Primary PCI in patients with STEMI Abbott Vascular. All rights reserved.
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1 Primary PCI in patients with STEMI
2 Primary PCI in patients with STEMI Agenda 2
3 Primary PCI in patients with STEMI Definition: angioplasty ± stenting without prior or concomitant fibrinolytic therapy Objectives : restoring coronary flow and myocardial tissue reperfusion 3
4 Primary PCI in patients with STEMI Compared with fibrinolytic therapy, in high-volume /experienced centers, P-PCI provide: more effective restoration of IR vessel patency less re-occlusion improved residual LV function better clinical outcome Meta-analysis of RCTS 4 Source: Lancet 2003;361:13-20
5 Primary PCI in patients with STEMI P-PCI should be considered as referred therapeutic option when performed: < 12 hours after symptom onset : Total Ischemic- Time Expeditiously: door-to-balloon time Experienced team : interventional cardiologists & supporting staff. key messages: Total ischemic time + staff s training/education 5 ESC guidelines on STEMI management EHJ, 2008
6 Primary PCI in patients with STEMI 6
7 Primary PCI in patients with STEMI a. Long delay times to reperfusion are associated with a worse clinical outcome PCI related delay n 30d death Lytics % 30d death PCI % Absolute Diff % > , > > > All Pts De Luca G et al..j Am Coll Cardiol 2003 Boersma E et al. EHJ 2006;. 7
8 Mortality reduction (%) Primary PCI in patients with STEMI Extent of Myocardial Salvage Time from symptom onset to reperfusion (h) Source: Gersh B et al. JAMA 2005; 293: 979
9 Primary PCI in patients with STEMI b. Delay times to be considered : Patient delays making the First medical call (FMC) Delay in ambulance arriving Travel time to hospital 1 Possible delay and transfer to hospital 2 Delay in door to balloon time at hospital 2. c. P-PCI : < 2h after FMC In patients with a large amount of myocardial at risk, the delay should be shorter: 90 min after FMC seems a reasonable recommendation 9 Source: ESC guidelines STEMI: EHJ, 2007
10 Primary PCI in patients with STEMI Discussion: how to minimise delays and cut door to balloon times in hospital? Wrap-up 10 Brodie et al. JACC 2006
11 Primary PCI in patients with STEMI 11
12 Primary PCI in patients with STEMI Plaque Rupture a-facilitated PCI Platelet Activation Coagulation Cascade Lytic therapy/gp IIb-IIIa inhibitors Rescue PCI post lytic therapy PCI post lytic therapy Adhesion Aggregation Platelet-rich Thrombus Fibrin Formation b-anti-platelet co-therapy c- Anti-thrombotic cotherapy 12 12
13 Primary PCI in patients with STEMI a- Facilitated PCI Lytic therapy/iib-iiia inhibitors Definition: Pharmacological reperfusion treatment delivered prior to a planned PCI in order to bridge the PCI-related time delay Hypothesis: combining early pharmacologically mediated reperfusion with subsequent & immediate mechanical stabilization of the ruptured plaque will overcome delays to transfer the patient to a second facility. 13
14 Primary PCI in patients with STEMI a- Facilitated PCI Lytic therapy/iib-iiia inhibitors Full-dose lytic therapy, half-dose lytic therapy + glycoprotein (GP)IIb/IIIa inhibitor and GPIIb/IIIa inhibitor alone have been tested There is no evidence of a significant clinical benefit with any of these agents More bleeding complications Source:ASSENT-4 Lancet 2006-Keeley EC. Meta-analysis Lancet FINESSE Abbott Vascular. All rights NEJM reserved
