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@olvz-aalst.be
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@olvz-aalst.be
Joint ESC - EACTS Guidelines
on Myocardial Revascularisation
Joint Task Force on Myocardial Revascularisation of
the European Society of Cardiology (ESC) and
the European Association for CardioThoracic Surgery (EACTS)
Developed with the special contribution of
the European Association for
Percutaneous Cardiovascular Interventions (EAPCI)
European Heart Journal (2010) 31, 2501-2555
European Journal of CardioThoracic Surgery 38, S1 (2010) S1-S52
www.escardio.org/guidelines
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 2005;26:804-847.
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 2006;27:1341-1381.
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 2007;28:1598-1660.
NSTE-ACS 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 2008;29:2909-2945.
STEMI in 2008
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
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%
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
Parachutes appear to reduce the risk of injury but ...
their effectiveness has not been proved with randomised controlled trials
Level of Evidence = C
Evidence of the « C » level is not
necessarily weak!
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
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-revascularisation
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
The Heart Team
Clinical cardiologist
(non interventional)
The patient
with CAD
Interventional
cardiologist
Cardiac
surgeon
Task Force composition = 7 clinical cardiologists (non interventional)
+ 9 interventional cardiologists + 7 cardiac surgeons
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
Joint ESC – EACTS Guidelines on Myocardial Revascularisation
Chairpersons & Task Force members
William Wijns
Cardiovascular Center
Aalst
Philippe Kolh
Cardiovascular Surgery Department
Liège
Carlo Di Mario
Nicolas Danchin
Volkmar Falk
Stefan James
Jean Marco
Miodrag Ostojic
Nicolaus Reifart
Flavio Ribichini
Martin Schalij
Patrick Serruys
Sigmund Silber
Scot Garg
Kurt Huber
Juhani Knuuti
Jose Lopez-Sendon
Massimo Piepoli
Charles Pirlet
Thirry Folliguet
Lorenzo Menicanti
Jose-Luis Pomar
Paul Sergeant
Miguel Sousa Uva
David Taggart
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
www.syntaxscore.com
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
CABG
PCI
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
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
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@olvz-aalst.be
Indications for revascularisation in patients
with 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
www.escardio.org/guidelines
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 2003;107:2900-6.
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
Indications for revascularisation in
stable angina or silent ischaemia
Subset of CAD by anatomy
For
symptoms
For
prognosis
Class
Level
I
A
IIa
B
No limit symptoms with OMT
III
C
Subset of CAD by anatomy
Class
Level
Left main > 50%*
I
A
Any proximal LAD > 50%*
I
A
2VD or 3VD with impaired LV function*
I
B
Proven large area of ischaemia (> 10% LV)
I
B
Single remaining patent vessel > 50% stenosis*
I
C
1VD without proximal LAD and without > 10% ischaemia
III
A
Any stenosis > 50% with limiting angina or angina equivalent,
unresponsive to OMT
Dyspnoea/CHF and > 10% LV ischaema/viability supplied by
> 50% stenotic artery
* With documented ischaemia or Fractional Flow Reserve (FFR) < 0.80 for % diameter
stenosis by angiography between 50 and 90 %
www.escardio.org/guidelines
Pressure wire pullback
Adenosine iv
Distal LAD
Distal LAD
Proximal LAD
A04/19
Specific PCI devices and pharmacotherapy
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
Appropriateness of revascularisation method for advanced
coronary artery disease
ACCF / SCAI / STS / AATS / AHA / ASNC 2009 report
Patel MR et al. JACC 2009;53:530-53
A = appropriate
www.escardio.org/guidelines
U = uncertain
I = inappropriate
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
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
IIb C
IC
1VD or 2VD - proximal LAD
IA
IIa B
3VD simple lesions, full functional revascularisation achievable
with PCI, SYNTAX score ≤ 22
IA
IIa B
3VD complex lesions, incomplete revascularisation achievable
with PCI, SYNTAX score > 22
IA
III A
Left main (isolated or 1VD, ostium/shaft)
IA
IIa B
Left main (isolated or 1VD, distal bifurcation)
IA
IIb B
Left main + 2VD or 3VD, SYNTAX score ≤ 32
IA
IIb B
Left main + 2VD or 3VD, SYNTAX score ≥ 33
IA
III B
1VD or 2VD - non-proximal LAD
 In the most severe patterns of CAD, CABG appears to offer a survival advantage
as well as a marked reduction in the need for repeat revascularisation
www.escardio.org/guidelines
MACCE to 3 Years by SYNTAX Score
Tercile Low Scores (0-22)
CABG (N=171)
TAXUS (N=181)
3VD
Cumulative Event Rate (%)
40
30
P=0.45
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
25.8%
22.2%
20
10
0
0
12
24
Months Since Allocation
Cumulative KM Event Rate ± 1.5 SE; log-rank P value
36
Site-reported Data; ITT population
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
IIb C
IC
1VD or 2VD - proximal LAD
IA
IIa B
3VD simple lesions, full functional revascularisation achievable
with PCI, SYNTAX score ≤ 22
IA
IIa B
3VD complex lesions, incomplete revascularisation achievable
with PCI, SYNTAX score > 22
IA
III A
Left main (isolated or 1VD, ostium/shaft)
IA
IIa B
Left main (isolated or 1VD, distal bifurcation)
IA
IIb B
Left main + 2VD or 3VD, SYNTAX score ≤ 32
IA
IIb B
Left main + 2VD or 3VD, SYNTAX score ≥ 33
IA
III B
1VD or 2VD - non-proximal LAD
 In the most severe patterns of CAD, CABG appears to offer a survival advantage
as well as a marked reduction in the need for repeat revascularisation
www.escardio.org/guidelines
MACCE to 3 Years by SYNTAX Score
Tercile Low Scores (0-22)
CABG (N=104)
TAXUS (N=118)
CABG
Left Main
Cumulative Event Rate (%)
40
30
P=0.33
23.0%
20
18.0%
10
PCI
P value
Death
6.0% >
2.6%
0.21
CVA
4.1% >
0.9%
0.12
< 4.3%
0.36
Death,
CVA or
MI
11.0% > 6.9%
0.26
Revasc.
