Thrombosis

Thrombosis / 2013 / Article / Tab 4

Review Article

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

Table 4

Outcomes of dabigatran in VTE studies [14, 35].

OutcomeRE-COVER  
(dabigatran versus warfarin)
RE-COVER II  
(dabigatran versus warfarin)

Primary efficacy endpoint: recurrent symptomatic VTE or VTE-Related Death2.4% versus 2.1%, HR 1.10 (95% CI 0.65–1.84)2.4% versus 2.2%, HR 1.08 (95% CI 0.64–1.8)
Secondary efficacy endpoint: recurrent, nonfatal PE1.0% versus 0.6%, HR 1.85 (07.4–4.64)NR
Total days overlap between warfarin/dabigatran and parenteral anticoagulant5–10 days (mean = 10 days)5–11 days (mean NR)
Major Bleeding1.6% versus 1.9%, HR 0.82 (95% CI 0.45–1.48)1.1% versus 1.7%, HR 0.69 (95% CI 0.36–1.32)
Major or clinically relevant non-major bleeding5.6% versus 8.8%, HR 0.63 (95% CI 0.47–0.84)NR
Any bleeding16.1% versus 21.9%, HR 0.71 (95% CI 0.59–0.85)15.6% versus 22.1%, HR 0.67 (95% CI 0.56–0.81)
Death1.6% versus 1.7%, HR 0.95 (0.53–1.79)1.9% in both groups
Warfarin TTR60%NR
Study conclusionDabigatran is noninferior to warfarin
Dabigatran is not superior to warfarin
Dabigatran is noninferior to warfarin
Dabigatran is not superior to warfarin

NR: not reported, TTR: time in therapeutic range.
Major bleeding as defined in RE-COVER: Clinical overt bleeding, with associated fall in hemoglobin of at least 20 g per liter, the need for transfusion of 2 or more units of red blood cells, involving a critical site or was fatal.
Minor bleeding as defined in RE-COVER: spontaneous skin hematoma of at least 25 cm2, spontaneous nose bleed of more than 5 minutes in duration, macroscopic hematuria lasting more than 24 hours, spontaneous rectal bleeding, gingival bleeding of greater than 5 minutes, bleeding leading to hospitalization and/or requiring surgical treatment, bleeding leading to transfusion of less than 2 units of red blood cells, or any other clinically relevant bleeding per the investigator.

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