PRESERVE

Incomplete

Weisbord et al. "Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine". The New England Journal of Medicine. 2018. 378(7):603-614.
PubMed • Full text • PDF

Clinical Question

Among patients undergoing coronary angiography who are at high risk for renal complications, does intravenous sodium bicarbonate vs IV isotonic sodium chloride or oral acetylcysteine vs. placebo prevent death or renal complications?

Bottom Line

Among patients at high risk for renal complications there is no benefit of IV sodium bicarbonate over IV isotonic sodium chloride or of oral acetylcysteine over placebo.

Design

• Two-by-two, factorial, double-blind, placebo and comparator-drug-controlled, randomized trial
• N= 4993 patients
  • 2511 to IV sodium bicarbonate group
  • 2482 to IV sodium chloride group
  • 2495 to oral acetylcysteine group
  • 2498 to placebo group
• Setting: Veterans Affairs sites and George Institute sites
• Enrollment: February 2013 through March 2017
• Follow-up: 90 days
• Analysis: Modified intention-to-treat
• Primary endpoint:
  • Composite of death, the need for dialysis, or a persistent increase of at least 50% from baseline in the serum creatinine level at 90 to 104 days after angiography
• Secondary endpoints:
  • contrast-associated acute kidney injury, which was defined as an increase in serum creatinine of either at least 25% or at least 0.5 mg per deciliter (44 μmol per liter) from baseline at 3 to 5 days after angiography
  • Death within 90 days; dialysis of any kind within 90 days
  • Confirmed persistent kidney impairment at 90 to 104 days
  • Hospitalization with acute coronary syndrome, heart failure, or stroke within 90 days
  • Hospitalization for any cause within 90 days.

Population

Inclusion Criteria

• Undergoing coronary or non-coronary angiographoy
• Pre-angiography eGFR <45ml/min/1.73m2, or eGFR <60ml/min with diabetes
• Able to provide informed consent

Exclusion Criteria

• Dialysis Patients
• Stage 5 CKD
• Unstable baseline creatinine
• Decompensated heart failure
• Emergent Angiogram (within 3 hours of presentation)
• Received iodine contrast in past 5 days
• Known allergy to acetylcysteine
• Known allergy to contrast
• Age <18 years
• Prisoner
• Pregnancy
• Unwilling to comply with 4 day and 90 day outcome assessments
• Participation in concurrent interventional trial

Baseline Characteristics

• Mean Age: 69.8 years old ± 8.2 years
• Male sex: 93.6%
• Diabetes prevalence: 80.9%
• Baseline median serum creatinine: 1.5mg/d (133 μmol/L)

Procedural Characteristics

Interventions

Patients were randomized to:

• Sodium bicarbonate
• Sodium chloride
• Acetylcysteine
• Placebo

Outcomes

'

Primary Outcomes

X

x vs. x

Secondary Outcomes

Hemodynamic effects

BP reduction (change in systolic/diastolic): 5/4 vs. 0/1 (significant but p-value not specified)

Significant increase in HR in ISDN/hydralazine group (p-value not specified)

Adverse Events

Comparisons are X vs. X

Funding

• U.S. Department of Veterans Affairs Cooperative Studies Program
• George Institute for Global Health