Thrombosis

Thrombosis / 2013 / Article / Tab 5

Review Article

New Oral Anticoagulants in the Treatment of Pulmonary Embolism: Efficacy, Bleeding Risk, and Monitoring

Table 5

Outcomes of rivaroxaban in VTE Studies [11, 40].

OutcomeEINSTEIN-DVT  
(rivaroxaban versus VKA + parenteral )
EINSTEIN-PE  
(rivaroxaban versus VKA + parenteral agent)

Primary efficacy endpoint: noninferiority  
 Recurrent symptomatic VTE2.1% versus 3.0%, 2.1% versus 1.8%,
HR = 0.68 (95% CI 0.44–1.04) HR = 1.12 (95% CI 0.75–1.68)
  # recurrent events that were
  any type of PE
25 versus 2432 versus 27

Secondary efficacy endpoint:
 All-cause mortality2.2% versus 2.9% 2.4% versus 2.1%
HR = 0.67 (95% CI 0.44–1.02) HR = 1.13 (95% CI 0.77–1.65)
 Net clinical benefit 2.9% versus 4.2% 3.4% versus 4.0%
HR = 0.67 (95% CI 0.47–0.95) HR = 0.85 (95% CI 0.63–1.14)

Primary safety outcome:
 Major bleeding or clinically relevant
 nonmajor bleeding
8.1% versus 8.1%10.3% versus 11.4%
HR = 0.97 (99% CI 0.76–1.22)HR = 0.90 (95% CI 0.76–1.07)
 Major bleeding0.8% versus 1.2% 1.1% versus 2.2%
HR = 0.65 (95% CI 0.33–1.30) HR = 0.49 (95% CI 0.31–0.79)
 Clinically relevant nonmajor
 bleeding
7.36% versus 7.0% 9.5% versus 9.8%
(statistics NR)(statistics NR)
 Warfarin TTR57.7% 62.7%
 Study conclusionRivaroxaban is noninferior to warfarin. Rivaroxaban is not superior to warfarin. Rivaroxaban is noninferior to warfarin. Rivaroxaban is not superior to warfarin

NR: not reported, TTR: time in therapeutic range.
Major bleeding as defined in EINSTEIN: Clinical overt bleeding, with associated fall in hemoglobin of at least 2.0 g per deciliter, the need for transfusion of 2 or more units of red blood cells, involving a critical site or was fatal.
Clinically relevant nonmajor bleeding as defined in EINSTEIN: overt bleeding that did not meet the criteria for major bleeding but was associated with medical intervention, unscheduled contact with a physician, interruption or discontinuation of a study drug or discomfort, or impairment of activities of daily life.

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