División Cardiovascular, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.
Instituto do Coracao, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
J Am Coll Cardiol. 2018 Sep 25;72(13):1466-1475. doi: 10.1016/j.jacc.2018.07.037.
There is limited information about the use of antithrombotic therapies and outcomes of Latin American (LatAm) subjects with atrial fibrillation. The global ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation Atrial Fibrillation-Thrombolysis In Myocardial Infarction 48) trial compared the efficacy and safety of edoxaban versus warfarin over a median follow-up of 2.8 years.
The authors aimed to compare adjusted outcomes in Latin America versus outside Latin America and to compare outcomes stratified by anticoagulant treatment and region.
The authors analyzed clinical characteristics and outcomes, adjusted for baseline characteristics, the Human Development Index, and randomized treatment of 2,661 LatAm versus 18,444 non-Latin American subjects (nLAS).
When compared with nLAS, LatAm subjects had a similar overall risk for stroke. After multivariate adjustment, the risks of stroke/systemic embolism (hazard ratio [HR]: 1.19; 95% confidence interval (CI): 0.96 to 1.47; p = 0.11) and major bleeding (HR: 1.10; 95% CI: 0.89 to 1.36; p = 0.39) were similar in LatAm and nLAS. LatAm subjects were at higher adjusted risk of death (HR: 1.48; 95% CI: 1.30 to 1.69; p < 0.001) and intracranial hemorrhage (ICH) (HR: 1.55; 95% CI: 1.00 to 2.41; p = 0.049). In both regions, when compared with warfarin, edoxaban reduced stroke/systemic embolism (HR: 0.64 and 0.91 in LatAm and nLAS, respectively), major bleeding (HR: 0.71 and 0.82), and cardiovascular death (HR: 0.78 and 0.88), without evidence of regional heterogeneity (p = 0.41, 0.50, and 0.70, respectively). There was a greater reduction in hemorrhagic stroke with edoxaban in LatAm (HR: 0.16) than in nLAS (HR: 0.64; p = 0.037).
After multivariable adjustment, LatAm subjects with atrial fibrillation had higher rates of intracranial hemorrhage and death than nLAS. Outcomes with higher-dose edoxaban versus warfarin were at least as favorable in LatAm subjects as in nLAS, with an even greater reduction in hemorrhagic stroke seen in LatAm.
关于抗血栓治疗的使用和拉丁美洲（LatAm）心房颤动患者结局的信息有限。全球 ENGAGE AF-TIMI 48（新型 Xa 因子抗凝剂在心肌梗死 48 小时内治疗心房颤动-溶栓）试验比较了利伐沙班与华法林的疗效和安全性，中位随访时间为 2.8 年。
作者旨在比较拉丁美洲与非拉丁美洲地区的调整结局，并比较按抗凝治疗和地区分层的结局。
作者分析了 2661 例拉丁美洲和 18444 例非拉丁美洲受试者（nLAS）的临床特征和结局，这些特征和结局经过了基线特征、人类发展指数和随机治疗的调整。
与 nLAS 相比，拉丁美洲受试者发生卒中的总体风险相似。经过多变量调整后，卒中/全身性栓塞（风险比[HR]：1.19；95%置信区间[CI]：0.96 至 1.47；p=0.11）和大出血（HR：1.10；95%CI：0.89 至 1.36；p=0.39）的风险在拉丁美洲和 nLAS 之间相似。拉丁美洲受试者的死亡（HR：1.48；95%CI：1.30 至 1.69；p<0.001）和颅内出血（ICH）（HR：1.55；95%CI：1.00 至 2.41；p=0.049）的调整风险更高。在两个地区，与华法林相比，利伐沙班降低了卒中/全身性栓塞（HR：0.64 和 0.91，分别在拉丁美洲和 nLAS）、大出血（HR：0.71 和 0.82）和心血管死亡（HR：0.78 和 0.88），且无区域异质性证据（p=0.41、0.50 和 0.70）。与 nLAS（HR：0.64；p=0.037）相比，在拉丁美洲，利伐沙班降低出血性卒中的效果更大（HR：0.16）。
经过多变量调整后，患有心房颤动的拉丁美洲受试者的颅内出血和死亡率高于 nLAS。与华法林相比，高剂量利伐沙班的结局在拉丁美洲受试者中至少与 nLAS 一样有利，并且在拉丁美洲观察到出血性卒中的更大降幅。
