Table 1.
Efficacy and safety outcomes of the phase III EINSTEIN DVT study
| Rivaroxaban | Enoxaparin/VKA | HR (95% CI) | P value | |
|---|---|---|---|---|
|
Efficacy outcomes (ITT population) |
(n = 1731) |
(n = 1718) |
|
|
| Recurrent VTE* (%) |
2.1 |
3.0 |
0.68 (0.44–1.04) |
<0.001 |
|
Safety outcomes (safety population) |
(n = 1718) |
(n = 1711) |
|
|
| First major or non-major clinically relevant bleeding† (%) |
8.1 |
8.1 |
0.97 (0.76–1.22) |
0.77 |
| Major bleeding (%) |
0.8 |
1.2 |
0.65 (0.33–1.30) |
0.21 |
| Non-major clinically relevant bleeding (%) |
7.3 |
7.0 |
|
|
| Total mortality (%) |
2.2 |
2.9 |
0.67 (0.44–1.02) |
0.06 |
| Any treatment-emergent adverse event (%) |
62.7 |
63.1 |
|
|
|
Net clinical benefit |
2.9 | 4.2 | 0.67 (0.47–0.95) | 0.03 |
| (composite of symptomatic, recurrent VTE plus major bleeding, %) |
*Primary efficacy outcome; †principal safety outcome.
CI, confidence interval; DVT, deep vein thrombosis; HR, hazard ratio; ITT, intention to treat; PE, pulmonary embolism; VKA, vitamin K antagonist; VTE, venous thromboembolism.