优化高缺血风险ACS患者PCI术后双联抗血小板治疗的研究

Research on optimizing dual antiplatelet therapy for ACS patients with high ischemic risk after PCI surgery

摘要:

目的]探讨经皮冠状动脉介入治疗(PCI)术后高缺血风险的急性冠脉综合征(ACS)患者,在12个月双联抗血小板治疗(DAPT)期间可改善预后的最佳方案。 [方法]回顾性收集2017年3月—2023年9月期间在我院接受PCI的ACS患者,依据OPT-BIRISK研究的高缺血风险评估标准,共纳入3 053例高缺血风险患者。依据术后12个月内DAPT方案的不同,分为三组:①常规治疗组1 729例,给予阿司匹林100 mg＋氯吡格雷75 mg治疗；②降阶治疗组270例,术后3个月内给予阿司匹林100 mg＋替格瑞洛180 mg(替格瑞洛90 mg,Bid)治疗,3个月后降阶为阿司匹林100 mg＋氯吡格雷75 mg或阿司匹林100 mg＋替格瑞洛120 mg(替格瑞洛60 mg,Bid)治疗；③强化治疗组1 054例,给予阿司匹林100 mg＋替格瑞洛180 mg(替格瑞洛90 mg,Bid)治疗。平均随访时间为(11.138±2.094)个月。主要终点为随访期间发生的主要不良心脑血管事件(MACCE),包括心源性死亡、心肌梗死、再次血运重建及卒中。安全性终点为出血事件,包括TIMI大出血和小出血。 [结果]强化治疗组MACCE发生率低于常规治疗组(2.372%比4.743%,P＝0.002)和降阶治疗组(2.372%比5.185%,P＝0.015),出血事件发生率高于常规治疗组(22.676%比13.939%,P＜0.001)和降阶治疗组(22.676%比13.333%,P＝0.001)。而常规治疗组与降阶治疗组之间MACCE、出血事件发生率差异无统计学意义,三组在大出血发生率方面差异亦无统计学意义(P＞0.05)。Cox回归分析显示,强化治疗与较低的MACCE发生风险相关(HR＝0.465,95%CI:0.265～0.816,P＝0.008),强化治疗与较高的出血事件发生风险相关(HR＝1.695,95%CI:1.369～2.098,P＜0.001)。 [结论]对于PCI术后存在高缺血风险的ACS患者,与术后应用氯吡格雷或采取降阶治疗方案相比,采用阿司匹林联合替格瑞洛的强化抗血小板治疗方案,在不增加大出血风险的前提下,与缺血事件发生率的降低具有相关性。

Abstract:

Aim To investigate the optimal dual antiplatelet therapy (DAPT) regimen within 12 months after percutaneous coronary intervention (PCI) for improving the prognosis of acute coronary syndrome (ACS) patients with high ischemic risk. Methods A total of 3 053 ACS patients who underwent PCI in our hospital from March 2017 to September 2023 and were identified as having high ischemic risk according to the OPT-BIRISK study criteria were retrospectively enrolled. According to the different DAPT within 12 months after PCI, they were divided into three groups:①There were 1 729 cases in the conventional treatment group, who were treated with aspirin 100 mg＋clopidogrel 75 mg; ②There were 270 cases in the de-escalation treatment group, who were treated with aspirin 100 mg＋ticagrelor 180 mg (ticagrelor 90 mg, Bid) within 3 months after surgery, and then downgraded to aspirin 100 mg＋clopidogrel 75 mg or aspirin 100 mg＋ticagrelor 120 mg (ticagrelor 60 mg, Bid) after 3 months;③There were 1 054 cases in the intensive treatment group, who were treated with aspirin 100 mg＋ticagrelor 180 mg (ticagrelor 90 mg, Bid). The average follow-up time was (11.138±2.094) months. The primary endpoint was the major adverse cardiovascular and cerebrovascular events (MACCE) that occurred during the follow-up period, including cardiac death, myocardial infarction, revascularization, and stroke. The safety endpoint was bleeding events, including TIMI major bleeding and minor bleeding. Results The incidence of MACCE in the intensive treatment group was lower than that in the conventional treatment group (2.372% vs. 4.743%, P＝0.002) and the de-escalation treatment group (2.372% vs. 5.185%, P＝0.015), and the incidence of bleeding events was higher than that in the conventional treatment group (22.676% vs. 13.939%, P＜0.001) and the de-escalation treatment group (22.676% vs. 13.333%, P＝0.001). There was no statistically significant difference in the incidence of MACCE and bleeding events between the conventional treatment group and the de-escalation treatment group, and there was also no statistically significant difference in the incidence of major bleeding among the three groups (P＞0.05). Cox regression results showed that intensive antiplatelet therapy was associated with a lower risk of MACCE (HR＝0.5,5%CI:0.265～0.816, P＝0.008) and a higher risk of bleeding events (HR＝1.5,5%CI:1.369～2.098, P＜0.001). Conclusion For ACS patients with high ischemic risk after PCI, intensive antiplatelet therapy (aspirin combined with ticagrelor) was associated with a reduced incidence of ischemic events without increasing the risk of major bleeding compared with treatment with clopidogrel and de-escalation therapy.