Optimal Revascularization in Multivessel Disease and Coronary CTO. Dr Simon Walsh MD FRCP FSCAI Consultant Cardiologist Belfast Trust

Transcription

1 Optimal Revascularization in Multivessel Disease and Coronary CTO Dr Simon Walsh MD FRCP FSCAI Consultant Cardiologist Belfast Trust

2 Potential Conflicts of Interest Speaker's name: Simon Walsh Consulting and Research Funding: Abbott Vascular Consulting and Research Funding: Boston Scientific Research Funding: Nitiloop Consulting: Vascular Solutions

3 Why treat CTOs at all? Patients are protected by collaterals The lesions can t get any worse It s too difficult, the risks outweigh the benefits Success rates are too low My personal favourite - There is no mortality benefit

4 The protection from collaterals

5 Mortality benefit in stable angina with PCI? RITA 2-7 yrs. Henderson et al. JACC 2003;42:1161 FAME 2. de Bruyne et al. NEJM 2012;367:991

6 To treat or not to treat? A 65 yr old male with limiting angina despite medical therapy

7 To treat or not to treat? A 65 yr old male with limiting angina despite medical therapy

8 To treat or not to treat? A 65 yr old male with limiting angina despite medical therapy

9 To treat or not to treat? A 65 yr old male with limiting angina despite medical therapy

10 The symptom burden and treatment benefits are the same if not more for CTO PCI Compared pts with successful SVCAD PCI 141 CTO pts and 1616 pts with non-cto lesions Compared standardised measures of symptoms (SAQ/RDS), function and QoL (EQ5D) CTO pts worse at baseline Benefit to the same endpoint after a successful procedure CCI 2014;84:

11 Current evidence in stable disease? OPEN ATERY CTO Mortality Benefit X X Maybe inferred from nonrandomised data Reduced Angina Improved exercise capacity Improved QoL

12 Established for CTO PCI Clear symptomatic and QoL benefits Successful opening reduces mortality versus failed CTO as non-culprit in STEMI doubles mortality risk from acute MI Potential to increase LV function in ischaemic cardiomyopathy with viable myocardium Potential to reduce arrhythmia

13 The treatment paradox: CTO is a barrier to PCI >8,000 sequential angiograms Cleveland Clinic CTO strong predictor of PCI not being performed (OR 0.26, ; p<0.0001) Christofferson et al. Am J Cardiol 2005;95: US centres >35,000 CTOs/>640,000 angiograms Indication for cardiac surgery excluded from analysis (valve disease) Grantham et al. JACC Int 2009;2:479

14 Current Practice: Patients undergoing angiography with CTO

15 Patients with CTO offered PCI 10-15%

16 Optimal Revascularization - Agreed?? Patients with CAD should have optimal revascularization by PCI or CABG Viable and ischaemic myocardium should be revascularized <5% of LV mass with residual ischaemia

17 Where has PCI PLC gone wrong in the past? 11,249 patients having PCI in NY state Predictor of MACE - 2 diseased vessels with a CTO Hannan et al. JACC Int 2009;2:17-25

18 Observational data from BCIS mandatory returns 5 calendar years of data (05-09 inclusive) 13,443 pts undergoing attempted CTO PCI Overall success rate 71% Mortality data linked from unique patient number from Office for National Statistics George et al. JACC 2014;64:235-43

19 The Syntax Trial: A Lucky Miss Mohr et al. Lancet 2013;381:629-38

20 CTO in Syntax? Very poor technical outcomes with PCI Farooq et al. JACC 2013;61:282-94

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22 Cause of a Poor Outcome in Syntax? Incomplete Revascularization Residual Syntax score >8 associated with 35.3% mortality at 5 years follow-up Farooq et al. Circulation 2013;128:

23 CTO: The biggest per lesion contributor to the Syntax score Likely the largest contributor to the residual Syntax score too

