Contra

1
The Impact of Practice Guideline Changes on
Revascularisation Strategies in Patients with
Multivessel and Left Main Disease William WIJNS
Aalst, Belgium
http//cardio-aalst.be William.Wijns_at_olvz-aalst.
be
2
The Impact of Practice Guideline Changes on
Revascularisation Strategies in Patients with
Multivessel and Left Main Disease William WIJNS
Aalst, Belgium
http//cardio-aalst.be William.Wijns_at_olvz-aalst.
be
3
Joint ESC - EACTS Guidelineson Myocardial
Revascularisation

• Joint Task Force on Myocardial Revascularisation
  ofthe European Society of Cardiology (ESC)
  andthe European Association for CardioThoracic
  Surgery (EACTS)
• Developed with the special contribution ofthe
  European Association forPercutaneous
  Cardiovascular Interventions (EAPCI)

European Heart Journal (2010) 31,
2501-2555 European Journal of CardioThoracic
Surgery 38, S1 (2010) S1-S52
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Previous ESC Guidelines

• The following ESC Guidelines are very relevant
  for Myocardial Revascularisation and served as
  background and foundation for our Task Force
• Silber S, Albertsson P, Aviles FF, et al.
• Guidelines for percutaneous coronary
  interventions. The Task Force for Percutaneous
  Coronary Interventions of the European Society of
  Cardiology.
• Eur Heart J 200526804-847. PCI in 2005
• Fox K, Garcia MA, Ardissino D, et al.
• Guidelines on the management of stable angina
  pectoris executive summary The Task Force on
  the Management of Stable Angina Pectoris of the
  European Society of Cardiology.
• Eur Heart J 2006271341-1381. Stable CAD in
  2006
• Bassand JP, Hamm CW, Ardissino D, et al.
• Guidelines for the diagnosis and treatment of
  non-ST-segment elevation acute coronary
  syndromes.Eur Heart J 2007281598-1660. NSTE-A
  CS in 2007
• Van De Werf F, Bax J, Betriu A, et al.
• Management of acute myocardial infarction in
  patients presenting with persistent ST-segment
  elevation the Task Force on the Management of
  ST-Segment Elevation Acute Myocardial Infarction
  of the European Society of Cardiology.
• Eur Heart J 2008292909-2945. STEMI in 2008

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Joint ESC EACTS Guidelines on Myocardial
Revascularisation

• First (ever) document based on consensus opinion
  between clinical cardiologists, interventional
  cardiologists and cardiac surgeons
• First available Guidelines on MYOCARDIAL
  REVASCULARISATION. Therefore, more than 70 of
  the recommendations are new compared to previous
  ESC guidelines
• Out of 273 recommendations, level of evidence
  was A in 28, B in 43 and C in 29

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Parachutes appear to reduce the risk of injury
but ... their effectiveness has not been proved
with randomised controlled trials
Level of Evidence C
7
New, Debated or Controversial Issues

• Patient information and process for decision
  making
• Risk stratification and use of risk scores
• Heart Team
• Issues related to self-referral and ad hoc PCI
  
• PCI vs CABG for multivessel and left main
  disease
• Revascularisation vs OMT only for stable CAD
• CAD and co-morbidities diabetes, CKD, PAD, ...
• Secundary prevention and OMT post-revascularisati
  on

8
The Heart Team
Clinical cardiologist(non interventional)
The patientwith CAD
Cardiacsurgeon
Interventionalcardiologist
Task Force composition 7 clinical cardiologists
(non interventional) 9 interventional
cardiologists  7 cardiac surgeons
9
Joint ESC EACTS Guidelines on Myocardial
Revascularisation

• Chairpersons Task Force members
• Carlo Di Mario
  Nicolas Danchin Volkmar Falk
• Stefan James
  Scot Garg Thirry Folliguet
• Jean Marco
  Kurt Huber Lorenzo Menicanti
• Miodrag Ostojic
  Juhani Knuuti Jose-Luis Pomar
• Nicolaus Reifart
  Jose Lopez-Sendon Paul Sergeant
• Flavio Ribichini
  Massimo Piepoli Miguel Sousa Uva
• Martin Schalij
  Charles Pirlet David Taggart
• Patrick Serruys
• Sigmund Silber

William WijnsCardiovascular CenterAalst
Philippe KolhCardiovascular Surgery
DepartmentLiège
www.escardio.org/guidelines
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www.syntaxscore.com
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CABG
PCI
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Tasks for each local Heart Team

