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

What this study is about

COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.

Who can join (things the study team will check)

✅ You may be able to join if…

• Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
• Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:
  • Amenable to successful treatment with PCI
  • At least 50% diameter stenosis by visual estimation
  • At least 2.5 mm in diameter
• Planned complete revascularization strategy for qualifying MI

🚫 You may not be able to join if…

• Planned or prior coronary artery bypass graft (CABG) surgery
• 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
• Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
• Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
• Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or >90% visual diameter stenosis
• 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)
• The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
• 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
• Non-cardiovascular co-morbidity with expected life expectancy <2 years
• Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up

Where this trial is running

• UCLA, Los Angeles, California, United States
• University of California, San Francisco, San Francisco, California, United States
• Cardiovascular Research Institute of Kansas, Wichita, Kansas, United States
• The Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
• University of Michigan, Ann Arbor, Michigan, United States
• Metropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI), Coon Rapids, Minnesota, United States
• RWJ Barnabas Health, Jersey City, New Jersey, United States
• Bassett Medical Center, Cooperstown, New York, United States
• VA New York Harbor HealthCare System, New York, New York, United States
• NYU Grossman School of Medicine, New York, New York, United States
• Montefiore Medical Center, The Bronx, New York, United States
• Cleveland Clinic, Cleveland, Ohio, United States

+ 101 more sites.

Who to contact

COMPLETE-2 Project Office · (905) 521-2100 · complete-2@phri.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05701358.