15 Primary PCI in patients with STEMI a- Facilitated PCI Lytic therapy/iib-iiia inhibitors There is some evidence of beneficial effects of early GP IIb/IIIa inhibitors administration (within 2-3 h) that should be considered a reasonable strategy, in high-risk patients within the first hours from symptom onset ( 2 3 h) but face transport delays to a PCI-capable centre. 15
16 Primary PCI in patients with STEMI 16
17 Primary PCI in patients with STEMI Definition: PCI performed on a coronary artery which remains occluded despite fibrinolytic therapy. Criteria: < 50% ST-segment resolution in the lead(s) with the highest ST-segment elevations min after start of fibrinolytic therapy± persistent chest pain 17
18 Primary PCI in patients with STEMI Meta-analysis Event-free survival at 6 months : - higher with rescue PCI as compared to repeated administration of a fibrinolytic agent or conservative treatment Sources: Gershlick AH, et al... N Engl J Med 2005;353: Wijeysundera HC, et al. J Am Coll Cardiol 2007;49: Carver A et al (REACT) JACC 2009;54:118 18
19 Primary PCI in patients with STEMI Rescue PCI should be considered : 1.evidence of failed fibrinolysis 2.clinical or ECG evidence of a large infarct 3.<12 h after onset of symptoms 19
20 Primary PCI in patients with STEMI 20
21 Primary PCI in patients with STEMI a-facilitated PCI Lytic therapy/gp IIb-IIIa inhibitors Rescue PCI post lytic therapy PCI post lytic therapy b-anti-platelet co-therapy c- Anti-thrombotic co-therapy 21 21
22 Primary PCI in patients with STEMI b-anti-platelet co-therapy 1. Aspirin: to all patients (exept CI) mg in a chewable form enteric-coated aspirin should not be given (slow onset of action) i.v mg (although no specific data ) followed by mg orally daily 2. Prasugrel: Loading dose 60 mg followed by 10 mg daily 22
23 Primary PCI in patients with STEMI b-anti-platelet co-therapy 3. Ticagrelor loading dose 180 mg followed by 90 mg twice daily 4. Clopidogrel: Loading dose 600 mg evidence on its usefulness as an adjunctive antiplatelet therapy on top of aspirin in patients undergoing PCI. 23
24 Primary PCI in patients with STEMI b-anti-platelet co-therapy: Abciximab: 3. Abciximab: Meta-analysis of RCTs abciximab reduced 30-day mortality without affecting the risk of haemorrhagic stroke and major bleeding (4.7% vs. 4.1% OR = 1.16 p=0.23) 6 Placebo Abciximab P=0.047 P=0.001 P= Death 30 Days Death/MI 30 Days Death 6/12 Mos 24 Sources: 3-De Luca G. JAMA 2005
25 CADILLAC Trial Design Controlled Abciximab and Device Investigation to Lower Late Angioplasty Combinations Randomized Comparison in the Setting of Acute MI Balloon angioplasty (+ abciximab) vs Inclusion Criteria Age > 18 years Stenting (+ abciximab) Nitrate-unresponsive chest pain consistent with acute MI (duration > 30 min but < 12 hours) Native coronary artery > 2.5 mm, < 4.0 mm 25 Lesion length < 70 mm
26 CADILLAC Trial Results PTCA 1,3 (n=517 ) PTCA + abciximab 2 (n=528 ) Stenting 3 (n=511 ) Stenting + abciximab (n=525) TIMI-3 flow 94% 92% 92% 96.7% Recurrent ischemia 4.5% 1.5% 3.9% 1.2% Mortality 1.4% 1.0% 1.6% 1.6% Need for ischemic TVR 2.3% 0.2% 0.8% 0.2% (1) 19.9% provisional stenting; (2) 15.0% provisional stenting; (3) about 5% crossover to abciximab Stone GR, et al. Presented at the AHA 72nd Scientific Sessions. November,
27 Primary PCI in patients with STEMI b-anti-platelet co-therapy BRAVE-3: Abciximab on top of 600 mg Clopidogrel P = Secondary Endpoint: 30 days 4 Abciximab 2 Placebo Source: Mehilli J. et al. Circulation 2009;119:
28 Primary PCI in patients with STEMI b-anti-platelet co-therapy BRAVE-3: Abciximab on top of 600 mg Clopidogrel Source: Mehilli J. et al. Circulation 2009;119:
