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Nick Curzen BM(Hons) PhD FRCP
Professor of Interventional Cardiology
University Hospital Southampton NHS FT
UK
FFR assessment: how it affects clinical judgement
4 October 2016
4 October 2016
Potential Conflicts of Interest
Unrestricted research grant for RIPCORD St Jude Medical
Speakers Fees
Unrestricted research grant for FFRCT RIPCORD HeartFlow
Speaker Fees
Unrestricted research grant for RIPCORD 2 Boston Scientific
Speaker Fees
Unrestricted education grant Volcano-Phillips
4-Oct-16
CAD present?

Benefit from aspirin/statin/ramipril?
Symptoms due to this CAD?
Needs revasc?

?
?
04/10/2016
Physiology versus anatomy
Despite the data we hardly use FFR
Can this be done non-invasively?
Decision-making
Revascularisation vs no revasc?
PCI vs CABG?
Which vessel(s) for PCI/CABG?
4-Oct-16
Current practice for assessment & management of
angina is fundamentally flawed.......
4-Oct-16
Patient with chest pain
Test for evidence of reversible ischaemia
Diagnostic Angiogram
OMT PCI CABG
4-Oct-16
Multivessel Disease.....
Stents or Surgery?
The problem is….
You can’t tell from the angiogram whether the lesion
is ischaemic or not…
4 October 2016
FFR
50mcg adenosine
LAD 0.54
OM 0.99
CX 0.89
FFR
50mcg adenosine
RCA 0.90
4-Oct-16
Multivessel Disease.....
Stents or Surgery?
You cannot rely on what you see at angiography if your currency is “significance”
4-Oct-16
Our current practice for assessment & management
of angina is flawed & confused.......
We get patient-level & lesion-specific ischaemia wrong in about 30%!!
4-Oct-16
Have we really exploited the value of FFR in routine practice yet?
Angiogram
Tree
4-Oct-16
Patient with chest pain
Test for evidence of reversible ischaemia
Diagnostic Angiogram
OMT PCI CABG
? ?DEFER
FAME
FAME 2
Non-randomised…….. “prospectively allocated”
137 patients (312 vessels)
FFR-PCI 57 patients, 128 vessels……. 48 patients, 53 vessels
Conventional PCI: 80 patients, 184 vessels
Am J Cardiol 2005;96:877-884
4 October 2016
4 October 2016
4-Oct-16
Circulation: Cardiovasc Interven 2014
Method
04/10/2016
The RIPCORD Study
Diagnostic Coronary Angiogram
by Cardiologist 1
Patient being investigated
for chest pain
TREATMENT PLAN 1
Medical/PCI/CABG/more info
FFR* of all patent vessels
of stentable (>2.25mm) diameter
by Cardiologist 2
TREATMENT PLAN 2
Medical/PCI/CABG/more info Primary endpoint based upon the difference
between Plan 1 and Plan 2
*FFR<0.8
Cardiologist 1 shown FFR results
n=200
4-Oct-16
The RIPCORD Study
4-Oct-16
Results: PRIMARY ENDPOINT
Management of population by angiogram versus FFR
Fishers exact test p<0.0001
Summary
 Agreement about category of management in 147 out of 200 (74%)
 ie after FFR management change in 26% of cases
FFR
The RIPCORD Study
ANGIO
PLAN 1
PLAN 2
4-Oct-16
Limitations
 No clinical outcome
 High denominator… selection of cases…
 CTOs not part of this trial
 Already VERY unpopular with non-interventional cardiologists!
The RIPCORD Study
But, even so, the message that FFR makes a more accurate diagnosis
& therefore leads to the patient getting more accurate treatment is
spookily consistent with other evidence…….
Toth et al EHJ 2014Curzen et al Circ Interven 2014
Tonino et al JACC 2010
4-Oct-16
Berry et al Eur Heart J 2014
4-Oct-16
The RIPCORD Study
 No matter how experienced you are…
 No matter how “tight” the lesion looks…
You will be wrong on the angio in about 30% of lesions!
