不同年龄中国患者接受碘克沙醇行PCI的主要不良心脑血管事件及对比剂所致急性肾损伤的差异研究

Studies on the differences of major adverse cardio-and cerebrovascular events and the acute renal injury caused by contrast agents in Chinese patients of different ages receiving iodoxadol for PCI

目的探讨不同年龄段的中国患者应用碘克沙醇行冠脉介入治疗(PCI)的主要不良心脑血管事件及对比剂所致急性肾损伤(CIAKI)的差异。方法自2013年10月30日-2015年10月7日在中国的30个中心入选3042例患者(本研究为IMPERIAL研究,注册号:Chi CTR-ONC-13003733),于其住院期间观察3 d,出院后随访1个月。根据患者年龄分为3组,A组患者≤65岁(n=1748),B组患者65~75岁(n=828),C组患者>75岁(n=466)。主要研究终点为住院期间即PCI术后72 h主要不良心脑血管事件(MACCE,包括靶病变再次血运重建、卒中、支架内血栓、心源性死亡及非致死性心肌梗死)及CIAKI的发生率。次要终点为PCI后72 h^30 d的MACCE发生率。结果3组患者主要终点事件发生情况(靶病变再次血运重建、卒中、支架内血栓、心源性死亡、非致死性心肌梗死)比较差异均无统计学意义(P>0.05)。A、B、C组CIAKI发生率[分别为:7.1%(121/1702),7.8%(63/806),10.7%(49/458)]差异有统计学意义(P=0.016)。次要终点事件发生情况比较:3组患者心源性死亡发生率[A组:0%(0/1748);B组:0.12%(1/828);C组:0.43%(2/466)]差异有统计学意义(P=0.031),而靶病变再次血运重建、卒中、支架内血栓、非致死性心肌梗死比较差异均无统计学意义(P>0.05)。结论不同年龄段的中国患者应用碘克沙醇行PCI安全可行,仅CIAKI及出院后心源性死亡的发生率随年龄增大有增高趋势。

Objective To explore the differences of the main adverse cardio-and cerebrovascular events(MACCE)and contrast-induced acute kidney injur y(CIAKI)in Chinese patients of different ages who receiving percutaneous coronar y intervention(PCI)therapy with iodoxanol.Methods A total of 3042 patients from 30 centers in China were enrolled in present IMPERIAL study(China clinical trial register:Chi CTR-ONC-13003733)from Oct.30,2013 to Oct.7,2015.Enrolled patients were observed for 3 days during hospitalization,and followed-up for one month after discharge.All the enrolled patients were divided into three groups according to their age:patients in group A aged less than 65 years(n=1748),in group B aged 65-75 years(n=828),and in group C were elder than 75 years(n=466).The primary end point was the incidence of MACCE(composite outcomes events of revascularization of target lesions,stroke,stent thrombosis,cardiac death and nonfatal myocardial infarction)and CIAKI in hospital 72 h after PCI.The secondary end point was the incidence of MACCE 72 h-30 d after PCI.Results Primary end point events among the three groups were shown as below:There was no statistical significance in revascularization of target lesions,stroke,stent thrombosis,cardiac death and nonfatal myocardial infarction(P>0.05).The incidence of CIAKI in group A,group B and group C[7.1%(121/1702),7.8%(63/806),and 10.7%(49/458),respectively]showed statistical difference(P=0.016).And the incidence of cardiac death was 0%(0/1748)in group A,0.12%(1/828)in group B,and 0.43%(2/466)in group C,showed significant difference(P=0.031).W hile the incidence showed no statistical significance(P>0.05)of revascularization of target lesions,stroke,stent thrombosis,and nonfatal myocardial infarction among the three groups.Conclusions Iodioxadol is safe and feasible for coronary intervention in Chinese patients of different ages,only CIAKI and the incidence of cardiogenic death after discharge increased with age.