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Edoxaban as effective as LMWH for treatment of cancer-associated VTE
Clinical Question
Is edoxaban as effective as dalteparin for the treatment of cancer-associated venous thromboembolism (VTE)?
Bottom line
In this non-inferiority study, oral edoxaban was shown to be as effective as subcutaneous dalteparin for treating cancer-associated VTE. While there were significantly more bleeding events with the use of edoxaban, these occurred mainly in patients with gastrointestinal cancer. 1b
Reference
Study design: Randomized controlled trial (nonblinded)
Funding: Industry
Setting: Outpatient (primary care)
Synopsis
Current guidelines recommend treatment with low-molecular-weight heparin (LMWH) over vitamin K antagonists for the treatment of cancer-associated VTE. The efficacy of direct oral anticoagulants as compared with LMWH for this indication has not yet been determined. These investigators compared edoxaban with subcutaneous dalteparin for the treatment of cancer-associated VTE. Adult with active cancer or cancer diagnosed within the last two years who had evidence of acute deep vein thrombosis or pulmonary embolism were randomized, using concealed allocation, to receive either edoxaban 60 mg daily after a 5-day course of LMWH (n=522) or dalteparin 200 IU per kg of body weight daily for 30 days followed by 150 IU per kg once daily (n=524). Treatment in both groups was continued for 6 months and up to 12 months. For the primary composite outcome of recurrent VTE or major bleeding, edoxaban was non-inferior to dalteparin (12.8% in edoxaban group vs. 13.5% in dalteparin group, p=0.006 for non-inferiority). Results were similar in a per-protocol analysis. When looking at individual outcomes, there was no statistically significant difference in the rate of recurrent VTE although there were fewer occurrences in the edoxaban group (7.9% vs. 11.3%, p=0.09). As far as safety outcomes, edoxaban group did have a higher rate of major bleeding (6.9% vs. 4.0%, HR 1.77, 95% CI 1.03-3.04, p=0.04). This was due to more gastrointestinal bleeding events in the edoxaban group, mainly in patients with gastrointestinal cancer.
Reviewer
Nita Shrikant Kulkarni, MD
Assistant Professor in Hospital Medicine
Northwestern University
Chicago, IL
Comments
Je ne fais pas de traitements aigües d’une thrombose veineuse profonde mais l’information de l’article me permettra de mieux comprendre les traitements choisis par les oncologues. Et peut être que je peux suggérer un changement
This is great! Wonder if this applies to other novel OAs as well?
As reported major GI bleeding is associated with hospital admission and as such increasing the morbidity in these patients with GI cancer : for identical results the balance is not in favour of the newer anticoagulant medication !
It would be helpful to know the cost to the patient for 12 months of edoxaban. Other ‘bans’ such as my apixaban, are quite costly. The frequency of gi bleeding is concerning
Efficacy no different but LMWH is safer. Easy choice.