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

Table 4

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

Outcome	RE-COVER; (dabigatran versus warfarin)	RE-COVER II; (dabigatran versus warfarin)
Primary efficacy endpoint: recurrent symptomatic VTE or VTE-Related Death	2.4% 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 PE	1.0% versus 0.6%, HR 1.85 (07.4–4.64)	NR
Total days overlap between warfarin/dabigatran and parenteral anticoagulant	5–10 days (mean = 10 days)	5–11 days (mean NR)
Major Bleeding^∧	1.6% 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 bleeding^∧ ∧	5.6% versus 8.8%, HR 0.63 (95% CI 0.47–0.84)	NR
Any bleeding	16.1% 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)
Death	1.6% versus 1.7%, HR 0.95 (0.53–1.79)	1.9% in both groups
Warfarin TTR	60%	NR
Study conclusion	Dabigatran 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.