Stents selection and optimal implantation: sizes, design, deployment Abbott Vascular. All rights reserved.

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1 Stents selection and optimal implantation: sizes, design, deployment

2 Stent classification: Mechanism of expansion - Self-expanding - Balloon expandable Design - Mesh structure - Coil - Slotted tube - Ring Composition - Stainless steel - Cobalt based alloy - Tantalum - Nitinol - Inert coating - Active coating - Biodegradable - Multidesign - Custom design 2

3 Stent Types Self-expanding Stent placed under a sheath Sheath retraction allows stent expansion Balloon-expandable Factory mounted on a balloon delivery system 3

4 Stent Types 4

5 Stent Types - Composition - The stainless steel is the most frequently used material, which is proved to be the most reliable based to clinical trials. - Nowadays cobalt-chromium alloys are more and more frequently used. 5

6 Stent Types - Composition - The peripheral stents are made of nickel-titanium alloys (nitinol). - The biodegradable stents made of magnesium are in trial phase. 6

7 Stent Manufacturing - Coronary stents are commonly manufactured from tube by laser cutting. - Other manufacturing processes are coiling, spinning or looping from wire. 7

8 Stent Terminology Self expanding Balloon expandable Stent strut Stent crowns and connectors Stent patterns, closed and open cells Metal-to-artery ratio Unsupported surface area Vessel scaffolding Foreshortening Flexibility and conformability Radiopacity Self-expanding vs. Balloonexpandable Balloon outside the stent / Overhang Stent jail Apposition / Expansion Recoil Radial strength 8

9 Ideal Stent Flexibility & conformability Good scaffolding High radial strength with minimal recoil Good visibility Minimal foreshortening Side-branch accessibility Appropriate metal-to-artery ratio Biocompatibility Optimal stent delivery system Variety of sizes and lengths 9

10 What about Technique? You can have a perfect stent but if you don t use a good technique you may as well throw it in the rubbish 10

11 Avoid under-expansion In BMS bigger is better was the rule In DES under-expansion is still the most important cause of stent faillure. BMS Cypher Taxus Endeavor 11

12 Good Technique Plaque preparation Adequate implantation pressure Post-dilatation 12

13 Plaque preparation Balloons Semi compliant High pressure Especial balloons Rotablation 13

14 Be careful when implanting stents without pre-dilatation!!! Not well expanded implanted stent 45 yearsfemale, smoker as only risk factor?? Proximal LAD 14

15 Can we follow chart instructions? DES achieved only 75% of manufacturer predicted diameter and 66% of predicted stent area. 24% of SES and 28% of PES did not achieve a final MSA of 5 mm 2 15

16 Post-dilatation Be generous In Postdilating Stents! 16

17 Why Post-dilatation? We cannot accurately predict stent expansion by angiography, so one should Iterative IVUS can be be used to to fine-tune the the final MSA during stent implantation - - Angio cannot Be generous postdilating even in very small residual stent stenosis QCA QCA MLD MLD (mm) (mm) p<0.05 p<0.05 p=ns p=ns p=ns p=ns ATM 8ATM 12ATM 12ATM 15ATM 15ATM 18ATM 18ATM IVUS IVUS Stent Stent CSA CSA (mm (mm 2 )* 2 )* p<0.05 p<0.05 p<0.05 p<0.05 p<0.05 p< ATM 8ATM 12ATM 12ATM 15ATM 15ATM 18ATM 18ATM *ANOVA P< Comparation of IVUS and QCA post stent + adjunt PTCA Iterative angio and IVUS a different atm 17

18 How postdilate? Non compliant balloons High pressure Adequate size Adequate length ( avoid geographical miss) 18

19 BMS vs IV. Adverse DES issues (clinical view) Presentation II. Risk assessment III. Build a strategy V. How to deal with the lesion VI. Post PCI treatment ntial techniques and es urcation Before selecting the revascularization technique : investigate the potential problems! tent restenosis er complex lesions l selection iding catheter Problem with prolonged A + C? Risk of surgery in coming months? Suspected compliance issue (+++) Allergy to ASA or Clopidogrel? YES Consider BMS or CABG for complex lesions? ide Wire lloon or other NO tents e PCI treatment non diabetic,?3.5 mm vessel, < 15mm lesion YES Consider BMS? NO ASA+ clopidogrel DES ++ Clearly Inform patient before PCI > SCENARIO

