Effect Of Nicorandil On Contrast-induced Acute Kidney Injury In Patients With Acute ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

【Objective】To investigate the effect of continuous intravenous injection of nicorandil on the incidence of contrast-induced acute kidney injury(CI-AKI)in patients with acute ST-segment elevation myocardial infarction(STEMI)undergoing primary percutaneous coronary intervention(PPCI).【Method】A total of 397 patients with STEMI undering PPCI from January 2015 to December 2017 in Fuzhou General Hospital were enrolled consecutively in this prospective randomized controlled trial.Patients were randomly assigned into two groups:the nicorandil group[2-6mg nicorandil blous before contrast media(CM)administration followed by 0.1ml/(kg·h)in the following 24 hours postoperation,n=199]and the control group[patients received the same dose of saline(NS),n=198].Serum creatinine(SCr),glomerular filtration rate(eGFR),cystatin-C(Cys-C),urinary beta-2-microglobulin(β2-MG)were measured before and after PPCI to evaluate renal function in STEMI patients.The primary outcome was the incidence of CI-AKI,the secondary outcomes included the major adverse cardiovascular events(MACE)during hospitalization[angina within 24 hours after PPCI,worsening cardiac function,malignant arrhythmia,target blood vessels were revascularized,intra aortic balloon counterpulsation(IABP),hypotensive state,cardiovascular death,allcause death]and the need of renal replacement therapy.【Result】1.The baseline characteristics of two groups were similar,without statistically significant difference(P > 0.05).2.With preoperative SCr as a reference,the SCr elevation and ratio,Cys-C difference,urinary β2-MG difference and eGFR difference in nicorandil group were lower than those in control group(all P < 0.05).Among 397 patients,53(13.4%)had CI-AKI,17(8.5%)in nicorandil group and 36(18.2%)in control group.The difference was statistically significant(P < 0.05).3.The results of correlation analysis showed that SCr was moderately correlated with Cys-C,but not with urinary β2-MG.Cys-C was moderately correlated with urinary β2-MG.eGFR was negatively correlated with Cys-C and urinary β2-MG(allP < 0.001).The incidence of CI-AKI after PCI was 22.2%(44/198)in the control group when Cys-C level was 25% higher than baseline level,which was 18.2%(36/198)higher than that of CI-AKI with SCr as diagnostic criterion(P<0.001).The sensitivity and specificity of plasma Cys-C in the diagnosis of CI-AKI after PCI were 94.4% and 93.8%,respectively.The positive predictive value was 77.3% and the negative predictive value was 98.7%.The two diagnostic methods had high consistency(Kappa=0.813,P<0.001).4.In the multivariate logistic regression model,nicorandil acted as an independent protective factor of CI-AKI(OR=0.38,95%CI 0.20~0.72,P=0.003.Whereas,the volume of CM(OR=1.03,95%CI 1.01~1.04,P<0.001)was an independent risk factor for CI-AKI.5.The incidence of angina within 24 hours post PPCI in control group was higher than that in nicorandil group(P<0.05),but there was no significant difference in other MACE and renal replacement therapy events between the two groups(P > 0.05).【Conclusion】1.Intravenous injection of nicorandil perioperatively can reduce the incidence of CI-AKI in STEMI patients undergoing PPCI,but does not improve the short-term prognosis.2.Cys-C is a sensitive and specific index for the detection of renal impairment.It can help clinicians to detect early changes in renal function and intervene in CI-AKI in order to prevent the occurrence of CI-AKI.