• To organise morbidity and mortality conferences
  and review institutional results in all
  transparency for benchmarking and guidance in
  decision making
• To ensure proper patient information and consent,
  including adequate discussion of alternatives,
  risks and benefits, short and longer term,
  avoiding anonymous treatment
• To design specific institutional protocols for
  disposal of patients with STEMI, NSTEMI, other
  ACS and stable CAD who should be treated ad hoc,
  or not
• To define clinical care pathways, accounting for
  lesion subsets, and compatible with the current
  Guidelines, to avoid systematic case by case
  review of all diagnostic angiograms

15
The Impact of Practice Guideline Changes on
Revascularisation Strategies in Patients with
Multivessel and Left Main Disease William WIJNS
Aalst, Belgium
http//cardio-aalst.be William.Wijns_at_olvz-aalst.
be
16
Indications for revascularisation in
patientswith stable or acute coronary artery
disease

• Depending on its symptomatic, functional and
  anatomic complexity, CAD can be treated by
  Optimal Medical Therapy (OMT) alone or combined
  with revascularisation using PCI or CABG
• The two issues to be addressed are
• the appropriateness of revascularisation
• the relative merits of CABG and PCI in different
  patterns of CAD
• Revascularisation can be readily justified
• on prognostic grounds in certain anatomical
  patterns of CAD or a proven significant ischaemic
  territory or acute CAD
• on symptomatic grounds in stable patients with
  persistent limiting symptoms despite OMT

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Revascularisation versus Medical Therapy after
Stress SPECT Survival Analysis
These two lines intersect at a value of 10 of
ischaemic myocardium, above which the survival
benefit for revascularization over medical
therapy increases as a function of increasing
amounts of inducible ischemia
Hachamovitch et al. Circulation 20031072900-6.
18
Indications for revascularisation instable
angina or silent ischaemia
Subset of CAD by anatomy Class Level
Forsymptoms Any stenosis gt 50 with limiting angina or angina equivalent, unresponsive to OMT I A
Forsymptoms Dyspnoea/CHF and gt 10 LV ischaema/viability supplied by gt 50 stenotic artery IIa B
Forsymptoms No limit symptoms with OMT III C
Subset of CAD by anatomy Class Level
Forprognosis Left main gt 50 I A
Forprognosis Any proximal LAD gt 50 I A
Forprognosis 2VD or 3VD with impaired LV function I B
Forprognosis Proven large area of ischaemia (gt 10 LV) I B
Forprognosis Single remaining patent vessel gt 50 stenosis I C
Forprognosis 1VD without proximal LAD and without gt 10 ischaemia III A
With documented ischaemia or Fractional Flow
Reserve (FFR) lt 0.80 for diameter stenosis by
angiography between 50 and 90
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Pressure wire pullback Adenosine iv
Distal LAD
Distal LAD
Proximal LAD
A04/19
20
Specific PCI devices and pharmacotherapy
21
Appropriateness of revascularisation method for
advanced coronary artery diseaseACCF / SCAI /
STS / AATS / AHA / ASNC 2009 report
Patel MR et al. JACC 200953530-53

A appropriate
U uncertain
I inappropriate
22
Indications for CABG versus PCI in stable
patients with lesions suitable for both
procedures and low predicted surgical mortality
Subset of CAD by anatomy Favours CABG Favours PCI
1VD or 2VD - non-proximal LAD IIb C I C
1VD or 2VD - proximal LAD I A IIa B
3VD simple lesions, full functional revascularisation achievable with PCI, SYNTAX score 22 I A IIa B
3VD complex lesions, incomplete revascularisation achievable with PCI, SYNTAX score gt 22 I A III A
Left main (isolated or 1VD, ostium/shaft) I A IIa B
Left main (isolated or 1VD, distal bifurcation) I A IIb B
Left main 2VD or 3VD, SYNTAX score 32 I A IIb B
Left main 2VD or 3VD, SYNTAX score 33 I A III B

• In the most severe patterns of CAD, CABG appears
  to offer a survival advantageas well as a marked
  reduction in the need for repeat
  revascularisation

23
MACCE to 3 Years by SYNTAX Score Tercile Low
Scores (0-22)
CABG PCI P value
Death 6.8 7.3 0.86
CVA 3.2 1.2 0.20
MI 4.9 5.1 0.93
Death, CVA or MI 12.3 11.2 0.75
Revasc. 11.6 18.8 0.06
3VD
P0.45
25.8
22.2
Months Since Allocation
Site-reported Data ITT population
Cumulative KM Event Rate 1.5 SE log-rank P
value
24
Indications for CABG versus PCI in stable
patients with lesions suitable for both
procedures and low predicted surgical mortality
Subset of CAD by anatomy Favours CABG Favours PCI
1VD or 2VD - non-proximal LAD IIb C I C
1VD or 2VD - proximal LAD I A IIa B
3VD simple lesions, full functional revascularisation achievable with PCI, SYNTAX score 22 I A IIa B
3VD complex lesions, incomplete revascularisation achievable with PCI, SYNTAX score gt 22 I A III A
Left main (isolated or 1VD, ostium/shaft) I A IIa B
Left main (isolated or 1VD, distal bifurcation) I A IIb B
Left main 2VD or 3VD, SYNTAX score 32 I A IIb B
Left main 2VD or 3VD, SYNTAX score 33 I A III B

