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. 2015 Jun 9;15(5):323–335. doi: 10.1007/s40256-015-0124-5

Table 4.

Summary of outcomes from the phase III clinical trials [40–43]

Stroke or systemic embolism Ischemic strokeb Primary safety outcomec GI bleeding Intracranial bleeding
Ratea HR
p value		 Ratea HR
p value		 Ratea HR
p value		 Ratea HR
p value
RE-LY
 Dabigatran
110 mg bid		 1.53 0.91 (0.74–1.11)
<0.001		 1.34 1.11 (0.89–1.40)
0.35		 2.71 0.80 (0.69–0.93)
0.003		 1.12 1.10 (0.86–1.41)
0.43		 0.23 0.31 (0.20–0.47)
<0.001
 Dabigatran
150 mg bid		 1.11 0.66 (0.53–0.82)
<0.001		 0.92 0.76 (0.60–0.98)
0.03		 3.11 0.93 (0.81–1.07)
0.31		 1.51 1.50 (1.19–1.89)
<0.001		 0.30 0.40 (0.27–0.60)
<0.001
 Warfarin 1.69 1.20 3.36 1.02 0.74
ROCKET AF
 Rivaroxaban
20 mg odd 		1.70 1.7 (0.66–0.96)
<0.001		 1.34 0.94 (0.75–1.17)
0.581		 14.90 1.03 (0.96–1.11)
0.44		 3.20 NR
<0.001		 0.50 0.67 (0.47–0.93)
0.02
 Warfarin 2.20 1.42 14.50 2.20 0.70
ARISTOTLE
 Apixaban
5 mg bide 		1.27 0.79 (0.66–0.95)
<0.01g 		0.97 0.92 (0.74–1.13)
0.42		 2.13 0.69 (0.60–0.80)
<0.001		 0.76 0.89 (0.70–1.15)
0.37		 0.33 0.42 (0.30–0.58)
<0.001
 Warfarin 1.60 1.05 3.09 0.86 0.80
ENGAGE AF
 Edoxaban
60 mg odf 		1.18 0.79 (0.63–0.99)
<0.001		 1.25 1.00 (0.83–1.19)
0.97		 2.75 0.80 (0.71–0.91)
<0.001		 1.51 1.23 (1.02–1.50)
0.03		 0.39 0.47 (0.34–0.63)
<0.001
 Edoxaban
30 mg odf 		1.61 1.07 (0.87–1.31)
0.005		 1.77 1.41 (1.19–1.67)
<0.001		 1.61 0.47 (0.41–0.55)
<0.001		 0.82 0.67 (0.53–0.83)
<0.001		 0.26 0.30 (0.21–0.43)
<0.001
 Warfarin 1.50 1.25 3.43 1.23 0.85

bid twice daily, HR hazard ratio vs. warfarin, NR not reported, od once daily

aRE-LY, ARISTOTLE, and ENGAGE AF-TIMI-48—annualized event rate; ROCKET AF—events per 100 patient-years

bRE-LY—ischemic or non-specified stroke; ARISTOTLE—ischemic or uncertain type of stroke

cRE-LY, ARISTOTLE, and ENGAGE AF-TIMI-48—major bleeding; ROCKET AF—major and nonmajor clinically relevant bleeding

dPatients with a ClCr 30–49 ml/min received 15 mg daily

ePatients with ≤2 of the following: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL (133 μmol/l) received a dose of 2.5 mg bid

fA 50 % dose reduction was given for patients with a ClCr 30–50 mL/min, body weight ≤60 kg, or concomitant treatment with P-glycoprotein inhibitors

gFor superiority