药物洗脱支架置入后氯吡格雷疗程及其对支架血栓的影响

Prevalence,Predictors,and Impact of discontinuation of clopidogrel therapy after drug-eluting stent implantation

目的了解置入药物洗脱支架(DES)患者术后的氯吡格雷治疗状况,探讨不同的疗程对晚期支架血栓(ST)发生的影响。方法连续入选2003年7月1日至2005年6月30日期间接受PCI并置入DES,且术后30天存活的患者,根据术后氯吡格雷的疗程将患者分为4组,即组1(<3月)、组2(3～6月)、组3(6～12月)和组4(>12月)。记录所入选患者住院期和随访期内临床资料,并根据ARCDublin定义判定ST事件。结果共2704例患者符合研究条件入选本研究。与组4患者相比,组1、组2的患者中合并糖尿病者较多,平均左室射血分数(LVEF)值较低,而ST段抬高型心肌梗死(STEMI)者较少,冠状动脉病变在各组之间无显著差异,但所置入DES数目较少。组1中断氯吡格雷治疗的患者中,自行停药比例较高;而组3中断氯吡格雷治疗的患者中,因医嘱停药的比例较高。多因素回归分析显示,影响患者提前中断氯吡格雷治疗的因素为:合并糖尿病(OR=1.542,95%CI1.184～2.008,P=0.001)和所置入DES的数目(OR=0.790,95%CI0.709～0.880,P<0.001)。晚期和晚晚期ST发生率在4组患者间差异有统计学意义(6.1%比1.2%比0.8%比0%,P<0.001),其中组3的ST发生率也较组4升高(0.8%比0%,P=0.013)。结论在临床实践中,有近3/4的患者在DES置入后的氯吡格雷疗程不足12个月。合并糖尿病和置入DES的数目是氯吡格雷疗程的独立影响因素。晚期和晚晚期ST的风险随氯吡格雷疗程的延长而降低。

Objective To evaluate the prevalence and the predictors of clopidogrel therapy after DES implantation, and to determine the impact of discontinuation of clopidogrel therapy on the occurrence of late stent thrombosis （ST） and very late stent thrombosis. Methods Between July 2003 and June 2005, 2 930 consecutive patients treated with PCI and DES implantation in Anzben hospital were involved in the study, and among them, 13 patients died within 3 dys after PCI. A total of 2 704 patients out of the 2 917 patients were followed up successfully for at least 2 years, or mortality. All of the clinical, angiographic and intervention treatment character were recorded. ST was adjudicated by the definition of ARC Dublin. Patients were grouped by the duration of clopidogrel therapy to 4 groups （group 1, 〈 3 months; group 2, 3-6 months; group 3, 6-12 months; group 4, 〉 12 months）. The duration of clopidogrel therapy and the predictors of the premature discontinuation of clopidogrel were evaluated, and the rate of late ST （ 1 month to 12 months） and very late ST （ after 12 months） in the 4 groups were analysised. Results There were 82 （3.0%） patients in group 1,333 （12. 3% ） patients in group 2, 1 590 （58. 8% ） patients in group 3, and 699 （25.9%） patients in group 4. In contrast with group 4, the mean level of total cholesterol were higher, mean LVEF value were lower, more patients were diabetes, less patients were STEMI, and the mean number of DES implantation was less in group 1-3. In group 1 and group 2, most of the discontinuation of clopidogrel therapy （95. 1% , 85.9% respectively） were directed by patients themselves; and in group 3, 71.1% of the patients discortinued elopidogrel therapy on the doctorg order. There was no significant differences among the 3 groups on discontinuation of clopidogrel for bleeding or other operations. By Cox regression, diabetes （OR = 1. 542, 95% CI = 1. 184 - 2. 008, P = 0. 001 ） and number and DES implantation （ OR = 0. 790, 95% CI=0. 709 -0. 880, P 〈 0. 001 ） were found to be the independent predictors of discontinuation of clopidogrel. There were significant differences among the 4 groups on the rate of late ST and very late ST （6.1% vs 1.2% vs0. 8% vs0%, P〈0. 001）. The late ST and very late ST rate of group3 were also significantly higher than that of group 4 （0. 8% vs 0%, P = 0. 013 ）. Conclusion In practice, approaching 75% of patients continue clopidogrel therapy no more than 12 months after DES implantation. Diabetes and number of DES implanted are the risk factors of prematurely discontinuation of clopidogrel therapy. The patients who premature discontinue clopidogrel therapy are prone to suffer from ST.