FAME II-10-year Follow-Up

Prior treatment

• Prior CABG
• Contra-indication to dual antiplatelet therapy
• Planned need for concomitant cardiac surgery (e.g., valve surgery or resection of aortic or left ventricular aneurysm etc.)

Other illness

• Patients with left main coronary artery disease requiring revascularization
• Refusal or inability to sign an informed consent. Mental condition (psychiatric or organ cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the trial or mental retardation or language barrier such that the patient is unable to give informed consent

Lab values

• LVEF \< 30%

Age

• Age under 21

Other

• Patients in whom the preferred treatment is CABG
• Patients with a recent (less than 1 WEEK) STEMI or Non-STEMI
• Severe LV hypertrophy (defined as a septal wall thickness at echocardiography of more than 13 mm)
• Extremely tortuous or calcified coronary arteries precluding FFR measurements
• A life expectancy of less than 2 years
• Pregnancy or intention to become pregnant during the course of the trial
• Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits
• Participation or planned participation in another cardiovascular clinical trial before two year follow-up is completed

• Patients with
  • stable angina pectoris (Canadian Cardiovascular Society Class \[CCS\] 1, 2, 3)
  • or, angina pectoris CCS class 4 subsequently stabilized medically (minimum 7 days) or,
  • atypical chest pain or no chest pain but with documented silent ischemia on non-invasive testing.
• In whom at least one stenosis was present of at least 50% in one major native epicardial coronary artery with a diameter of at least 2.5 mm and supplying viable myocardium
• Eligible for PCI
• Signed written informed consent was obtained. Patients will have to sign a specific informed consent for the present 10-year follow-up.