20 BMS vs DES : Check list for DES sment III. Build a III. strategy Build a strategy IV. Adverse IV. issues Adverse issues V. How to deal V. with How the tolesion deal with the VI. lesion Post PCI treatment VI. Post PCI treatment e Before selecting selecting the revascularization the revascularization technique technique : : tigate investigate the potential the potential problems! problems! em Problem with prolonged with prolonged A + C? A + C? f surgery Risk of surgery in coming months? coming months? Suspected Suspected compliance issue (+++) issue (+++) y to Allergy ASA or to Clopidogrel ASA or Clopidogrel?? YES Consider BMS Consider BMS YES or CABG or CABG for complex for lesions? complex lesions? NO NO iabetic, non diabetic,?3.5 mm?3.5 vessel, mm vessel, m < lesion 15mm lesion YES YES Consider BMS Consider? BMS? NO NO ASA+ clopidogrel ASA+ clopidogrel DES DES ++ Clearly Inform 20 Clearly Inform ++ patient before patient PCI before PCI

21 election g catheter Wire n or other Risk of surgery in coming months? Suspected compliance issue (+++) Allergy to ASA or Clopidogrel? BMS vs DES (clinical view) NO YES Consider BMS or CABG for complex lesions? ts I treatment non diabetic,?3.5 mm vessel, < 15mm lesion YES Consider BMS? NO ASA+ clopidogrel DES ++ Clearly Inform patient before PCI > SCENARIO

22 BMS vs DES (clinical view) BMS Short lesions Large reference diameter Second lesion in 2VD Difficult anatomy (tortuosity, calcification) Planned short - term interruption in antiplatelet medication most AMI Lack of reimbursement DES Long lesions Small reference diameter Instent restenosis Chronic total occlusion Good compliance anticipated with ASA+ thienopyridine Adequate reimbursement 22

23 Mortality in RCTs comparing DES vs BMS Conclusion Drug-eluting stents for the treatment of coronary artery disease do not reduce total mortality when compared with bare metal stents. Preliminary evidence suggests that sirolimus- but not paclitaxel-eluting stents may lead to increased non-cardiac mortality. Long-term follow-up and assessment of cause-specific deaths in patients receiving drug-eluting stents is mandatory to determine the long-term safety of these devices. 23 Source: Nordmann AJ et al, Eur Heart J Oct 2006

24 Mortality in RCTs comparing DES vs BMS 24 Source: Nordmann AJ et al, Eur Heart J Oct 2006

25 Mortality in RCTs comparing DES vs BMS 25 Source: Nordmann AJ et al, Eur Heart J Oct 2006

26 Mortality in RCTs comparing DES vs BMS 26 Source: Nordmann AJ et al, Eur Heart J Oct 2006

27 Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta analysis 38 trials, pts Cumulative incidence of overall death & cardiac death Source: Stettler et al. Lancet 2007; 370:

28 Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta analysis Cumulative incidence of MI & death or MI Source: Stettler et al. Lancet 2007; 370:

29 Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta analysis Cumulative incidence of Definite SR & TLR Source: Stettler et al. Lancet 2007; 370:

30 Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta analysis Stratified analysis according to presence or absence of diabetes mellitus Cumulative incidence of death or MI Source: Stettler et al. Lancet 2007; 370:

31 31

32 DES vs BMS in STEMI : Massachusetts Registry DES BMS Death Death or IM TLR Mauri et al, N Eng J Med

33 Potential Mechanisms for Stent Thrombosis 33

34 Hypothetic Major Mechanisms? Delayed Endothelialisation Late Stent Thrombosis Abnormal Blood Flow Increased Blood Thrombogenicity 34

35 Percent Percentage Endothelialization Percent Incomplete Strut Endothelialization is Usual in Patients Sirolimus-eluting stent Incomplete coverage Complete coverage Grade 0 Grade 1 Grade 2 Grade 3 75 Bare metal stent Angioscopy at 8 months post SES implantation BMS DES >40 Duration in months Virmani autopsy data 35 Source: Kotani J et al. JACC. 2006,47:2108 Source: Joner M et al. JACC. 2006;48:193.

