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Bristol-Myers Squibb and Pfizer presented positive results from their Phase 4 trial ‘EMANATE’ which compared apixaban (Eliquis), an oral selective Factor Xa inhibitor, to standard of care (parenteral heparin and/or vitamin K antagonist [VKA]) in patients with recently diagnosed non-valvular atrial fibrillation (NVAF) undergoing cardioversion. Data was presented at the ESC Congress 2017 in Barcelona, Spain.
This investigational study included a total of 1,500 patients: 753 received apixaban and 747 received heparin/VKA. The outcomes measured in this study were the occurrence of acute stroke, systemic embolism, major bleeding, clinically relevant non-major bleeding and all-cause death in non-valvular atrial fibrillation patients undergoing cardioversion.
Results showed that in the intent-to-treat population, the apixaban group had no strokes or systemic emboli compared to six strokes (one hemorrhagic and five ischemic) and no systemic emboli in the standard care group. There were 11 and 13 clinically relevant non-major bleeding events in the apixaban and standard of care group, respectively. There were three deaths in the study, two in the apixaban group (one due to acute alcoholic hepatitis prior to dosing and one due to complications related to perforation of the colon) and one in the standard of care group.
“The EMANATE study points to apixaban as a potential alternative approach [for reducing risk of stroke in the setting of cardioversion],” said Michael D. Ezekowitz, MB, ChB, DPhil, Professor at Thomas Jefferson University. “Further research is merited to confirm these finding.”
Eliquis is currently approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF); prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients who have undergone hip or knee replacement surgery; treatment of DVT or PE; and to reduce risk of recurrent DVT and PE following initial therapy.
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