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Direct oral anticoagulants appear safe for preventing cancer-related VTE
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Direct oral anticoagulants may be as safe and effective as conventional anticoagulation for the prevention of venous thromboembolism in patients with cancer, according to data from a meta-analysis conducted in Italy.
Patients with cancer are four to seven times more likely than those without cancer to develop VTE. Because cancer causes bleeding complications, the risk for VTE recurrence while on anticoagulant treatment is especially high among patients with malignancies.
Maria Cristina Vedovati, MD, of the stroke unit in the department of internal and cardiovascular medicine at the University of Perugia, and colleagues performed a meta-analysis to compare the safety and efficacy of new direct anti-Xa and anti-IIa oral anticoagulants vs. standard treatment — low–molecular-weight heparin followed by vitamin K antagonists — in patients with VTE and cancer.
The researchers used the Medline, Embase and Central databases to search for randomized controlled trials that assessed the use of direct oral anticoagulants in patients with VTE and cancer.
They included six studies in their meta-analysis. All studies were either phase 2 or phase 3 randomized controlled trials that compared direct oral anticoagulants with vitamin K antagonists in patients with VTE. VTE recurrence and bleeding events were assessed in both groups, and patients with active cancer were included in all studies.
The six studies — which encompassed a combined 1,132 patients — included two with dabigatran (Pradaxa, Boehringer Ingelheim), two with rivaroxaban (Xarelto, Janssen), one with edoxaban (Savaysa, Daiichi Sankyo) and one with apixaban (Eliquis, Bristol-Myers Squibb).
Results showed patients with cancer were less likely to experience VTE recurrence when treated with direct oral anticoagulants than with conventional treatment (3.9% vs. 6%; OR = 0.63; 95% CI, 0.37-1.1). Major bleeding also was lower among those treated with direct oral anticoagulants (3.2% vs. 4.2%; OR = 0.77; 95% CI, 0.41-1.44).
Although the meta-analysis included studies of different direct oral anticoagulants, it was not constructed to show differences among those agents. Yet, when analyzing the outcomes of recurrent VTE or clinically relevant bleeding, there was no indication of heterogeneity, suggesting that efficacy and safety were similar and consistent regardless of the agent used.
The researchers acknowledged several limitations of their study, including the fact they could not adjust for time in therapeutic range, type of VTE, and the type and stage of malignancy. Also, because some of the studies in the meta-analysis did not include patients with cancer for whom treatment with low–molecular-weight heparin was considered more appropriate, it remains unclear whether the patients with cancer included in the meta-analysis are representative of the overall population of patients with cancer.
“[Still], direct oral anticoagulants seem to be as effective and safe as conventional treatment for the prevention of VTE in patients with cancer,” Vedovati and colleagues wrote. “Further clinical trials in patients with cancer-associated VTE should be performed to confirm these results.” – by Anthony SanFilippo
Disclosure: The researchers report personal fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo and Sanofi, as well as speaking fees from Bayer and Boehringer Ingelheim.
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