In the Journals Plus

Direct oral anticoagulants safe, effective in patients with VTE and thrombophilia

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February 22, 2019

Patients with thrombophilia had low rates of venous thromboembolism recurrence and bleeding events after treatment with direct oral anticoagulants, according to results of a meta-analysis published in Journal of Thrombosis and Haemostasis.

The safety and efficacy of direct oral anticoagulants (DOACs) appeared similar to that of vitamin K antagonists among this patient population.

“The use of DOACs in patients with thrombophilic conditions has recently garnered increasing attention, mainly due to their promising ability to improve safety profile and reduce cost and quality-of-life considerations associated with long-term anticoagulation,” Manila Gaddh, MD, assistant professor in the department of hematology and medical oncology at Emory University School of Medicine, and colleagues wrote. “Findings from recent systematic reviews and meta-analyses pooling results of high-quality randomized controlled trials in patients with cancer indicate DOACs can effectively treat VTE in this highly prothrombotic state.”

Guidelines issued in 2016 by the American College of Chest Physicians recommend DOACs over vitamin K antagonists for the prevention and treatment of VTE in patients without active cancer. However, the guidelines do not specify a choice of anticoagulation for treating VTE in patients with inherited or acquired thrombophilia.

Gaddh and colleagues conducted a random-effects meta-analysis of eight studies reporting results of phase 2 or phase 3 randomized controlled trials that compared DOACs with vitamin K antagonists among patients with VTE, including those with thrombophilia.

The studies reported data on 1,994 patients with thrombophilia.

Of the eight studies, four evaluated rivaroxaban (Xarelto, Janssen), three evaluated dabigatran (Pradaxa, Boehringer Ingelheim), and one evaluated edoxaban (Savaysa, Daiichi Sankyo).

Researchers could not obtain data on use of apixaban (Eliquis; Bristol-Myers Squibb, Pfizer).

Results of the meta-analysis showed patients with thrombophilia who received DOACs and those who received vitamin K antagonists had similar rates of VTE recurrence (RR = 0.7; 95% CI, 0.34-1.44) and major or clinically relevant bleeding events (RR = 0.92; 95% CI, 0.62-1.36).

Among patients without thrombophilia, researchers observed comparable results of VTE recurrence (RR = 1.02; 95% CI, 0.8-1.3) and major or clinically relevant bleeding events (RR = 0.72; 95% CI, 0.57-0.9).

In addition, a subgroup analysis of six studies comparing DOACs with vitamin K antagonists in managing acute VTE showed no significant differences in risks for VTE recurrence (RR = 0.71; 95% CI, 0.29-1.72) or clinically relevant bleeding (RR = 1.03; 95% CI, 0.62-1.7).

Study limitations included the fact that patients in the studies were not routinely screened for inherited or acquired thrombophilia and testing for thrombophilia was not performed at a central location.


“Based on the best available evidence so far, the efficacy and safety of DOACs for treatment and secondary prevention of acute VTE was not significantly different from [vitamin K antagonists] in patients with thrombophilia,” Gaddh and colleagues wrote. “These observations seem to support DOAC use in low-risk thrombophilias without any efficacy or safety concerns.” – by John DeRosier

Disclosures: Gaddh reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.


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