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The BHF FAMOUS NSTEMI Trial. 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. For the FAMOUS NSTEMI Investigators
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The BHF FAMOUS NSTEMI Trial 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 For the FAMOUS NSTEMI Investigators ESC Hotline for Myocardial Infarction, 1 Sep 2014
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 • Urgentdiagnostic 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 • 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. ESC Hotline 1 Sep 2014
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. Berry C et al Am Heart J 2013; NCT01764334 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 Freeman Sunderland Royal Blackburn Southampton
Oct. 2011 May 2013 Screened n = 444 Screened Consent Registry n = 503 n = 174 n = 176 Randomise 350 ESC Hotline 1 Sep 2014
Baseline characteristics 350 randomised trial participants GRACE Score for Death/MI 6 months = 146 Time from event to angiography 3 (2,5) days Radial access – 90% % ESC Hotline 1 Sep 2014
FFR vs. Stenosis Severity 350 patients 706 lesions ≥ 30% severity FFR successful 100% of patients >99% lesions 2 (0.03%) wire dissections FFR Stenosis severity, % ESC Hotline 1 Sep 2014
FFR-disclosure - Impact on treatment plan Change post-FFR Final decision Initial treatment FFR treatment change ~ 22% of patients
Primary outcome % medical therapy only 22.7 % 13.2 p = 0.054 p = 0.022 ESC Hotline 1 Sep 2014
% medical therapy only Post-randomisation & 1 year % p = 0.054 p = 0.022 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%) Log Rank p = 0.79 MACE 1 year FFR – guided n = 14 (8.0%) Days ESC Hotline 1 Sep 2014
Procedure-related MI FFR-guided vs. Angio-guided Type 4 MI Procedure-related p = 0.12 Angiography - guided FFR - guided ESC Hotline 1 Sep 2014
Myocardial infarction type FFR-guided vs. Angio-guided Type 4 MI Procedure-related Types 1-3 MI Spontaneous p = 0.12 p = 0.56 Angiography - guided FFR - guided FFR - guided Angiography - guided ESC Hotline 1 Sep 2014
Summary • Trial popn represented > 40% of NSTEMI patients who gave informed consent. • FFR was successful in 100% of patients and safe (0.03% guidewire dissections). 3. Randomisation & adherence to protocol were successful. • FFR-disclosure commonly changed therapy, and reduced revascularisation & Type 4 MIs. • Health outcomes were similar.
Conclusions • FFR is feasible & safe initially, and optimises PCI in NSTEMI. • The trial was designed but not powered to assess health outcomes (no differences). • 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.
FAMOUS-NSTEMI Thank you. Patients, staff, funders. Clinical Event Committee Dr Andrew Hannah, Dr Andrew Stewart Data & Safety Monitoring Committee Prof John Norrie, Prof Andrew Clark, Dr Saqib Chowdhary European Heart Journal 1 Sept. 2014 on-line