冠脉复杂病变PCI术后伊诺肝素抗凝对临床事件的影响

Effect of enoxaparin on clinical events in complicated coronary lesions after percutaneous coronary intervention

目的 探讨复杂病变经皮冠状动脉介入治疗（PCI）术后伊诺肝素抗凝对临床事件的影响。方法 入选复杂冠脉病变（B2、C型病变）行PCI术后无特殊并发症的患者288例,随机分为伊诺肝素抗凝组（n=145）与非抗凝组（n=143）,记录住院期间出血事件发生率及住院时间,并分别在住院期间及术后1个月、1年随访时记录主要心血管不良事件（MACEs）。结果 伊诺肝素抗凝组与非抗凝组住院期间、术后1个月、1年时MACEs的发生率差异无统计学意义（住院期间：2.1%vs1.4%,P〉0.05;1个月时：2.8%vs 2.8%,P〉0.05;1年时：5.5%vs 6.3%,P=0.780）。两组间MACEs累计发生率差异无统计学意义（HR=0.875,95%CI 0.337~2.273,P=0.79）。抗凝组与非抗凝组住院期间主要出血发生率（4.8%vs 2.8%,P=0.369）差异无统计学意义,但抗凝组小出血发生率较高（26.2%vs 16.1%,P=0.036）。抗凝组的平均住院天数多于非抗凝组[（6.04±1.64）d vs（5.43±1.54）d,P=0.001]。结论 复杂病变PCI术后非抗凝治疗组不仅不增加心血管事件,而且减少出血事件、缩短住院天数。提示即使是复杂冠脉病变,PCI术后若无特殊并发症可无需肝素抗凝治疗。

Objective To explore the influence of enoxaparin on clinical events in complicated coronary lesions after percutaneous coronary intervention（PCI）.Methods Totally 288 patients with complicated coronary lesions（type B2 and type C）,who had no notable complications following PCI,were recruited in the present study.The patients were randomly assigned to receive either enoxaparin or not.Patients were assessed for major adverse cardiac events（MACEs）during hospitalization and at 1and 12 months after PCI.Results There were no significant differences in the frequency of MACEs between the two groups during hospitalization（2.1% vs 1.4%,P〉0.05）,at 1 month（2.8% vs 2.8%,P〉0.05）or 12 months post-PCI（5.5% vs 6.3%,P=0.780）.The cumulative incidence rates of MACEs were not significantly different between the two groups（HR=0.875,95%CI 0.337-2.273;P=0.79）.The two groups had comparable rates of major bleeding（4.8% vs2.8%,P=0.369）,but that of the minor bleeding was significantly higher in the anticoagulation group（26.2% vs 16.1%,P=0.036）.The average hospital stay in the anticoagulation group were significantly longer than that in the non-anticoagulation group（[6.04±1.64]d vs [5.43±1.54]d,P=0.001）.Conclusion MACEs after PCI is not increased in patients with complicated coronary lesions receiving no anticoagulation compared with those receiving,with less minor bleeding and shorter hospital stay,suggesting that for the patients with complicated coronary lesions,routine anticoagulation therapy is not necessary after PCI without procedure complications.