Edoxaban Noninferior To Dalteparin For Recurrent VTE Prevention In Cancer Patients

For cancer patients with venous thromboembolism, the direct oral anticoagulant edoxaban is noninferior to low molecular weight heparin for the prevention of recurrent events and major bleeding

medwireNews: A study of cancer patients with venous thromboembolism (VTE) suggests that the direct oral anticoagulant edoxaban equals the low molecular weight heparin (LMWH) dalteparin for the composite endpoint of preventing recurrent VTE and major bleeding.

The findings of the open-label Hokusai VTE Cancer study of patients with acute symptomatic or incidental VTE during or within 2 years of active cancer were reported at the 2017 American Society of Hematology annual meeting in Atlanta, Georgia, USA, and published simultaneously in The New England Journal of Medicine.

The primary endpoint occurred in 12.8% of the 522 patients who were treated with a therapeutic dose of LMWH for at least 5 days for acute symptomatic or incidental VTE, followed by thromboprophylactic edoxaban 60 mg for 6–12 months. Likewise, 13.5% of the 524 patients given subcutaneous dalteparin 200 IU/kg once daily for 1 month, followed by a reduced 150 IU/kg dose for 6–12 months, experienced this composite endpoint.

This gave a hazard ratio (HR) of 0.97 with a p value indicating noninferiority of edoxaban to dalteparin, although the p value for edoxaban superiority did not reach significance, report Gary Raskob, from the University of Oklahoma Health Sciences Center in Oklahoma City, USA, and co-investigators

Edoxaban was comparable to dalteparin with regard to the secondary endpoint of recurrent VTE alone (7.9 vs 11.3%). However, major bleeding was significantly more common with edoxaban than dalteparin (6.9 vs 4.0%), with a HR of 1.77.

“This difference was mainly due to the higher rate of upper gastrointestinal bleeding with edoxaban”, the investigators say, observing that this was mainly found in patients with gastrointestinal cancer.

But they emphasize that although edoxaban showed a trend towards a higher rate of category 2 nonemergency bleeding events than dalteparin (66.7 vs 38.1%), the trial arms had comparable rates of both category 3 emergency bleeding events (33.3 vs 57.1%) and category 4 bleeding events that led to death (0.0 vs 4.8%).

“[T]he trial included a broad spectrum of patients with cancer who had received a wide array of cytotoxic and biologic therapies”, Gary Raskob et al comment on their findings. 

“[B]ut the sample size limits our ability to make definitive conclusions about outcomes associated with individual tumor types”, they admit.

Reference

Raskob GE, van Es N, Verhamme P, et al. Edoxaban for the treatment of cancer-associated venous thromboembolism. N Engl J Med; Advance online publication 12 December 2017. DOI: 10.1056/NEJMoa1711948

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