Division of Cardiology, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Hubei Key Laboratory of Genetics and Molecular Mechanism of Cardiologic Disorders, Huazhong University of Science and Technology, Wuhan, 430030, China.
Division of Cardiology, Hebei General Hospital, Shijiazhuang, 050051, China.
Atherosclerosis. 2019 Nov;290:52-58. doi: 10.1016/j.atherosclerosis.2019.09.011. Epub 2019 Sep 21.
International guidelines recommend ticagrelor over clopidogrel as preferred antiplatelet agent in patients following coronary stenting. However, no large real-life evidence is available in East Asians in general, and Chinese in particular, with regard to associated clinical outcomes. The present study aimed to assess the early and delayed outcomes after ticagrelor versus clopidogrel in post stenting Chinese patients.
We conducted the pre-specified interim analysis of Comparison Of Efficacy and Safety Between TIcagrelor and Clopidogrel In Chinese (COSTIC), the ongoing prospective, observational, single-center trial. Primary outcomes include first occurrence of myocardial infarction, stroke, vascular death and Bleeding Academic Research Consortium (BARC) scale bleeding event. Propensity score matching (PSM) was carried out to adjust for differences in baseline characteristics between treatment arms.
In total, 4,465 patients were enrolled. After PSM, the patients prescribed with ticagrelor had a lower incidence of primary efficacy endpoint relative to those with clopidogrel (0.6% vs. 1.4%, HR = 0.44, 95%CI: 0.22-0.89, p = 0.019) at 1 month, but similar at 7 days, 6 months and 12 months. Further analysis indicated that the difference only exists in the subgroup of acute myocardial infarction (AMI) patients. With regard to safety, ticagrelor consistently increased the risk of BARC type 2 bleeding compared to clopidogrel at 1 month, 6 months and 12 months.
These preliminary data indicate that ticagrelor is superior to clopidogrel with regard to major vascular thrombotic outcomes at 1 month, especially in the AMI population, but both groups are similar at 7 days, 6 months and 12 months. Ticagrelor consistently caused significantly more BARC type 2 bleeding.
国际指南建议，在接受冠状动脉支架置入术的患者中，替格瑞洛优于氯吡格雷作为首选抗血小板药物。然而，一般来说，东亚人群，特别是中国人，在相关临床结局方面，缺乏大型真实世界证据。本研究旨在评估中国支架置入术后患者使用替格瑞洛与氯吡格雷的早期和延迟结局。
我们对正在进行的前瞻性、观察性、单中心试验——比较替格瑞洛和氯吡格雷在中国患者中的疗效和安全性（COSTIC）进行了预先设定的中期分析。主要结局包括首次发生心肌梗死、卒中和血管性死亡以及出血学术研究联合会（BARC）出血事件。采用倾向评分匹配（PSM）来调整治疗组之间的基线特征差异。
共纳入 4465 例患者。PSM 后，与氯吡格雷相比，替格瑞洛组的主要疗效终点发生率较低（0.6%比 1.4%，HR=0.44，95%CI：0.22-0.89，p=0.019），但在 7 天、6 个月和 12 个月时相似。进一步分析表明，这种差异仅存在于急性心肌梗死（AMI）患者亚组中。至于安全性，替格瑞洛在 1 个月、6 个月和 12 个月时，与氯吡格雷相比，BARC 2 型出血风险持续增加。
这些初步数据表明，替格瑞洛在 1 个月时在主要血管血栓形成结局方面优于氯吡格雷，尤其是在 AMI 人群中，但在 7 天、6 个月和 12 个月时两组相似。替格瑞洛持续导致 BARC 2 型出血显著增加。