24 Contemporary CTO Practice & Results What is possible?

25 The necessary skill sets to facilitate the hybrid approach?

26 Antegrade Wire Escalation

27 Antegrade Dissection Re-entry

28 Retrograde wire escalation

29 Retrograde Dissection Re-entry

30 Hybrid CTO PCI Success requires flexbility in approach No dogma Open the artery safely, but open the artery Apply every option you have to help the patient Aim for efficiency (i.e. safety)

31 The Hybrid Algorithm for CTO PCI initial approaches Dual Catheter Angiography yes 1. Clear proximal cap 2. Good distal target no Antegrade Retrograde yes no 3. Length < 20mm yes no Wire escalation Dissection Reentry (crossboss-stingray) Wire escalation Dissection Reentry (reverse CART)

32 The Hybrid Algorithm for CTO PCI provisional approaches Dual Catheter Angiography Antegrade yes 1. Clear proximal cap 2. Good distal target Retrograde yes no yes no 3. Length < 20mm no When you stall: CHANGE STRATEGY Wire escalation fail Dissection Reentry (crossboss-stingray) Wire escalation fail Dissection Reentry (reverse CART) fail fail Dissection Reentry (reverse CART) Dissection Reentry (crossboss-stingray)

33 CTO PCI: Integration of good technology with the right skill mix

34 Good principles and fundamental to hybrid: Exit failure modes early - don t waste time failing X X X 180 minutes?? 4 Gray?? 300 mls contrast??

35 This can be taught and transferred Sharma et al. Open Heart 2015;2:e doi: /openhrt

36 Belfast CTO data 2012 / procedures Per lesion success 91% Easy (0) Intermediate (1) Difficult (2) V Difficult ( 3) Japanese 2012 data 1553 procedures 44 hospitals Presented: NY CTO 2014

37 Different complexity, different pathology? Post CABG 30% vs 9% Belfast JCTO 70 52, ,5 0 Easy (0) Intermediate (1) Difficult (2) V Difficult ( 3)

38 Optimal Revascularization - Agreed?? Patients with CAD should have optimal revascularization by PCI or CABG Viable and ischaemic myocardium should be revascularized <5% of LV mass with residual ischaemia

39 Multi-vessel CAD and complete revascularization: We can and must do better in 2015

40 Contemporary complete revascularization: The portfolio matters

41 3v CAD?

42 ifr negative FFR = 0.86

43 ifr negative FFR = 0.94

44 Now single vessel CTO CrossBoss Stingray

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47 Syntax 2 is not just simple 3vCAD

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49 With no Guidezilla, no PCI!

50 New technology gets us from.

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53 Calcium

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56 rcart for RCA CTO

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58 You need all the tools to get the right result for the patient

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61 CTO crossing

62 Threader

63 HSRA

64 Guidezilla

65 38mm Synergy stents

66 Deliverable NC balloons

67 Putting the portfolio together

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69 Durability of Outcome for CTO PCI, DES Choice and Vessel Healing

70 Success Complexity Morino et al. JACC CI 2011;4:

71 UK data: Complexity not reliably amenable to wire based strategies

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75 Is there a downside to dissection and re-entry? All CTOs are not wire cases Anatomy should inform strategy, not dictate to attempt or not As complexity rises, advanced techniques are needed for success Healing is crucial for durability and long-term results Individual patients demonstrate vast differences in bleeding risk and DAPT tolerability

76 rcart case 4 months after CTO PCI

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79 After 5mm NC and then tentative 6mm balloon inflation

80 Appearance 20 months after index PCI

81 SYNERGY Everolimus-Eluting Stent with Synchrony Bioabsorbable Coating Polymer and drug applied as ultra-thin abluminal coating Synchronized drug release and polymer absorption Polymer gone shortly after completion of drug elution at 3 months SYNERGY Stent Abluminal Coating Coating Microstructure PLGA Polymer Everolimus Drug PROMUS Element Stent Strut Cross Sections SYNERGY PVDF durable polymer 360º around stent strut PLGA bioabsorbable polymer only on abluminal surface Arterial Wall Data on file at BSC. The SYNERGY stent is an investigational device in the US and not for sale. IC AB AUG2013 Slide

