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Table 1 Efficacy and safety outcomes of the phase III EINSTEIN DVT study

From: XALIA: rationale and design of a non-interventional study of rivaroxaban compared with standard therapy for initial and long-term anticoagulation in deep vein thrombosis

  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, %)
  1. *Primary efficacy outcome; principal safety outcome.
  2. CI, confidence interval; DVT, deep vein thrombosis; HR, hazard ratio; ITT, intention to treat; PE, pulmonary embolism; VKA, vitamin K antagonist; VTE, venous thromboembolism.