Coronary Artery Disease
Conditions
Brief summary
The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design. The overall purpose of the FAME-II trial was to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease and in whom both PCI and medical treatment can be considered on the basis of the presently existing scientific evidence. FAME-II was conducted from 2009 to 2012 and 1-year, 2-year and 5-year results have been published. The purpose of this 10-Year Follow-up is to evaluate the 10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization). Patients will have to sign a specific informed consent for the present 10-year follow-up. This study will be conducted for about approximately 6 months.
Interventions
None listed
Sponsors
Abbott Medical Devices
CoreAalst BV
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with 1. stable angina pectoris (Canadian Cardiovascular Society Class \[CCS\] 1, 2, 3) 2. or, angina pectoris CCS class 4 subsequently stabilized medically (minimum 7 days) or, 3. atypical chest pain or no chest pain but with documented silent ischemia on non-invasive testing. 2. 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 3. Eligible for PCI 4. Signed written informed consent was obtained. Patients will have to sign a specific informed consent for the present 10-year follow-up.
Exclusion criteria
1. Patients in whom the preferred treatment is CABG 2. Patients with left main coronary artery disease requiring revascularization 3. Patients with a recent (less than 1 WEEK) STEMI or Non-STEMI 4. Prior CABG 5. Contra-indication to dual antiplatelet therapy 6. LVEF \< 30% 7. Severe LV hypertrophy (defined as a septal wall thickness at echocardiography of more than 13 mm) 8. Planned need for concomitant cardiac surgery (e.g., valve surgery or resection of aortic or left ventricular aneurysm etc.) 9. Extremely tortuous or calcified coronary arteries precluding FFR measurements 10. A life expectancy of less than 2 years 11. Age under 21 12. Pregnancy or intention to become pregnant during the course of the trial 13. 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 14. Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits 15. Participation or planned participation in another cardiovascular clinical trial before two year follow-up is completed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of major adverse cardiac events after 10 years of follow-up | 10 years | 10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the rate of all-cause death between randomization arms (of the original FAME2 study). | 10 years | Comparison of the rate of all-cause death between randomization arms (of the original FAME2 study). |
| Comparison of the rate of documented myocardial infarction between randomization arms (of the original FAME2 study). | 10 years | Comparison of the rate of documented myocardial infarction between randomization arms (of the original FAME2 study). |
| Comparison of the rate of unplanned hospitalization leading to urgent revascularization between randomization arms (of the original FAME2 study). | 10 years | Comparison of the rate of unplanned hospitalization leading to urgent revascularization between randomization arms (of the original FAME2 study). |
Countries
Belgium, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Serbia, Sweden, United States
Outcome results
None listed