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evident
Original paper
2018NEJMNephrology

PRESERVE

Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine

RCTContrast-associated AKI

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Overview

In high-risk angiography, IV bicarbonate was not better than saline, and oral acetylcysteine was not better than placebo, for 90-day death, dialysis, or persistent creatinine rise.

Clinical takeaway

Do not use intravenous sodium bicarbonate or oral acetylcysteine to prevent death, dialysis, persistent creatinine rise, or contrast-associated AKI after angiography.

Key result

In the modified intention-to-treat analysis, the 90-day composite occurred in 4.4% with bicarbonate versus 4.7% with saline (OR 0.93; 95% CI 0.72-1.22; P=0.62) and in 4.6% with acetylcysteine versus 4.5% with placebo (OR 1.02; 95% CI 0.78-1.33; P=0.88).

Practice impact

Skip bicarbonate and acetylcysteine for kidney protection around angiography; use saline if you are giving IV fluid.

Evidence

Study design

Randomized 2-by-2 factorial trial of intravenous 1.26% sodium bicarbonate versus 0.9% sodium chloride and 5 days of oral acetylcysteine versus oral placebo.

Enrollment

5,177

Follow-up

Primary composite at 90 days.

Geography

Not listed

Clinical question

Do intravenous sodium bicarbonate or oral acetylcysteine prevent death, dialysis, or a persistent creatinine rise after angiography in patients at high risk for renal complications?

Population

  • Patients at high risk for renal complications who were scheduled for angiography.

Intervention

Intravenous 1.26% sodium bicarbonate and 5 days of oral acetylcysteine (factorial assignment).

Comparator

Intravenous 0.9% sodium chloride and oral placebo (factorial assignment).

Primary outcome

Composite of death, the need for dialysis, or a persistent increase of at least 50% from baseline in the serum creatinine level at 90 days.

Neither factorial comparison showed a benefit. Bicarbonate versus saline: OR 0.93 (95% CI 0.72-1.22; P=0.62). Acetylcysteine versus placebo: OR 1.02 (95% CI 0.78-1.33; P=0.88).

Odds ratio (bicarbonate vs sodium chloride) / 0.93 / 95% CI 0.72-1.22 / p=0.62

Key results

  • Of 5177 patients randomly assigned, 4993 were included in the modified intention-to-treat analysis. The sponsor stopped the trial after a prespecified interim analysis.
  • There was no interaction between sodium bicarbonate and acetylcysteine for the primary end point (P=0.33).
  • The primary end point occurred in 110 of 2511 patients (4.4%) with sodium bicarbonate versus 116 of 2482 (4.7%) with sodium chloride; odds ratio 0.93 (95% CI 0.72-1.22; P=0.62).
  • The primary end point occurred in 114 of 2495 patients (4.6%) with acetylcysteine versus 112 of 2498 (4.5%) with placebo; odds ratio 1.02 (95% CI 0.78-1.33; P=0.88). There were no significant between-group differences in the secondary end point of contrast-associated acute kidney injury.

Harms

Not listed.

Clinical Use

Practice impact

  • Do not order intravenous bicarbonate or oral acetylcysteine to prevent contrast-associated kidney injury or 90-day death, dialysis, or persistent creatinine rise after angiography.

Applicability

  • Most applicable to patients judged at high risk for renal complications who are undergoing angiography.

Limitations

  • The sponsor stopped the trial after a prespecified interim analysis; the abstract does not state the stopping rule result beyond the null findings.
  • The primary analysis used a modified intention-to-treat population (4993 of 5177 randomized).
  • Contrast-associated AKI was a secondary end point; the abstract reports no significant differences without giving rates.

Common misinterpretations

  • A null result on a 90-day hard composite is not the same as proving contrast never injures the kidney; it means these two prophylaxes did not help.
  • This is not a trial of giving no intravenous fluid; the control fluid was 0.9% sodium chloride.

Citation

Weisbord SD, Gallagher M, Jneid H, et al. Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine. N Engl J Med. 2018;378(7):603-614. doi:10.1056/NEJMoa1710933

Among patients at high risk for renal complications who were undergoing angiography, there was no benefit of intravenous sodium bicarbonate over intravenous sodium chloride or of oral acetylcysteine over placebo for the prevention of death, need for dialysis, or persistent decline in kidney function at 90 days or for the prevention of contrast-associated acute kidney injury.