Trial Outcomes & Findings for Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (F.A.M.E.) (NCT NCT00267774)
NCT ID: NCT00267774
Last Updated: 2017-11-13
Results Overview
All cause death, Documented myocardial infarction, Repeat revascularization (PCI and/or CABG) as adjudicated by the Clinical Event Committee
COMPLETED
NA
1005 participants
1 year
2017-11-13
Participant Flow
Participant milestones
| Measure |
FFR Guided PCI
Fractional flow reserve
|
Angio-guided PCI
Angio-guided PCI
|
|---|---|---|
|
Overall Study
STARTED
|
509
|
496
|
|
Overall Study
COMPLETED
|
509
|
496
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (F.A.M.E.)
Baseline characteristics by cohort
| Measure |
FFR Guided PCI
n=509 Participants
Fractional flow reserve
|
Angio-guided PCI
n=496 Participants
Angio-guided PCI
|
Total
n=1005 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
64.4 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
384 Participants
n=5 Participants
|
360 Participants
n=7 Participants
|
744 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearAll cause death, Documented myocardial infarction, Repeat revascularization (PCI and/or CABG) as adjudicated by the Clinical Event Committee
Outcome measures
| Measure |
FFR Guided PCI
n=509 Participants
Fractional flow reserve
|
Angio-guided PCI
n=496 Participants
Angio-guided PCI
|
|---|---|---|
|
Major Adverse Cardiac Events
|
67 participants
|
91 participants
|
SECONDARY outcome
Timeframe: 1 yearCosts for each strategy included the initial procedural costs and costs during the 1-year follow-up. The costs of the index procedures were calculated from the actual resource consumption by determining the amount of guiding catheters, regular wires, pressure wires, balloon dilatation catheters, stents, antiplatelet therapy, adenosine, contrast media, and hospital days used for each patient's index procedure. These were multiplied by the cost of each resource in US dollars. All costs were converted to 2008 US dollars using the consumer price index (www.bls.gov).
Outcome measures
| Measure |
FFR Guided PCI
n=509 Participants
Fractional flow reserve
|
Angio-guided PCI
n=496 Participants
Angio-guided PCI
|
|---|---|---|
|
Cost Effectiveness Measured as Index Procedural and Hospitalization Costs
|
13,182 US dollars
Standard Deviation 9667
|
14,878 US dollars
Standard Deviation 9509
|
Adverse Events
FFR Guided PCI
Angio-guided PCI
Serious adverse events
| Measure |
FFR Guided PCI
n=509 participants at risk
Fractional flow reserve
|
Angio-guided PCI
n=496 participants at risk
Angio-guided PCI
|
|---|---|---|
|
Cardiac disorders
Death
|
1.8%
9/509 • 1 year
Per protocol, major cardiac events were collected as adverse events.
|
3.0%
15/496 • 1 year
Per protocol, major cardiac events were collected as adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
5.7%
29/509 • 1 year
Per protocol, major cardiac events were collected as adverse events.
|
8.7%
43/496 • 1 year
Per protocol, major cardiac events were collected as adverse events.
|
|
Cardiac disorders
Repeat vascularization
|
6.5%
33/509 • 1 year
Per protocol, major cardiac events were collected as adverse events.
|
9.5%
47/496 • 1 year
Per protocol, major cardiac events were collected as adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place