Results from the FAME 2 trial William Fearon Bernard De Bruyne Nico Pijls David Shilane Derek Boothroyd Pim Tonino Emmanuele Barbato Peter Juni ID: 778753
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Slide1
Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients with Stable Coronary Disease: Results from the FAME 2 trial
William
Fearon
, Bernard De
Bruyne
,
Nico
Pijls
, David
Shilane
, Derek
Boothroyd
,
Pim
Tonino
,
Emmanuele
Barbato
, Peter
Juni
, and Mark
Hlatky
on behalf of the FAME 2 Trial Investigators
Slide2Disclosure Statement of Financial Interest
Grant/Research Support
Consulting Fees/Honoraria
Major Stock Shareholder/Equity
Royalty Income
Ownership/FounderIntellectual Property RightsOther Financial Benefit
St. Jude Medical, NIHHeartFlow
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
Company
FAME 2 was sponsored by St. Jude Medical
Slide3Fractional Flow Reserve
Distal
Pressure (Pd)
Proximal
Pressure (Pa)
FFR =
P
d
/ Pa during maximal flow
Pd
P
a
P
d
/ P
a
= 60 / 100
FFR = 0.60
Slide4Primary Endpoint: Death, MI, Urgent Revascularization at 2 years
FAME 2 Trial
Stable patients with 1, 2, or 3 vessel CAD evaluated for PCI with DES
n=1220
FFR in all target lesions
At least 1 stenosis with FFR ≤ 0.80 (n=888)Randomization 1:1
PCI + MTMT
All FFR > 0.80
(n=322)MT
Randomized Trial
Registry
50% randomly assigned to follow-up
Slide5FAME 2 Trial Results
De Bruyne, et al. New Engl J Med 2012;367:991-1001.
FFR-Guided PCI
(n=447)MT(n=441)P-ValuePrimary Endpoint
4.3
12.7
<0.001 Death0.2
0.70.31 Myocardial Infarction
3.43.20.89 Urgent Revascularization1.611.1<0.001Free
from Angina (1 month)7148<0.001%
Slide6Results
Quality of
Life at 1 Month
FFR-Guided PCIMTp-value
Angina (%)
Class 0-1
89
71
<0.001Class 2-41129
<0.001Utility Change0.0540.003
<0.001
Slide7Cumulative Costs over 12 Months
$2,508
$5,485
100%56%11%
% of study population
Slide8FFR-Guided PCI Cost-Effectiveness
In-trial results
$2,500 / 0.047 QALY = $53,000 / QALY Three Year Projection$2,500 / 0.079 QALY = $32,000 / QALY
Slide9Cost-Effectiveness
Study
ComparatorsCE RatioCOURAGEAngio-Guided PCI vs Medical Therapy≥ $168,000 / QALYFAME 1Angio-Guided PCI vs FFR-Guided PCIFFR-Guided PCI is Dominant (↓$ / ↑QALY)FAME 2FFR-Guided
PCI vs Medical Therapy$32,000 / QALYCE Benchmarks:Hemodialysis ≈ $50,000 / QALYWHO GDP std ≈ $150,000 / QALY
>$150,000 / QALY
$50K-150K / QALY
<$50,000 / QALY
Slide10Conclusion:FFR-Guided PCI has higher initial cost than medical therapy.
The cost gap narrows >50% by one year.
Angina and quality of life are significantly improved by PCI.FFR-Guided PCI appears to be economically attractive in cost-effectiveness analysis