Direct Oral Anticoagulants for Acute Venous Thromboembolism
Closing the Circle?
In the past decades, the two-stage treatment of initial parenteral heparin followed by vitamin K antagonists has been the standard therapy for patients with acute venous thromboembolism (VTE). With the advent of direct oral anticoagulants (DOACs), previously known as new oral anticoagulants, this era has come to an end.
Article see p 764
In this issue of Circulation, Schulman et al1 report on the results of the RE-COVER II study that investigated the efficacy and safety of dabigatran for the treatment of acute VTE. The study included patients with acute deep vein thrombosis (DVT) and pulmonary embolism who were treated for 6 months with 150 mg of dabigatran twice daily or warfarin targeted to an international normalized ratio between 2 and 3, after initial parenteral heparin, mostly low-molecular-weight heparin (LMWH). The study shows that parenteral heparin followed by dabigatran was as effective as heparin overlapped with and followed by warfarin. The primary endpoint of recurrent symptomatic VTE occurred in 2.3% of patients randomized to dabigatran and in 2.2% of patients randomized to warfarin. Moreover, bleeding was less frequent in the dabigatran group. Thus, the RE-COVER II study confirms the results of the RE-COVER study with an identical design.2
This study completes the phase III clinical development program of dabigatran in VTE, further encompassing 2 studies for the long-term secondary prevention of recurrent VTE, totaling 9372 patients in 4 phase III studies.
The RE-MEDY study showed comparable efficacy and less bleeding of dabigatran compared with warfarin in patients with an indication for long-term anticoagulant therapy and is the only warfarin-controlled study evaluating a DOAC for the long-term secondary prevention of VTE.3 In the RE-SONATE study, a placebo-controlled study, dabigatran was effective in preventing recurrent VTE in patients who …