Prevention of Serious Adverse Events Following Angiography - PRESERVE

Contribution To Literature:

The PRESERVE trial failed to show benefit for n-acetylcysteine or for sodium bicarbonate at preventing contrast-induced nephropathy.

Description:

The goal of the trial was to evaluate sodium bicarbonate versus sodium chloride and n-acetylcysteine versus placebo among high-risk patients undergoing angiography with contrast dye.


Study Design

  • Randomized
  • Parallel
  • Placebo

High-risk patients undergoing angiography with contrast dye were randomized to intravenous 1.26% sodium bicarbonate versus 0.9% sodium chloride and to oral n-acetylcysteine versus placebo.

Study fluids were given pre-angiography 1-3 cc/kg/hr over 1-12 hours, intra-angiography 1-1.5 cc/kg/hr, and post-angiography 1-3 cc/kg/hr over 2-12 hours. N-acetylcysteine was given as 1200 mg twice daily for 5 days, starting 1 hour before angiography.

  • Total number of enrollees: 4,993 (the trial was stopped early after a prespecified interim analysis)
  • Duration of follow-up: 90 days
  • Mean patient age: 70 years
  • Percentage female: 6.5%
  • Percentage with diabetes: 81%

Inclusion criteria:

  • Patients undergoing coronary or noncoronary angiography
  • Chronic kidney disease; estimated glomerular filtration rate (eGFR) 45-60 cc/min plus diabetes or 15-45 with cc/min ± diabetes

Exclusion criteria:

  • Emergent procedure
  • Ongoing acute kidney injury

Other salient features/characteristics:

  • Baseline serum creatinine: 1.5
  • Baseline eGFR: 50.2
  • Pre-angiography fluid: median 344 cc
  • Intra-angiography fluid: median 114 cc
  • Post-angiography fluid: median 570 cc

Principal Findings:

The primary outcome, incidence of death, need for dialysis, or persistent ≥50% increase in serum creatinine at 90 days, occurred in 4.4% of the sodium bicarbonate group versus 4.7% of the sodium chloride group (p = 0.62).

The primary outcome, incidence of death, need for dialysis, or persistent ≥50% increase in serum creatinine at 90 days, occurred in 4.6% of the n-acetylcysteine group versus 4.5% of the placebo group (p = 0.88).

Secondary outcomes:

  • Contrast-induced nephropathy: 9.5% of the sodium bicarbonate group versus 8.3% of the sodium chloride group (p = 0.13)
  • Contrast-induced nephropathy: 9.1% of the n-acetylcysteine group versus 8.7% of the placebo group (p = 0.58)

Interpretation:

Among high-risk patients undergoing angiography with contrast dye, sodium bicarbonate was not superior to sodium chloride and n-acetylcysteine was not superior to placebo at preventing major adverse renal events or at preventing contrast-induced nephropathy. This study likely represents the last major trial on the topic after numerous smaller studies suggested benefit from these strategies. Routine use of sodium bicarbonate and/or n-acetylcysteine can no longer be recommended among high-risk patients undergoing angiography.

References:

Weisbord SD, Gallagher M, Jneid H, et al., on behalf of the PRESERVE Trial Group. Outcomes After Angiography With Sodium Bicarbonate and Acetylcysteine. N Engl J Med 2017;Nov 12:[Epub ahead of print].

Presented by Dr. Steven Weisbord at the American Heart Association Annual Scientific Sessions (AHA 2017), Anaheim, CA, November 12, 2017.


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