Trial Outcomes & Findings for FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT (NCT NCT01132495)
NCT ID: NCT01132495
Last Updated: 2019-09-16
Results Overview
MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1170 participants
Primary outcome timeframe
24 Month
Results posted on
2019-09-16
Participant Flow
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).
Participant milestones
| Measure |
Cohort A - PCI Plus OMT
PCI plus optimal medical treatment
Stenting plus OMT: FFR guided PCI, plus OMT
|
Cohort A - OMT Alone
Optimal medical treatment alone
Standard of care: OMT alone
|
Cohort B - Follow-up
Observation with treatment based on physician preference
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
447
|
441
|
166
|
116
|
|
Overall Study
COMPLETED
|
407
|
403
|
146
|
104
|
|
Overall Study
NOT COMPLETED
|
40
|
38
|
20
|
12
|
Reasons for withdrawal
| Measure |
Cohort A - PCI Plus OMT
PCI plus optimal medical treatment
Stenting plus OMT: FFR guided PCI, plus OMT
|
Cohort A - OMT Alone
Optimal medical treatment alone
Standard of care: OMT alone
|
Cohort B - Follow-up
Observation with treatment based on physician preference
|
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
|
|---|---|---|---|---|
|
Overall Study
Various reasons
|
40
|
38
|
20
|
12
|
Baseline Characteristics
FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
Baseline characteristics by cohort
| Measure |
Cohort A - PCI Plus OMT
n=447 Participants
PCI plus optimal medical treatment
Stenting plus OMT: FFR guided PCI, plus OMT
|
Cohort A - OMT Alone
n=441 Participants
Optimal medical treatment alone
Standard of care: OMT alone
|
Cohort B - Follow-up
n=166 Participants
Observation with treatment based on physician preference
|
Cohort B - No Follow-up Re-consented
n=116 Participants
Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data.
|
Total
n=1170 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
63.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
63.7 years
STANDARD_DEVIATION 9.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
286 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
354 Participants
n=5 Participants
|
338 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
884 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 MonthPopulation: The primary outcome analysis was designed for Cohort A only.
MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.
Outcome measures
| Measure |
Cohort A - PCI Plus OMT
n=447 Participants
PCI plus optimal medical treatment - Stenting plus OMT: FFR guided PCI, plus OMT
|
Cohort A - OMT Alone
n=441 Participants
Optimal medical treatment alone - Standard of care: OMT alone
|
Cohort B: Registry Cohort
Patients in whom all stenoses had an FFR \>0.80 were entered into a registry
|
|---|---|---|---|
|
Major Adverse Cardiac Event Rate (MACE)
Non Urgent Revascularization
|
6.7 percentage of subjects with SAEs
|
32.7 percentage of subjects with SAEs
|
—
|
|
Major Adverse Cardiac Event Rate (MACE)
Death or Myocardial Infarction
|
9.4 percentage of subjects with SAEs
|
12.2 percentage of subjects with SAEs
|
—
|
|
Major Adverse Cardiac Event Rate (MACE)
Myocardial Infarction
|
6.7 percentage of subjects with SAEs
|
9.3 percentage of subjects with SAEs
|
—
|
|
Major Adverse Cardiac Event Rate (MACE)
Unplanned Hospitalizations with urgent revasc
|
1.8 percentage of subjects with SAEs
|
13.4 percentage of subjects with SAEs
|
—
|
|
Major Adverse Cardiac Event Rate (MACE)
Death
|
3.6 percentage of subjects with SAEs
|
3.9 percentage of subjects with SAEs
|
—
|
|
Major Adverse Cardiac Event Rate (MACE)
Cerebrovascular Event
|
2.2 percentage of subjects with SAEs
|
1.4 percentage of subjects with SAEs
|
—
|
|
Major Adverse Cardiac Event Rate (MACE)
Other Serious Adverse Event (SAE)
|
0.2 percentage of subjects with SAEs
|
0.7 percentage of subjects with SAEs
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: 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.