82 Drug Release and Polymer Absorption Profiles SYNERGY Nobori and Biomatrix Flex % Recovery Polymer: PLGA Absorption Time: 3-4m Everolimus PLGA % Recovery Polymer: PLA Absorption Time: >9m BA9 PLA Time (months) Time (months) Orsiro Absorb BVS % Recovery Polymer: PLLA Absorption Time: >12m Sirolimus PLLA (molecular weight change) % Recovery Scaffold: PLLA Polymer: PDLLA Absorption Time: 3y Everolimus PDLLA Time (months) Time (months) The SYNERGY Stent polymer absorbs shortly after drug elution is complete at 3 months oston Scientific data on file; World J Cardiol 2011 March 26; 3(3): 84-92; arg, S, J Am Coll Cardiol. 2010;56(10s1):S43-S78. doi: Presented by Stephen Windecker, MD, TCT2012. he Synergy Stent is an investigational device in the US and not for sale. IC AB AUG2013 Slide

83 Complex RCA occlusion with SVG failure Belfast 2 case 4 clip 2

84 Acute result after RDR - note distal dissection planes Belfast 2 case 4 clip 19

85 6/12 follow-up Picton follow up 63_3

86 BSc CTO: Investigator Sponsored Research CONSISTENT Enrolling CTO Indication (US) & Safety (Sub-Intimal Stenting) with Synergy Stent Prospective, Multi-Center, Single Arm N=200 Patients PI: Dr Simon Walsh, United Kingdom RECHARGE REGISTRY Enrolling Safety & Effectiveness of Hybrid Algoithm & CrossBoss and Stingray Technologies Prospective, Multi-Centre, Non-Randomised Clinical Registry N=1000 coronary CTO procedures, acute results PI: Professor Jo Dens, Belgium Enrolling OPEN CTO Long-term outcome from contemporary CTO PCI (US) Prospective, Multi-Centre, Non-Randomised Clinical Registry N=1000 coronary CTO procedures PI: Dr Aaron Grantham, Mid American Heart Institute

87 Synergy in Belfast

88 Non-study cases - clinical indication for bioabsorbable polymer stent Audit of clinical outcomes - 1st 100 cases At present, management imposed limits on use due to cost Use is biased towards complex disease and patients at high-risk of bleeding Majority stopping DAPT at 3 months

89 Patients N=100 Mean Age 72 ± 10 37% >75 years old, 8% >85 years old 25% Diabetic 35% ACS 12 surgical turn-down at MDM, 16 revascularization after prior CABG Mean Euroscore 11.37

90 Short DAPT Indication 20% 16% Frail/Elderly Anticoagulation Non-cardiac Op Bleeding Risk Other 26% 10% 28%

91 Complex Disease Mean Syntax Score 22.7 ± 12.1

92 PCI & Outcomes Mean Syntax score 22.7 (range 6-53) 58=tertile 1, 20=tertile 2, 22=tertile 3 Mean 1.4 lesions per patient Mean 2.7 stents per patient Mean stent length 75.3 ± 41.5

93 PCI & Outcomes 76% off DAPT at 3 months 0 stent thrombosis 4 TLR by 6 months/144 lesions (2.8%) 1 non-tlr 10 non-cardiac ops/procedures 3-6 months 5 non-cardiac deaths by 6 months (2 Ca, 1 AAA, 1 sepsis, 1 vascular post TAVI)

94 Clinical Trials & Synergy Syntax 2-57 cases, 1 TVR, 0 ST Ideal LM - 12 cases, 0 TVR, 0 ST Consistent CTO, 22 cases, 0 TVR, 0 ST Celtic Bifurcation, 13 cases, 0 TVR, 0 ST ~200 cases, complex disease - no stent thrombosis

95 Conclusions Default: Complete revascularization should be considered mandatory Optimal revascularization means opening CTOs where myocardium is viable and ischaemic Almost every lesion can be treated Provided you have the rights skills and tools Complete revascularization with Synergy leads to excellent short & medium term outcomes

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