Abstract：
OBJECTIVE: Data on glycoprotein IIb/IIIa inhibitor (GPI) use in real-world acute coronary syndrome (ACS) patients following the introduction of potent P2Y12 inhibitors and newer-generation stents are scant. Here, we aimed to assess the utilization, effectiveness, and safety of GPI in a large prospective multicentre cohort of contemporary ACS patients.
RESULTS: SPUM-ACS prospectively recruited patients presenting with ACS between 2009 and 2017. The primary endpoint of the present study was major adverse cardiovascular events (MACE), a composite of all-cause death, non-fatal myocardial infarction, and non-fatal stroke at 1 year. Secondary endpoints were defined as any bleeding events, Bleeding Academic Research Consortium (BARC) 3-5 bleeding, and net adverse cardiovascular events (NACE). A total of 4395 ACS patients were included in the analysis. GPI-treated patients had more total coronary artery occlusion (56% vs. 35%, P < 0.001) and thrombus (60% vs. 35%, P < 0.001) at angiography. Among the propensity score-matched (PSM) population (1992 patients equally split into two groups), GPI-treated patients showed lower risk of MACE [PSM adjusted hazard ratio (HR) 0.70, 95% CI 0.49-0.99], but a higher risk of any (PSM adjusted HR 1.46, 95% CI 1.06-1.99) and major bleedings (PSM adjusted HR 1.73, 95% CI 1.09-2.76), resulting in a neutral effect on NACE (PSM adjusted HR 0.87, 95% CI 0.65-1.17). These results remained consistent across all subgroups.
CONCLUSIONS: In patients with ACS undergoing percutaneous coronary intervention and receiving potent P2Y12 inhibitors, we observed a reduced risk of MACE and an increased risk of major bleedings at 1 year in patients treated with GPI. Although the routine use of GPI is currently not recommended, they might be considered in selected patients following a personalized balancing between ischaemic and bleeding risks.
RESULTS: SPUM-ACS prospectively recruited patients presenting with ACS between 2009 and 2017. The primary endpoint of the present study was major adverse cardiovascular events (MACE), a composite of all-cause death, non-fatal myocardial infarction, and non-fatal stroke at 1 year. Secondary endpoints were defined as any bleeding events, Bleeding Academic Research Consortium (BARC) 3-5 bleeding, and net adverse cardiovascular events (NACE). A total of 4395 ACS patients were included in the analysis. GPI-treated patients had more total coronary artery occlusion (56% vs. 35%, P < 0.001) and thrombus (60% vs. 35%, P < 0.001) at angiography. Among the propensity score-matched (PSM) population (1992 patients equally split into two groups), GPI-treated patients showed lower risk of MACE [PSM adjusted hazard ratio (HR) 0.70, 95% CI 0.49-0.99], but a higher risk of any (PSM adjusted HR 1.46, 95% CI 1.06-1.99) and major bleedings (PSM adjusted HR 1.73, 95% CI 1.09-2.76), resulting in a neutral effect on NACE (PSM adjusted HR 0.87, 95% CI 0.65-1.17). These results remained consistent across all subgroups.
CONCLUSIONS: In patients with ACS undergoing percutaneous coronary intervention and receiving potent P2Y12 inhibitors, we observed a reduced risk of MACE and an increased risk of major bleedings at 1 year in patients treated with GPI. Although the routine use of GPI is currently not recommended, they might be considered in selected patients following a personalized balancing between ischaemic and bleeding risks.
摘要：
目的：在引入强效P2Y12抑制剂和新一代支架后，糖蛋白IIb/IIIa抑制剂（GPI）在真实世界ACS患者中使用的数据很少。这里,我们的目标是评估利用率，有效性,在当代ACS患者的大型前瞻性多中心队列中，GPI的安全性。
结果：SPUM-ACS前瞻性招募了2009年至2017年间出现ACS的患者。本研究的主要终点是主要不良心血管事件（MACE），全因死亡的复合,非致死性心肌梗死（MI）和非致死性卒中一年。次要终点定义为任何出血事件，BARC3-5放血,和净不良心血管事件（NACE）。总共4395名ACS患者被纳入分析。GPI治疗的患者冠状动脉闭塞更多(56%vs35%,p<0.001）和血栓（60%vs35%，血管造影时p<0.001）。在倾向评分匹配(PSM)人群中(1992名患者平均分为两组)，GPI治疗的患者MACE风险较低（PSM调整后的HR0.70，95％CI0.49-0.99），但任何(PSM调整HR1.46，95%CI1.06-1.99)和重大出血(PSM调整HR1.73，95%CI1.09-2.76)的风险较高，对NACE产生中性效应(PSM调整HR0.87，95%CI0.65-1.17)。这些结果在所有亚组中保持一致。
结论：在接受PCI并接受强效P2Y12抑制剂的ACS患者中，我们观察到接受GPI治疗的患者在1年时MACE风险降低,大出血风险增加.尽管目前不建议常规使用GPI，在缺血性和出血风险之间进行个性化平衡后,可能会在选定的患者中考虑它们.
结果：SPUM-ACS前瞻性招募了2009年至2017年间出现ACS的患者。本研究的主要终点是主要不良心血管事件（MACE），全因死亡的复合,非致死性心肌梗死（MI）和非致死性卒中一年。次要终点定义为任何出血事件，BARC3-5放血,和净不良心血管事件（NACE）。总共4395名ACS患者被纳入分析。GPI治疗的患者冠状动脉闭塞更多(56%vs35%,p<0.001）和血栓（60%vs35%，血管造影时p<0.001）。在倾向评分匹配(PSM)人群中(1992名患者平均分为两组)，GPI治疗的患者MACE风险较低（PSM调整后的HR0.70，95％CI0.49-0.99），但任何(PSM调整HR1.46，95%CI1.06-1.99)和重大出血(PSM调整HR1.73，95%CI1.09-2.76)的风险较高，对NACE产生中性效应(PSM调整HR0.87，95%CI0.65-1.17)。这些结果在所有亚组中保持一致。
结论：在接受PCI并接受强效P2Y12抑制剂的ACS患者中，我们观察到接受GPI治疗的患者在1年时MACE风险降低,大出血风险增加.尽管目前不建议常规使用GPI，在缺血性和出血风险之间进行个性化平衡后,可能会在选定的患者中考虑它们.
