The Impact of Practice Guideline Changes

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@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@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

4. 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 Previous ESC Guidelines

5. Joint ESC – EACTS Guidelines on Myocardial Revascularisation • First (ever) document based on consensus opinion between clinical cardiologists, interventional cardiologistsand 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%

6. Evidence of the « C » level is not necessarily weak! 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-revascularisation

8. The Heart Team Clinical cardiologist(non interventional) The patientwith CAD Interventionalcardiologist Cardiacsurgeon Task Force composition = 7 clinical cardiologists (non interventional)+ 9 interventional cardiologists + 7 cardiac surgeons

9. 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 2010 ESC - EACTS Guidelineson Myocardial Revascularisation Joint ESC – EACTS Guidelines on Myocardial Revascularisation William WijnsCardiovascular CenterAalst Philippe KolhCardiovascular Surgery DepartmentLiège www.escardio.org/guidelines

12. www.syntaxscore.com

13. CABG PCI

14. 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@olvz-aalst.be

16. 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

17. 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.

18. Indications for revascularisation instable angina or silent ischaemia * With documented ischaemia or Fractional Flow Reserve (FFR) < 0.80 for % diameter stenosis by angiography between 50 and 90 %

19. 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 2009;53:530-53 U = uncertain A = appropriate I = inappropriate

22. 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

23. MACCE to 3 Years by SYNTAX Score Tercile Low Scores (0-22) CABG(N=171) TAXUS(N=181) 40 30 Cumulative Event Rate (%) 20 10 0 0 12 24 36 Months Since Allocation 3VD P=0.45 25.8% 22.2% Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

24. 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

25. MACCE to 3 Years by SYNTAX Score Tercile Low Scores (0-22) CABG(N=104) TAXUS(N=118) 40 30 Cumulative Event Rate (%) 20 10 0 0 12 24 36 Months Since Allocation Left Main > > P=0.33 23.0% < Cumulative Event Rate (%) 18.0% > < Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

26. MACCE to 3 Years by SYNTAX Score Tercile Intermediate Scores (23-32) CABG(N=92) TAXUS(N=103) 40 30 Cumulative Event Rate (%) 20 10 0 0 12 24 36 Months Since Allocation Left Main > > P=0.90 23.4% < 23.4% > < Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

27. MACCE to 3 Years by SYNTAX Score Tercile Left Main SYNTAX Score 33 CABG(N=149) TAXUS(N=135) 40 30 Cumulative Event Rate (%) 20 10 0 0 12 24 36 Months Since Allocation Left Main Left Main < P=0.003 37.3% > < 21.2% < < Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

28. 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

29. Classes of Recommendations is recommended should be considered may be considered is not recommended

30. Consensus Heart Team Agreement Acceptable for CABG Not acceptable for CABG Acceptable for PCI Randomization in randomized trial Follow-up in PCI-only registry Not acceptable for PCI Follow-up in CABG-only registry

31. Registry arms in SYNTAX Unfavourable anatomy is the only reason for not performing PCI in the DES era: feasibility = indication 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)

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 patient’s 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@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 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

40. 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

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(N=208) TAXUS(N=207) 40 30 Cumulative Event Rate (%) 20 10 0 0 12 24 36 Months Since Allocation 3VD 29.4% P=0.003 16.8% Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

46. MACCE to 3 Years by SYNTAX Score Tercile High Scores (33) CABG(N=166) TAXUS(N=155) 40 30 Cumulative Event Rate (%) 20 10 0 0 12 24 36 Months Since Allocation 3VD P=0.004 31.4% 17.9% Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population