Komplexe Koronarintervention heute: Von Syntax zu bioresorbierbaren Stents
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1 Komplexe Koronarintervention heute: Von Syntax zu bioresorbierbaren Stents Prof. Dr. med. Julinda Mehilli Medizinische Klinik und Poliklinik I Klinikum der Universität München Campus Großhadern
2 Key Factors Determining Technical and Clinical Success of PCI INTERVENTION DRUGS EXPERIENCE STRATEGY DEVICES
3 Key Factors Determining Technical and Clinical Success of PCI INTERVENTION STRATEGY DEVICES
4 One Day in Cathlab
5 Impact of Lesion Complexity to Detect Differences in Stent Performance Hausleiter et al., Am Heart J 2003
6 Impact of Vessel Size on Risk of Revascularization ISAR-SMART 3 BASKET-PROVE vessel size <2.8mm vessel size >3.0mm Mehilli et al., Eur Heart J 2006 Kaiser et al., New Engl J Med 2010
7 BASKET-PROVE N=2314 Simple Lesions Do Benefit From Drug-Eluting Stents vessel size >3.0mm Revascularization Stent thrombosis months months Kaiser et al., New Engl J Med 2010
8 Complex Lesions Do Benefit From DES Failed Saphenous Vein Grafts
9 ISAR-CABG N=610 PCI: High-Risk Patients - Failed Saphenous Vein Graft- Death/MI/TLR Mehilli et al., Lancet 2011
10 ISAR-CABG PCI: High-Risk Patients - Failed Saphenous Vein Graft- Target Lesion Revascularization 20 % P= DES BMS Mehilli et al., Lancet 2011
11 Technically and Clinically Successful PCI Drug-Eluting Stent are Superior To Bare Metal Stent Simple and Complex Lesions Which is DES of Choice?
12 PCI: Improvements in DES Technology - Biodegradable Polymer - TEST 4 N=2603 Cardiac death/mi/tlr 20 % Biodegradable Polymer DES Permanent Polymer DES BP-DES PP-DES Byrne Mehilli, Eur Heart J 2009
13 PCI: Improvements in DES Technology - Biodegradable Polymer - Metaanalysis of 3 Randomized Controlled Trials N=4062 Target Lesion Revascularization Definite Stent Thrombosis Cumulative incidence, % Biodegradable polymer Cumulative incidence, % Biodegradable polymer Years after implantation Years after implantation Stefanini et al., Eur Heart J 2012
14 Improvements in Intracoronary Imaging Technology - Optical Coherence Tomography - Optimal coverage Suboptimal coverage
15 PCI: Improvements in DES Technology - Biodegradable Polymer - TEST 6 OCT proportion of lesions with > 30% uncovered stent struts % P=0.78 Mehilli et al., LBCT, EuroPCR 2012
16 Optical Coherence Tomography for Monitoring New DES Technologies Bioabsorbable Vascular Scaffold Plaque sealing and vessel enlargement Restoration of vasomotion OCT acute OCT 6-month OCT 60-month
17 Bioabsorbable Vascular Scaffolds Similar to the Standard-Barer DES Serruys et al., TCT 2012
18 Technically and Clinically Successful PCI Excellent Drug-Eluting Stents + Temporary Drug-Eluting Vascular Scaffold = DES for every lesion and every patient?
19 PCI: Complex Lesions - Bifurcation lesions - BBC One N=500 Simple Stenting Strategy one stent in main branch + provisional stenting in side branch Complex Stenting Strategy 2 stents in main and side branch Myocardial Infarction Revascularization Hildick-Smith et al., Circulation 2010
20 PCI: High-Risk Patients - Left Main Coronary Artery Disease - LEFT MAIN, n= % distally located lesions 50% two-stent stenting technique Mehilli et al., J Am Coll Cardiol 2009
21 30 % PCI: High-Risk Patients - Left Main Coronary Artery Disease - LEFT MAIN RR 0.78 (95% CI, ) P=.31 RR 0.68 (95% CI, ) P= RR 1.46 (95% CI, ) P= TLR Taxus Cypher Mehilli et al., J Am Coll Cardiol 2009
22 PCI: High-Risk Patients - Left Main Coronary Artery Disease - Independent Predictors of TLR Age Female sex Diabetes mellitus Ejection fraction Multivessel PCI Double Stent Implantation Taxus vs. Cypher Body vs. Distal Ostial vs. Body RR [95% CI] 0.81 [ ] 0.78 [ ] 1.13 [ ] 1.03 [ ] 0.78 [ ] 2.43 [ ] 0.81 [ ] 1.20 [ ] 0.57 [ ]
23 PCI: High-Risk Patients - Left Main Coronary Artery Disease - LEFT MAIN 2, n= % distally located lesions 35% two-stent stenting technique Mehilli et al., J Am Coll Cardiol 2013
24 PCI: High-Risk Patients - LEFT MAIN 2: Stent Thrombosis - 4 % Probable stent thrombosis Definite stent thrombosis Resolute n=324 Xience n= Mehilli et al., J Am Coll Cardiol 2013
25 PCI: High-Risk Patients - LEFT MAIN 2: Revascularization - 25 % 20 RR 1.26 (95% CI ) P= Resolute Xience TLR Repeat PCI Bypass surgery Mehilli et al., J Am Coll Cardiol 2013
