Direct-Acting Oral Anticoagulants: Practical Considerations for Emergency Medicine Physicians
Table 3
Summary of bleeding outcomes of DOACs from phase 3 clinical trials for the treatment and secondary prevention of VTE [29–33].
Major bleeding
Clinically relevant bleeding
(%)
HR (95% CI) P value
(%)
HR (95% CI) P value
RECOVER I/II
Dabigatran 150 mg BID
37
0.73 (0.48–1.11)
136
0.62 (0.50–0.76)
()
(1.4)
NR
(5.3)
NR
Heparin/VKA
51
217
()
(2.0)
(8.5)
EINSTEIN-DVT
Rivaroxaban
14
0.65 (0.33–1.30)
139
0.97 (0.76–1.22)
()
(0.8)
0.21
(8.1)
0.77
Heparin/VKA
20
138
( = 1711)
(1.2)
(8.1)
EINSTEIN-PE
Rivaroxaban
26
0.49 (0.31–0.79)
249
0.90 (0.76–1.07)
()
(1.1)
0.003
(10.3)
0.23
Heparin/VKA
52
274
()
(2.2)
(11.4)
AMPLIFY
Apixaban
15
0.31 (0.17–0.55)
115
0.44 (0.36–0.55)
()
(0.6)
<0.001
(4.3)
<0.001
Heparin/VKA
49
261
()
(1.8)
(9.7)
Hokusai-VTE
Edoxaban 60 mg QD
56
0.84 (0.59–1.21)
349
0.81 (0.71–0.94)
()
(1.4)
0.35
(8.5)
0.004
Heparin/VKA
66
423
()
(1.6)
(10.3)
With a parenteral anticoagulation lead-in. 15 mg BID for 3 weeks followed by 20 mg QD. 10 mg BID for the first 7 days followed by 5 mg BID for 6 months. 30 mg QD in patients with creatinine clearance 30–50 mL/min or body weight ≤60 kg or receiving concomitant potent P-glycoprotein inhibitors. AMPLIFY, apixaban for the initial management of pulmonary embolism and deep-vein thrombosis as first-line therapy; BID, twice daily; CI, confidence interval; DOACs, direct-acting oral anticoagulants; DVT, deep-vein thrombosis; HR, hazard ratio; NR, not reported; PE, pulmonary embolism; QD, once daily; VKA, vitamin K antagonist; VTE, venous thromboembolism.
