Atrial Fibrillation Clinical Trial
Official title:
The Role of Additional Antiplatelet Therapy in the Ischemic Stroke With Atrial Fibrillation and Co-morbiD Atherosclerosis During edOxaban treatmeNt. (ADD-ON) Study, Multicenter Registry-based Analysis
This study aims to compare the effectiveness and safety regarding treatment with standard anticoagulant only or adding antiplatelet to anticoagulant in patients with non-valvular atrial fibrillation and significant atherosclerosis including extracranial, intracranial, coronary or peripheral artery.
Although there is a significant increase in the risk of cerebral infarction in the presence
of atrial fibrillation, it is difficult to say that all cerebral infarctions occurring in
patients with atrial fibrillation are caused by atrial fibrillation. Carotid stenosis is
found in 1/4 of patients with atrial fibrillation, which increases the risk of cerebral
infarction. Additional antiplatelet therapy to standard anticoagulation therapy should be
considered in some patients. To date, the best medical treatment for prevention of cerebral
infarction in patients with atrial fibrillation and accompanying atherosclerosis has not been
evaluated yet.
Edoxaban reduced bleeding complication compared to warfarin in patients with atrial
fibrillation. In addition, the ENGAGE AF TIMI-48 study showed a tendency to reduce cerebral
infarction (p for interaction = 0.08) when administered in combination with one antiplatelet
agent and edoxaban. The administration of antiplatelet agents may be due to patients had
accompanying myocardial infarction or cerebral infarction. This group is also thought to have
a high risk of bleeding due to high HAS-BLED scores. Nonetheless, there was a similar degree
of bleeding in patients receiving additional antiplatelet agents. There was also less
bleeding in the warfarin arm than in the use of additional antiplatelet agents. (Major
bleeding: 0.19 vs 0.24% / yr; intracranial hemorrhage: 0.43 vs 0.57% / yr)
Thus, Edoxaban have good clinical trial results in combination with antiplatelet agents in
atrial fibrillation with atherosclerosis compared to other NOACs(new oral anticoagulants). It
is also considered to be suitable for combination therapy with antiplatelet agents because of
its advantages in different bleeding compared to other warfarin. However, there is no
evidence to suggest that Edoxaban alone or in combination with additional antiplatelet agents
is better for stroke patients with atrial fibrillation and significant arteriosclerosis.
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