29 Primary PCI in patients with STEMI b-anti-platelet co-therapy: Tirofiban 4. Tirofiban: On-TIME 2 trial pre-hospital high-bolus dose tirofiban + infusion + aspirin+ clopidogrel and heparin: improved ST-segment resolution Non statistically significant clinical benefit Sources: De Luca G. JAMA 2005; Van t Hof AW, et al; Lancet
30 Primary PCI in patients with STEMI b-anti-platelet co-therapy ON-TIME 2 trial ASA+600 mg Clopidogrel ± Tirofiban in ambulance Survival free from MACE All-Cause 30 Days 30
31 Primary PCI in patients with STEMI Antiplatelet co-therapy Class Level Aspirin I B Prasugrel I B Ticagrelor I B Clopidogrel loading dose 600 mg. I C GPIIb/IIIa antagonist Abciximab IIa A Eptifibatide IIa B Tirofiban IIb B Source: ESC Guidelines on STEM; EHJ
32 Primary PCI in patients with STEMI Plaque Rupture a-facilitated PCI Platelet Activation Coagulation Cascade Lytic therapy/gp IIb-IIIa inhibitors Rescue PCI post lytic therapy PCI post lytic therapy Adhesion Aggregation Platelet-rich Thrombus Fibrin Formation b-anti-platelet co-therapy c- Anti-thrombotic cotherapy 32 32
33 Primary PCI in patients with STEMI c- Anti-thrombotic co-therapy 1. Heparin :i.v. bolus Usual starting dose: 100 U/kg + GPIIb/IIIa antagonists : 60 U/kg. It is recommended to perform the procedure under activated clotting time (ACT) guidance/ No GPIIb/IIIa antagonists : ACT: s GPIIb/IIIa antagonists given: ACT : s 33 Source: ESC guidelines; EHJ 2008
34 Primary PCI in patients with STEMI c- Anti-thrombotic co-therapy 2. Bivalirudin: i.v. bolus of 0.75 mg/kg followed by an infusion of 1.75 mg/kg/h not titrated to ACT usually terminated at the end of the procedure 34 Source: Stone GW,. N Engl J Med 2008;358:
35 30 day event rates (%) Primary PCI in patients with STEMI c- Anti-thrombotic co-therapy Heparin + GPIIb/IIIa inhibitor (N=1802) Bivalirudin monotherapy (N=1800) ,1 10 9,2 8,3 5 4,9 5,5 5,4 0 Net adverse clinical events Major bleeding (non CABG) MACE 1 endpoint 1 endpoint Major 2 endpoint 35 Source: Stone GW,. N Engl J Med 2008;358:
36 Primary PCI in patients with STEMI c- Anti-thrombotic co-therapy Antithrombin therapy Class Level Bivalirudin I B UFH I C Fondaparinux III B Source: ESC Guidelines on STEM; EHJ
37 Primary PCI in patients with STEMI Inadequate (absence or reduced) myocardial reperfusion (microvascular flow) despite restoration of epicardial IR coronary patency 10 40% of patients 37 Sources: Ito Het al. Circulation Henriques et al, EHJ 2002
38 Primary PCI in patients with STEMI Multifactorial Downstream microvascular embolization thrombotic atheromatous (lipid-rich) debris Reperfusion injury Microvascular disruption Endothelial dysfunction Inflammation Myocardial oedema May be accelerated after reperfusion as a result of liberation of oxygen free radicals 38 Sources: Ito Het al. Circulation Henriques et al, EHJ 2002
39 Primary PCI in patients with STEMI c-how to evaluate coronary flow & myocardial perfusion 39
40 Primary PCI in patients with STEMI Plaque Rupture Platelet Activation Coagulation Cascade Adhesion Aggregation Fibrin Formation Platelet-rich Thrombus 40
41 Primary PCI in patients with STEMI Stent-PAMI trial BMS stent implantation decreases the need for TVR but is not associated with significant in death or re-mi rates Cadillac trial Source: Grines et al. N Engl J Med 1999;341: Stone GW et al. N Engl J Med 2002;346:
