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. 2017 Jun 27;33(4):345–367. doi: 10.1016/j.joa.2017.05.004

Table 9.

Efficacy and safety of NOACs in patients with CKD.

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

a

Stroke and systemic embolization events;

b

Major bleeding.