N-acetylcysteine and contrast-induced nephropathy in primary angioplasty

N Engl J Med. 2006 Jun 29;354(26):2773-82. doi: 10.1056/NEJMoa054209.

Abstract

Background: Patients with acute myocardial infarction undergoing primary angioplasty are at high risk for contrast-medium-induced nephropathy because of hemodynamic instability, the need for a high volume of contrast medium, and the lack of effective prophylaxis. We investigated the antioxidant N-acetylcysteine for the prevention of contrast-medium-induced nephropathy in patients undergoing primary angioplasty.

Methods: We randomly assigned 354 consecutive patients undergoing primary angioplasty to one of three groups: 116 patients were assigned to a standard dose of N-acetylcysteine (a 600-mg intravenous bolus before primary angioplasty and 600 mg orally twice daily for the 48 hours after angioplasty), 119 patients to a double dose of N-acetylcysteine (a 1200-mg intravenous bolus and 1200 mg orally twice daily for the 48 hours after intervention), and 119 patients to placebo.

Results: The serum creatinine concentration increased 25 percent or more from baseline after primary angioplasty in 39 of the control patients (33 percent), 17 of the patients receiving standard-dose N-acetylcysteine (15 percent), and 10 patients receiving high-dose N-acetylcysteine (8 percent, P<0.001). Overall in-hospital mortality was higher in patients with contrast-medium-induced nephropathy than in those without such nephropathy (26 percent vs. 1 percent, P<0.001). Thirteen patients (11 percent) in the control group died, as did five (4 percent) in the standard-dose N-acetylcysteine group and three (3 percent) in the high-dose N-acetylcysteine group (P=0.02). The rate for the composite end point of death, acute renal failure requiring temporary renal-replacement therapy, or the need for mechanical ventilation was 21 (18 percent), 8 (7 percent), and 6 (5 percent) in the three groups, respectively (P=0.002).

Conclusions: Intravenous and oral N-acetylcysteine may prevent contrast-medium-induced nephropathy with a dose-dependent effect in patients treated with primary angioplasty and may improve hospital outcome. (ClinicalTrials.gov number, NCT00237614[ClinicalTrials.gov]).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetylcysteine / administration & dosage
  • Acetylcysteine / therapeutic use*
  • Acute Kidney Injury / chemically induced
  • Acute Kidney Injury / prevention & control
  • Aged
  • Angioplasty, Balloon, Coronary*
  • Contrast Media / adverse effects*
  • Creatinine / blood
  • Female
  • Humans
  • Kidney Diseases / chemically induced
  • Kidney Diseases / mortality
  • Kidney Diseases / prevention & control*
  • Logistic Models
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Myocardial Infarction / therapy

Substances

  • Contrast Media
  • Creatinine
  • Acetylcysteine

Associated data

  • ClinicalTrials.gov/NCT00237614