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 |
|
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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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