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【論文摘要】Evaluation of the Safety and Efficacy of Edoxaban in AF Patients Undergone PCI
摘要
Previous studies report approximately 5~8% of patients undergoing PCI (percutaneous coronary intervention) have atrial fibrillation. Treatment for atrial fibrillation includes oral anticoagulant for stroke prevention in patients with 1 or more stroke risk factors. On the other hand, patients undergoing PCI should be on dual antiplatelet therapy (DAPT) for at least 6 months or 1 year depending clinical presentation. Triple therapy, simple combination of the two treatment, is necessary to achieve both prevention for stroke and ischemic cardiac events, but with the expense of increased risk of bleeding. It is well known that triple therapy increases risk of bleeding up to 2 to 3 folds compared to oral anticoagulant alone. Thus, maintaining DAPT during the period when ischemic cardiac event risk is high and discontinuation thereafter is a generally adopted strategy to avoid excessive risk of bleeding. In the ENGAGE AF-TIMI 48 trial, edoxaban was noninferior to warfarin for the prevention of stroke or systemic embolism and was associated with significantly lower rates of bleeding and death from cardiovascular causes in patients with nonvalvular atrial fibrillation. However, the safety and efficacy of Edoxaban in patients with nonvalvular atrial fibrillation undergoing PCI. The ENTRUST-AF PCI trial is a multinational, multicenter, randomized, open-label to compare an edoxaban-based antithrombotic strategy with warfarin plus conventional dual-antiplatelet therapy in patients receiving oral anticoagulation for atrial fibrillation and undergoing PCI. Between 4 hours and 5 days after successful PCI, a total of 1500 patients are randomized to the edoxaban group (experimental arm; 60 mg [or 30 mg according to dose reduction criteria] once daily plus a P2Y12 antagonist [default clopidogrel, 75 mg once daily] for 12 months) or the warfarin group (control arm; VKA plus a P2Y12 antagonist [default clopidogrel, 75 mg once daily] plus aspirin [100 mg once daily] for 30 days to 12 months). The primary safety end point is the International Society on Thrombosis and Haemostasis-defined major or clinically relevant non-major bleeding. The main efficacy end point is the composite of cardiovascular death, stroke, systemic embolic events, spontaneous myocardial infarction, and definite stent thrombosis. The results of the ENTRUSTAF PCI trial will be presented soon.