Over the past decade, the use of direct-acting oral anticoagulants (DOACs) for the treatment of acute venous thromboembolism (VTE) has been on the rise. DOACs offer many benefits compared with vitamin K antagonists, including fewer drug-drug interactions, fewer dietary concerns, and fixed-dosing options. As a result, several clinical trials are ongoing to explore further therapeutic indications and evaluate the safety of these agents in different patient populations.1
Currently, 4 DOACs (dabigatran, apixaban, rivaroxaban, and edoxaban) have been approved for use by the US Food and Drug Administration (FDA). Two main treatment categories exist for these agents: use for the prevention of thromboembolism (stroke or systemic embolism) in patients with nonvalvular atrial fibrillation and use for the treatment of patients with acute VTE (DVT with or without pulmonary embolism [PE]).1
In a recent systematic review and meta-analysis published in PLoS One, Raghavendra Charan Makam, MD, of the department of medicine at the University of Massachusetts in Worcester, and colleagues summarized various clinical outcomes from trials assessing DOACs for the treatment of patients with acute VTE.
“Although clinical trials have demonstrated at least equivalent therapeutic efficacy of these newer agents, concerns about the safety profile and net clinical benefit of DOACs have remained,” the reviewers wrote.
Efficacy and Safety of DOACs in Acute VTE and PE
The current body of literature includes 5 phase 3 studies that evaluated DOAC therapy in patients with acute VTE. Collectively, the results of these studies showed that DOAC therapy was not superior to warfarin, a vitamin K antagonist, in terms of efficacy, which was defined as composite risk of recurrent VTE or death. However, patients who received a DOAC still saw a lower risk of adverse drug events, such as transaminase elevations, suggesting an overall clinical benefit.1
“We recommend giving eligible patients and their families information about the risks and benefits of DOACs, along with one’s expert opinion on their expected net clinical benefit, when discussing options for oral anticoagulation treatment,” the authors added.
A recent study evaluating nonstandard dosing of DOACs in the treatment of acute PE was presented and discussed at the 68th Annual Scientific Sessions and Expo of the American College of Cardiology.