | 1.04 | 0.4496 | ||
(0.63–0.98) | (0.84–1.14) | (0.96–1.13) | ||||||
ARISTOTLE | ||||||||
eGFR (mL/min) | ≤50 | >50–80 | >80 | ≤50 | >50–80 | >80 | ||
Api 5 | 2.11 | 1.24 | 0.99 | 3.21 | 2.45 | 1.46 | ||
Warfarin | 2.67 | 1.69 | 1.12 | 6.44 | 3.21 | 1.84 | ||
HR (95% CI) | ||||||||
Api/W | 0.79 | 0.74 | 0.88 | 0.705 | 0.50 | 0.77 | 0.80 | 0.030 |
(0.55–1.14) | (0.56–0.97) | (0.64–1.22) | (0.38–0.66) | (0.62–0.94) | (0.61–1.04) | |||
ENGAGE AF | ||||||||
CrCl (mL/min) | 30–50 | >50 | 30–50 | >50 | ||||
HDER 60/30 | 2.3 | 1.4 | 4.0 | 2.5 | ||||
Warfarin | 2.7 | 1.6 | 5.3 | 3.1 | ||||
HR | ||||||||
HDER/W | 0.87 | 0.87 | 0.94 | 0.76 | 0.82 | 0.62 | ||
(0.65–1.18) | (0.72–1.04) | (0.58–0.98) | (0.71–0.95) |
Api: apixaban; CI: confidence interval; CKD: chronic kidney disease; CrCl: creatinine clearance; Dabi: dabigatran; eGFR: estimated glomerular filtration rate; HDER: high-dose edoxaban regimen; HR: hazard ratio: Int: interaction; NOACs: non-vitamin K antagonists; Riva: rivaroxaban; W: warfarin
Stroke and systemic embolization events;
Major bleeding.