不同出血风险ST段抬高型心肌梗死患者经皮冠状动脉介入治疗应用比伐卢定的疗效与安全性研究

Efficacy and safety of bivalirudin in ST-segment elevation myocardial infarction patients with different bleeding risks during emergency percutaneous coronary intervention

  • 摘要:
    目的 比较比伐卢定和普通肝素应用于不同出血风险ST段抬高型心肌梗死(STEMI)患者急诊经皮冠状动脉介入治疗(PCI)围术期的疗效与安全性。
    方法 选取行急诊PCI的615例STEMI患者作为研究对象,根据CRUSADE出血风险评分将其分为低危出血组患者421例(CRUSADE评分≤30分)和中高危出血组患者194例(CRUSADE评分>30分),再根据不同抗凝方案将低危出血组患者分为低危普通肝素组患者203例、低危比伐卢定组患者218例,将中高危出血组患者分为中高危普通肝素组患者95例、中高危比伐卢定组患者99例。观察并比较各组患者术后冠状动脉罪犯血管心肌梗死溶栓治疗(TIMI)血流分级、术后30 d内主要心血管不良事件(MACE)和出血事件的发生情况。
    结果 中高危出血组STEMI患者中,中高危比伐卢定组与中高危普通肝素组的术后TIMI血流分级、MACE发生情况比较,差异均无统计学意义(P>0.05); 中高危比伐卢定组欧美出血学术研究会(BARC)2~5型出血事件发生率、总出血事件发生率分别为13.13%、15.15%, 低于中高危普通肝素组的24.21%、29.47%, 差异有统计学意义(P < 0.05); 中高危比伐卢定组BARC 3~5型出血发生率低于中高危普通肝素组,但差异无统计学意义(P>0.05)。低危出血组STEMI患者中,低危比伐卢定组术后TIMI血流分级、MACE及出血事件发生情况与低危普通肝素组比较,差异均无统计学意义(P>0.05)。
    结论 相较于普通肝素,中高危出血STEMI患者急诊PCI围术期应用比伐卢定进行抗凝治疗能降低出血风险,但并无包括全因死亡在内的最终获益; 低危出血STEMI患者急诊PCI围术期应用比伐卢定或普通肝素在出血和缺血事件方面比较均无显著差异。STEMI患者PCI术前应接受CRUSADE出血风险评估,并根据出血风险选用合适的抗凝药物。

     

    Abstract:
    Objective To compare the perioperative efficacy and safety of bivalirudin and unfractionated heparin in ST-segment elevation myocardial infarction (STEMI) patients with different bleeding risks undergoing emergency percutaneous coronary intervention (PCI).
    Methods A total of 615 STEMI patients who underwent emergency PCI were enrolled in the study. According to CRUSADE bleeding risk score, they were divided into low risk bleeding group(CRUSADE score ≤30, 421 patients) and medium and high risk bleeding group(CRUSADE score >30, 194 patients). Patients in the low risk bleeding group were divided into low-risk heparin group(n=203) and low-risk bivalirudin group(n=218)according to the anticoagulant treatment plan, while the patients in the medium and high risk bleeding group were divided into medium and high risk heparin group (n=95) and medium and high risk bivalirudin group (n=99). The blood flow grade, major adverse cardiovascular events (MACE) and occurrence of bleeding events 30 days after operation in patients with thrombolysis in myocardial infarction (TIMI) were observed and compared in different groups.
    Results Of STEMI patients in moderate and high risk of bleeding group, there were no significant differences in postoperative TIMI blood flow grading and MACE events between the medium and high risk bivalirudin group and the medium and high risk heparin group(P>0.05). The incidence of European and American Hemorrhage Research Committee(BARC)type 2 to 5 bleeding events and total bleeding events in the medium-high risk bivalirudin group were 13.13% and 15.15%, respectively, which were lower than 24.21% and 29.47% in the medium and high risk heparin group (P < 0.05). The incidence of BARC type 3 to 5 bleeding in the medium and high risk bivalirudin group was lower than that in the medium and high risk heparin group, but the difference was not statistically significant (P>0.05). Among STEMI patients in the low risk bleeding group, there were no significant differences in TIMI blood flow grade, MACE and bleeding events between the low risk bivalirudin group and the low risk heparin group (P>0.05).
    Conclusion Compared with unfractionated heparin, perioperative application of bivalirudin anticoagulant therapy can reduce the risk of bleeding in STEMI patients with moderate and high risk of bleeding during emergency PCI, but it does not bring the ultimate benefit including all-cause death. In STEMI patients with low risk of bleeding, there are no significant differences in the incidence of bleeding and ischemic events between bivalirudin and unfractionated heparin. Patients with STEMI should undergo CRUSADE bleeding risk assessment before PCI, and select appropriate anticoagulants according to bleeding risk.

     

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