ACCEL | Venous thromboembolism (VTE) is the third most common cardiovascular disease after myocardial infarction and stroke. About one-third of patients with a deep venous thrombosis (DVT) or pulmonary embolism (PE) will suffer a recurrence within 10 years. There are some limitations of current therapy. Low-molecular-weight heparin (LMWH) requires daily subcutaneous injection and warfarin requires monitoring with dose adjustments. One new option is the novel oral anticoagulant (NOAC) dabigatran.

On April 7, 2014, the US Food and Drug Administration (FDA) approved the anticoagulant for the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for 5-10 days and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. The approval is based on results from four global phase III studies evaluating the efficacy and safety of dabigatran in the treatment of DVT and PE: RE-COVER, RE-COVER II, RE-MEDY, and RE-SONA TE.

As for other NOACs:

• Extended anticoagulation with apixaban at either a treatment dose (5 mg) or a thromboprophylactic dose (2.5 mg) reduced the risk of recurrent VTE without increasing the rate of major bleeding.¹
• In a pooled analysis of the EINSTEIN-DVT and EINSTEIN-PE studies, investigators compared the efficacy and safety of rivaroxaban (15 mg twice daily for 21 days, followed by 20 mg once daily) with standard therapy (enoxaparin mg/kg twice daily and warfarin or acenocoumarol). Single-agent therapy with rivaroxaban resulted in similar efficacy to standard therapy and was associated with a significantly lower rate of major bleeding.²
• Edoxaban administered once daily after initial treatment with heparin was noninferior to highquality standard therapy and caused significantly less bleeding in patients VTE, including those with severe PE.³

Jeffrey I. Weitz, MD, notes that there are patients with incidental VTE who are not good candidates for the NOACs, including those:

• with severe PE or extensive DVT
• with severe renal or hepatic insufficiency
• with a high initial risk of bleeding
• who cannot afford the new agents

The same is true for prevalent VTE patients; some are not necessarily candidates for the NOACs, such as:

• patients who are stable on warfarin
• individuals with frequent missed doses
• patients with antiphospholipid antibody syndrome or other high-risk thrombophilias

References

1. Agnelli G, Buller HR, Cohen A, et al. N Engl J Med. 2013;368:699-708.
2. Prins MH, Lensing AW , Bauersachs R, et al. Thromb J. 2013;11:21.
3. Hokusai-VTE Investigators, Buller HR, Decousus H, Grosso MA, et al. N Engl J Med. 2013;369:1406-15.

To listen to an interview with Jeffrey I. Weitz, MD, about warfarin and deep venous thrombosis, visit youtube.cswnews.org. The interview was conducted by Peter A. McCullough, MD, MPH.

Keywords: CardioSource WorldNews Interventions

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