Comparación de los riesgos de isquemia y sangrado a corto y medio plazo entre heparina no fraccionada y bivalirudina en pacientes con síndrome coronario agudo tras ICP

Objective: To compare the short-and medium-term ischemia and bleeding risk between unfractionated heparin and bivalirudin in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). Methods: A total of 742 patients with ACS who underwent emergency PCI in Xinxiang Central Hospital of Henan Province from January 2016 to June 2022 were selected and divided into unfractionated heparin group (385 cases) and bivalirudin group (357 cases) according to the anticoagulant regimen. All patients were followed up for 6 months. The incidence of ischemic and bleeding events at 30 days and 6 months after operation were compared between the two groups. Multivariate Cox proportional regression model was used to analyze the risk factors of ischemic and bleeding events in the two groups. Kaplan Meier method was used to calculate the cumulative survival rate, and log rank method was used to analyze the difference in survival rates. Results: The age of 742 patients was (62.5±14.8) years old, and male accounted for 58.5% (434 cases). The age of unfractionated heparin group was (61.8±14.8) years old, and male accounted for 59.2% (228 cases); The age of bivalirudin group was (63.3±14.8) years old, and male accounted for 57.7% (206 cases). The incidence of bleeding events at 30 days and 6 months in the unfractionated heparin group were 6.8% (26 cases) and 9.9% (38 cases), respectively, which were higher than 3.4% (12 cases) and 4.5% (16 cases) in the bivalirudin group (all P0.05); The incidence of ischemic events at 30 days and 6 months in the unfractionated heparin group were 7.5% (29 cases) and 11.2% (43 cases), respectively, which were not observed to be significantly different with those in the bivalirudin group [6.2% (22 cases) and 9.5% (34 cases)] (all P0.05). Compared with patients using bivalirudin, the HR value (95%CI) of bleeding events after emergency PCI in patients using unfractionated heparin was 1.964 (1.317-3.125) (P0.05), and the HR value (95%CI) of ischemic events was 0.948(0.595-1.510) (P0.05). The cumulative incidence of bleeding events was 9.9% in unfractionated heparin group and 4.5% in bivalirudin group (P=0.005); The cumulative incidence of ischemic events was 11.2% in unfractionated heparin group and 9.5% in bivalirudin group (P=0.459). Conclusions: The incidence of short-term hemorrhage events in ACS patients treated with bivalirudin anticoagulation after emergency PCI is lower than that of unfractonated heparin, which can reduce the risk of short-term hemorrhage. 目的： 比较普通肝素与比伐芦定应用于急性冠状动脉综合征（ACS）患者经皮冠状动脉介入治疗（PCI）术后中短期缺血及出血风险。 方法： 回顾性纳入河南省新乡市中心医院2016年1月至2022年6月收治的急诊行PCI治疗的ACS患者742例，根据抗凝方案分为普通肝素组（385例）和比伐芦定组（357例），所有患者术后均随访6个月。比较两组患者术后30 d、6个月缺血及出血事件发生情况，采用多因素Cox风险比例回归模型分析两组患者缺血及出血事件发生风险的相关因素，同时采用Kaplan-Meier法计算累积生存率，Log-rank方法分析生存率差异。 结果： 742例患者的年龄为（62.5±14.8）岁，男性占58.5 %（434例）。普通肝素组年龄为（61.8±14.8）岁，男性占 59.2%（228例）；比伐卢定组年龄为（63.3±14.8）岁，男性占 57.7%（206例）。普通肝素组30 d、6个月出血事件发生率分别为6.8%（26例）、9.9%（38例），均高于比伐芦定组的3.4%（12例）、4.5%（16例）（均P0.05）；普通肝素组30 d、6个月缺血事件发生率分别为7.5%（29例）、11.2%（43例），均高于比伐芦定组的6.2%（22例）、9.5%（34例）（均P0.05）。与比伐卢定组相比，普通肝素组急诊PCI术后发生出血事件的HR值（95%CI）为1.964（1.317~3.125）（P0.05），发生缺血事件的HR值（95%CI）为0.948（0.959~1.510）（P0.05）。普通肝素组术后6个月的出血事件累积发生率为9.9%，比伐芦定组为4.5%（P=0.005）；普通肝素组术后6个月的无缺血事件累积发生率为11.2%，比伐芦定组为9.5%（P=0.459）。 结论： 采用比伐芦定抗凝方案的ACS患者急诊PCI术后中短期出血事件发生率比普通肝素低，可降低术后中短期出血的风险。.

Resumen tomado de PubMed (NCBI) para el registro citado, en el idioma original. La versión de referencia es la de la publicación original.

El resumen se deja sin traducir para conservar la redacción original de los autores.

En 742 pacientes con síndrome coronario agudo tras ICP de urgencia (385 heparina no fraccionada; 357 bivalirudina) se compararon hemorragia e isquemia a 30 días y 6 meses. Las hemorragias fueron más frecuentes con heparina (9,9 % frente a 4,5 %; p = 0,005; HR 1,964; IC 95 % 1,317-3,125), sin diferencias significativas en eventos isquémicos (11,2 % frente a 9,5 %; p = 0,459). Según los autores, la bivalirudina puede reducir el riesgo hemorrágico a corto y medio plazo.

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