Left Main Disease: what is left to surgery? Prof. Jacques Monségu CardioVascular Institute Grenoble, France

Transcription

1 Left Main Disease: what is left to surgery? Prof. Jacques Monségu CardioVascular Institute Grenoble, France

2 Background on LM stenosis 5% of patients undergoing angiography Of the myocardium 80% Bifurcation involved MDV CABG : standard of care for LM stenosis

3 Background on LM stenosis Over the past 20 years Improvement of stent technology DES first generation DES new generation CABG More arterial revascularization Improvement of stent implantation Improvement of operator experience Reduction of stent thrombosis

4 Good sense

5 A real discussion 75-years old man HTA, smoker Old COPD Mid LAD PCI 2 years ago AAA surgery 2 years ago De novo angina Creatinin 89 EF 60%

6 RCTs PCI vs CABG before 2016 LE MANS JACC 2008 BOUDRIOT JACC 2011 SYNTAX LM circulation 2010 PRE COMBAT NEJM 2011 n DES type PEP Results % sup FEVG FEVG PCI> FEVG CABG % First G non inf CV death/mi/ TVR % First G non inf MACCE % First G non inf MACCE First Generation of DES Non inferiority trial Relative small sample size PCI non Inferior CABG (more TVR in PCI group) PCI non Inferior CABG (more TVR in PCI group) PCI non Inferior CABG (more TVR in PCI group) Capodanno JACC 2011;58:

7 Left main SYNTAX: 5-years CABG 348 pts PCI 357 pts Mohr Lancet 2013;381:629-38

8 Left Main SYNTAX 5-years: MACCE CABG PCI SYNTAX score 0-32 SYNTAX score > 33 Serruys Lancet 2013;381:629-38

9 Left Main SYNTAX 5-years: MACCE SYNTAX score 0-32

10 MACCE N=600 patients PRECOMBAT Non inferiority margin : absolute difference of 7% Repeat revasc@ 2 years 9% vs 4.2% (p=0.02) PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events Park NEJM 2011;364:

11 PRECOMBAT 5-years Primary End-point MACCE Ahn JACC 2015;65:

12 Pooled analysis SYNTAX LM and PRECOMBAT 5-year outcomes n=1305 patients 5 years: 28.3% PCI vs 23.0% CABG; p =0.045 Low to intermediate Syntax Scores High Syntax Scores PCI CABG PCI CABG Trend of lower total death and cardiac mortality in PCI group PCI equivalent to CABG in LM disease with SYNTAX Score < 32 Subgroup of subgroup of a negative study! Cavalcante JACC 2016;68:

13 Recommendations for LM revascularization United States Europe PCI CABG SS 0-22 IIa B I B SS IIb B I B SS > 32 III B I B Levine JACC 2011;58: PCI CABG SS 0-22 I B I B SS IIa B I B SS > 32 III B I B Windecker Eur Heart J 2014; 35:

14 Limitations of these trials Relative small studies Left main disease was a sub-group in SYNTAX Patients where CABG has proved benefits (high SYNTAX score) were included First generation DES were used IVUS/FFR guidance was uncommon Discretional angiographic follow up overly inflated the number of events in PCI arm Best standards of CABG were underused Non inferiority margin was large (6-7%)

15 SYNTAX Score II SYNTAX Score Age Renal function VG function Gender Peripheral artery disease COPD Farooq Lancet 2013; 381:639-50

16 SYNTAX Score II 4-year mortality Farooq Lancet 2013; 381:639-50

17 New trials: EXCEL and NOBLE SYNTAX EXCEL NOBLE All comers Yes No No Patient population LM/3VD LM LM SYNTAX Score Any 32 low Primary EP Death/MI/CVA/TVR Death/MI/CVA Death/MI/CVA/TVR Follow up 1 year 3 year 5 year IVUS/FFR Infrequent Recommended Recommended Stent PES EES BES Angio FU At discretion Not recommended Not recommended Stone NEJM 2016; 375: Mäkikallio Lancet 2016; 388:

18 Study features EXCEL NOBLE Patients 1905 at 126 sites US, EU) 1201 at 36 sites (EU) Recruitment Age 66 years 66 years Diabetes 30% 15% LVEF 57% 60% ACS 24% 18% SYNTAX Score Distal location 82% 81% IVUS use 77% 74% Off-pump CABG 29% 16% Arterial conduits used 99% 95% Only arterial conduits used 25% 14%

