替格瑞洛用于亚洲患者急性卒中或短暂性脑缺血发作：来自SOCRATES试验（阿司匹林或替格瑞洛治疗急性卒中或短暂性脑缺血发作及患者预后）
Ticagrelor in Acute Stroke or Transient Ischemic Attack in Asian Patients: From the SOCRATES Trial (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes).
作者信息
Wang Yongjun, Minematsu Kazuo, Wong Ka Sing Lawrence, Amarenco Pierre, Albers Gregory W, Denison Hans, Easton J Donald, Evans Scott R, Held Peter, Jonasson Jenny, Molina Carlos A, Johnston S Claiborne
机构信息
From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Y.W.); China National Clinical Research Center for Neurological Diseases, Beijing (Y.W.); Center of Stroke, Beijing Institute for Brain Disorders, China (Y.W.); Beijing Key Laboratory of Translational Medicine for Cerebrovascular Disease, China (Y.W.); National Cerebral and Cardiovascular Center, Suita, Osaka, Japan (K.M.); Department of Medicine and Therapeutics, Chinese University of Hong Kong (K.S.L.W.); Department of Neurology and Stroke Center, Bichat University Hospital and Medical School, Paris, France (P.A.); Department of Neurology, Stanford University Medical Center, Stanford Stroke Center, Palo Alto, CA (G.W.A.); AstraZeneca, Gothenburg, Sweden (H.D., P.H., J.J.); Department of Neurology, University of California, San Francisco (D.E.); Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA (S.R.E.); Stroke Unit, Hospital Vall d'Hebron, Barcelona, Spain (C.A.M.); and Dean's Office, Dell Medical School, University of Texas, Austin (S.C.J.).
出版信息
Stroke. 2017 Jan;48(1):167-173. doi: 10.1161/STROKEAHA.116.014891. Epub 2016 Nov 29.
BACKGROUND AND PURPOSE
In the SOCRATES trial (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes), ticagrelor was not superior to aspirin. Because of differences in patient demographics and stroke disease pattern in Asia, outcomes of ticagrelor versus aspirin were assessed among Asian patients in a prespecified exploratory analysis.
METHODS
Baseline demographics, treatment effects, and safety of ticagrelor and aspirin were assessed among Asian patients. Differences in outcomes between groups were assessed using Cox proportional hazard model.
RESULTS
A total of 3858 (29.2%) SOCRATES participants were recruited in Asia. Among the Asian patients, the primary end point event occurred in 186 (9.6%) of the 1933 patients treated with ticagrelor, versus 224 (11.6%) of the 1925 patients treated with aspirin (hazard ratio, 0.81; 95% confidence interval, 0.67-0.99). The exploratory P value for treatment-by-region interaction was 0.27. The primary end point event rate in the Asian subgroup was numerically higher than that in the non-Asian group (10.6% versus 5.7%; nominal P<0.01). Among the Asian patients, the rate of PLATO (Platelet Inhibition and Patient Outcomes)-defined major bleeding was similar in the ticagrelor group and the aspirin group (0.6% versus 0.8%; hazard ratio, 0.76; 95% confidence interval, 0.36-1.61).
CONCLUSIONS
The event rates were numerically higher in the Asian patients. Among the Asian patients with acute stroke or transient ischemic attacks, there was a trend toward a lower hazard ratio in reducing risk of the primary end point of stroke, myocardial infarction, or death in the ticagrelor group.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01994720.
背景与目的
在SOCRATES试验（阿司匹林或替格瑞洛治疗急性卒中或短暂性脑缺血发作及患者预后）中，替格瑞洛并不优于阿司匹林。由于亚洲患者的人口统计学特征和卒中疾病模式存在差异，因此在一项预先设定的探索性分析中评估了亚洲患者中替格瑞洛与阿司匹林的疗效。
方法
评估了亚洲患者中替格瑞洛和阿司匹林的基线人口统计学特征、治疗效果及安全性。使用Cox比例风险模型评估组间结局差异。
结果
共有3858名（29.2%）SOCRATES试验参与者来自亚洲。在亚洲患者中，1933例接受替格瑞洛治疗的患者中有186例（9.6%）发生主要终点事件，而1925例接受阿司匹林治疗的患者中有224例（11.6%）发生主要终点事件（风险比，0.81；95%置信区间，0.67 - 0.99）。按地区进行治疗交互作用的探索性P值为0.27。亚洲亚组的主要终点事件发生率在数值上高于非亚洲组（10.6%对5.7%；名义P<0.01）。在亚洲患者中，替格瑞洛组和阿司匹林组中PLATO（血小板抑制和患者预后）定义的大出血发生率相似（0.6%对0.8%；风险比，0.76；95%置信区间，0.36 - 1.61）。
结论
亚洲患者的事件发生率在数值上更高。在患有急性卒中或短暂性脑缺血发作的亚洲患者中，替格瑞洛组在降低卒中、心肌梗死或死亡等主要终点风险方面有风险比更低的趋势。
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