COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events

Other illness

• Patients with MVD requiring coronary artery bypass grafting (CABG) treatment (operator / local heart team decision)
• Patients with severe valvular heart disease likely to require cardiac surgery within the next 2 years

Lab values

• Renal insufficiency (Glomerular Filtration Rate (GFR) \< 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5)

Other

• Lesion located in a grafted segment or in a vein graft
• In-stent restenosis lesions
• Left main trifurcation
• Left main lesion stand-alone (without other lesions)
• Patients with severe tortuous lesions (where FFR and OCT is judged impossible or dangerous)
• Chronic total occlusion
• Spontaneous coronary dissection
• Patients with left ventricle (LV) function less than 30%
• Life expectancy less than 3 years

• Patients undergoing PCI, aged 30-80 years with any clinical presentation
• Angiographic criteria: presence of ≥ 2 de novo target lesions\* located in 2 different native coronary arteries feasible for treatment with PCI (operator / Heart team decision)
  • Angiographic criteria target lesion\* (all criteria I-IV should be applicable):
• DS ≥ 50% on visual estimation II. de novo lesion located in native (non-grafted) vessel III. lesion reference diameter of ≥ 2.0 mm IV. Thrombolysis In Myocardial Infarction (TIMI) 3 flow in all vessels (with exclusion of culprit lesions if MI at presentation)
  • \*Target lesions are either culprit MI lesions or lesions where FFR will be performed. Patients are eligible if they have ≥ 2 target lesions or one culprit and ≥ 1 target lesion.