Individual components of the primary end point, cardiac death, and nonurgent revascularization
Outcome measures
| Measure |
Cohort A - PCI Plus OMT
n=447 Participants
PCI plus optimal medical treatment - Stenting plus OMT: FFR guided PCI, plus OMT
|
Cohort A - OMT Alone
n=441 Participants
Optimal medical treatment alone - Standard of care: OMT alone
|
Cohort B: Registry Cohort
n=166 Participants
Patients in whom all stenoses had an FFR \>0.80 were entered into a registry
|
|---|---|---|---|
|
Overall MACE
Overall MACE
|
10.1 percentage of subjects
|
22 percentage of subjects
|
12.7 percentage of subjects
|
|
Overall MACE
Death from any cause
|
2.7 percentage of subjects
|
3.6 percentage of subjects
|
3.0 percentage of subjects
|
|
Overall MACE
Myocardial infarction
|
6.3 percentage of subjects
|
7.7 percentage of subjects
|
6.6 percentage of subjects
|
|
Overall MACE
Urgent revascularization
|
4.3 percentage of subjects
|
17.2 percentage of subjects
|
6.6 percentage of subjects
|
|
Overall MACE
Any revascularization
|
10.3 percentage of subjects
|
44.2 percentage of subjects
|
14.5 percentage of subjects
|
|
Overall MACE
Nonurgent revascularization
|
6.3 percentage of subjects
|
30.2 percentage of subjects
|
9.0 percentage of subjects
|
|
Overall MACE
Cardiac death
|
1.1 percentage of subjects
|
1.1 percentage of subjects
|
1.8 percentage of subjects
|
Adverse Events
Cohort A - PCI Plus OMT
Serious events: 137 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort A - OMT Alone
Serious events: 324 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B - Follow-up
Serious events: 55 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B - No Follow-up Re-consented
Serious events: 28 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A - PCI Plus OMT
n=447 participants at risk
PCI plus optimal medical treatment
Stenting plus OMT: FFR guided PCI, plus OMT
|
Cohort A - OMT Alone
n=441 participants at risk
Optimal medical treatment alone
Standard of care: OMT alone
|
Cohort B - Follow-up
n=166 participants at risk
Observation with treatment based on physician preference
|
Cohort B - No Follow-up Re-consented
n=116 participants at risk
Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
|
|---|---|---|---|---|
|
Vascular disorders
Non Urgent Revacularization
|
6.7%
30/447 • Number of events 32 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
32.7%
144/441 • Number of events 162 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
8.4%
14/166 • Number of events 18 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
8.6%
10/116 • Number of events 11 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
|
Cardiac disorders
Death or MI
|
9.4%
42/447 • Number of events 48 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
12.2%
54/441 • Number of events 65 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
9.6%
16/166 • Number of events 18 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
6.0%
7/116 • Number of events 7 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
|
Cardiac disorders
Myocardial Infarction
|
6.7%
30/447 • Number of events 32 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
9.3%
41/441 • Number of events 48 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
6.6%
11/166 • Number of events 12 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
2.6%
3/116 • Number of events 3 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
|
Vascular disorders
Unplanned Hospitalization with Urgent Revascularization
|
1.8%
8/447 • Number of events 8 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
13.4%
59/441 • Number of events 63 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
3.6%
6/166 • Number of events 6 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
2.6%
3/116 • Number of events 4 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
|
General disorders
Death
|
3.6%
16/447 • Number of events 16 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
3.9%
17/441 • Number of events 17 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
3.6%
6/166 • Number of events 6 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
3.4%
4/116 • Number of events 4 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
|
General disorders
Cerebrovascular Event
|
2.2%
10/447 • Number of events 10 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
1.4%
6/441 • Number of events 7 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
1.2%
2/166 • Number of events 2 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
0.86%
1/116 • Number of events 1 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
|
General disorders
Other SAE
|
0.22%
1/447 • Number of events 1 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
0.68%
3/441 • Number of events 3 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
0.00%
0/166 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
0.00%
0/116 • Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60