12 FFR Sayan S aimradial2016 - iFr trials
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iFR trials regarding current practice - Sayan Sen
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12 FFR Sayan S aimradial2016 - iFr trials
- 1. iFR trials regarding current practice Dr Sayan Sen Consultant Cardiologist & Honorary Senior Lecturer Imperial College London
- 2. Disclosure I have no conflict of interest to declare Sayan Sen
- 3. Introduction • How I use iFR used clinical practice today? • What is limiting its use • Clinical Trials – FLAIR – SWEDE HEART – How they compare to FFR trials….
- 4. ADVISE study Oct 2011 Sen et al J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402. LBCT TCT 2011 • Using iFR and FFR together ADVISE Registry May 2012 Petraco et al. Eurointervention, August 2012. LBCT EuroPCR 2012 HYBRID strategy Aug 2012 iFR and FFR can be used together, sparing patients from adenosine Petraco et al. Eurointervention, 2012. ESC 2012 Park et al, International J Cardiol iFR in Clinical Practice Today
- 5. iFR in all intended to treat vessels iFR <0.86* Implantation of SYNERGYTM stent(s) iFR >0.93 No stent implantation in lesion Optimization by IVUS guidance (modified MUSIC Criteria) Optimal medical therapy with a strict control of LDL (≤1.8 mmol) Patient ‘Signed Off’ by Heart Team for PCI iFR 0.86-0.93 FFR FFR≤0.80 FFR>0.80 MSCT with anatomic and functional Syntax Score (exploratory) SYNTAX II
- 6. 73% (n=839) of lesions assessed without adenosine
- 7. iFR used in >3500 labs around the world (as of June 2016) EuroIntervention. 2013 May 20;9(1):11-3
- 8. Physiological stenosis assessment Pa Pd 0 100 200 300 400 500 600 700 800 900 70 120 Pressure(mmHg) Time (ms) Wave-free period FFR iFR Hyperaemia Resting Pa Pd
- 10. What we know about iFR? • iFR and FFR have similar ability to detect ischaemia
- 11. Vasodilators do not improve physiological diagnostic accuracy 1. Van de Hoef et al. Circ Cardiovasc Interv. 2012;5(4):508-14 2. Sen et al. J Am Coll Cardiol. 2013;61(13):1409-20 5. Petraco et al. Circ. Int. 2014 6. de Waard et al. (ACC 2014) 3. Van de Hoef Euroint.. 2015 Dec;11(8):914-25 4. Sen et al. J Am Coll Cardiol. 2013;62(6):566 0 20 40 60 80 100 HSR HSR SPECT PET CFR Accuracy(%)orROC(%) FFR iFR p=ns p<0.01 p=ns p=ns p<0.01
- 12. 0 20 40 60 80 100 FFR iFR iFRa N=184 Koo BK et al., PCR 2015 p=ns for all iFR and FFR have the same diagnostic power to predict ischaemia against hyperaemic PET
- 13. • iFR and FFR have similar ability to detect ischaemia • iFR is not FFR What we know about iFR?
- 14. Differences between iFR and FFR • 1 in 5 patients iFR and FFR will disagree • What does this mean – Flow – Hyperaemia – Distal disease – RA pressure…..
- 15. Coronary Live Case Transmission Hammersmith Hospital, Imperial College NHS Trust, London, UK Physiological assessment of Cx iFR Co-Registration simplifying serial lesion assessment
- 16. • iFR and FFR have similar ability to detect ischaemia • iFR is not FFR • Simple to perform What we know about iFR?
- 17. iFR is simple, safe, reliable and cost effective • No adenosine1 • A few seconds to perform (5 beats)2 • Avoid serious complications (1%) of cases3 • Avoids unpleasant adenosine side effects • Avoids off-label use of adenosine 1. Sen S et al. J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402 2. Petraco R et al. Am Heart J. 2014 Nov;168(5):739-48 3. Curzen N et al. RIPCORD Circ. Cv. Intervention 2014 (Apr)
- 18. • iFR and FFR have similar ability to detect ischaemia • iFR is not FFR • Simple to perform • iFR has NO clinical outcome data What we know about iFR?