26 FAME, n= 1005 PCI: High-Risk Patients - Functional Revascularization - Tonino et al., New Engl J Med 2009
27 PCI: High-Risk Patients - Complete Functional Revascularization - SYNTAX Randomized and Nested registry N=2636 Farooq et al., J Am Coll Cardiol 2013
28 PCI: High-Risk Patients - Complete Functional Revascularization - PCI (Taxus stent) CABG surgery Farooq et al., J Am Coll Cardiol 2013
29 PCI: High-Risk Patients - Complete Functional Revascularization - SYNTAX trial LMCA disease subgroup Kaplan-Meier cumulative event curves for MACCE by baseline SYNTAX score tercile Mohr et al., Lancet 2013
30 Technically and Clinically Successful PCI Excellent Drug-Eluting Stents + Temporary Drug-Eluting Vascular Scaffold = LESS is MORE Complete Functional Revascularization
31 Very High-Risk Subsets Diabetic Patients 32,966 Patients were screened for eligibility 3,309 were eligible (10%) 1,409 did not consent 1,900 consented (57%) 953 Randomized to PCI/DES* 5 underwent CABG 3 withdrew prior to procedure 3 died prior to procedure 3 underwent neither PCI/DES or CABG 947 Randomized to CABG 18 underwent PCI/DES 26 withdrew prior to procedure 3 died prior to procedure 7 underwent neither PCI/DES or CABG 16 withdrew post-procedure 43 were lost to follow-up 36 withdrew post-procedure 51 were lost to follow-up Farkouh et al., New Engl J Med 2012
32 FREEDOM trial N=1900 Very High-Risk Subsets Diabetic Patients Farkouh et al., New Engl J Med 2012
33 Technically and Clinically Successful PCI Excellent Drug-Eluting Stents + Temporary Drug-Eluting Vascular Scaffold = LESS is MORE Complete Functional Revascularization Tailoring of Revascularization Strategy Interdisciplinary Approach
34
35
36 Complex Lesions Do Benefit From DES Restenotic Lesions
37 ISAR-DESIRE 3 PCI: High-Risk Patients - In-DES Restenosis patients with in-limus-eluting stent restenose PTCA Paclitaxel-eluting stent Paclitaxel-eluting balloon Primary Endpoint: % in-segment diameter stenosis at 8-month FU Byrne, Neumann, Mehilli Kastrati, Lancet 2012
38 ISAR-DESIRE 3 PCI: High-Risk Patients - In-DES Restenosis - Target Lesion Revascularization Byrne, Neumann, Mehilli Kastrati, Lancet 2012
39 PCI: High-Risk Patients - Unprotected Left Main Coronary Artery Disease - Bare-metal stent vs. CABG Drug-eluting stent vs. CABG Seung et al., New Engl J Med 2008
40 PCI: High-Risk Patients - Unprotected Left Main Coronary Artery Disease - ca. 260.hr ISAR-LEFT MAIN Mehilli Schömig, J Am Coll Cardiol 2009
41 PCI: High-Risk Patients - Unprotected Left Main Coronary Artery Disease - ISAR-LEFT MAIN 3-year MACE Mehilli Schömig, J Am Coll Cardiol 2009
42 PCI: High-Risk Patients - Unprotected Left Main Coronary Artery Disease - ISAR-LEFT MAIN 3-year cardiac death Mehilli Schömig, J Am Coll Cardiol 2009
43 PCI: High-Risk Patients - Unprotected Left Main Coronary Artery Disease - ISAR-LEFT MAIN 3-year all-cause death Mehilli Schömig, J Am Coll Cardiol 2009
44 PCI: High-Risk Patients - Unprotected Left Main Coronary Artery Disease - ISAR-LEFT MAIN patients with unprotected left main lesions Zotarolimus-eluting stent (Endeavor Resolute) N= 324 Everolimus-eluting stent (Xience) N=326 Primary Endpoint: Combined incidence of death, MI or TLR at 1 year Mehilli et al., Late Breaking Clinical Trial at TCT 2012
45 PCI vs. CABG Surgery for ulmca Meta-analysis of Randomized Controlled Studies Similar Risk of Death or Myocardial Infarction Higher Risk of Revascularization Capodanno et al., J Am Coll Cardiol 2011
46 PCI vs. CABG Surgery for ulmca Meta-analysis of Randomized Controlled Studies Similar Risk of Death or Myocardial Infarction Higher Risk of Revascularization Capodanno et al., J Am Coll Cardiol 2011
47 Clinical impact of extending DAPT after PCI in the DES era: a meta-analysis of RCTs All-cause death: extending DAPT vs. control DAPT Cassese Kastrati, ESC 2012
48 Clinical impact of extending DAPT after PCI in the DES era: a meta-analysis of RCTs Ischemic events: extending DAPT vs. control DAPT Cassese Kastrati, ESC 2012
49 Clinical impact of extending DAPT after PCI in the DES era: a meta-analysis of RCTs Stroke and Bleeds: extending DAPT vs. control DAPT
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