13.4% < 15.4%
0.69
MI
2.0%
0
0
12
24
Months Since Allocation
Cumulative KM Event Rate ± 1.5 SE; log-rank P value
36
Site-reported Data; ITT population
MACCE to 3 Years by SYNTAX Score
Tercile Intermediate Scores (23-32)
CABG (N=92)
TAXUS (N=103)
CABG
Left Main
Cumulative Event Rate (%)
40
30
P=0.90
23.4%
23.4%
20
10
PCI
P value
Death
12.4% >
4.9%
0.06
CVA
2.3% >
1.0%
0.46
< 5.0%
0.63
MI
3.3%
Death,
CVA or
MI
15.6% > 10.8%
0.29
Revasc.
14.0% < 15.9%
0.75
0
0
12
24
Months Since Allocation
Cumulative KM Event Rate ± 1.5 SE; log-rank P value
36
Site-reported Data; ITT population
MACCE to 3 Years by SYNTAX Score
Tercile Left Main SYNTAX Score 33
CABG (N=149)
TAXUS (N=135)
Cumulative Event Rate (%)
40
CABG
Left Main
P=0.003
Death
7.6%
PCI
< 13.4%
P value
0.10
37.3%
CVA
30
21.2%
20
MI
Death,
CVA or
MI
10
4.9% >
6.1%
1.6%
0.13
< 10.9%
0.18
15.7% < 20.1%
0.34
0
0
12
24
Months Since Allocation
Cumulative KM Event Rate ± 1.5 SE; log-rank P value
36
Revasc.
9.2%
< 27.7%
<0.001
Site-reported Data; ITT population
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
IIb C
IC
1VD or 2VD - proximal LAD
IA
IIa B
3VD simple lesions, full functional revascularisation achievable
with PCI, SYNTAX score ≤ 22
IA
IIa B
3VD complex lesions, incomplete revascularisation achievable
with PCI, SYNTAX score > 22
IA
III A
Left main (isolated or 1VD, ostium/shaft)
IA
IIa B
Left main (isolated or 1VD, distal bifurcation)
IA
IIb B
Left main + 2VD or 3VD, SYNTAX score ≤ 32
IA
IIb B
Left main + 2VD or 3VD, SYNTAX score ≥ 33
IA
III B
1VD or 2VD - non-proximal LAD
 In the most severe patterns of CAD, CABG appears to offer a survival advantage
as well as a marked reduction in the need for repeat revascularisation
www.escardio.org/guidelines
Classes of Recommendations
is recommended
should be considered
may be considered
is not recommended
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
Consensus Heart Team Agreement
Acceptable for
CABG
Not acceptable for
CABG
Acceptable for PCI
Randomization in
randomized trial
Follow-up in PCIonly registry
Not acceptable for
PCI
Follow-up in CABGonly registry
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
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 patient’s condition & risk
Proposed treatment should account for the experience of the local
team
Properly inform the patient and consider his preferences
SYNTAX Trial Patient Distribution: 3 VD
CABG
72%
PCI only
8%
CABG
+
PCI
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
20%
PW Serruys et al.
SYNTAX Trial Patient Distribution: LM
Surgery
For LM Still
gold standard
66%
PCI LM
Legitimate
34%
PW Serruys et al.
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
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@olvz-aalst.be
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
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
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 cofounder of Cardio³BioSciences, a start-up company focusing on cellbased regeneration cardiovascular therapies
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?”
Evidence basis for myocardial revascularisation
Optimal 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
www.escardio.org/guidelines
Evidence basis for myocardial revascularisation
Optimal 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 significant
difference in the composite of death, MI, stroke, or hospitalisation
for unstable angina
– Freedom from angina was greater by 12% in the PCI group at
one year but was eroded by five years
www.escardio.org/guidelines
Potential indications for ad hoc PCI versus
revascularisation 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.
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
Potential indications for ad hoc PCI versus
revascularisation 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.
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
Recommendations for decision making and patient information
time ?
informed ?
www.escardio.org/guidelines
Joint 2010 ESC - EACTS Guidelines
on Myocardial Revascularisation
Patient information and consent
When asked, most patients will prefer the less
invasive PCI over surgery
MACCE to 3 Years by SYNTAX Score
Tercile Intermediate Scores (23-32)
CABG (N=208)
TAXUS (N=207)
3VD
Cumulative Event Rate (%)
40
30
29.4%
P=0.003
20
16.8%
10
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
0
0
12
24
Months Since Allocation
Cumulative KM Event Rate ± 1.5 SE; log-rank P value
36
Site-reported Data; ITT population
MACCE to 3 Years by SYNTAX Score
Tercile High Scores (33)
CABG (N=166)
TAXUS (N=155)
3VD
Cumulative Event Rate (%)
40
P=0.004
31.4%
30
20
17.9%
10
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
0
0
12
24
Months Since Allocation
Cumulative KM Event Rate ± 1.5 SE; log-rank P value
36
Site-reported Data; ITT population