Objective To evaluate the infl uence of iodixanol on Chinese patients who had chronic kidney disease(CKD) and received percutaneous coronary intervention complicated with major adverse cardiovascular and cerebrovascular events(MACCE) and contrast-induced acute kidney injury(CIAKI). Methods From 30th October 2013 to 7th October 2015, 3042 patients were enrolled in 30 centers in China. Patients were monitored in the hospital for 3 days and followed-up at 1 month. Patients were divided into chronic kidney disease group(n=105)and non chronic kidney disease group (n=2937) according to whether the patient has chronic nephropathy or not.The primary end point was the incidence rate of MACCE (re-revascularization of target lesions, stroke, stent thrombosis,cardiac death and myocardial infarction) and CIAKI in hospital 72 hours after PCI. The secondary end point was the incidence rate from 72 hours to 30 days post-PCI. Resuits (1)There were obvious differences between the two groups in baseline demographic date including age,BMI,comorbidities of hypertension,congestive heart failure, dyslipidemia,diabetes mellitus,peptic ulcer,ischemic stroke,previous use of antihypertensive drugs, diuretics,lipid-regulating drugs,hypoglycemic drugs,antiplatelet drugs and anticoagulants(all P<0.05).(2) There were obvious differences the CKD and non-CKD groups in perioperative date including operative route,preoperative hydration volume,postoperative hydration volume,total hydration volume,degree of postoporation lesion stenosis, contrast media used and machine injection rate(all P<0.05).(3)There were signifi cant diff erences between the two groups in the percentage of prescription of β-blocker,lipid-regulating drugs and antiplatelet drugs after PCI(all P<0.05).(4)There was not statistical diff erences between two groups in MACCE incidence in hospital and from 72 hours to 30 days post-PCI(P>0.05). (5)There was not statistical diff erences between two the groups in CIAKI incidence in hospital (P>0.05). Conclusions Iodixanol had no signifi cant eff ect on the incidence of MACCE and CIAKI in Chinese chronic kidney disease patients and non-CKD patients who received PCI.%目的 评估碘克沙醇对中国慢性肾病患者行经皮冠状动脉介入治疗(PCI)术后发生主要不良心脑血管事件(MACCE)和对比剂诱发急性肾损伤(CIAKI)的影响.方法 自2013年10月30日至2015年10月9日在中国的30个中心入选3042例患者,对入选的患者住院期间观察3 d,出院后随访1个月.根据患者是否存在慢性肾病分为慢性肾病组(105例)和非慢性肾病组(2937例).主要研究终点为住院期间即PCI术后72 h MACCE(包括靶病变再次血运重建、卒中、支架内血栓、心源性死亡及心肌梗死)和CIAKI的发生率 .次要终点为PCI术后72 h~30 d的MACCE发生率.结果 (1)慢性肾病组患者年龄[(66.28±9.32)岁比(62.89±10.90)岁,P=0.003]、高血压病(83.81% 比59.14%,P<0.001)、充血性心力衰竭(15.24% 比1.94%,P<0.001)、血脂异常(73.33% 比 57.44%,P=0.001)、糖尿病(51.43% 比23.90%,P<0.001)、消化性溃疡(6.67%比2.86%,P=0.036)及缺血性卒中(20.00%比9.02%,P<0.001)比例均高于非慢性肾病组,既往应用抗高血压药(83.81%比69.83%,P=0.002)、利尿药(11.43% 比4.09%,P=0.002)、调脂药物(84.76%比 74.60%,P=0.018)、降糖药物(43.81% 比17.23%,P<0.001)、抗血小板聚集药物(94.29% 比78.21%,P<0.001)和抗凝药物(39.05% 比 24.28%,P=0.001)比例均高于非慢性肾病组,差异均有统计学意义.(2)慢性肾病组和非慢性肾病组患者手术路径(桡动脉路径92.38%比 96.97%,尺动脉路径5.71% 比 2.83%,股动脉路径0.95% 比 0.03%,肱动脉路径0.95%比 0.17%;P=0.006)、术前水化容积[(905.94±486.04)ml 比(521.20±344.76)ml,P<0.001]、术后水化容积[(859.00±433.97)ml比(712.42±419.74)ml,P=0.011]、水 化 总 量[(1407.78±773.45)ml 比(976.20±592.68)ml, P<0.001]、术后病变狭窄程度[(2.10±3.81)%比(1.04±4.15)%,P<0.001]、对比剂剂量[(114.48±52.44)ml比(141.35±57.86)ml,P<0.001]和机器注射对比剂流率[(3.38±1.02)ml/s比(4.67±1.29)ml/s, P<0.001]等围术期指标比较,差异均有统计学意义.(3)慢性肾病组PCI术后应用β阻滞药(11.43%比 19.31%,P=0.043)、调脂药物(17.14% 比 28.77%,P=0.009)、他汀类药物(16.19%比27.99%, P=0.008)及抗血小板聚集药物(28.57% 比 39.94%,P=0.019)比例均低于非慢性肾病组患者,差异均有统计学意义.(4)两组患者住院期间及PCI术后72 h~30 d MACCE发生率比较,差异均无统计学意义(均P>0.05).(5)两组患者住院期间CIAKI发生率比较,差异无统计学意义(P>0.05).结论 碘克沙醇对行PCI的中国慢性肾病患者与非慢性肾病患者MACCE和CIAKI发生率无显著影响.
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