Direct-Acting Oral Anticoagulants: Practical Considerations for Emergency Medicine Physicians
Table 2
Summary of bleeding outcomes of DOACs from phase 3 clinical trials for the prevention of stroke and SEE in patients with NVAF [19–22].
Major bleeding
Intracranial bleeding
Gastrointestinal bleeding
HR (95% CI)
HR (95% CI)
HR (95% CI)
(%)
value
(%)
value
(%)
value
RE-LY
Dabigatran 150 mg BID
375
0.93 (0.81–1.07)
36
0.40 (0.27–0.60)
182
1.50 (1.19–1.89)
()
(3.11)
0.31
(0.30)
<0.001
(1.51)
<0.001
Dabigatran 110 mg BID
322
0.80 (0.69–0.93)
27
0.31 (0.20–0.47)
133
1.10 (0.86–1.41)
()
(2.71)
0.003
(0.23)
<0.001
(1.12)
0.43
Warfarin
397
87
120
()
(3.36)
(0.74)
(1.02)
ROCKET AF
Rivaroxaban 20 mg QD
395
1.04 (0.90–1.20)
55
0.67 (0.47–0.93)
224
NR
()
(5.60)
0.58
(0.80)
0.02
(3.15)
Warfarin
386
84
154
()
(5.40)
(1.20)
(2.16)
ARISTOTLE
Apixaban 5 mg BID
327
0.69 (0.60–0.80)
52
0.42 (0.30–0.58)
105
0.89 (0.70–1.15)
()
(2.13)
<0.001
(0.33)
<0.001
(0.76)
0.37
Warfarin
462
122
119
()
(3.09)
(0.80)
(0.86)
ENGAGE AF-TIMI 48
Edoxaban 60 mg QD
418
0.80 (0.71–0.91)
61
0.47 (0.34–0.63)
232
1.23 (1.02–1.50)
()
(2.75)
<0.001
(0.39)
<0.001
(1.51)
0.03
Edoxaban 30 mg QD
254
0.47 (0.41–0.55)
41
0.30 (0.21–0.43)
129
0.67 (0.53–0.83)
()
(1.61)
<0.001
(0.26)
<0.001
(0.82)
<0.001
Warfarin
524
132
190
()
(3.43)
(0.85)
(1.23)
15 mg QD in patients with creatinine clearance 30–49 mL/min. 2.5 mg BID in patients meeting 2 or more of the following criteria: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥15 mg/L. ARISTOTLE, apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation; BID, twice daily; CI, confidence interval; DOACs, direct-acting oral anticoagulants; ENGAGE AF-TIMI 48, effective anticoagulation with factor Xa next generation in atrial fibrillation-thrombolysis in myocardial infarction 48; HR, hazard ratio; NR, not reported; QD, once daily; NVAF, nonvalvular atrial fibrillation; RE-LY, randomized evaluation of long-term anticoagulation therapy; ROCKET AF, rivaroxaban once daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation; SEE, systemic embolic event.