4-Oct-16
IMPLICATIONS
 These results have potentially important implications for clinical practice:
- management of patients with stable angina by angiogram alone is flawed
- management of patients would be improved by routine use of FFR at the
diagnostic stage
 A large scale randomised trial of angiographic- versus FFR-guided assessment &
management of patients undergoing diagnostic angiography with stable angina is
now warranted
The RIPCORD Study
RIPCORD 2
4-Oct-16
Circulation 2014
-n=1075 consecutive patients undergoing diagnostic angiography including an FFR
Investigation
-Patients had to have at least 1 angiographically ambiguous lesion
-Primary objective was to describe the rate of reclassification of the patient’s
coronary revascularisation strategy by an intention to use FFR in patients referred for
coronary angiography
4-Oct-16
4-Oct-16
4-Oct-164 October 2016
4-Oct-164 October 2016
Circulation Cardiov Interven 2016
• Multicentre registry
• Non-selected patients undergoing angiography in whom at least 1 lesion underwent FFR
• n=918 patients with 1293 lesions
• FFR-determined change in management cf angio alone
• Endpoint = MACE at 1 year (CV death + MI + unplanned revasc)
4-Oct-164 October 2016
4-Oct-164 October 2016
4-Oct-164 October 2016
4-Oct-164 October 2016
Cardiovasc Inter & Ther 2014
Am J Cardiol 2007
Eurointervention 2016
Circulation Cardiov Interv 2014
Eur Heart J 2014
Circulation 2014
Circulation Cardiov Interv 2016
4-Oct-164 October 2016
Study Year
No.
Patients Setting
FFR
Limit Stenosis Limit
Change in
management
Lesion
Change
Sant'Anna et al 2007 250 Elective 0.75 >50% 48% 32%
RIPCORD 2014 200 Elective 0.8 >30% 26% 32%
CVIT-DEFER Registry 2014 3093 Elective & ACS 0.8 50-90% 39%
FAMOUS 2014 350 ACS 0.8 >30% 22%
FFR-R3F 2014 1075 Elective & ACS 0.8 35-65% 43%
POST-IT 2016 918 Elective & ACS 0.75-0.8 Intermediate 44% 45%
Danish Registry 2016 1,716 Elective 0.8 50-89% 31% 48%
FFRCT RIPCORD 2016 200 Elective 0.8 >30% 36%
4-Oct-164 October 2016
Conclusion:
FFR assessment – how it affects clinical judgement
 A discrepancy exists between anatomical (angiographic) and physiological (FFR) assessment of lesion “significance”
 It has been repeatedly shown that in around 30% of lesions, it is not possible to predict whether they are ischaemic
based on the angogram alone
 As a result, there is a consistent difference in the angio-directed management of patients and the management
derived from FFR data ….
 Specifically, in between 22-48% of cases, the management changes when FFR is available
 There is a already strong case to use FFR routinely at diagnostic angiography…. Difficult to justify not using FFR!
 RIPCORD 2
4 October 2016
FFR
50mcg adenosine
LAD after 3x24 DES = 0.73
FFR
50mcg adenosine
LAD after 3x12 DES = 0.76
Only after 3.5 NC balloon in top stent
FFR 50mcg adenosine = 0.90
4-Oct-16
4-Oct-164 October 2016

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06 FFR Curzen N aimradial2016 - clinical judgment

  • 1. Nick Curzen BM(Hons) PhD FRCP Professor of Interventional Cardiology University Hospital Southampton NHS FT UK FFR assessment: how it affects clinical judgement 4 October 2016
  • 2. 4 October 2016 Potential Conflicts of Interest Unrestricted research grant for RIPCORD St Jude Medical Speakers Fees Unrestricted research grant for FFRCT RIPCORD HeartFlow Speaker Fees Unrestricted research grant for RIPCORD 2 Boston Scientific Speaker Fees Unrestricted education grant Volcano-Phillips
  • 3. 4-Oct-16 CAD present?  Benefit from aspirin/statin/ramipril? Symptoms due to this CAD? Needs revasc?  ? ?
  • 4. 04/10/2016 Physiology versus anatomy Despite the data we hardly use FFR Can this be done non-invasively? Decision-making Revascularisation vs no revasc? PCI vs CABG? Which vessel(s) for PCI/CABG?
  • 5. 4-Oct-16 Current practice for assessment & management of angina is fundamentally flawed.......
  • 6. 4-Oct-16 Patient with chest pain Test for evidence of reversible ischaemia Diagnostic Angiogram OMT PCI CABG
  • 7. 4-Oct-16 Multivessel Disease..... Stents or Surgery? The problem is…. You can’t tell from the angiogram whether the lesion is ischaemic or not… 4 October 2016
  • 8. FFR 50mcg adenosine LAD 0.54 OM 0.99 CX 0.89 FFR 50mcg adenosine RCA 0.90 4-Oct-16 Multivessel Disease..... Stents or Surgery?
  • 9. You cannot rely on what you see at angiography if your currency is “significance”
  • 10. 4-Oct-16 Our current practice for assessment & management of angina is flawed & confused....... We get patient-level & lesion-specific ischaemia wrong in about 30%!!
