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Novel Oral Anticoagulants for Acute Venous Thromboembolism

Summary and Comment |
April 25, 2014

Novel Oral Anticoagulants for Acute Venous Thromboembolism

  1. David Green, MD, PhD

These agents offer safety advantages over vitamin K antagonists.

  1. David Green, MD, PhD

Vitamin K antagonists (VKAs), such as warfarin, have been the standard treatment for acute venous thromboembolism (VTE) for several decades. However, several novel oral anticoagulants (NOACs), including rivaroxaban, dabigatran, apixaban, and edoxaban, now pose a challenge to the established regimens.

To evaluate the effectiveness and safety of NOACs versus VKAs, investigators in the Netherlands conducted a systematic review and meta-analysis of studies comparing these two classes of anticoagulants. They analyzed two trials of rivaroxaban, and one trial each of dabigatran, apixaban, and edoxaban, comprising 24,455 patients with acute VTE.

Recurrent VTE occurred in similar numbers of patients receiving NOACs versus VKAs (2.0% and 2.2%, respectively), and the combined relative risk (RR) showed no significant difference (0.88; 95% confidence interval, 0.74–1.05). Fatal pulmonary emboli occurred in nine patients (0.07%) in each group, and the RR for all-cause mortality was 0.97 (95% CI, 0.83–1.14).

Major bleeding occurred less often with NOACs than with VKAs (1.1% vs. 1.7%; RR, 0.6; 95% CI, 0.41–0.88), as did nonfatal intracranial bleeding (0.09% vs. 0.25%; RR, 0.39; 95% CI, 0.16–0.94) and fatal bleeding (0.06% vs. 0.17%; RR, 0.36; 0.15–0.87), although dabigatran was associated with more gastrointestinal bleeding (0.71% vs. 0.39%). There were no significant differences in outcomes when dabigatran, apixaban, and edoxaban were compared with rivaroxaban.

Comment

Compared with vitamin K antagonists, novel oral anticoagulants provide more-predictable anticoagulation, fewer drug interactions, and no need for monitoring. Their major drawbacks are the current lack of a reversing agent and higher cost. Now, we should include greater safety with no loss of efficacy as advantages.

  • Disclosures for David Green, MD, PhD at time of publication Consultant / Advisory board Altor Bioscience Grant / research support NIH

Citation(s):

Reader Comments (2)

Robert Moss, M.D. Physician, Hematology, Private Practice

Do we know how efficacious these agents are in patients with moderate to severe Antiphospholipid Syndrome?

Richard Lloyd Physician, Oncology

What has been the experience with these agents with thrombosis associated with malignancy, both re efficacy and safety?

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