Preventive Effect of Pretreatment with Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients with Renal Dysfunction Undergoing Coronary Angiography (PRINCIPLE Study)

Abstract

Purpose: To investigate the effect of pretreatment with intravenous nicorandil on the incidence of contrast-induced nephropathy (CIN) in patients with renal dysfunction undergoing coronary angiography. Materials and Methods: This randomized controlled multicenter study enrolled a total of 166 patients (nicorandil n=81; control n=85) with an estimated glomerular filtration rate <60 mL/min. Nicorandil 12 mg dissolved in 100 mL of 0.9% saline was administered intravenously for 30 minutes just prior to coronary angiography in the nicorandil group. The same volume of only saline was given to the control group. The primary endpoint was the incidence of CIN, defined as >0.5 increase or >25% rise in serum creatinine (SCr) concentration within 48 hours of contrast exposure compared to baseline. Results: The final analysis included 149 patients (nicorandil n=73; control n=76). The baseline characteristics and the total volume of the used contrast (Iodixanol, 125.6 +/- 69.1 mL vs. 126.9 +/- 74.6 mL,p=0.916) were similar between the two groups. The incidence of CIN also did not differ between the nicorandil and control groups (6.8% vs. 6.6%, p=0.794). There was no difference between the two groups in the relative change in SCr from baseline to peak level within 48 hours after coronary angiography (-1.58 +/- 24.07% vs. 0.96 +/- 17.49%, p=0.464), although the nicorandil group showed less absolute change in SCr than the control group (-0.01 +/- 0.43 mg/mL vs. 0.02 +/- 0.31 mg/mL, p=0.005). Conclusion: Prophylactic intravenous infusion of nicorandil did not decrease the incidence of CIN in patients with renal dysfunction undergoing coronary angiography.