• In the most severe patterns of CAD, CABG appears
  to offer a survival advantageas well as a marked
  reduction in the need for repeat
  revascularisation

25
MACCE to 3 Years by SYNTAX Score Tercile Low
Scores (0-22)
CABG PCI P value
Death 6.0 2.6 0.21
CVA 4.1 0.9 0.12
MI 2.0 4.3 0.36
Death, CVA or MI 11.0 6.9 0.26
Revasc. 13.4 15.4 0.69
Left Main
gt
gt
P0.33
23.0
lt
Cumulative Event Rate ()
18.0
gt
lt
Months Since Allocation
Site-reported Data ITT population
Cumulative KM Event Rate 1.5 SE log-rank P
value
26
MACCE to 3 Years by SYNTAX Score Tercile
Intermediate Scores (23-32)
CABG PCI P value
Death 12.4 4.9 0.06
CVA 2.3 1.0 0.46
MI 3.3 5.0 0.63
Death, CVA or MI 15.6 10.8 0.29
Revasc. 14.0 15.9 0.75
Left Main
gt
gt
P0.90
23.4
lt
23.4
gt
lt
Site-reported Data ITT population
Cumulative KM Event Rate 1.5 SE log-rank P
value
27
MACCE to 3 Years by SYNTAX Score Tercile Left
Main SYNTAX Score ?33
CABG PCI P value
Death 7.6 13.4 0.10
CVA 4.9 1.6 0.13
MI 6.1 10.9 0.18
Death, CVA or MI 15.7 20.1 0.34
Revasc. 9.2 27.7 lt0.001
Left Main
Left Main
lt
P0.003
37.3
gt
lt
21.2
lt
lt
Site-reported Data ITT population
Cumulative KM Event Rate 1.5 SE log-rank P
value
28
Indications for CABG versus PCI in stable
patients with lesions suitable for both
procedures and low predicted surgical mortality
Subset of CAD by anatomy Favours CABG Favours PCI
1VD or 2VD - non-proximal LAD IIb C I C
1VD or 2VD - proximal LAD I A IIa B
3VD simple lesions, full functional revascularisation achievable with PCI, SYNTAX score 22 I A IIa B
3VD complex lesions, incomplete revascularisation achievable with PCI, SYNTAX score gt 22 I A III A
Left main (isolated or 1VD, ostium/shaft) I A IIa B
Left main (isolated or 1VD, distal bifurcation) I A IIb B
Left main 2VD or 3VD, SYNTAX score 32 I A IIb B
Left main 2VD or 3VD, SYNTAX score 33 I A III B

• In the most severe patterns of CAD, CABG appears
  to offer a survival advantageas well as a marked
  reduction in the need for repeat
  revascularisation

29
Classes of Recommendations
is recommended
should be considered
may be considered
is not recommended
30
Consensus Heart Team Agreement
Not acceptable for CABG
Acceptable for CABG
Follow-up in PCI-only registry
Randomization in randomized trial
Acceptable for PCI
Follow-up in CABG-only registry
Not acceptable for PCI
31
Registry arms in SYNTAX

• PCI-only registry (CABG not acceptable) in 198
  patients
• CABG not feasible because of co-morbidity in 71
  or lack of graft material in 9
• CABG-only registry (PCI not acceptable) in 1.077
  patients
• PCI not feasible because coronary anatomy was
  not suitable in 92 (including 22 CTO)

Unfavourable anatomy is the only reason for not
performing PCI in the DES era feasibility
indication
32
Integrated decision-making process

• The objective is to propose the best possible
  treatment
• to each individual patient with any presentation
  of CAD
• Reflect and apply the available the scientific
  evidence
• Is that evidence relevant to this patient?
• Appraisal of the patients condition risk
• Proposed treatment should account for the
  experience of the local team
• Properly inform the patient and consider his
  preferences

33
SYNTAX Trial Patient Distribution 3 VD
CABG72
Results of the SYNTAX trial suggest that 72 of
3 VD patients are still best treated with CABG
however, for the remaining patients PCI is an
alternative to surgery at least for 3 years
CABG PCI
8
PCI only
20
PW Serruys et al.
34
SYNTAX Trial Patient Distribution LM
Surgery For LM Still gold standard 66
Results of the SYNTAX trial suggest that 34 of
all patients with Left Main Stem disease are best
treated with PCI, an excellent alternative to
surgery up to three years
PCI LM Legitimate 34
PW Serruys et al.
35
The Impact of Practice Guideline Changes on
Revascularisation Strategies in Patients with
Multivessel and Left Main Disease William WIJNS
Aalst, Belgium
http//cardio-aalst.be William.Wijns_at_olvz-aalst.
be
36
Impact of the ESC EACTS Myocardial
Revascularisation Guidelines

