The Impact of Practice Guideline Changes on Revascularisation Strategies in Patients with...

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 & [email protected]

www.escardio.org/guidelines

Joint ESC - EACTS Guidelineson Myocardial Revascularisation

Joint Task Force on Myocardial Revascularisation ofthe European Society of Cardiology (ESC) and

the European Association for CardioThoracic Surgery (EACTS)

Developed with the special contribution ofthe European Association for

Percutaneous Cardiovascular Interventions (EAPCI)

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

www.escardio.org/guidelinesJoint 2010 ESC - EACTS Guidelineson Myocardial Revascularisation

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

Only 2 chapters out of 12

on « techniques »

of PCI or CABG


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%


Parachutes appear to reduce the risk of injury but ...their effectiveness has not been proved with randomised controlled trials

Evidence of the « C » level is not necessarily weak!

Level of Evidence = C


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


The Heart Team

Clinical cardiologist(non interventional)

Cardiacsurgeon

Interventionalcardiologist

Task Force composition = 7 clinical cardiologists (non interventional)+ 9 interventional cardiologists + 7 cardiac surgeons

The patientwith CAD


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

Joint ESC – EACTS Guidelines on Myocardial Revascularisation

William WijnsCardiovascular CenterAalst

Philippe KolhCardiovascular Surgery Department

Liège


www.syntaxscore.com

CABG

PCI


• 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

Tasks for each local Heart Team


● 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

Indications for revascularisation in patientswith stable or acute coronary artery disease


Revascularisation versus Medical Therapy after Stress SPECT: Survival Analysis

Hachamovitch et al. Circulation 2003;107:2900-6.

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


* With documented ischaemia or Fractional Flow Reserve (FFR) < 0.80 for % diameter stenosis by angiography between 50 and 90 %

Indications for revascularisation instable angina or silent ischaemia

Subset of CAD by anatomy Class Level

Forprognosis

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

Subset of CAD by anatomy Class Level

Forsymptoms

Any stenosis > 50% with limiting angina or angina equivalent, unresponsive to OMT

I A

Dyspnoea/CHF and > 10% LV ischaema/viability supplied by > 50% stenotic artery

IIa B

No limit symptoms with OMT III C

Distal LAD

A04/19

Pressure wire pullbackPressure wire pullbackAdenosine ivAdenosine iv

Distal LAD Proximal LAD


Specific PCI devices and pharmacotherapy


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 U = uncertain I = inappropriate


Indications for CABG versus PCI in stable patients with lesions suitable for both procedures and low predicted surgical mortality

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

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 > 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

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

MI12.3% 11.2% 0.75

Revasc. 11.6% 18.8% 0.06Months Since Allocation

P=0.45

3VDTAXUS (N=181)

CABG (N=171)

MACCE to 3 Years by SYNTAX Score Tercile Low Scores (0-22)

25.8%

22.2%

Months Since Allocation

Cum

ula

tive E

vent

Rate

(%

)

0 12 24

40

0

20

30

10

36

Site-reported Data; ITT populationCumulative KM Event Rate ± 1.5 SE; log-rank P value








I A IIa B


I A III A





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

MI11.0% 6.9% 0.26


Cum

ula

tive E

vent

Rate

(%

)

P=0.33

Left MainTAXUS (N=118)

CABG (N=104)

MACCE to 3 Years by SYNTAX Score Tercile Low Scores (0-22)

18.0%

23.0%


Cum

ula

tive E

vent

Rate

(%

)

0 12 24

40

0

20

30

10

36


>

>

>

<

<

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

MI15.6% 10.8% 0.29

Revasc. 14.0% 15.9% 0.75

P=0.90


CABG (N=92)

MACCE to 3 Years by SYNTAX Score Tercile Intermediate Scores (23-32)

23.4%23.4%


Cum

ula

tive E

vent

Rate

(%

)

0 12 24

40

0

20

30

10

36


>

>

>

<

<

P=0.003


CABG (N=149)

MACCE to 3 Years by SYNTAX Score Tercile Left Main SYNTAX Score 33

37.3%

21.2%

Left Main


Cum

ula

tive E

vent

Rate

(%

)

0 12 24

40

0

20

30

10

36

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

MI15.7% 20.1% 0.34

Revasc. 9.2% 27.7% <0.001


>

<

<

<

<








I A IIa B


I A III A






Classes of Recommendations

is recommended

should be considered

may be considered

is not recommended

Consensus Heart Team Agreement

Not acceptable for CABG

Acceptable for CABG

Follow-up in CABG-only registry

Not acceptable for PCI

Follow-up in PCI-only registry

Randomization in randomized trial

Acceptable for PCI

PCI-only registry (CABG not acceptable) in 198 patientsCABG not feasible because of co-morbidity in 71 % or lack of graft material in 9 %

CABG-only registry (PCI not acceptable) in 1.077 patientsPCI not feasible because coronary anatomy was not suitable in 92 % (including 22% CTO)

Registry arms in SYNTAX

Unfavourable anatomy is the only reason for not performing PCI in the DES era: feasibility = indication

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 evidenceIs that evidence relevant to this patient?

Appraisal of the patient’s condition & riskProposed treatment should account for the experience of the local

teamProperly inform the patient and consider his preferences

Integrated decision-making process

SYNTAX Trial Patient Distribution: 3 VDSYNTAX Trial Patient Distribution: 3 VD

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

CABG72%

CABG +

PCI

20%

8%PCI only

PW Serruys et al.

SYNTAX Trial Patient Distribution: LMSYNTAX Trial Patient Distribution: LM

PCI LM Legitimate

34%

Surgery For LM Still

gold standard66%

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

PW Serruys et al.


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

Disclosures for William WijnsCardiovascular Center Aalst, Belgium

• Consulting Fees: on my behalf go to the Cardiovascular Research Consulting Fees: on my behalf go to the Cardiovascular Research Center AalstCenter Aalst

• Contracted Research between the Cardiovascular Research Center Contracted Research between the Cardiovascular Research Center Aalst and several pharmaceutical and device companies Aalst and several pharmaceutical and device companies

• Ownership Interest: Cardiovascular Research Center Aalst is co-Ownership Interest: Cardiovascular Research Center Aalst is co-founder of Cardio³BioSciences, a start-up company focusing on cell-founder of Cardio³BioSciences, a start-up company focusing on cell-based regeneration cardiovascular therapiesbased regeneration cardiovascular therapies

• “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.

Watch for your “Team” member!

Yediot Journal 17.12.2006“Stents in the arteries: a ticking bomb or a huge achievement?”


Evidence basis for myocardial revascularisationOptimal 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


Evidence basis for myocardial revascularisationOptimal 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


• 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.

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.

Potential indications for ad hoc PCI versusrevascularisation at an interval


Recommendations for decision making and patient information

informed ?time ?

Patient information and consent

When asked, most patients will prefer the less invasive PCI over surgery

When asked, most patients will prefer the less invasive PCI over surgery

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

MI11.3% 16.1% 0.16


P=0.003

3VDTAXUS (N=207)

CABG (N=208)

MACCE to 3 Years by SYNTAX Score Tercile Intermediate Scores (23-32)

29.4%

16.8%


Cum

ula

tive E

vent

Rate

(%

)

0 12 24

40

0

20

30

10

36


3VDTAXUS (N=155)

CABG (N=166)

MACCE to 3 Years by SYNTAX Score Tercile High Scores (33)

P=0.00431.4%

17.9%


Cum

ula

tive E

vent

Rate

(%

)

0 12 24

40

0

20

30

10

36


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

MI8.3% 17.7% 0.01

Revasc. 10.5% 21.5% 0.006

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