13 FFR Berry C aimradial2016 - FFR in non-STEMI
•
3 likes•333 views
This document summarizes a presentation on using fractional flow reserve (FFR) to guide management of patients with non-ST-segment elevation myocardial infarction (NSTEMI). It discusses evidence that practice variations in treating NSTEMI can increase mortality, and that FFR may help reduce variations. The FAMOUS-NSTEMI trial found that FFR-guided management increased medical therapy without revascularization compared to angiography alone. Ongoing and planned trials involving over 10,000 patients total aim to further evaluate FFR's role in guiding treatment of culprit and non-culprit lesions in acute coronary syndrome patients.
Recommended
Recommended
More Related Content
What's hot
What's hot (20)
Viewers also liked
Viewers also liked (20)
Similar to 13 FFR Berry C aimradial2016 - FFR in non-STEMI
Similar to 13 FFR Berry C aimradial2016 - FFR in non-STEMI (20)
More from International Chair on Interventional Cardiology and Transradial Approach
More from International Chair on Interventional Cardiology and Transradial Approach (20)
Recently uploaded
Recently uploaded (20)
13 FFR Berry C aimradial2016 - FFR in non-STEMI
- 1. FAMOUS: FFR in NSTEMI Prof. Colin Berry Golden Jubilee National Hospital, University of Glasgow. FFR Workshop Budapest, 21 September 2016
- 2. Body text Disclosures Institutional agreements between the University of Glasgow (employer) and St Jude Medical, Novartis, DalCor and AstraZeneca. No personal contracts / disclosures.
- 3. Body text 1.Practice variations, incomplete revascularisation, and prognosis. 2.FFR in culprit and non-culprit disease in patients with recent NSTEMI Learning objectives
- 4. Body text 2013 80,724 MIs, 61% NSTEMI 2010 £3.6 billion expenditure & losses £9.8 billion societal loss NSTEMI: 2013/2014 commonest indication for invasive angio. Angiograms, n = 26,510 PCI, n = 23,053 Economic costs Revascularisation
- 5. Body text Practice variation in NSTEMI increases 30-day mortality Revascularisation Hospitals Median (IQR) % 30-day Mortality Rat of revascularisation Half in UK (19.2%) vs Sweden (34.8%) with twice the variation (21.9% vs. 10.2%) Practice variation was directly associated with 30-day mortality % Chung, James, Gale, Hemingway et al BMJ 2015
- 6. Cx Cx LAD Clinical conundrums: NSTEMI – which lesion(s) to treat ? Can functional testing reduce practice variation ? Subjective visual interpretation
- 7. Evidence base for FFR in ACS patients
- 8. Body text Sels et al JACC Intervention 2011 FAME - NSTEMI
- 9. Body text Conclusions FAME - NSTEMI “.. It is desirable to confirm these findings in a prospective trial in NSTEMI.” Pijls and de Bruyne Sels et al JACC Intervention 2011
- 10. Body text FFR → ↓ deferred management ↑ medical therapy, ↓ stents Carrick, Berry Am J Cardiol 2013 Inter-observer variability for treatment decisions 5 Cardiologists: Treatment decision before & after FFR disclosure Consensus ≥ 3 of 5, n = 100 NSTEMI patients Left shift with FFR disclosure
- 11. 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
- 12. Body text 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 - Sep 2014
- 13. Screened Consent Oct. 2011 May 2013 n = 174n = 176 350 Randomise Registry n = 503 Screened n = 1297 Exclusions, n=444 ESC Hotline - Sep 2014
- 14. Body text FFR-disclosure Impact on initial treatment pan Initial treatment Change post-FFR Final decision FFR treatment change ~ 22% of patients
- 15. Body text 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 similar ESC Hotline - Sep 2014
- 16. Body text Myocardial infarction type FFR-guided vs. Angio-guided Type 4 MI Procedure-related Types 1-3 MI Spontaneous Angiography - guided FFR - guided FFR - guided Angiography - guided p = 0.12 p = 0.56
- 17. NSTEMI – Non-culprit √ – Culprit ? / X Is the FFR ≤ 0.80 decision threshold valid in ACS? Is FFR valid in ACS ?
