药物支架术后低剂量氯吡格雷抗血小板方案的安全性研究

A pilot study on efficacy and safety profile of a low clopidogrel maintenance dose following drug eluting stent implantation

目的比较冠心病患者在置入药物洗脱支架（DES）后服用50 mg氯吡格雷和75 mg氯吡格雷加阿司匹林的双重抗血小板方案的疗效和安全性。方法连续入选2005年6月到2006年12月间在我院初次行经皮冠状动脉介入治疗确定为冠状动脉简单病变并置入1～2枚药物洗脱支架的冠心病患者294例。将符合入选标准的患者随机分成强化管理条件下75 mg组（75IM）和50 mg组（50IM）和一般管理条件下75 mg组（75NM）三组。对于强化管理组的患者通过出院时发放教育材料,电话预约,邮件提醒等强化措施提高患者依从性。三组患者通过门诊或电话随访1年,比较组间死亡、非致死性心肌梗死、支架内血栓、靶血管重建、脑卒中和任何缺血原因的再入院率,以及出血、胃肠道不良反应等药物安全性的差异。结果两组患者基线水平特征无明显差异。75IM组和50IM组6个月及1年期死亡、非致死性心肌梗死、紧急靶血管重建、脑卒中联合终点的发生率差异均无统计学意义;1年期次要联合终点（MACE、脑卒中、任何原因的再血管化及任何缺血原因的再入院）50IM组和75NM组间差异也无统计学意义（OR=0.47,95%CI0.21～1.09,P=0.069）。结论冠状动脉简单病变患者置入DES术后，使用氯吡格雷50mg维持剂量与75mg标降维持剂量相比较，1年期缺血不良事件发生率差异无统计学意义。

Objective To investigate the efficacy and safety profile of a low clopidogrel maintenance dose following drug eluting stent implantation in patients with simple coronary lesions.Methods From June 2005 to Dec 2006,a total of 294 patients who underwent first-time PCI in our center for simple coronary lesions were enrolled consecutively.They were randomized into three subgroups including： treatment with 75 mg of domestic clopidogrel per day,or with 50 mg of domestic clopidogrel per day,and both subgroups belonged to the intensive management （IM） group. Patients in non-intensive management （NM） group would receive 75 mg of clopidogrel （Plavix） treatment per day. All patients were followed for 11 months of dual antiplatelet therapy with adjustable individualized clopidogrel dosage. The primary end point of the study was composite of death, non-fatal myocardial infarction, revascularization and re-hospitalization for cardiac reason. The safety profile including bleeding, leukocytopenia and thrombocytopenia was analyzed. Results Baseline characteristics were similar among the 3 sabgroups. After 1 year of clinical follow-up, the 6-month and 1-year incidences of MACE were similar between the 2 subgroups in the 1M group （ all P 〉 0. 05 ）. There were no statistical difference between the 50 mg IM group and the 75 mg NM group in secondary end-point. Conclusion Maintenance therapy with 50 mg domestic clopidogrel did not increase the 1-year incidence of major adverse cardiac events when compared with standard 75 mg of Plavix therapy.