Coronary Artery Disease
Conditions
Keywords
Stable angina, angina pectoris, PCI, FAME, FAME II, FFR, Fractional Flow Reserve, Pressure wire
Brief summary
The overall purpose of the FAME II trial is 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.
Detailed description
Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.
Interventions
OTHERStenting plus OMT
FFR guided PCI, plus OMT
OTHEROMT
OMT alone
OTHERStandard of care
FFR \> 0.80; treatment according to local practice
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with * stable angina or, * stabilized angina pectoris or, * atypical chest pain or no chest pain but with documented silent ischemia 2. at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium 3. Eligible for PCI 4. Signed written informed consent
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 STEMI or Non-STEMI 4. Prior CABG 5. Contra-indication to dual antiplatelet therapy 6. LVEF \< 30% 7. Severe LV hypertrophy 8. Planned need for concomitant cardiac surgery 9. Extremely tortuous or calcified coronary arteries precluding FFR measurements 10. A life expectancy of less than 2 years 11. Age under 21
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Event Rate (MACE) | 24 Month | MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall MACE | 3 years | Individual components of the primary end point, cardiac death, and nonurgent revascularization |
Countries
Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Serbia, Sweden, United Kingdom, United States
Participant flow
Pre-assignment details
Participants were randomized to Cohort A if at least one stenoses had an FFR value of \<=0.80. Participants with FFR \>0.80 were treated according to local practice and were randomized to study follow-up / no study follow-up in Cohort B. Therefore, participants are either in cohort A or cohort B (not both).
Participants by arm
| Arm | Count |
|---|---|
| Cohort A - PCI Plus OMT PCI plus optimal medical treatment
Stenting plus OMT: FFR guided PCI, plus OMT | 447 |
| Cohort A - OMT Alone Optimal medical treatment alone
Standard of care: OMT alone | 441 |
| Cohort B - Follow-up Observation with treatment based on physician preference | 166 |
| Cohort B - No Follow-up Re-consented Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data. | 116 |
| Total | 1,170 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Various reasons | 40 | 38 | 20 | 12 |
Baseline characteristics
| Characteristic | Cohort A - PCI Plus OMT | Cohort A - OMT Alone | Cohort B - Follow-up | Cohort B - No Follow-up Re-consented | Total |
|---|---|---|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 9.3 | 63.9 years STANDARD_DEVIATION 9.6 | 63.6 years STANDARD_DEVIATION 9.8 | 64.4 years STANDARD_DEVIATION 8.8 | 63.7 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 93 Participants | 103 Participants | 53 Participants | 37 Participants | 286 Participants |
| Sex: Female, Male Male | 354 Participants | 338 Participants | 113 Participants | 79 Participants | 884 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 137 / 447 | 324 / 441 | 55 / 166 | 28 / 116 |
Outcome results
Primary
Major Adverse Cardiac Event Rate (MACE)
MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.