36 Cypher A B 65 yo male with h/o Cypher stent placement to the prox LAD and BXVelocity to the distal LAD 15-months prior to non-cardiac death C No endothelialization Fibrin BxVelocity D E F Strut Fibrin Neointima Source: Joner M & Finn AV. J Am Coll Cardiol Jul 4;48(1):

37 Delayed Endothelialization Overlapping SES vs PES BMS SES BMS PES Overlap Overlap Conclusions: BMS showed far greater endothelialization than DES Lack of coverage highlighted in areas of overlap Less surface coverage by endothelial cells in PES than SES 37 Source: Finn AV. Circulation 2005

38 Which stent is not cobalt chromium : 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx (Tantalium) 38

39 Which stent is not cobalt chromium : 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx (Tantalium) 39

40 Which stent is not cobalt chromium : 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx (Tantalium) 40

41 This presentation and its content is copyright of Abbott Vascular Abbott Vascular. All rights reserved. Any redistribution or reproduction of part or all the contents in any form is strictly prohibited. You may not, except with our express 41 written permission, distribute or commercially exploit the content. Nor may you transmit or store it in any electronic retrieval system.

42 Which stent is not cobalt chromium : 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx (Tantalium) 42

43 Which stent is not cobalt chromium : 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx (Tantalium) 43

44 Which stent is not cobalt chromium : 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx (Tantalium) 44

45 Which stent is not cobalt chromium : 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx (Tantalium) 45

46 Which stent is not cobalt chromium: 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx 46

47 Which stent is not cobalt chromium: 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx 47

48 DES vs BMS in STEMI : Massachusetts Registry 48

49 Which stent is not cobalt chromium: 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx 49

50 HORIZONS-AMI 3-Year Results DES vs BMS : DES BMS P-value TLR 9.4% 15.1% TLR: No Routine Angio 8.7% 12.7%

51 SUMMARY 51

52 DES represent an unique step forward We did not pay sufficient attention to possible complications: only placebo has almost no complications! Efforts should concentrate to prevent: early thrombosis-technique and antiplatelets late thrombosis-innovative solutions and further understanding DES allow treatment of more complex lesions with less immediate and late complications (personal opinion!) A.Colombo: The Drug eluting stent summit, TCT

53 Quick Self Assessment 53

54 Most important cause of stent failure is: 1. Calcified lesion 2. Under expansion 3. Tortuosity 4. Lenght 54

55 Most important cause of stent failure is: 1. Calcified lesion 2. Under expansion 3. Tortuosity 4. Lenght 55

56 In-stent postdilatation is performed with: 1. NC balloons 2. Longer balloons 3. Semi compliant balloons 4. Balloons from the stent 56

57 In-stent postdilatation is performed with: 1. NC balloons 2. Longer balloons 3. Semi compliant balloons 4. Balloons from the stent 57

58 Which are indications for DES stenting (all true EXCEPT): 1. Long lesions 2. In stent restenosis 3. Difficult anatomy (tortuosity/calcifications) 4. CTO 58

59 Which are indications for DES stenting (all true EXCEPT): 1. Long lesions 2. In stent restenosis 3. Difficult anatomy (tortuosity/calcifications) 4. CTO 59

60 Which stent doesn t belong to limus family? 1. Cypher select 2. Taxus 3. Xience V 4. Endeavor Resolute 60

61 Which stent doesn t belong to limus family? 1. Cypher select 2. Taxus 3. Xience V 4. Endeavor Resolute 61

62 BMS can be used in all situations EXCEPT : 1. Short lesions 2. Most AMI 3. Difficult anatomy 4. In stent restenosis 62

