I Clinica Medica, Atherothrombosis Center, Department of Clinical, Internal, Anesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Rome, Italy.
I Clinica Medica, Atherothrombosis Center, Department of Clinical, Internal, Anesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Rome, Italy; Mediterranea Cardiocentro, Naples, Italy.
Mayo Clin Proc. 2021 Mar;96(3):658-665. doi: 10.1016/j.mayocp.2020.06.057. Epub 2020 Dec 9.
To determine the association between direct oral anticoagulant (DOAC) use and risk of major adverse cardiac events (MACEs) in patients with atrial fibrillation (AF).
This study is a single-center prospective observational cohort study including 2366 outpatients with non-valvular AF on treatment with DOACs or vitamin K antagonists (VKAs) from February 2008 for patients on VKA and September 2013 for patients on novel oral anticoagulants. The primary endpoint was the incidence of MACE including fatal and non-fatal myocardial infarction (MI), cardiac revascularization, and cardiovascular death.
The mean age was 75.1±9.0 years; 44.7% were women. During a mean follow-up of 33.3±21.9 months (6567 patients/years) 133 MACEs occurred (2.03%/year): 79 MI/cardiac revascularization and 54 cardiovascular deaths. Of these, 101 were on VKAs (2.42%/year) and 32 on DOACs (1.34%/year; log-rank test P=.040). This difference was evident also considering MI alone (1.53%/year and 0.63%/year in the VKA and DOAC group, respectively, log-rank test P=.009). At multivariable Cox proportional hazard regression analysis, use of DOACs was associated with a lower risk of MACE (hazard ratio, 0.636; 95% CI, 0.417 to 0.970; P=.036) and MI (hazard ratio, 0.497; 95% CI, 0.276 to 0.896; p=.020). Sensitivity analysis showed that this association was consistent in younger patients (<75 years), in patients with anemia, and in those without chronic obstructive pulmonary disease and heart failure. We also found that both dabigatran and apixaban/rivaroxaban were associated with a lower rate of MACE, with similar efficacy between full and low doses.
DOACs are associated with a lower risk of MACE in patients with AF independently from dosage.
确定直接口服抗凝剂（DOAC）的使用与非瓣膜性心房颤动（AF）患者主要不良心脏事件（MACE）风险之间的关系。
这是一项单中心前瞻性观察队列研究，纳入了 2008 年 2 月至 2013 年 9 月间分别接受维生素 K 拮抗剂（VKA）和新型口服抗凝剂（NOAC）治疗的 2366 例非瓣膜性房颤门诊患者。主要终点是包括致命性和非致命性心肌梗死（MI）、心脏血运重建和心血管死亡在内的 MACE 发生率。
平均年龄为 75.1±9.0 岁，44.7%为女性。平均随访 33.3±21.9 个月（6567 患者/年），共发生 133 例 MACE（2.03%/年）：79 例 MI/心脏血运重建和 54 例心血管死亡。其中 101 例服用 VKA（2.42%/年），32 例服用 DOAC（1.34%/年；log-rank 检验 P=.040）。仅考虑 MI 时也存在这种差异（VKA 和 DOAC 组分别为 1.53%/年和 0.63%/年，log-rank 检验 P=.009）。多变量 Cox 比例风险回归分析显示，DOAC 的使用与较低的 MACE 风险相关（风险比，0.636；95%可信区间，0.417 至 0.970；P=.036）和 MI（风险比，0.497；95%可信区间，0.276 至 0.896；p=.020）。敏感性分析显示，这种关联在年龄较轻的患者（<75 岁）、贫血患者和无慢性阻塞性肺疾病和心力衰竭的患者中是一致的。我们还发现，达比加群和阿哌沙班/利伐沙班均与较低的 MACE 发生率相关，全剂量和低剂量之间的疗效相似。
DOAC 与 AF 患者的 MACE 风险降低相关，与剂量无关。
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