低剂量替格瑞洛治疗稳定型冠心病患者的疗效及安全性评价

 目的  评价低剂量替格瑞洛治疗稳定型冠心病 （stable coronary artery disease,SCAD）患者的疗效及安全性。方法  采用随机平行对照的方法入选SCAD患者413例,分别给予替格瑞洛60 mg/次、2次/日 (n=192)或氯吡格雷50 mg/次、1次/日 (n=221),两组均联合应用阿司匹林100 mg/次、1次/日,疗程12个月。采用3种检测方法多时点评价两组患者的血小板功能;比较两组患者的心血管死亡、非致死性心肌梗死、卒中等主要不良心脑血管事件及出血事件发生率。结果  替格瑞洛组在各时点的血小板高反应性发生率均低于氯吡格雷组,差异有统计学意义;替格瑞洛组较氯吡格雷组主要不良心脑血管事件发生率显著降低,差异有统计学意义 (5.2% vs. 11.7%,HR＝0.412,95%CI为0.193～0.878,P＝0.022);替格瑞洛组出血事件发生率高于氯吡格雷组,但差异无统计学意义。结论  低剂量替格瑞洛抗血小板方案可以降低SCAD患者主要不良心脑血管事件发生率。

Efficacy and safety of low-dose ticagrelor in patients with stable coronary artery disease

Objective  To evaluate the efficacy and safety of low-dose ticagrelor in patients with stable coronary artery disease. Methods  In the randomized,parallel designed clinical trial,413 patients with stable coronary artery disease were assigned to receive either ticagrelor 60 mg twice daily or clopidogrel 50 mg once daily for 12 months (all were given aspirin 100 mg once daily).Platelet function were serially measured at various time points by 3 assessment methods.The main adverse cardiovascular and cerebrovascular events (cardiovascular death,nonfatal myocardial infarction and stroke) and bleeding events were evaluated. Results  Patients with high on-treatment platelet reactivity (HPR) was fewer in ticagrelor group compared with clopidogrel group at various time points.The main adverse cardiovascular and cerebrovascular events occurred in fewer patients in ticagrelor group than in clopidogrel group (5.2% vs. 11.7%,HR＝0.412,95%CI:0.193-0.878,P＝0.022).There was no statistical difference in the rate of bleeding events between clopidogrel and ticagrelor groups. Conclusions  For patients with stable coronary artery disease,low-dose ticagrelor reduced cardiovascular and cerebrovascular events than low-dose clopidogrel.