- 18. Body text FAMOUS – NSTEMI: Diagnostic accuracy 3.0 T stress perfusion MRI sub-study 106 patients 20% pre-angio, 80% post-angio •3T MRI vs. FFR; IV adenosine • 168 arteries (57% infarct related) Infarct size 5.4% LV mass • Area-at-risk (MRI) vs. FFR Correlation, r = - 0.85 • FFR ≤ 0.80 PPV 91.4%, NPV 91.4%
- 19. NSTEMI practice guidelines ESC NSTEMI guideline, 2015 5.6.1.3. FFR may be overestimated and the haemodynamic relevance of a coronary stenosis underestimated.(320) So far, the value of FFR-guided PCI in this setting has not been properly addressed. 5.6.5.1 While FFR is considered the invasive gold standard for the functional assessment of lesion severity in stable CAD, its role in NSTE-ACS still needs to be defined.
- 20. Body text Conclusions: FFR in NSTEMI 1. Incomplete revascularisation and practice variations are common & prognostically important. 2. FFR is safe, valid in non-culprit vessels, and diagnostically useful. 3. Phase 3 trials of FFR in NSTEMI - focus on prognosis & timing of intervention 4. The clinical utility of FFR in NSTEMI will be defined within 5 – 7 years.
- 21. Thank you for your attention
- 22. J Am Coll Cardiol 2016, September; Editorial Fearon, de Bruyne & Pijls n = 576 206 ACS 370 SIHD ROC for MACE FFR ACS 0.84, SIHD 0.81 35% of the ACS cohort were discharged on DAPT
- 23. Body text Layland, Oldroyd, Berry et al Circ Cardiovasc Int 2013 Non-culprit Angina NSTEMI STEMI IMR is similar in patients with angina vs. NSTEMI; not STEMI IMR n=140 50 angina 50 NSTEMI 40 STEMI Culprit
- 24. Primary PCI for STEMI or very high-risk NSTEMI Exclude: Previous CABG Left main disease Shock ≥ 1 non-culprit lesion(s) 50 - 99% severity vessels diameter ≥ 2.5 mm; FFR-guided PCI to non-culprit lesions Index admission* Eligible but not randomised Registry follow-up Randomization Initial conservative management of non-culprit lesions Visual assessment All-cause mortality and non fatal MI 30 days and at least 1 year Residual non-culprit disease Felix Böhm, Stefan James, et al, 2016 n = 2026 n = 2026 n = 4052
- 25. PRESSUREwire Observational cohort study of real-world practice Purpose: to assess the routine use of FFR and alternate indices in stable CAD and ACS. Primary Objectives: FFR 1. Disclosure and impact on decisions. 2. FFR-guided PCI and outcomes in ACS. 3. FFR vs. resting indices, stable CAD & outcome Secondary Objective: IMR, CFR, RRR Impact on decisions & outcomes. Outcomes: 2000 patients, 200 sites, 12 month MACE Colin Berry et al, 2016
- 26. STEMI COMPARE-ACUTE International 885 patients, COMPLETE International 4000 patients, staged PCI FLOWER-AMI France 1170 patients FULL REVASC International 4052 PRIMULTI UK under review NSTEMI FAMOUS-NSTEMI-2 UK under-review PRESSUREWire International registry Total >> 10,000 patients Current & future trials of FFR use in ACS
- 27. Body text Myocardial FFR Pressure sensor Aorta 3 cm Fractional flow reserve (FFR) = distal coronary pressure / proximal aortic pressure hyperaemia ⇒ resistance is minimal ⇒ pressure α flow Wire
Editor's Notes
- 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.
- This is the flow diagram of the clinical trial. Of 853 patients who gave informed consent, 350 were randomised. Consent was obtained in the urgent clinical care pathway before going to the cath lab. Then, after the angiogram was obtained, the patient remained eligible if there was at least one mild stenosis of at least 30% severity. At that point, the cardiologist then stated the treatment plan based on all of the usual clinical data and the angiographic findings. All treatment options were possible, including OMT, PCI or CABG. The patient was then randomised to either the FFR disclosed group or the FFR not disclosed group. FFR was obtained in all patients but only disclosed in the FFR-guided group.
- Following a decision for the initial treatment plan for CABG, PCI or CABG, FFR disclosure changed the plan in 22% of patients in the FFR-guided group.
- The reduction in the use of PCI and CABG was sustained during follow-up to 1 year, and quality of life was similar in the two groups.
- For spontaneous MI (types 1 – 3), no differences were detected between the FFR-guided and Angiography-guided groups.
- In summary, Trial popn represented more than 40% of all-comers. FFR was successful in 100% of patients and safe (2 dissections in 706 lesions). 3.Randomisation & adherence to protocol were successful. FFR-disclosure commonly changed therapy, reduced PCIs & Type 4 MIs and was cost neutral. 5. Health outcomes were similar.