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FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD. Fractional Flow Reserve–Guided PCI versus Medical Therapy in Stable Coronary Disease FAME 2 Clinicaltrials.gov NCT01132495. Bernard De Bruyne, Nico H.J. Pijls, William F Fearon, Peter Juni, Emanuele Barbato, Pim Tonino,
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FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Fractional Flow Reserve–Guided PCI versus Medical Therapy in Stable Coronary Disease FAME 2 Clinicaltrials.gov NCT01132495 Bernard De Bruyne, Nico H.J. Pijls, William F Fearon, Peter Juni, Emanuele Barbato, Pim Tonino, for the FAME 2 study group
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Potential conflicts of interest Speaker’s name: Bernard De Bruyne I have the following potential conflicts of interest to report: Research contracts Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest Study Supported by St. Jude Medical
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Background • In patients with stable coronary disease, PCI has not been • shown to improve prognosis • FAME 1 demonstrated the superiority of FFR-guided over • angiography-guided PCI • In previous trials, revascularization has been guided by • the angiographic appearance of the lesions • It is likely that in previous trials a sizable proportion of • patients had no or little ischemia
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Objective To compare clinical outcomes of FFR- guided contemporary PCI plus the best available medical therapy (MT) versus MT alone in patients with stable coronary disease
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Inclusion Criteria • Referred for PCI because of • Stable angina pectoris (CCS 1, 2, 3) • Stabilized angina pectoris CCS class 4 • Atypical or no chest pain with documented • ischemia • And • Angiographic 1, 2, or 3 vessel disease
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Exclusion Criteria • Prior CABG • LVEF < 30% • LM disease
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Primary End Point • Composite of • all cause death • myocardial infarction • unplanned hospitalization with urgent revascularization
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Flow Chart Stable CAD patients scheduled for 1, 2 or 3 vessel DES-PCI N = 1220 FFR in all target lesions Registry Randomized Trial When all FFR > 0.80 (n=332) At least 1 stenosis with FFR ≤ 0.80 (n=888) Randomization 1:1 PCI + MT MT MT 27% 73% 50% randomly assigned to FU Follow-up after 1, 6 months, 1, 2, 3, 4, and 5 years
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Study Centers (n=28)
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Study Centers (n=28)
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD DSMB Recommendation On recommendation of the independent Data and Safety Monitoring Board* recruitment was halted on January 15th, 2012 after inclusion of 1220 patients (± 54% of the initially planned number of randomized patients) *DSMB: Stephan Windecker, Chairman, Stuart Pocock, Bernard Gersh
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Baseline Clinical Characteristics (1) *P value compares all RCT patients with patients in registry
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Baseline Clinical Characteristics (2) *P value compares all RCT patients with patients in registry
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Angiographic Characteristics *P value compares all RCT patients with patients in registry
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD FFR Measurements * P value compares all RCT patients with patients in registry ** Chronic occlusions in the registry patients were arbitrarily assigned an FFR value of 0.50. These patients also had another lesion >50% with an FFR >0.80.
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Primary Outcomes PCI+MT vs. MT: HR 0.32 (0.19-0.53); p<0.001 30 PCI+MT vs. Registry: HR 1.29 (0.49-3.39); p=0.61 MT vs. Registry: HR 4.32 (1.75-10.7); p<0.001 25 20 Cumulative incidence (%) 15 10 5 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Months after randomization No. at risk MT 441 414 370 322 283 253 220 192 162 127 100 70 37 PCI+MT 447 414 388 351 308 277 243 212 175 155 117 92 53 Registry 166 156 145 133 117 106 93 74 64 52 41 25 13
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Death from any Cause PCI+MT vs. MT: HR 0.33 (0.03-3.17); p=0.31 30 PCI+MT vs. Registry: HR 1.12 (0.05-27.33); p=0.54 25 MT vs. Registry: HR 2.66 (0.14-51.18); p=0.30 20 Cumulative incidence (%) 15 10 5 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Months after randomization No. at risk MT 441 423 390 350 312 281 247 219 188 154 122 90 54 PCI+MT 447 423 396 359 318 288 250 220 183 163 122 95 54 Registry 166 156 145 134 118 107 96 76 67 55 43 27 13
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Myocardial Infarction 30 PCI+MT vs. MT: HR 1.05 (0.51-2.19); p=0.89 PCI+MT vs. Registry: HR 1.61 (0.48-5.37); p=0.41 25 MT vs. Registry: HR 1.65 (0.50-5.47); p=0.41 20 Cumulative incidence (%) 15 10 5 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Months after randomization No. at risk MT 441 421 386 341 304 273 239 212 182 148 117 85 48 PCI+MT 447 414 388 352 309 278 244 214 177 157 119 94 54 Registry 166 156 145 134 118 107 95 75 65 53 42 26 13
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Urgent Revascularization 30 PCI+MT vs. MT: HR 0.13 (0.06-0.30); p<0.001 PCI+MT vs. Registry: HR 0.63 (0.19-2.03); p=0.43 25 MT vs. Registry: HR 4.65 (1.72-12.62); p=0.009 20 Cumulative incidence (%) 15 10 5 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Months after randomization No. at risk MT 441 414 371 325 286 256 223 195 164 129 101 71 38 PCI+MT 447 421 395 356 315 285 248 217 180 160 119 93 53 Registry 166 156 145 133 117 106 94 75 65 53 42 26 13
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Patients with urgent revascularization Myocardial Infarction 21.4% 51.8% 26.8% Unstable angina +evidence of ischemia on ECG
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Kaplan-Meier plots of Landmark Analysis of Death or MI 30 ≤7 days: HR 7.99 (0.99-64.6); p=0.038 > 8 days: HR 0.42 (0.17-1.04); p=0.053 25 p-interaction: p=0.003 20 PCI plus MT ≤7 days Cumulative incidence (%) 15 MT alone 10 MT alone 5 >8 days PCI plus MT 0 7days 0 1 2 3 4 5 6 7 8 9 10 11 12 Months after randomization
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Medications at 6 Months of Follow-up
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Patients with Angina Class II to IV PCI+MT PCI+MT PCI+MT PCI+MT MT MT MT MT Baseline Registry Registry Registry Registry P<0.001 30 days P=0.002 P=0.002 6 months P=0.073 12 months 0 20 40 60 80 Percentage of patients with CCS II to IV, %
FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Conclusions • In patients with stable coronary artery disease, FFR-guided • PCI, improves patient outcome as compared with medical • therapy alone • This improvement is driven by a dramatic decrease in the • need for urgent revascularization for ACS • In patients with functionally non-significant stenoses • medical therapy alone resulted in an excellent outcome, • regardless of the angiographic appearance of the stenoses
FAME 2: FFR-Guided PCI versus Medical Therapy in Stable CAD Available on-line on Aug 28, 2012 on www.nejm.org