Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

Launched by POPULATION HEALTH RESEARCH INSTITUTE · Jan 25, 2023

Keywords

ClinConnect Summary

The COMPLETE-2 trial is studying different ways to treat patients who have had a heart attack (either STEMI or NSTEMI) and also have multiple blocked arteries. After successfully treating the main blockage (the culprit lesion) with a procedure called Percutaneous Coronary Intervention (PCI), this trial compares two approaches: one that uses physiological measurements to guide treatment and another that relies on visual assessments from imaging tests (angiography). The goal is to see which method is more effective for helping patients with their heart condition.

To join the trial, patients need to have experienced a heart attack within the last 72 hours and have at least one additional artery that can be treated with PCI. However, patients who have had certain types of heart surgeries or whose heart problems are caused by non-blockage issues will not be eligible. Participants can expect to receive either of the treatment strategies and will be monitored throughout the study to determine the best approach for managing their heart disease. This research aims to help improve future care for patients with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
• 2. Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:
• • 1. Amenable to successful treatment with PCI
• • 2. At least 50% diameter stenosis by visual estimation
• • 3. At least 2.5 mm in diameter
• • 3. Planned complete revascularization strategy for qualifying MI
• Exclusion Criteria:
• • 1. Planned or prior coronary artery bypass graft (CABG) surgery
• • 2. Inability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion abnormalities
• • 3. Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
• • 4. Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
• • 5. Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or \>90% visual diameter stenosis
• • 6. Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion (patients with a CTO plus additional qualifying non-culprit lesions are eligible)
• • 7. The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
• • 8. Baseline STEMI or NSTEMI was due to a suspected non-atherothrombotic mechanism such as type 2 MI (supply-demand mismatch), including spontaneous coronary artery dissection or coronary artery embolism
• • 9. Non-cardiovascular co-morbidity with expected life expectancy \<2 years
• • 10. Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up