63 BMS can be used in all situations EXCEPT : 1. Short lesions 2. Most AMI 3. Difficult anatomy 4. In stent restenosis 63

64 Which stent is not stainless steel: 1. Cypher Select 2. Taxus Liberte 3. Xience V 4. Nobori 64

65 Which stent is not stainless steel: 1. Cypher Select 2. Taxus Liberte 3. Xience V (Cobalt chromium) 4. Nobori 65

66 Which stent is not cobalt chromium: 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx 66

67 Which stent is not cobalt chromium : 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx (Tantalium) 67

68 Cases Review 68

69 Case 1 P. S. Age : 58 years Gender : female Risk factors : - hypertension - HBI 69

70 Location, approach, type of stent p RCA p LAD Approach Guidewire Balloon catheter Stent to LAD intermediate 100%, thrombus trans radial BMW 2.0/20mmx10atm BMS 2.75/20mmx15atm 70

71 RCA 71

72 Prox LAD occlusion (STEMI) 72

73 Prox LAD occlusion (STEMI) 73

74 Balloon catheter 2.0/20mm/10atm pre dilatation 74

75 Result 75

76 BMS 2.75/20mm x 20atm 76

77 Final result 77

78 P. S. Two months later (p LAD : stent occlusion) 78

79 Location, approach, type of stent p RCA p LAD Approach Guidewire Guidewire Guidewire Balloon pre dilatation Balloon pre dilatation Balloon pre dilatation Stent to LAD intermediate 100% in stent trans radial Pilot 50, 150 Hydrophilic BMW 1.5/20mmx15atm 2.0/20mmx13atm 3.0/30mmx6atm DES 3.0/28mmx15atm 79

80 Prox LAD : in stent occlusion 80

81 Balloon catheter 1.5/20mm/15atm pre dilatation 81

82 Result 82

83 Balloon catheter 2.0/20mm/13atm pre dilatation 83

84 Balloon catheter 2.0/20mm/13atm pre dilatation 84

85 Result 85

86 DES 3.0/28mm - positioning 86

87 DES 3,0/28mm x 15atm - deployment 87

88 Cx control 88

89 Final result 89

90 Final result 90

91 CASE 2 I. F. Age : 57 years Gender : male Risk factors : - hypertension - prior IM - prior PCI/stenting to p LAD 91

92 Location, approach, type of stent p LAD m LCx 1 st OM Approach Balloon pre dilatation Stent to p RCA Balloon post dilatation 100%+instent+thrombus 90%+TIMI flow=3 80%+TIMI flow=3 trans radial 3.5/20x10atm DES 4.0/18x16atm NC balloon 4.0/9x18atm 92

93 Left coronary artery 93

94 p LAD 100% + thrombus 94

95 BMW guidewire in LAD 95

96 DES 4.0/18mm - positioning 96

97 DES 4.0/18mm x 16atm - deployment 97

98 Result 98

99 NC Balloon catheter post dilatation 4.0/9mmx18atm 99

100 Final result 100

101 Case 3 R. G. Age : 60 years Gender : female Risk factors : - hypertension - hiperlipidemia - smoker 101

102 Location, approach, type of stent m LAD p LCx m LCx Approach Guidewire Guidewire Balloon pre dilatation Balloon pre dilatation Stent to LAD 99%+TIMI flow=3 80%+TIMI flow=3 100%+CTO+collateral trans radial BMW Floppy Extra Support 2.0/20 x 15atm 2.5/15 x 15atm BMS 2.75/17x15atm 102

103 RCA 103

104 Left coronary artery 104

105 Balloon catheter 2.0/20mm x 15 atm 105

106 Balloon catheter 2.5/15mm x 15 atm 106

107 Result after balloon dilatation 107

108 BMS 2.75/17mm x 15atm 108

109 Final result 109