Time frame: 24 Month
Population: The primary outcome analysis was designed for Cohort A only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A - PCI Plus OMT | Major Adverse Cardiac Event Rate (MACE) | Death or Myocardial Infarction | 9.4 percentage of subjects with SAEs |
| Cohort A - PCI Plus OMT | Major Adverse Cardiac Event Rate (MACE) | Death | 3.6 percentage of subjects with SAEs |
| Cohort A - PCI Plus OMT | Major Adverse Cardiac Event Rate (MACE) | Myocardial Infarction | 6.7 percentage of subjects with SAEs |
| Cohort A - PCI Plus OMT | Major Adverse Cardiac Event Rate (MACE) | Cerebrovascular Event | 2.2 percentage of subjects with SAEs |
| Cohort A - PCI Plus OMT | Major Adverse Cardiac Event Rate (MACE) | Non Urgent Revascularization | 6.7 percentage of subjects with SAEs |
| Cohort A - PCI Plus OMT | Major Adverse Cardiac Event Rate (MACE) | Other Serious Adverse Event (SAE) | 0.2 percentage of subjects with SAEs |
| Cohort A - PCI Plus OMT | Major Adverse Cardiac Event Rate (MACE) | Unplanned Hospitalizations with urgent revasc | 1.8 percentage of subjects with SAEs |
| Cohort A - OMT Alone | Major Adverse Cardiac Event Rate (MACE) | Other Serious Adverse Event (SAE) | 0.7 percentage of subjects with SAEs |
| Cohort A - OMT Alone | Major Adverse Cardiac Event Rate (MACE) | Non Urgent Revascularization | 32.7 percentage of subjects with SAEs |
| Cohort A - OMT Alone | Major Adverse Cardiac Event Rate (MACE) | Myocardial Infarction | 9.3 percentage of subjects with SAEs |
| Cohort A - OMT Alone | Major Adverse Cardiac Event Rate (MACE) | Unplanned Hospitalizations with urgent revasc | 13.4 percentage of subjects with SAEs |
| Cohort A - OMT Alone | Major Adverse Cardiac Event Rate (MACE) | Death | 3.9 percentage of subjects with SAEs |
| Cohort A - OMT Alone | Major Adverse Cardiac Event Rate (MACE) | Cerebrovascular Event | 1.4 percentage of subjects with SAEs |
| Cohort A - OMT Alone | Major Adverse Cardiac Event Rate (MACE) | Death or Myocardial Infarction | 12.2 percentage of subjects with SAEs |
Secondary
Overall MACE
Individual components of the primary end point, cardiac death, and nonurgent revascularization
Time frame: 3 years
Population: For registry cohort B, 50% of the patients with an FFR \>0.80 across all lesions were followed up in a registry, and therefore, cohort B group for 'No Follow-up Re-consented' arm had no follow-up result and was not included in the endpoint analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A - PCI Plus OMT | Overall MACE | Nonurgent revascularization | 6.3 percentage of subjects |
| Cohort A - PCI Plus OMT | Overall MACE | Overall MACE | 10.1 percentage of subjects |
| Cohort A - PCI Plus OMT | Overall MACE | Death from any cause | 2.7 percentage of subjects |
| Cohort A - PCI Plus OMT | Overall MACE | Myocardial infarction | 6.3 percentage of subjects |
| Cohort A - PCI Plus OMT | Overall MACE | Urgent revascularization | 4.3 percentage of subjects |
| Cohort A - PCI Plus OMT | Overall MACE | Any revascularization | 10.3 percentage of subjects |
| Cohort A - PCI Plus OMT | Overall MACE | Cardiac death | 1.1 percentage of subjects |
| Cohort A - OMT Alone | Overall MACE | Death from any cause | 3.6 percentage of subjects |
| Cohort A - OMT Alone | Overall MACE | Myocardial infarction | 7.7 percentage of subjects |
| Cohort A - OMT Alone | Overall MACE | Nonurgent revascularization | 30.2 percentage of subjects |
| Cohort A - OMT Alone | Overall MACE | Urgent revascularization | 17.2 percentage of subjects |
| Cohort A - OMT Alone | Overall MACE | Cardiac death | 1.1 percentage of subjects |
| Cohort A - OMT Alone | Overall MACE | Overall MACE | 22 percentage of subjects |
| Cohort A - OMT Alone | Overall MACE | Any revascularization | 44.2 percentage of subjects |
| Cohort B: Registry Cohort | Overall MACE | Urgent revascularization | 6.6 percentage of subjects |
| Cohort B: Registry Cohort | Overall MACE | Death from any cause | 3.0 percentage of subjects |
| Cohort B: Registry Cohort | Overall MACE | Any revascularization | 14.5 percentage of subjects |
| Cohort B: Registry Cohort | Overall MACE | Overall MACE | 12.7 percentage of subjects |
| Cohort B: Registry Cohort | Overall MACE | Myocardial infarction | 6.6 percentage of subjects |
| Cohort B: Registry Cohort | Overall MACE | Nonurgent revascularization | 9.0 percentage of subjects |
| Cohort B: Registry Cohort | Overall MACE | Cardiac death | 1.8 percentage of subjects |