Iloprost Prevents Contrast-Induced Nephropathy in Patients With Renal Dysfunction Undergoing Coronary Angiography or Intervention - Iloprost Prevents Contrast-Induced Nephropathy

Oct 29, 2009
Font Size
A
A
A
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Bayer AG, Leverkusen, Germany
Date Published:
01/01/2009
Date Updated:
10/29/2009
Original Posted Date:
10/29/2009
References

Description:

The goal of the trial was to evaluate treatment with the prostacyclin analog iloprost in patients with renal insufficiency undergoing coronary angiography or intervention.

Hypothesis:

Iloprost would be more effective in preventing contrast-induced nephropathy.

Study Design

  • Placebo Controlled
  • Randomized
  • Blinded
  • Parallel

Patients Enrolled: 208
Mean Follow Up: 2-5 days
Mean Patient Age: 71 years
Female: 12
Mean Ejection Fraction: 48

Patient Populations:

  • Patients with renal insufficiency undergoing coronary angiography or intervention
  • Renal insufficiency defined as serum creatinine ≥1.4 mg/dl

Exclusions:

  • Circulatory shock of any etiology
  • Systolic blood pressure <95 mm Hg
  • Acute renal failure or end-stage renal disease requiring hemodialysis
  • Administration of contrast dye within the previous 10 days or anticipated re-administration within 6 days
  • Inability to administer study medication within 30 minutes of left heart catheterization
  • ST-elevation myocardial infarction

Primary Endpoints:

  • Contrast-induced nephropathy defined as an absolute increase in serum creatinine ≥0.5 mg/dl or a relative increase ≥25% measured 2-5 days after the procedure

Drug/Procedures Used:

Patients with renal insufficiency undergoing left heart catheterization were randomized to iloprost (n = 103) or placebo (n = 105). Study medication was administered by intravenous infusion 30-90 minutes before and 4 hours after the procedure. All patients received intravenous hydration with normal saline (1.5 ml/kg/h) at least 4 hours before the procedure and at least 12 hours after the procedure.

Concomitant Medications:

At baseline (in the iloprost group), 37% of patients were on a loop diuretic, 49% on an angiotensin-converting enzyme inhibitor, 83% on a statin, and 7% on N-acetylcysteine.

Principal Findings:

Overall, 208 patients were randomized. In the iloprost group at baseline, the mean age was 71 years, 12% were women, body mass index was 27.7 kg/m2, left ventricular ejection fraction was 48%, blood pressure was 144/75 mm Hg, diabetes was 50%, clinical heart failure was 23%, volume of contrast agent was 257 ml, and total intravenous hydration was 2232 ml. Serum creatinine was 1.63 mg/dl in the iloprost group versus 1.59 mg/dl in the placebo group.

Iso-osmolar contrast was administered in 68% and low osmolar in 35%. Coronary intervention was performed in 85 stable patients and 11 acute coronary syndrome patients. The Mehran contrast-induced risk score was 9.7 in the iloprost group and 9.8 in the placebo group, which corresponds to a predicted contrast nephropathy incidence of 20%.

Contrast-induced nephropathy (defined by absolute or relative increase in serum creatinine) occurred in 8% of the iloprost group versus 22% of the placebo group (p = 0.005). The absolute change in serum creatinine was 0.03 mg/dl with iloprost versus 0.14 mg/dl with placebo (p = 0.11), while the change in estimated glomerular filtration rate was 1.1 ml/min/1.73 m2 with iloprost versus -3.1 ml/min/1.73 m2 with placebo (p = 0.008). Follow-up serum creatine was 1.66 mg/dl with iloprost versus 1.73 mg/dl with placebo (p = 0.49).

Interpretation:

Among patients with renal insufficiency undergoing coronary angiography ± revascularization, the use of iloprost appears to be beneficial. This agent was associated with a reduced incidence of contrast-induced nephropathy of approximately 70%. Moreover, there was a slight increase in estimated glomerular filtration rate with iloprost and a slight decrease with placebo. Despite the reduction in contrast-induced nephropathy, follow-up creatinine was similar between the groups 2-5 days after the procedure.

Initial studies indicated that N-acetylcysteine and sodium bicarbonate infusion could prevent contrast-induced nephropathy; however, the benefit appeared less robust with more studies. Therefore, iloprost will need to be corroborated with additional studies.

References:

Spargias K, Adreanides E, Demerouti E, et al. Iloprost prevents contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention. Circulation 2009;120:1793-9.

Keywords: Acute Coronary Syndrome, Iloprost, Follow-Up Studies, Cardiac Catheterization, Blood Pressure, Sodium Bicarbonate, Creatinine, Contrast Media, Renal Insufficiency, Kidney Diseases, Body Mass Index, Coronary Angiography, Heart Failure, Stroke Volume, Glomerular Filtration Rate, Prostaglandins I, Infusions, Intravenous, Diabetes Mellitus


< Back to Listings