  • 11. 4-Oct-16 Have we really exploited the value of FFR in routine practice yet? Angiogram Tree
  • 12. 4-Oct-16 Patient with chest pain Test for evidence of reversible ischaemia Diagnostic Angiogram OMT PCI CABG ? ?DEFER FAME FAME 2
  • 13. Non-randomised…….. “prospectively allocated” 137 patients (312 vessels) FFR-PCI 57 patients, 128 vessels……. 48 patients, 53 vessels Conventional PCI: 80 patients, 184 vessels Am J Cardiol 2005;96:877-884 4 October 2016
  • 16. Method 04/10/2016 The RIPCORD Study Diagnostic Coronary Angiogram by Cardiologist 1 Patient being investigated for chest pain TREATMENT PLAN 1 Medical/PCI/CABG/more info FFR* of all patent vessels of stentable (>2.25mm) diameter by Cardiologist 2 TREATMENT PLAN 2 Medical/PCI/CABG/more info Primary endpoint based upon the difference between Plan 1 and Plan 2 *FFR<0.8 Cardiologist 1 shown FFR results n=200
  • 18. 4-Oct-16 Results: PRIMARY ENDPOINT Management of population by angiogram versus FFR Fishers exact test p<0.0001 Summary  Agreement about category of management in 147 out of 200 (74%)  ie after FFR management change in 26% of cases FFR The RIPCORD Study ANGIO PLAN 1 PLAN 2
  • 19. 4-Oct-16 Limitations  No clinical outcome  High denominator… selection of cases…  CTOs not part of this trial  Already VERY unpopular with non-interventional cardiologists! The RIPCORD Study But, even so, the message that FFR makes a more accurate diagnosis & therefore leads to the patient getting more accurate treatment is spookily consistent with other evidence…….
  • 20. Toth et al EHJ 2014Curzen et al Circ Interven 2014 Tonino et al JACC 2010 4-Oct-16 Berry et al Eur Heart J 2014
  • 21. 4-Oct-16 The RIPCORD Study  No matter how experienced you are…  No matter how “tight” the lesion looks… You will be wrong on the angio in about 30% of lesions!
  • 22. 4-Oct-16 IMPLICATIONS  These results have potentially important implications for clinical practice: - management of patients with stable angina by angiogram alone is flawed - management of patients would be improved by routine use of FFR at the diagnostic stage  A large scale randomised trial of angiographic- versus FFR-guided assessment & management of patients undergoing diagnostic angiography with stable angina is now warranted The RIPCORD Study RIPCORD 2
  • 23. 4-Oct-16 Circulation 2014 -n=1075 consecutive patients undergoing diagnostic angiography including an FFR Investigation -Patients had to have at least 1 angiographically ambiguous lesion -Primary objective was to describe the rate of reclassification of the patient’s coronary revascularisation strategy by an intention to use FFR in patients referred for coronary angiography
  • 27. 4-Oct-164 October 2016 Circulation Cardiov Interven 2016 • Multicentre registry • Non-selected patients undergoing angiography in whom at least 1 lesion underwent FFR • n=918 patients with 1293 lesions • FFR-determined change in management cf angio alone • Endpoint = MACE at 1 year (CV death + MI + unplanned revasc)
  • 32. Cardiovasc Inter & Ther 2014 Am J Cardiol 2007 Eurointervention 2016 Circulation Cardiov Interv 2014 Eur Heart J 2014 Circulation 2014 Circulation Cardiov Interv 2016
  • 33. 4-Oct-164 October 2016 Study Year No. Patients Setting FFR Limit Stenosis Limit Change in management Lesion Change Sant'Anna et al 2007 250 Elective 0.75 >50% 48% 32% RIPCORD 2014 200 Elective 0.8 >30% 26% 32% CVIT-DEFER Registry 2014 3093 Elective & ACS 0.8 50-90% 39% FAMOUS 2014 350 ACS 0.8 >30% 22% FFR-R3F 2014 1075 Elective & ACS 0.8 35-65% 43% POST-IT 2016 918 Elective & ACS 0.75-0.8 Intermediate 44% 45% Danish Registry 2016 1,716 Elective 0.8 50-89% 31% 48% FFRCT RIPCORD 2016 200 Elective 0.8 >30% 36%
  • 34. 4-Oct-164 October 2016 Conclusion: FFR assessment – how it affects clinical judgement  A discrepancy exists between anatomical (angiographic) and physiological (FFR) assessment of lesion “significance”  It has been repeatedly shown that in around 30% of lesions, it is not possible to predict whether they are ischaemic based on the angogram alone  As a result, there is a consistent difference in the angio-directed management of patients and the management derived from FFR data ….  Specifically, in between 22-48% of cases, the management changes when FFR is available  There is a already strong case to use FFR routinely at diagnostic angiography…. Difficult to justify not using FFR!  RIPCORD 2
  • 36. FFR 50mcg adenosine LAD after 3x24 DES = 0.73 FFR 50mcg adenosine LAD after 3x12 DES = 0.76 Only after 3.5 NC balloon in top stent FFR 50mcg adenosine = 0.90 4-Oct-16