替格瑞洛用于急性冠脉综合征行药物洗脱支架植入患者抗血小板治疗有效性及安全性分析

Comparison of ticagrelor with clopidogrel in patients with acute coronary syndromes underwent DES implantation

目的探讨替格瑞洛对急性冠脉综合征行药物洗脱支架植入患者抗血小板治疗的有效性及安全性。方法选取4 401例接受药物洗脱支架植入的急性冠脉综合征患者,在规律应用阿司匹林的基础上（300 mg负荷剂量,100 mg 1次/d）,联用替格瑞洛（180 mg负荷剂量,90 mg 2次/d）或氯吡格雷（300-600 mg负荷剂量,75 mg 1次/d）,并根据联合用药分为替格瑞洛组和氯吡格雷组。研究终点为术后1年内的有效性终点事件（心血管死亡、心肌梗死、缺血性脑卒中、支架内血栓及复合终点事件）和安全性终点事件（根据美国出血学术研究会制定的标准定义划分的全部出血、大出血和小出血事件）。结果替格瑞洛组的有效性的复合终点事件（HR=0.64,95%可信区间0.42-0.99,P〈0.05）和心血管死亡事件（HR=0.07,95%可信区间0.02-0.30,P〈0.01）明显低于氯吡格雷组,且安全性终点中大出血事件,差异无统计学意义（HR=0.97,95%可信区间0.50-1.87,P〉0.05）,但替格瑞洛组小出血和总出血事件明显高于氯吡格雷组。结论对于急性冠脉综合征行药物洗脱支架植入的患者,替格瑞洛与氯吡格雷相比能够明显减少血栓事件再发风险且不增加致命性大出血事件。

Objective To explore the efficacy and safety of ticagrelor in patients with ACS undergoing drug eluting stent （DES） im- plantation. Methods A retrospective study was performed on 4 401 cases of patients with ACS who underwent DES in Beijing Anzhen Hospital from September 2014 to August 2015. All patients received aspirin,2 166 patients were assigned to ticagrelor（ 180 mg loading dose followed by 90 mg twice a day）and 2 344 patients were assigned to clopidogrel （300-600 mg loading dose or continuation with ma- intenance dose followed by 75 mg per day）. The primary endpoints were MACE（ defined as a composite of cardiovascular death,myo- cardial infarction, stroke and stent thrombosis）. The safety endpoint was the incidence of bleeding events defined according to bleeding academic research consortium （BARC）. Results Compared with clopidogrel, the incidence of MACE （2. 94 versus 4. 21, HR = 0. 64, 95 % CI 0. 42-0. 99 ; P = 0.04 ） and the cardiovascular death （ 0. 13 versus 1.88, HR = 0. 07,95 % CI 0. 02-0. 30 ; P 〈 0.01 ） were signif- icantly reduced by ticagrelor. There was no difference between clopidogrel and ticagrelor groups in the rates of major bleeding（ BARC 3 to 5 ） （ 1.27 versus 1.27,HR = 0. 97,95% CI 0. 50-1.87 ;P = 0.93）. However, the risk of BARC 1 and 2 bleeding was increased by ti- cagrelor. Conclusion Ticagrelor seems to be a better option compared with clopidogrel to patients with ACS underwent DES implanta-