Inclusion and Exclusion Criteria for Complete vs Culprit-Only Revascularization Trial
For a trial comparing culprit-lesion-only versus complete revascularization in ACS, include hemodynamically stable adults aged 18-80 years with STEMI or NSTEMI and multivessel coronary artery disease, while excluding patients with cardiogenic shock, cardiac arrest, or those requiring mechanical circulatory support.
Key Inclusion Criteria
Patient Demographics and Presentation
- Age range: 18-80 years (though evidence supports extending to ≥75 years based on the FIRE trial 1)
- Clinical presentation: Acute coronary syndrome (both STEMI and NSTEMI) 2
- Coronary anatomy: Multivessel coronary artery disease with at least one significant non-culprit lesion 3, 1
- Hemodynamic status: Hemodynamically stable patients only 3
Lesion Characteristics
- Visually assessed intermediate coronary artery stenoses in one or more native major epicardial coronary arteries 4
- For NSTEMI patients: non-culprit vessels only should be considered for randomization 4
- Suitable non-culprit lesions amenable to PCI 5
Critical Exclusion Criteria
Hemodynamic Instability
Cardiogenic shock is an absolute exclusion criterion 2, 6. The 2025 ACC/AHA/ACEP/NAEMSP/SCAI guidelines explicitly state that "in patients with ACS and cardiogenic shock, emergency revascularization of the culprit vessel is indicated; however, routine PCI of non-infarct-related arteries at the time of PCI is not recommended" 2. This represents a critical safety consideration, as complete revascularization in shock can be harmful 7.
Procedural Exclusions
- Cardiac arrest at presentation 6
- Need for mechanical circulatory support 6
- Planned or concurrent coronary artery bypass grafting (CABG) 6
Clinical Complexity
- Active bleeding or conditions precluding dual antiplatelet therapy
- Severe renal dysfunction (as this affects outcomes with multivessel PCI) 7
- Life expectancy <1 year from non-cardiac causes
Important Nuances and Considerations
Age Considerations
While the traditional upper age limit is 80 years, the FIRE trial 1 specifically studied patients ≥75 years with high bleeding risk and found that complete revascularization remained beneficial even in this vulnerable population. In elderly patients with high bleeding risk, complete revascularization reduced the composite of death, MI, stroke, or revascularization (HR 0.73,95% CI 0.55-0.96) 1, suggesting age alone should not be an exclusion if patients are otherwise suitable.
Timing Window
For STEMI patients, the MULTISTARS AMI trial 3 enrolled patients who were hemodynamically stable after successful culprit lesion PCI, with staged procedures planned within 19-45 days. This provides a reasonable timeframe for trial enrollment and randomization.
Lesion Assessment Strategy
The trial should specify whether non-culprit lesion significance will be determined by:
- Angiography alone (strongest evidence base) 5
- Physiology-guided assessment (FFR or angiography-derived vFFR) 4, 1
- Hybrid approach
The FIRE trial 1 used physiology-guided assessment (either angiography- or wire-based), which may reduce unnecessary PCI while maintaining benefit.
Common Pitfalls to Avoid
- Do not include patients with cardiogenic shock - this is associated with harm from non-culprit PCI 2, 7
- Ensure hemodynamic stability is confirmed before randomization, not just assumed
- Exclude patients with uncomplicated single-vessel disease - these patients don't have equipoise for the research question
- Document bleeding risk status - the prevalence of high bleeding risk is 71% in elderly MI patients 1, which significantly impacts outcomes
- Verify suitability of non-culprit lesions for PCI - not all multivessel disease is appropriate for complete PCI versus CABG 7
The evidence strongly supports that achieving complete anatomic revascularization (residual SYNTAX score = 0) drives the benefit 8, so inclusion criteria should focus on patients where complete revascularization is technically feasible.