水化对行经皮冠状动脉介入治疗患者发生主要不良心脑血管事件及肾损伤的影响

The effect of hydration on the main adverse cardiovascular and cerebrovascular events and kidney injury in patients undergoing percutaneous coronary intervention

目的评估水化治疗对应用碘克沙醇作为对比剂的行经皮冠状动脉介入治疗(PCI)患者预后的影响。方法选取2013年10月至2015年10月来自中国30个中心的行PCI治疗的3 042例冠状动脉粥样硬化性心脏病患者,对所有患者进行术后72 h的观察及出院后30 d的随访。根据患者术前是否进行水化治疗,分为水化组和非水化组。水化组846例,男617例,女229例;非水化组2 196例,男1 596例,女600例。本研究主要终点事件为PCI术后72 h内不良心脑血管事件(MACCE)。其中MACCE定义为:靶病变再次血运重建、卒中、支架内血栓形成、心源性死亡、心肌梗死。次要终点为术后至30 d内的MACCE的发生率及对比剂诱导急性肾损伤(CI-AKI)的发生率。结果(1)两组患者的基线资料比较:水化组与非水化组在年龄[(61.91±10.61)岁、(63.43±10.93)岁,P<0.001)]、体质量指数[(25.19±3.17)kg/m^2、(24.37±3.11)kg/m^2,P<0.001)]、疾病史/手术史[91.84%(777/846)、84.15%(1 848/2 196),P<0.001)]、高脂血症[70.09%(593/846)、53.32%(1 171/2 196),P<0.001]、糖尿病[28.96%(245/846)、23.27%(511/2 196),P=0.001]、应用β受体阻滞剂[38.77%(328/846)、44.99%(988/2 196),P=0.002]、服用降糖药[21.63%(183/846)、16.80%(369/2 196),P=0.002]、阻塞性冠状动脉疾病类型(P<0.001)等方面比较,差异有统计学意义。(2)围术期及用药情况:水化组与非水化组患者PCI水化容量[(641.55±358.52)ml、(813.20±472.17)ml,P<0.001]、水化总容量[(1 113.60±653.08)ml、(813.20±472.17)ml,P<0.001]等比较,差异有显著统计学意义。两组患者术中使用碘克沙醇容量[(153.29±59.69)ml、(135.48±56.42)ml,P<0.001]、利尿剂[1.18%(10/846)、3.42%(75/2 196),P<0.001]、β受体阻滞剂[14.89%(126/846)、20.63%(453/2 196),P<0.001]、其他药物[62.17%(526/846)、56.47%(1 240/2 196),P=0.004]比较,差异有统计学意义。(3)主要终点:术后72 h内发生MACCE,水化组患者27例(3.19%),非水化组44例(2.00%)发生MACCE,其中水化组心肌梗死27例(3.19%),非水化组心源性死亡1例(0.05%),心肌梗死43例(1.96%),差异均无统计学意义。次要终点:行PCI后72 h后至30 d发生MACCE,水化组1例(0.12%),非水化组5例(0.24%),其中水化组心肌梗死1例(0.12%),非水化组靶血管血运重建1例(0.05%),支架内血栓形成1例(0.05%)、心源性死亡3例(0.14%),差异均无统计学意义。PCI术后72 h内两组患者CI-AKI的发生率比较[7.09%(58/846)、8.15%(175/2 196)],差异无统计学意义(P=0.339)。结论等渗对比剂碘克沙醇在中国PCI人群中安全性再次得到证明,水化治疗对于患者预后无不良影响。

Objective To evaluate the prognosis of hydration therapy on patients undergoing percutaneous coronary intervention(PCI)with iodixanol. Methods A retrospective study was performed on 3 042 cases of patients who were admitted from October 2013 to October 2015.All the patients were performed observation 72 hours after operation and 30 days after discharge.According to whether the patients received hydration treatment before surgery, they were divided into the hydration group and the non-hydration group.There were 846 cases in the hydration therapy group, including 617 male cases and 229 female cases.There were 2 196 cases in the non-hydrated therapy group, including 1 596 male cases and 600 female cases.The main endpoint event of this study was major adverse cerebrovascular events(MACCE)within 72 hours after PCI.MACCE was defined as target lesion revascularization, stroke, stent thrombosis, cardiac death, and myocardial infarction.The secondary endpoint was the incidence of MACCE and the incidence of contrast induced acute kidney injury(CI-AKI)within 30 days after surgery. Results (1)Baseline data of The two groups: there were significant differences between hydration therapy group and non-hydrated therapy group in age[(61.91±10.61) years old,(63.43±10.93) years old, P<0.001)], BMI[(25.19±3.17) kg/m^2,(24.37±3.11)kg/m^2, P<0.001)], history of disease/surgery[91.84%(777/846)、84.15%(1 848/2 196), P<0.001)], hyperlipemia[70.09%(593/846)、53.32%(1 171/2 196), P<0.001], diabetes mellitus[28.96%(245/846)、23.27%(511/2 196), P=0.001],β-blocker[38.77%(328/846)、44.99%(988/2 196), P=0.002], hypoglycemic agents[21.63%(183/846)、16.80%(369/2 196), P=0.002]and the obstruction of coronary artery disease(P<0.001).(2)Perioperative period and medication: PCI hydration capacity[(641.55±358.52)ml,(813.20±472.17)ml, P<0.001], and total hydration capacity[(1 113.60±653.08)ml,(813.20±472.17)ml, P<0.001]were differ between the groups.Significant differences were observed in: the dosage of iodixanol[(153.29±59.69)ml,(135.48±56.42)ml, P<0.001], diuretic[1.18%(10/846)、3.42%(75/2 196), P<0.001],β-blocker[14.89%(126/846)、20.63%(453/2 196), P<0.001], and other drugs[62.17%(526/846)、56.47%(1 240/2 196), P=0.004]between the two groups during intraoperation.(3)Main endpoint: MACCE occurred within 72 hours after surgery in 27(3.19%)patients in the hydration group and 44(2.00%)patients in the non-hydration group, including 27(3.19%)patients in the hydration group, 1(0.05%)patients in the non-hydration group and 43(1.96%)patients in the myocardial infarction group.The difference was not statistically significant(P>0.05). Secondary end points: 72 hours after PCI to 30 days after MACCE, hydration group 1 case(0.12%), the hydration group 5 cases(0.24%), the hydration group of myocardial infarction, 1 case(0.12%), 1 case of nonhydratable group target essel revascularization(0.05%), stent thrombosis in 1 case(0.05%), 3 cases(0.14%), cardiac death differences had no statistical significance.The incidence of CI-AKI in the two groups within 72 hours after PCI was compared[7.09%(58/846)、8.15%(175/2 196)], and the difference was not statistically significant(P=0.339). Conclusion The safety of isosmotic contrast agent iodixanol is demonstrated again in Chinese PCI population and no adverse effect is observed of hydration therapy on patient prognosis.