比伐卢定或肝素联合替罗非班在ST段抬高心肌梗死患者直接经皮冠状动脉介入治疗围术期对血栓、出血及P-选择素的影响

摘要

目的 研究急性ST段抬高心肌梗死(STEMI)行直接经皮冠状动脉介入治疗(PCI)患者围术期使用比伐卢定或肝素联合替罗非班对患者血栓、出血发生情况及P-选择素水平的影响.方法 纳入STEMI患者260例,按随机法分为比伐卢定组(129例)和肝素+替罗非班组(131例),分别在PCI术前(用药之前)、术中(用药20 min左右)、术后(手术结束后3h)采取静脉血,检测血清P-选择素水平.观察30 d内出血、血小板减少症和支架内血栓形成事件的预后评估.结果 肝素+替罗非班组患者用药后P-选择素水平先逐渐升高,随时间延长逐渐下降,因而P-选择素水平术中、术后显著大于术前,差异均有统计学意义(均P ＜0.05).比伐卢定组患者用药后,P-选择素水平明显下降,用药后维持在较低水平,停药后回升,因而P-选择素水平术中、术后均显著低于术前,差异均有统计学意义(均P ＜0.05);而术中与术后相比,差异无统计学意义(P＞0.05).两组患者术前P-选择素水平比较,差异无统计学意义(P =0.863),比伐卢定组P-选择素水平术中-术前的差值[(-2.1279±4.81552)pg/ml比(2.5238±6.96788) pg/ml,P＜0.001]、术后-术前的差值[(-1.1692 ±4.43138)pg/ml比(0.9748±6.20749) pg/ml,P=0.006]均显著低于肝素+替罗非班组,差异均有统计学意义.随访30 d,比伐卢定组患者美国出血学术研究会出血标准(BRAC)2 ～5型发生率(0.8％比5.3％,P=0.029)显著低于肝素+替罗非班组,差异有统计学意义.两组患者BRAC3～5型出血、获得性血小板减少症、24 h急性血栓和30 d亚急性血栓发生率比较,差异均无统计学意义(均P＞0.05).结论 比伐卢定可以在短期内降低STEMI患者直接PCI围术期P-选择素水平,而肝素则升高围术期P-选择素水平;比伐卢定可以降低BRAC2～5型出血发生率.%Objective To study effects of bivalirudin and heparin plus tirofiban on plasma P-selectin in patients with ST-segment elevation acute myocardial infarction (STEMI) undergoing emergency percutaneous coronary intervention (PCI) and compare the clinical effects on bleeding and thrombosis.Methods 260 hospitalized patients with acute STEMI who accepted emergency PCI were enrolled in the study.They were randomly divided into the bivalirudin group (129 cases) and the heparin plus tirofiban group (131 cases).Blood samples were taken before operation,during operation (about 20 minutes after medicacion injection) and after operation (three hours after the end of operation).Serum P-selectin levels were measured.All patients were followed-up for 30 days.The main events included hemorrhage within 30 days,acquired thrombocytopenia and stent thrombosis.Results The level of P-selectin increased significantly in the heparin group during operation compared to the preoperative level and remained statistically higher at three hours after the end of operation than preoperative level (P ＜ 0.05).Compared with preoperative level,the P-selectin level of the bivalirudin group was significantly lower than that of heparin group (P ＜ 0.05).After 30 days of follow-up,bivalirudin had lower rates bleeding events compared to the heparin group(5.4％ vs.15.3％,P =0.009).The need of medical intervention for bleeding events (BRAC2-5 hemorrhage) was less in the bivalirudin group(0.8％ vs.5.3％,P =0.029).There was no significant difference in the major bleeding events between the 2 groups (BRAC3-5 hemorrhage) (0 vs.0.8％,P =0.32).No significant difference found between the two groups in acquired thrombocytopenia (P ＞ 0.05).Conclusion Bivalirudin may reduce P-selectin levels in STEMI patients undergone emergency PCI during perioperative period.Heparin increases perioperative P-selectin.Bivalirudin may reduce the bleeding events.