title: Preventive effect of pretreatment with intravenous nicorandil on contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography (PRINCIPLE Study).
abstract: OBJECTIVE
  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.
  
  
  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 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).
  
  
  CONCLUSIONS
  Prophylactic intravenous infusion of nicorandil did not decrease the incidence of CIN in patients with renal dysfunction undergoing coronary angiography.
authors.affiliation: Division of Cardiology, Severance Cardiovascular Hospital and Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 135-720, Korea.
authors.forename: Young-Guk
authors.initials: YG
authors.lastname: Ko
authors.forename: Byoung-Kwon
authors.initials: BK
authors.lastname: Lee
authors.forename: Woong Chol
authors.initials: WC
authors.lastname: Kang
authors.forename: Jae-Youn
authors.initials: JY
authors.lastname: Moon
authors.forename: Yun Hyeong
authors.initials: YH
authors.lastname: Cho
authors.forename: Seong Hun
authors.initials: SH
authors.lastname: Choi
authors.forename: Myeong-Ki
authors.initials: MK
authors.lastname: Hong
authors.forename: Yangsoo
authors.initials: Y
authors.lastname: Jang
authors.forename: Jong-Youn
authors.initials: JY
authors.lastname: Kim
authors.forename: Pil-Ki
authors.initials: PK
authors.lastname: Min
authors.forename: Hyuck-Moon
authors.initials: HM
authors.lastname: Kwon
mesh_terms: D061605:Administration, Intravenous; D000368:Aged; D003287:Contrast Media / Q000009:adverse effects*; D017023:Coronary Angiography / Q000009:adverse effects* / Q000379:methods; D003404:Creatinine / Q000097:blood; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D015994:Incidence; D007674:Kidney Diseases / Q000139:chemically induced* / Q000453:epidemiology / Q000503:physiopathology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D020108:Nicorandil / Q000008:administration & dosage* / Q000627:therapeutic use
chemical_list: D003287:Contrast Media; D020108:Nicorandil; D003404:Creatinine
keywords: Contrast media; acute kidney injury; coronary artery disease