碘克沙醇对行经皮冠状动脉介入治疗的中国慢性肾病患者主要不良心脑血管事件和对比剂诱发急性肾损伤的多中心前瞻性注册研究A multicenter prospective registration study of iodixanol in the treatment of major adverse cardiovascular and cerebrovascular events and contrast-induced acute kidney injury,in Chinese patients with chronic kidrey disease undergoing percutaneous coronary
公锐,孙蕾,王效增,荆全民,赵昕,马颖艳,王耿,韩雅玲
摘要(Abstract):
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。
关键词(KeyWords): 经皮冠状动脉介入治疗;主要不良心脑血管事件;对比剂诱发急性肾损伤
基金项目(Foundation): 通用电气药业对本研究的支持
作者(Author): 公锐,孙蕾,王效增,荆全民,赵昕,马颖艳,王耿,韩雅玲
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