42 Primary PCI in patients with STEMI b- DES vs BMS? RCTs 1 year: in carefully selected & low-risk patients DES reduce the risk of TLR vs BMS Without a significant impact on the risk of stent thrombosis, recurrent MI and death. Long term FU is needed Source: Spaulding Ch; N Engl J Med 2006 Laarman GJ; N Engl J Med 2006;355: Kastrati A; Eur Heart J 2007 Horizon MI 2008 Kelbæk H. et al Circulation. 2008;118:
43 Primary PCI in patients with STEMI b- DES vs BMS? DEDICATION trial Secondary end points: MACE during 8 months of follow-up. The 8-month mortality rate of pts not included in the trial: 13% Source: Kelbæk H. et al Circulation. 2008;118:
44 Primary PCI in patients with STEMI b- DES vs BMS? Rotterdam Registry Large thrombus burden is an independent predictor of MACE and IRA-ST in patients treated with DES for STEMI. 44 Source : Sianos et al. J. Am. Coll. Cardiol. 2007;50;
45 Primary PCI in patients with STEMI S T E N T T H R O M B O S I S H I G H L O w Low BMS Physician judgment, preference R E S T E N O S I S DES ors BMS: patient selection Physician judgment, preference DES High 45 Expected Low Compliance - DAP Co-Morbidities Bleeding tendency Unknown patient Emergency Large Vessel Small vessel Long, diffuse lesion Diabetic patients Expected good compliance Physician judgment and preference based on patient assessment
46 Primary PCI in patients with STEMI 46
47 Primary PCI in patients with STEMI One shot vs staged revascularisation 1. P- PCI should be restricted to culprit vessel only 2. Immediate non-culprit vessel PCI: reasonable strategy in patients with shock or hemodynamic compromise 3. Staged revascularisation procedure : recommended for stable STEMI patient after successful P-PCI cardiogenic 47
48 Primary PCI in patients with STEMI One shot vs staged revascularisation 4. The best timing for non-culprit Vx revascularisation: - should be defined inside of the HEART TEAM judgement based on the clinical condition & objective signs of ischemia. 48
49 Primary PCI in patients with STEMI 1-MVD One shot vs staged revascularisation 5. Patient with recurrent ischemia revascularisation of non-culprit vessels before discharge 6. For the others patients: the best timing depend on each particular clinical and angiographic situation: 3 weeks? 3 months? 6 months? Ischemia-driven? 49
50 Primary PCI in patients with STEMI Background Clinical state of hypoperfusion: systolic pressure < 90 mmhg wedge pressure > 20 mmhg, or a cardiac index,1.8 L/min/m2 50
51 Primary PCI in patients with STEMI Background 7.5% -15 % of patients The leading cause of death: 70-80% mortality rate Supportive treatment with an early stage. Emergency PCI may be life-saving Source: Hochman Jset al. JAMA 2001; 51
52 Primary PCI in patients with STEMI 52
53 Wrap-up & Consensus Network, local organisation, team education & training 53 53
54 Primary PCI in patients with STEMI 1-Quick appraisal of each individual patient: long lasting DAP Tx Optimal pharmacological Tx 2-Passing a wire 3-Manual catheter aspiration without predilatation 4-Sizing the vessel & residual thrombus burden evaluation 5- Repeat aspiration? Low risk of restenosis Excessive thrombus burden CI/ uncertaincies for DAP Tx High risk of restenosis, No excessive thrombus burden, No CI for long lasting DAP Tx POBA or BMS (using thiner struts) 54 DES or BMS (regulation/choice) 54
55 Which stent is not cobalt chromium : 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx (Tantalium) 55
56 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 56 written permission, distribute or commercially exploit the content. Nor may you transmit or store it in any electronic retrieval system.