- 19. FFR Clinical Outcome Data • DEFER • FAME • FAME 2
- 20. FFR>0.8 Defer PCI FFR≤0.8 Perform PCI FFR guided PCI iFR<0.9 Perform PCI iFR≥0.9 Defer PCI Intermediate lesion requiring physiological assessment In ACS : intermediate non-culprit lesion N=2500, 1:1 Randomisation iFR guided PCI 30 day, 1, 2 and 5yr follow-up Functional Lesion Assessment of Intermediate stenosis to guide Revascularisation NCT02053038
- 21. FFR>0.8 Defer PCI FFR≤0.8 Perform PCI FFR guided PCI iFR<0.9 Perform PCI iFR≥0.9 Defer PCI Intermediate lesion requiring physiological assessment In ACS : intermediate non-culprit lesion N=2500, 1:1 Randomisation iFR guided PCI 30 day, 1, 2 and 5yr follow-up Functional Lesion Assessment of Intermediate stenosis to guide Revascularisation NCT02053038
- 22. Global Representation of DEFINE-FLAIR 16 Countries 47 Centers
- 23. FFR>0.8 Defer PCI FFR≤0.8 Perform PCI FFR guided PCI iFR<0.9 Perform PCI iFR≥0.9 Defer PCI Intermediate lesion requiring physiological assessment In ACS : intermediate non-culprit lesion N=2500, 1:1 Randomisation iFR guided PCI 30 day, 1, 2 and 5yr follow-up Functional Lesion Assessment of Intermediate stenosis to guide Revascularisation PI: Davies J, Escaned J. Chairmen: Serruys P, Patel MNCT02053038
- 24. Functional Lesion Assessment of Intermediate stenosis to guide Revascularisation The primary objective of DEFINE-FLAIR is to assess the safety and efficacy of decision-making on coronary revascularisation based on iFR measurements of stenosis severity, compared with FFR. Primary Objective
- 25. Functional Lesion Assessment of Intermediate stenosis to guide Revascularisation • Costs associated to iFR or FFR guidance • Quality of life (QOL) to iFR or FFR guidance • Prediction of events from post-PCI iFR/FFR measures • Reliability of iFR/FFR in non-culprit ACS Primary endpoint • Major adverse cardiac events (MACE) rate in the iFR and FFR groups at 30 days, 1, 2, and 5 years. Secondary endpoints
- 26. SWEDEHEART FFR>0.8 Defer PCI FFR≤0.8 Perform PCI FFR guided PCI iFR<0.9 Perform PCI iFR≥0.9 Defer PCI Intermediate lesion requiring physiological assessment In ACS : intermediate non-culprit lesion N=2000, 1:1 Randomisation iFR guided PCI 30 day, 1, 2 and 5yr follow-up PI: Matthias Gotberg Ole Frobert NCT02166736
- 27. 91 509 441 2000 2500 DEFER FAME FAME 2 iFR-SwedeHeart Define-FLAIR DEFINE-FLAIR Largest Physiology Clinical Outcome Study n=patients in the physiological guided group SWEDEHEART SWEDEHEART
- 28. 91 509 441 2000 2500 4500 DEFER FAME FAME 2 iFR-SwedeHeart Define-FLAIR SwedeHeart+FLAIR SWEDEHEART SWEDEHEART n=patients in the physiological guided group SWEDEHEART SWEDEHEAR + DEFINE-FLAIR + iFR SWEDEHEART Largest combined prospective clinical outcomes dataset
- 29. Summary Physiology is superior to angiography Real physiological differences between iFR and FFR
- 30. Summary DEFINE-FLAIR and iFR Swede-Heart will be the largest physiology studies to date. • Physiology simpler and easier to perform • More cost effective • Safer • Patient friendly
- 31. SO who’s the winner? iFR or FFR?
- 32. SO who’s the winner? iFR or FFR? Our patients
- 33. SO the winner? • Our patients • Explosion of interest in coronary physiology • Field is open • Many more centers, more indices • New pressure wires • Non-invasive techniques