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PCI & AimRadial 2018 | Use of physiology in ACS - Colin Berry

1. Use of physiology in ACS Prof. Colin Berry University of Glasgow Golden Jubilee National Hospital AIMRADIAL 2018, Sarasota Memorial Hospital 28 November 2018 2.…
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  • 1. Use of physiology in ACS Prof. Colin Berry University of Glasgow Golden Jubilee National Hospital AIMRADIAL 2018, Sarasota Memorial Hospital 28 November 2018
  • 2. Anterior STEMI Angiogram Multivessel coronary disease in STEMI PCI to culprit only or PCI to all lesions? Colin Berry, 28.11.2018
  • 3. Incidence, stenosis ≥ 75% = 31% Stenosis ≥ 50% ≈ 50% Multivessel PCI only in 10% 2014 Multivessel disease STEMI Contemporary UK practice Colin Berry, 28.11.2018
  • 4. • Timing: immediate or index stay. Yes - randomised trials  Guideline statement  ESC 2018 practice guideline recommendations Colin Berry, 28.11.2018
  • 5. NEJM September 1st, 2013 Hypothesis: In STEMI patients with multivessel CAD, immediate preventative PCI would improve outcomes compared to medical therapy PRAMI trial
  • 6. PRAMI – primary outcome Cardiac death, recurrent MI, refractory ischaemia Cardiac death, non-fatal MI, refractory angina n = 465
  • 7. Primary outcome Cardiac death Refractory anginaNon-fatal MI PRAMI - components of primary outcome directionally consistent treatment effect Wald et al NEJM 2013
  • 8. CULPRIT Trial MV-PCI  risk of cardiac events 64% immediate PCI n = 150 n = 146 Gershlick et al JACC 2015 Colin Berry, 28.11.2018
  • 9. 101 ACS patients (n = 75 STEMI, n = 26 NSTEMI); n = 112 non-culprit lesions PCI in culprit lesion then FFR measured in non-culprit lesion FUP – repeat 1 month later JACC Intervention 2010
  • 10. In only 2 patients with FFR >0.80 was observed to <0.75 at FUp Colin Berry, 28.11.2018
  • 11. Smits et al NEJM 2017Colin Berry, 28.11.2018
  • 12. COMPARE-ACUTE 885 patients, STEMI + MVD • FFR, immediate, all Control = FFR blind FFR = guide PCI • FFR achieved = 99% FFR ≤ 0.80 = 54% PCI index = 83% + 6 min, 1.6 stents Smits et al NEJM 2017 1 : 2 Colin Berry, 28.11.2018
  • 13. Primary end point, MACCE at 12 months Death, non-fatal MI, revascularization (>45 days), stroke/TIA MACCE 23 (7.8) vs. 121 (20.5); p<0.001 MI 7 (2.4) vs. 28 (4.7); p=0.10 Death or MI 11 (3.7) vs. 38 (6.4); p=0.10 COMPARE-ACUTE Results Smits et al NEJM 2017Colin Berry, 28.11.2018
  • 14. DANAMI-3 PRIMULTI FFR-guided revascularisation vs. culprit only in STEMI with MVD n = 627 All-cause mortality, recurrent MI, non-culprit PCI Engstrøm T et al. Lancet 2015 40% revascularisations were urgent Interaction of primary endpoint in 3-vessel disease No differences in secondary endpoints or angina
  • 15. Primary PCI for STEMI or high-risk NSTEMI Exclude: Previous CABG Left main disease Shock One or more non-culprit lesions (non- culprit vessels at least 2.5mm) on angiography (50-99%) Index admission FFR-guided PCI to non-culprit lesions* Eligible but not randomised Registry follow-up Randomization Initial conservative management of non- culprit lesions Visual assessment Trial follow-up for all-cause mortality and non fatal MI at 30d and at least 1 year Residual non-culprit disease Non-CTO n = 4400
  • 16.  Completed trials PRAMI, CULPRIT, COMPARE-ACUTE  Default strategy (selected approach)  On-going clinical trials: FULL-REVASC – all-cause death / MI COMPLETE – staged, post discharge Complete MV-PCI – index or in-patient staged in STEMI ? Colin Berry, 28.11.2018
  • 17. STEMI COMPARE-ACUTE International 885 patients, COMPLETE International 4000 staged PCI DANAMI-PRIMULTI International 627 FLOWER-AMI France 1170 FULL REVASC Sweden 4400 NSTEMI FAMOUS-NSTEMI-2 UK trial PRESSUREWire International registry Clinical trials of FFR-guided treatment in ACS Colin Berry, 28.11.2018