57 Which stent is not cobalt chromium : 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx (Tantalium) 57
58 Which stent is not cobalt chromium : 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx (Tantalium) 58
59 Which stent is not cobalt chromium : 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx (Tantalium) 59
60 Which stent is not cobalt chromium : 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx (Tantalium) 60
61 Which stent is not cobalt chromium: 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx 61
62 Which stent is not cobalt chromium: 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx 62
63 DES vs BMS in STEMI : Massachusetts Registry 63
64 Which stent is not cobalt chromium: 1. NEVO 2. Promus 3. Endeavor Resolute 4. Zomaxx 64
65 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%
66 SUMMARY 66
67 Primary PCI in patients with STEMI MVD: P-PCI on culprit IRV only staged revasc ularisation for other vessels after evaluation (HEART TEAM) Cardiogenic shock: IABP + "complete revascularisation 67
68 Cases Review 68
69 Case 1 A. D. Age : 37 years Gender : male Risk factors : - smoker - hiperlipidemia 69
70 Location, approach, type of stent p LAD Approach Balloon pre dilatation Stent Balloon post-dilatation Balloon post-dilatation 99%+TIMI flow=3 trans radial 2.5/10 x 10atm DES 3.5/15mm x 16atm 3.5/9 x 14atm 3.5/9 x 18atm 70
71 ECG pre intervention 71
72 Left coronary artery 72
73 LAD stenosis 73
74 Balloon pre dilatation 2.5/10mm x 10atm 74
75 Result 75
76 DES 3.5/15mm x 16atm 76
77 Result 77
78 Result 78
79 Balloon 3.0/15mm x 5 atm post dilatation 79
80 NC Balloon 3.0/9 x 18atm in stent post dilatation 80
81 Final result 81
82 Final result 82
83 ECG post intervention 83
84 Case 2 Z. G. Age : 43 years Gender : male Risk factors : - hypertension - hiperlipidemia 84
85 Location, approach, type of stent p LAD m RCA 1 st Diag Approach Thrombaspiration cath Stent to p LAD Stent to m LAD 80%+TIMI flow=3 100%+TIMI flow=0 95%+TIMI flow=2 trans radial 6Fr DES 4.0/12mm x 12atm DES 2.75/18mm x 14atm 85
86 ECG pre intervention 86
87 Right coronary artery 87
88 Left coronary artery 88
89 mlad : 100% + thrombus 89
90 After thromboaspiration 90
91 DES 2.75/18mm x 14atm 91
92 Result 92
93 plad stenosis 93
94 DES 4.0/12mm x 12atm 94
95 Final result 95
96 ECG post intervention 96
97 Thrombectomy, Protection Devices
98 Manual thrombus aspiration 98 98
99 Manual thrombus aspiration 99 99
100 Manual thrombus aspiration Manual Thrombectomy Trials Non-manual Thrombectomy Trials Source: Burzotta F,et al.; Int J Cardiol
101 Manual thrombus aspiration TAPAS Study 101
102 Manual thrombus aspiration
103 Patients (%) Primary endpoint: Myocardial blush grade 60 P < / Thrombus-Aspiration Conventional PCI 103
104 TAPAS - One year follow-up 12 Conventional PCI Thrombus-Aspiration 10 Mortality (%) Time (days)
105 Manual thrombus aspiration 1-year MACE Aspiration No aspiration p Cardiac death 3.6% 6.7%.02 Reinfarction 2.2% 4.3%.05 TVR 12.9% 11.2%.34 ST 1.1% 2.2%.15 Source: TAPAS trial : Svilaas et al. N Engl J Med Vlaar Pjet al Lancet
106 Guidelines Recommendations Class Level Prevention Thrombus aspiration IIa B Abciximab IIa B Treatment Adenosin : 70μg/kg/mn IV over 3 h during & after PCI) Adenosin: IC bolus of μg during PCI Verapamil: IC bolus of 0.5-1mg during PCI IIb IIb IIb B C C 106