• ESC requested endorsement from its National
  Societies
• Guidelines have been endorsed by nearly all ESC
  constituent bodies
• Guidelines were endorsed by a number of National
  Surgical Societies
• The Heart Team concept has been heavily
  discussed is some countries
• Changes in practice have been reported
• No reports yet of potential impact on patient
  outcome

37
Disclosures for William Wijns Cardiovascular
Center Aalst, Belgium

• Consulting Fees on my behalf go to the
  Cardiovascular Research Center Aalst
• Contracted Research between the Cardiovascular
  Research Center Aalst and several pharmaceutical
  and device companies
• Ownership Interest Cardiovascular Research
  Center Aalst is co-founder of Cardio³BioSciences,
  a start-up company focusing on cell-based
  regeneration cardiovascular therapies

38
Watch for your Team member!

• All this stent affair is a direct continuous of
  an non-responsible behavior of the cardiologist
  community. We are talking about many patients who
  are living with a time-ticking bomb in their
  body. The cardiologists are light headed in
  their attitude towards repeated revascularization
  procedure. If the patients needs more and more
  catheter-based procedures, their quality of life
  would be jeopardized and deteriorate.
• The cardiologists are the gate keepers as they
  both diagnose and treat the cardiac patients.
  When the poor patient lay on the table and the a
  catheter is inserted into his groin, he does not
  get a fair chance to decide what is best for him,
  e,g, stent or surgery. The tremendous pressure of
  the stent maker companies with the financial
  interest existing in the private catheterization
  sector, are the reason that patients would
  undergo catheterizations again and again without
  obtaining the relevant information concerning
  their situation.

Yediot Journal 17.12.2006 Stents in the
arteries a ticking bomb or a huge achievement?
39
Evidence basis for myocardial revascularisationOp
timal medical therapy versus CABG

• Survival benefit of CABG in patients with Left
  Main or three vessel CAD, particularly when it
  involved the proximal LAD coronary artery
• Benefits were greater in those with severe
  symptoms, early ischaemia during stress testing
  and impaired LV function
• Both optimal medical therapy and CABG have
  improved lately

40
Evidence basis for myocardial revascularisationOp
timal medical therapy versus PCI

• Most meta-analyses reported no mortality benefit
  but
• increased non-fatal peri-procedural MI
• reduced need for repeat revascularisation with
  PCI
• COURAGE Trial
• At a median follow-up of 4.6 years, there was no
  significantdifference in the composite of death,
  MI, stroke, or hospitalisationfor unstable
  angina
• Freedom from angina was greater by 12 in the PCI
  group atone year but was eroded by five years

41
Potential indications for ad hoc PCI
versusrevascularisation at an interval

• Ad hoc PCI is convenient for the patient,
  associated with fewer access site complications,
  and often cost-effective.
• Ad hoc PCI is reasonable for many patients, but
  not desirable for all, and should not be
  automatically applied as a default approach.

42
Potential indications for ad hoc PCI
versusrevascularisation at an interval

• Hospital teams without a cardiac surgical unit or
  with interventional cardiologists working in an
  ambulatory setting should refer to standard
  evidence-based protocols designed in
  collaboration with an expert interventional
  cardiologist and a cardiac surgeon, or seek their
  opinion for complex cases.

43
Recommendations for decision making and patient
information
time ?
informed ?
44
Patient information and consent
When asked, most patients will prefer the less
invasive PCI over surgery
45
MACCE to 3 Years by SYNTAX Score Tercile
Intermediate Scores (23-32)
CABG PCI P value
Death 5.7 10.3 0.09
CVA 3.6 2.5 0.53
MI 3.1 8.9 0.01
Death, CVA or MI 11.3 16.1 0.16
Revasc. 8.4 18.2 0.004
3VD
29.4
P0.003
16.8
Months Since Allocation
Site-reported Data ITT population
Cumulative KM Event Rate 1.5 SE log-rank P
value
46
MACCE to 3 Years by SYNTAX Score Tercile High
Scores (?33)
CABG PCI P value
Death 4.5 11.1 0.03
CVA 1.9 4.3 0.28
MI 1.9 7.2 0.02
Death, CVA or MI 8.3 17.7 0.01
Revasc. 10.5 21.5 0.006
3VD
P0.004
31.4
17.9
Site-reported Data ITT population
Cumulative KM Event Rate 1.5 SE log-rank P
value