  • 18. Practice variation in NSTEMI increases 30-day mortality Revascularisation rate, % Hospitals Median (IQR) % 30-day Mortality, % Revascularisation Half in UK (19.2%) vs Sweden (34.8%) with twice the variation (21.9% vs. 10.2%) Practice variation directly associated with 30-day mortality Incomplete revascularisation – 50% of NSTEMI cases in the UK % Chung et al BMJ 2015Colin Berry, 28.11.2018
  • 19. MACE during 2 years follow-up Sels et al JACC Intervention 2011 FAME - NSTEMI Colin Berry, 28.11.2018
  • 20. Screened Consent Oct. 2011 May 2013 n = 174n = 176 350 Randomise ESC Hotline 1 Sep 2014 Registry n = 503 Screened n = 1297 Exclusions, n=444
  • 21. FFR-disclosure Impact on initial treatment Initial treatment Change post-FFR Final decision FFR treatment change ~ 22% of patients
  • 22. FFR-guided management increased medical therapy without PCI / CABG 0 5 10 15 20 25 Post-Randomisation 1-year FFR-guided Angiography-guided % p = 0.022 p = 0.054 Costs and quality of life were similarESC Hotline 1 Sep 2014
  • 23. Myocardial infarction type FFR-guided vs. Angio- guidedType 4 MI Procedure-related Angiography - guided FFR - guided FFR - guided Angiography - guided p = 0.12 p = 0.56 ESC Hotline 1 Sep 2014 Types 1-3 MI Spontaneous
  • 24. NSTEMI / STEMI – Non-culprit  – Culprit X Similar conclusions for NHPR Is FFR valid in ACS ? Colin Berry, 28.11.2018
  • 25. METHODS: Direct measurement of coronary microvascular function in acute MI patients Aorta 3 cm Saline, 18 º C Intra-coronary injection 3 ml Dual sensor Pressure Temperature 0.014” Coronary flow reserve, CFR = Tmn rest / Tmn hyperaemia Index of microvascular resistance, IMR = Distal coronary pressure x mean transit time during hyperaemia Colin Berry, 28.11.2018
  • 26. Non-culprit Angina NSTEMI STEMI IMR is similar patients with angina vs. NSTEMI; not STEMI IMR n=140 50 angina 50 NSTEMI 40 STEMI Layland, Oldroyd, Berry et al Circ Cardiovasc Int 2013 Colin Berry, 28.11.2018
  • 27. • 3 primary PCI centres (Stanford, Glasgow, Singapore), n=253 patients • Primary endpoint = death or HF hospitalisation • Mean Fup = 2.8 years, 13.8% PEP, 4.3% died • Prognostic value of IMR compared to CFR, TMP, clinical variables. Colin Berry, 28.11.2018
  • 28. IMR hazard ratio, p-value Death or HF hospitalisation 2.1, p=0.034 Death, HR 3.95, p=0.028 Fearon et al Circulation 2013 IMR > 40 predicts death post-STEMI
  • 29. IMR 13 IMR 50 Validation of prognostic value of IMR. n=300 STEMI: IMR at end of PCI is independently predicts: • IMR 27 - Adverse remodelling – HR 1.01(1.00,1.03) • IMR 40 - All-cause death / HF – HR 4.4 (2.1, 9.1) Carrick, Berry, Circ 2016
  • 30. CFVR predicts cardiac death CFVR (hyperaemic velocity / resting velocity) correlates inversely with ST-resolution at end of P-PCI. Laskey et al. CCI 2008; CFVR ≥ 2.1 predicts reduced risk at 10 yrs, n = 100 STEMI patients Van de Hoef et al. Circ Cardiovasc Interven 2013
  • 31. Conclusions Physiology in ACS Colin Berry, 28.11.2018 1. Incomplete revascularisation and practice variations are common and prognostically important. 2. FFR / NHPR are safe, valid in non-culprit vessel disease, and diagnostically useful. 3. Phase 3 trials of FFR in STEMI are on-going. 4. The clinical utility of physiology-guided decisions in ACS will be defined within the next 5 years. 5. IMR holds promise for risk stratify therapy
  • 32. Conclusions FFR in ACS 1. Incomplete revascularisation and practice variations are common and prognostically important. 2. FFR is safe, valid in non-culprit vessel disease, and diagnostically useful. 3. Phase 3 trials of FFR in NSTEMI and STEMI are on-going. 4. The clinical utility of FFR in ACS will be defined within the next 5 years. Colin Berry, 28.11.2018
  • 33. Thank you for your attention
  • 34.  465 STEMI patients with multivessel CAD amenable to PCI & successful culprit PCI  Strategy: Complete revascularization acutely of all stenoses ≥50% amenable to PCI vs. OMT and ischaemia-driven revasc.  Procedure duration = + 20 min  n, arteries / patient = 1.36  n, stents / artery = 1.29 PRAMI – key points Wald et al NEJM 2013Colin Berry, 28.11.2018
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