1 / 25

Fractional Flow Reserve–Guided PCI versus Medical Therapy in Stable Coronary Disease FAME 2 Clinicaltrials.gov NCT01132

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,

eliora
Download Presentation

Fractional Flow Reserve–Guided PCI versus Medical Therapy in Stable Coronary Disease FAME 2 Clinicaltrials.gov NCT01132

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Exclusion Criteria • Prior CABG • LVEF < 30% • LM disease

  7. 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

  8. 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

  9. FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Study Centers (n=28)

  10. FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Study Centers (n=28)

  11. 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

  12. 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

  13. 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

  14. FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Angiographic Characteristics *P value compares all RCT patients with patients in registry

  15. 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.

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Medications at 6 Months of Follow-up

  23. 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, %

  24. 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

  25. FAME 2: FFR-Guided PCI versus Medical Therapy in Stable CAD Available on-line on Aug 28, 2012 on www.nejm.org

More Related