Presentation on theme: "The BHF FAMOUS NSTEMI Trial For the FAMOUS NSTEMI Investigators ESC Hotline for Myocardial Infarction, 1 Sep 2014 J. Layland, K.G. Oldroyd, N. Curzen,"— Presentation transcript:
The BHF FAMOUS NSTEMI Trial For the FAMOUS NSTEMI Investigators ESC Hotline for Myocardial Infarction, 1 Sep 2014 J. Layland, K.G. Oldroyd, N. Curzen, A. Sood, K. Balachandran, R. Das, S. Junejo, N. Ahmed, M. Lee, A. Shaukat, A. O'Donnell, J. Nam, A. Briggs, R. Henderson, A. McConnachie, C. Berry
Body text Disclosures British Heart Foundation Project Grant. St Jude Medical provided the pressure wires to the 6 hospitals that participated in this study. Investigators: CB, NC, KGO are Consultants / Speakers to St Jude Medical and/or Volcano Corp. Institutional research agreement between St Jude Medical and University of Glasgow / CB. Travel support from Pfizer.
Natural history & prognosis after NSTEMI Cardiac events Coronary - Spontaneous plaque rupture - Longer term remodelling Myocardial - Sudden death & heart failure Non-cardiac events - co-morbidity
Standard care Anatomy vs. Anatomy + Function Urgent diagnostic angiography Treatment decisions for OMT, PCI & CABG are based on visual interpretation of the angiogram. FFR Class I recommendation in stable CAD No guideline recommendation in ACS, evidence is lacking. ESC Hotline 1 Sep 2014
Rationale: FFR in NSTEMI ESC Hotline 1 Sep 2014 Ischaemia hypothesis = Lesion-level ischaemia predicts coronary risk. FFR ischaemic threshold = 0.80 specifies CABG vs. PCI vs. medical therapy (OMT) FFR in angina – Optimises the PCI strategy, and reduces procedure-related MIs & MACE. FFR in NSTEMI - Validity of FFR in culprit & non-culprit arteries is uncertain.
Berry C et al Am Heart J 2013; NCT01764334 FAMOUS-NSTEMI trial Hypothesis Routine FFR is feasible in NSTEMI patients and adds diagnostic, clinical and economic benefits, compared to standard angiography-guided management. Objective Developmental trial for evidence-synthesis to inform a definitive health outcome trial. ESC Hotline 1 Sep 2014
FAMOUS-NSTEMI Outcomes Primary outcome The proportion of patients allocated to medical management only at baseline in each group. Secondary outcomes 1. Feasibility & safety of routine FFR. 2. Relationship of FFR vs. stenosis severity. 3. MACE – cardiac death, non-fatal MI, heart failure. 4. Resource use 5. Quality of life ESC Hotline 1 Sep 2014
Golden Jubilee, Glasgow Hairmyres Southampton Freeman Royal Blackburn Sunderland
Screened Consent Screened n = 444 Oct. 2011 May 2013 n = 174 n = 176 350 Randomise ESC Hotline 1 Sep 2014 Registry n = 503
GRACE Score for Death/MI 6 months = 146 Time from event to angiography 3 (2,5) days Radial access – 90% % Baseline characteristics 350 randomised trial participants ESC Hotline 1 Sep 2014
FFR-disclosure - Impact on treatment plan Initial treatment Change post-FFR Final decision FFR treatment change ~ 22% of patients
Primary outcome % medical therapy only % p = 0.022 p = 0.054 22.7 13.2 ESC Hotline 1 Sep 2014
% medical therapy only Post-randomisation & 1 year % p = 0.022 p = 0.054 Costs and quality of life were similar ESC Hotline 1 Sep 2014
All MACE FFR-guided vs. Angio-guided Angiography – guided n = 15 (8.6%) MACE 1 year FFR – guided n = 14 (8.0%) Log Rank p = 0.79 Days ESC Hotline 1 Sep 2014
Procedure-related MI FFR-guided vs. Angio-guided Angiography - guided FFR - guided p = 0.12 Type 4 MI Procedure-related ESC Hotline 1 Sep 2014
Myocardial infarction type FFR-guided vs. Angio-guided Type 4 MI Procedure-related Types 1-3 MI Spontaneous Angiography - guided FFR - guided Angiography - guided p = 0.12 p = 0.56 ESC Hotline 1 Sep 2014
Summary 1.Trial pop n represented > 40% of NSTEMI patients who gave informed consent. 2.FFR was successful in 100% of patients and safe (0.03% guidewire dissections). 3.Randomisation & adherence to protocol were successful. 4.FFR-disclosure commonly changed therapy, and reduced revascularisation & Type 4 MIs. 5.Health outcomes were similar.
Conclusions 1.FFR is feasible & safe initially, and optimises PCI in NSTEMI. 2.The trial was designed but not powered to assess health outcomes (no differences). 3.FFR-guided group outcomes Most MACE Not related to FFR disclosure. Late MACE Natural history of CAD progression. 4.A large trial is needed to assess health outcomes & cost-effectiveness.
Thank you. Patients, staff, funders. FAMOUS-NSTEMI European Heart Journal 1 Sept. 2014 on-line Clinical Event Committee Dr Andrew Hannah, Dr Andrew Stewart Data & Safety Monitoring Committee Prof John Norrie, Prof Andrew Clark, Dr Saqib Chowdhary