Yonsei Med J.  2013 Jul;54(4):957-964. 10.3349/ymj.2013.54.4.957.

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

• Ko YG
• Lee BK
• Kang WC
• Moon JY
• Cho YH
• Choi SH
• Hong MK
• Jang Y
• Kim JY
• Min PK
• Kwon HM
• PRINCIPLE Investigators

• KMID: 2158232
• DOI: http://doi.org/10.3349/ymj.2013.54.4.957

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 end-point was the incidence of CIN, defined as >0.5 mg/dL 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.

Keyword

Contrast media; acute kidney injury; coronary artery disease

MeSH Terms

Administration, Intravenous
Aged
Contrast Media/*adverse effects
Coronary Angiography/*adverse effects/methods
Creatinine/blood
Female
Glomerular Filtration Rate
Humans
Incidence
Kidney Diseases/*chemically induced/epidemiology/physiopathology/*prevention & control
Male
Middle Aged
Nicorandil/*administration & dosage/therapeutic use
Contrast Media
Nicorandil
Creatinine

Figure

• 

  Fig. 1 Changes in serum creatinine levels. (A) Incidence of contrast-induced nephropathy. (B) Frequency of an increase in serum creatinine level >0.5 mg/dL from baseline. (C) Frequency of an increase in serum creatinine level >25% from baseline. CIN, contrast-induced nephropathy; SCr, serum creatinine.

• 

  Fig. 2 Changes in serum cystatin C levels. Frequency of increases in serum cystatin C >10% (A), >20% (B), and >30% (C) from baseline.

• 

  Fig. 3 Incidences of CIN (A and C) and increase in serum cystatin C >10% from baseline (B and D) in patient subgroups with baseline glomerular filtration rate (GFR) >30 mL/min (A and B) and ≤30 mL/min (C and D). *p value by Fisher exact test. CIN, contrast-induced nephropathy.

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