19 EXCEL: results Primary endpoint Death, stroke or MI at 3 years Secondary enpoints Death, stroke or MI at 30 days Death, stroke, MI or ischemia-driven revasc at 3 years Death, stroke or MI at 3 years PCI CABG p INF p SUP 15.4% 14.7% % 7.9% < % 19.1% % 14.7% 0.98 PCI non inferior to CABG for LM disease Stone NEJM 2016; 375:

20 NOBLE results PCI CABG p SUP MACCE 29% 19% Death 12% 9% 0.77 Non-procedural MI 7% 2% Stroke 5% 2% 0.07 Repeat revascularization 16% 10% PCI not non-inferior to CABG for LM disease (HR>1.35) Mäkikallio Lancet 2016; 388:

21 One Question: PCI vs CABG in LM disease EXCEL study Two Studies NOBLE study Two Answers!! How to explain different results?

22 Different devices Better long term results with EES Pooled NEXT + COMPARE II BES vs EES, n=5942 Vlachojannis Eurointervention 2016

23 Primary endpoint: Definition of component EXCEL study NOBLE study Death MI* Stroke Death MI* Stroke Repeat Revascularisation * All MI (including procedural) * Only Non procedural MI

24 Impact of MI definition EXCEL study NOBLE study CABG PCI CABG PCI All MI in EXCEL Only Non procedural MI in NOBLE Early Hazard in CABG group of EXCEL

25 Follow-up Duration EXCEL study: 3 YEARS NOBLE study: 5 YEARS CABG PCI CABG PCI 28% 19% Follow-up too short to show difference? But low rates of BIMA in CABG group (25% EXCEL, 14% NOBLE) Probable SVG failure to occur after 3-5 years

26 If we summarize EXCEL study NOBLE study Xience stent Biomatrix Stent 3 years FU 5 years FU PEP: All MI PEP: Only non procedural MI PEP without repeat revasc. PEP with repeat revasc. Positive Study Non Inferiority of PCI Negative study No Non inferiority of PCI

27 Limit of «evidence based medicine» in cardiovascular interventions EBM try to find a «black or white» answer While practice is a large scale of grey Deconnexion between studies and routine use EXCEL and NOBLE studies PCI or CABG for LM Practice PCI and CABG for LM with Individualized medicine

28 Decision making for LM disease: Heart team Clinical factors PATIENT Anatomical factors ANGIOGRAPHY LM Revascularization Local factors OPERATOR HOSPITAL The best solution for MY patient

29 Revascularization strategy Clinical factors Surgery risk, Scores (Euroscore, STS, Global Risk score) Age / Gender/ Comorbidity Clinical presentation (stable SCA) Diabetes LV function DAP compliance Patient preference, cultural specificity Patient will drive the decision!

30 Revascularization strategy Anatomical factors SYNTAX score (< 22, 23 to 31, < 32) Lesion located (Ostium/mid vs. Distal) CTO or not Previous PCI /CABG Anatomy is KEY for decision

31 Revascularization strategy Local factors Cost, delay, availability Skills of PCI operator Skills of surgeon (IMA vs. SVG) Volume / Center and operator quality

32 Surgery prefered: Lack of DAPT compliance Diffuse disease with SS > 32 or non protectable Cx or CTO non accessible Diabetes Incompleted PCI revascularization No vascular access Patient preference

33 PCI prefered: Simple anatomy with SS < 22 Completed revascularization High PCI volume center and optimal technique used Comorbidities associated Age? Patient preference

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36 Conclusions PCI and CABG show similar rates of the safety endpoint of mortality Higher rate of repeat revascularisation with PCI (5% absolute increased risk) Different results related to stent and study design Decision making process instead of SYNTAX Score based But should also take into account important clinical comorbidities and demographic factors

37 Conclusions The SYNTAX score II is a useful tool to help this decision process Heart team discussion for higher chance of optimal decision Possible guidelines change In the subset of less anatomic complexity, PCI leads to lower overall and cardiac mortality PCI should be the prefered strategy