What is the recommended stress ulcer prophylaxis (SUP) regimen for mechanically ventilated patients in the intensive care unit (ICU)?

Pantoprazole for Stress Ulcer Prophylaxis in Mechanically Ventilated ICU Patients: REVISE Study Findings

Based on the REVISE study findings, pantoprazole 40 mg IV daily significantly reduces the risk of clinically important upper gastrointestinal bleeding in mechanically ventilated ICU patients (1.0% vs 3.5%, HR 0.30,95% CI 0.19-0.47), with a number needed to treat of 40 to prevent one episode of clinically important bleeding.

Risk Assessment for Stress Ulcer Prophylaxis

According to the 2024 Society of Critical Care Medicine (SCCM) and American Society of Health-System Pharmacists (ASHP) guidelines, specific risk factors should guide SUP use:

• Primary risk factors that warrant SUP 1:

  • Coagulopathy
  • Shock
  • Chronic liver disease

• Important note: Mechanical ventilation alone is no longer considered an independent risk factor for stress-related upper GI bleeding 1

Interpreting the REVISE Study Results

The REVISE study demonstrates several key findings that support pantoprazole use in high-risk patients:

1. Primary efficacy outcome: Pantoprazole reduced clinically important upper GI bleeding at 90 days (1.0% vs 3.5%, HR 0.30)
2. Secondary outcome: Reduction in patient-important upper GI bleeding in ICU (1.5% vs 4.2%, HR 0.36)
3. Safety considerations:
   • No significant difference in 90-day mortality (29.1% vs 30.9%, HR 0.94)
   • No significant increase in ventilator-associated pneumonia (23.2% vs 23.8%, HR 1.00)
   • Potential increase in C. difficile infection (1.2% vs 0.7%, HR 1.78) that did not reach statistical significance

Algorithmic Approach to SUP in Mechanically Ventilated Patients

1. Assess risk factors:

   • Identify if patient has coagulopathy, shock, or chronic liver disease 1
   • Mechanical ventilation alone is not an indication for SUP

2. Consider enteral nutrition status:

   • Enteral nutrition provides some protection against stress-related GI bleeding 1
   • However, patients with risk factors still benefit from SUP even when enterally fed 1

3. Select appropriate agent and dose:

   • For high-risk patients: Pantoprazole 40 mg IV daily (based on REVISE data)
   • Either PPIs or H2RAs are acceptable first-line options 1
   • Low-dose therapy is preferred over high-dose therapy 1

4. Monitor for complications:

   • Watch for signs of GI bleeding
   • Monitor for potential adverse effects (C. difficile infection)

5. Discontinue when no longer needed:

   • Discontinue SUP when risk factors resolve or when critical illness is no longer evident 1

Important Clinical Considerations

• NNT vs NNH: The number needed to treat with pantoprazole to prevent clinically important upper GI bleeding (40) is much lower than the number needed to harm for ventilator-associated pneumonia (200), suggesting a favorable benefit-risk profile.

• Potential pitfalls:

  • Overuse of SUP in patients without risk factors increases costs and potential harms
  • Continuing SUP beyond ICU discharge when no longer indicated
  • Failure to recognize that mechanical ventilation alone is not an indication for SUP

• Route of administration:

  • Either enteral or IV routes are acceptable for SUP administration 1
  • The REVISE study used IV pantoprazole specifically

Conclusion for Hospital Critical Care Committee

When presenting to your hospital's critical care committee, emphasize that the REVISE study supports using pantoprazole 40 mg IV daily as SUP in mechanically ventilated ICU patients who have additional risk factors (coagulopathy, shock, or chronic liver disease). The significant reduction in GI bleeding events without increased mortality or pneumonia risk provides a strong rationale for this approach in appropriate patients.