医学
阿哌沙班
维生素K拮抗剂
内科学
危险系数
心房颤动
急性冠脉综合征
阿司匹林
传统PCI
经皮冠状动脉介入治疗
心脏病学
抗血栓
心肌梗塞
华法林
置信区间
拜瑞妥
作者
Renato D. Lópes,Gretchen Heizer,Ronald Aronson,Amit N. Vora,Tyler Massaro,Roxana Mehran,Shaun G. Goodman,Stephan Windecker,Harald Darius,J. Li,Averkov Ov,M. Cecilia Bahit,Otávio Berwanger,Andrzej Budaj,Ziad Hijazi,Alex Parkhomenko,Peter Sinnaeve,Robert F. Storey,Holger Thiele,Dragoş Vinereanu,Christopher B. Granger,John H. Alexander,Augustus Investigators
标识
DOI:10.1056/nejmoa1817083
摘要
Appropriate antithrombotic regimens for patients with atrial fibrillation who have an acute coronary syndrome or have undergone percutaneous coronary intervention (PCI) are unclear.In an international trial with a two-by-two factorial design, we randomly assigned patients with atrial fibrillation who had an acute coronary syndrome or had undergone PCI and were planning to take a P2Y12 inhibitor to receive apixaban or a vitamin K antagonist and to receive aspirin or matching placebo for 6 months. The primary outcome was major or clinically relevant nonmajor bleeding. Secondary outcomes included death or hospitalization and a composite of ischemic events.Enrollment included 4614 patients from 33 countries. There were no significant interactions between the two randomization factors on the primary or secondary outcomes. Major or clinically relevant nonmajor bleeding was noted in 10.5% of the patients receiving apixaban, as compared with 14.7% of those receiving a vitamin K antagonist (hazard ratio, 0.69; 95% confidence interval [CI], 0.58 to 0.81; P<0.001 for both noninferiority and superiority), and in 16.1% of the patients receiving aspirin, as compared with 9.0% of those receiving placebo (hazard ratio, 1.89; 95% CI, 1.59 to 2.24; P<0.001). Patients in the apixaban group had a lower incidence of death or hospitalization than those in the vitamin K antagonist group (23.5% vs. 27.4%; hazard ratio, 0.83; 95% CI, 0.74 to 0.93; P = 0.002) and a similar incidence of ischemic events. Patients in the aspirin group had an incidence of death or hospitalization and of ischemic events that was similar to that in the placebo group.In patients with atrial fibrillation and a recent acute coronary syndrome or PCI treated with a P2Y12 inhibitor, an antithrombotic regimen that included apixaban, without aspirin, resulted in less bleeding and fewer hospitalizations without significant differences in the incidence of ischemic events than regimens that included a vitamin K antagonist, aspirin, or both. (Funded by Bristol-Myers Squibb and Pfizer; AUGUSTUS ClinicalTrials.gov number, NCT02415400.).
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