107 Manual thrombus aspiration - device 107
108 Manual thrombus aspiration - result 108
109 Treatment Approaches for Microvascular Obstruction Vasoconstrictive Thrombotic Serotonin Release Platelet aggregates Vasoconstriction Microvascular Occlusion Ca++ blockers (Verapamil µg IC) Adenosine (40µg IC) Sodium-Nitroprusside (40 µg IC) GP IIb/IIIa blockers ASA ADP blockers LMWH Pre-treatment 109
110 Mechanical Prevention of Microvascular Obstruction Distal Embolization Mechanical Plugging Embolic Protection 110
111 Embolic protection device Routine embolic protection device: not effective on clinical outcome Selective embolic protection in specifics cases: to be discussed with attendees 111 Source: Burzotta et al, Int J Cardiol 2007
112 Case 3 P. S. Age : 54 years Gender : male Risk factors : - hypertension - hiperlipidemia - smoker - positive family history Chest pain: 4.30 h before admission 112
113 Location, approach, type of stent m RCA m LAD Door to balloon Approach Thrombaspiration cath Stent 100%+thrombus intermediate 30 min trans radial Export 6 BMS 3.0/18 x 16atm 113
114 ECG pre intervention 114
115 Left coronary artery 115
116 Left coronary artery 116
117 Left coronary artery 117
118 RCA mid 100% ( thrombus ) 118
119 PCI wire
120 Thromboaspiration catheter 6Fr. 120
121 Result 121
122 Result 122
123 BMS 3.0/18mm x 16atm 123
124 Final result 124
125 Final result 125
126 ECG post intervention 126
127 Quick Self Assessment Acute myocardial infarction 127
128 Which drug is antithrombotic co-therapy in STEMI (all true EXCEPT): a) Clopidogrel b) UFH c) Bivalirudin d) LMWH 128
129 Which drug is antithrombotic co-therapy in STEMI (all true EXCEPT): a) Clopidogrel b) UFH c) Bivalirudin d) LMWH 129
130 Which drug is not GP IIb/IIIa inhibitor: a) Abciximab b) Tirofiban c) Fondaparinux d) Eptifibatide 130
131 Which drug is not GP IIb/IIIa inhibitor: a) Abciximab b) Tirofiban c) Fondaparinux d) Eptifibatide 131
132 Usual starting dose of Heparin given with GP IIb/IIIa inhibitors in STEMI is: a) 30 IU/kg b) 60 IU/kg c) 100 IU/kg d) 150 IU/kg 132
133 Usual starting dose of Heparin given with GP IIb/IIIa inhibitors in STEMI is: a) 30 IU/kg b) 60 IU/kg c) 100 IU/kg d) 150 IU/kg 133
134 Which drugs are used in no-reflow fenomenon (all true EXCEPT): a) Adenosine i.c. b) Verapamil i.c. c) Na-nitropruside i.c. d) Amiodarone i.c. 134
135 Which drugs are used in no-reflow fenomenon (all true EXCEPT): a) Adenosine i.c. b) Verapamil i.c. c) Na-nitropruside i.c. d) Amiodarone i.c. 135
136 Clinical state of hypoperfusion is (all true EXCEPT): a) Systolic pressure < 90 mmhg b) Wedge pressure > 20 mmhg c) Systolic pressure < 120 mmhg d) Cardiac index 1.8 L/min/m2 136
137 Clinical state of hypoperfusion is (all true EXCEPT): a) Systolic pressure < 90 mmhg b) Wedge pressure > 20 mmhg c) Systolic pressure < 120 mmhg d) Cardiac index 1.8 L/min/m2 137
138 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 written permission, distribute or commercially exploit the content. Nor may you transmit or store it in any electronic retrieval system.
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