| |
EINSTEIN-DVT[8]
|
EINSTEIN-PE[9]
|
EINSTEIN pooled
|
|---|
| |
Rivaroxaban
|
Enoxaparin/VKA
|
Rivaroxaban
|
Enoxaparin/VKA
|
Rivaroxaban
|
Enoxaparin/VKA
|
|---|
| |
(N = 1731)
|
(N = 1718)
|
(N = 2419)
|
(N = 2413)
|
(N = 4151)
|
(N = 4131)
|
|---|
|
Male sex–n (%)
|
993 (57.4)
|
967 (56.3)
|
1309 (54.1)
|
1247 (51.7)
|
2302 (55.5)
|
2214 (53.6)
|
|
Mean age–years ± SD
|
55.8 ± 16.4
|
56.4 ± 16.3
|
57.9 ± 7.3
|
57.5 ± 7.2
|
57.0 ± 17.0
|
57.0 ± 16.8
|
|
Risk factor associated with VTE–n (%)
| | | | | | |
|
Recent surgery or trauma
|
338 (19.5)
|
335 (19.5)
|
415 (17.2)
|
398 (16.5)
|
753 (18.1)
|
733 (17.7)
|
|
Previous VTE
|
336 (19.4)
|
330 (19.2)
|
455 (18.8)
|
489 (20.3)
|
791 (19.1)
|
819 (19.8)
|
|
Active cancer
|
118 (6.8)
|
89 (5.2)
|
114 (4.7)
|
109 (4.5)
|
232 (5.6)
|
198 (4.8)
|
|
Estrogen therapy
|
140 (8.1)
|
115 (6.7)
|
207 (8.6)
|
223 (9.2)
|
347 (8.4)
|
338 (8.2)
|
|
Immobilization
|
265 (15.3)
|
260 (15.1)
|
384 (15.9)
|
380 (15.7)
|
649 (15.6)
|
640 (15.5)
|
|
Known thrombophilic condition
|
107 (6.2)
|
116 (6.8)
|
138 (5.7)
|
121 (5.0)
|
245 (5.9)
|
237 (5.7)
|
|
Unprovoked VTE
|
1055 (60.9)
|
1083 (63.0)
|
1566 (64.7)
|
1551 (64.3)
|
2621 (63.1)
|
2634 (63.8)
|
|
Duration of study treatment–days (mean [SD])*
|
193.6 (89.3)
|
187.5 (92.5)
|
216.3 (98.7)
|
214.3 (98.9)
|
207.6 ± 95.9
|
203.8 ± 97.4
|
- *Duration of actual study treatment after randomization until end of treatment (safety population).
- SD Standard deviation, VKA Vitamin K antagonist, VTE Venous thromboembolism.
