COMPLETE Trial Inclusion and Exclusion Criteria
Inclusion Criteria
The COMPLETE trial enrolled patients with STEMI and multivessel coronary artery disease who were hemodynamically stable after successful primary PCI of the culprit lesion 1.
Specific Inclusion Requirements:
- Age ≥18 years
- STEMI presentation requiring primary PCI
- Multivessel coronary artery disease documented on angiography
- Hemodynamically stable after successful culprit vessel PCI
- Significant non-culprit stenosis meeting ALL of the following criteria:
- Stenosis severity ≥70% by visual estimation, OR
- Stenosis severity 50-69% with fractional flow reserve ≤0.80
- Vessel diameter ≥2.5 mm
- Lesion amenable to successful treatment with PCI 1
The trial specifically required that patients have non-culprit vessels suitable for PCI and that the culprit lesion PCI be successful before randomization 1.
Exclusion Criteria
Absolute Exclusions:
- Cardiogenic shock or hemodynamic instability after primary PCI 2, 1
- Failed primary PCI of the culprit vessel 1
- Patient refusal or leaving against medical advice 1
- Death during admission prior to staged procedure 1
Medical Contraindications (Exceptions):
- Acute renal insufficiency precluding additional contrast exposure
- Active bleeding at the time of planned staged PCI
- Coronary anatomy not amenable to further revascularization
- CABG planned for revascularization of non-infarct arteries
- Do not resuscitate status 1
Critical Context
The trial design reflects the principle that complete revascularization should only be pursued in stable STEMI patients with anatomically and physiologically significant non-culprit disease 1. The hemodynamic stability requirement is paramount—patients in cardiogenic shock were explicitly excluded because the CULPRIT-SHOCK trial demonstrated worse outcomes with immediate multivessel PCI in this population 2, 1.
The functional and anatomic thresholds (≥70% stenosis or 50-69% with FFR ≤0.80, vessel ≥2.5 mm) were designed to identify lesions likely to cause future ischemic events while avoiding intervention on lesions unlikely to benefit from revascularization 1.