Komplexe Koronarintervention heute: Von Syntax zu bioresorbierbaren Stents Prof. Dr. med. Julinda Mehilli Medizinische Klinik und Poliklinik I Klinikum der Universität München Campus Großhadern
Key Factors Determining Technical and Clinical Success of PCI INTERVENTION DRUGS EXPERIENCE STRATEGY DEVICES
Key Factors Determining Technical and Clinical Success of PCI INTERVENTION STRATEGY DEVICES
One Day in Cathlab
Impact of Lesion Complexity to Detect Differences in Stent Performance Hausleiter et al., Am Heart J 2003
Impact of Vessel Size on Risk of Revascularization ISAR-SMART 3 BASKET-PROVE 10 8 7.2 6 4 3.4 2 0 vessel size <2.8mm vessel size >3.0mm Mehilli et al., Eur Heart J 2006 Kaiser et al., New Engl J Med 2010
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
Complex Lesions Do Benefit From DES Failed Saphenous Vein Grafts
ISAR-CABG N=610 PCI: High-Risk Patients - Failed Saphenous Vein Graft- Death/MI/TLR Mehilli et al., Lancet 2011
ISAR-CABG PCI: High-Risk Patients - Failed Saphenous Vein Graft- Target Lesion Revascularization 20 % P=.02 15 13.1 10 7.2 5 0 DES BMS Mehilli et al., Lancet 2011
Technically and Clinically Successful PCI Drug-Eluting Stent are Superior To Bare Metal Stent Simple and Complex Lesions Which is DES of Choice?
PCI: Improvements in DES Technology - Biodegradable Polymer - TEST 4 N=2603 Cardiac death/mi/tlr 20 % 15 13.8 14.4 Biodegradable Polymer DES Permanent Polymer DES 10 5 0 BP-DES PP-DES Byrne Mehilli, Eur Heart J 2009
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
Improvements in Intracoronary Imaging Technology - Optical Coherence Tomography - Optimal coverage Suboptimal coverage
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
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
Bioabsorbable Vascular Scaffolds Similar to the Standard-Barer DES Serruys et al., TCT 2012
Technically and Clinically Successful PCI Excellent Drug-Eluting Stents + Temporary Drug-Eluting Vascular Scaffold = DES for every lesion and every patient?
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
PCI: High-Risk Patients - Left Main Coronary Artery Disease - LEFT MAIN, n= 607 60% distally located lesions 50% two-stent stenting technique Mehilli et al., J Am Coll Cardiol 2009
30 % PCI: High-Risk Patients - Left Main Coronary Artery Disease - LEFT MAIN RR 0.78 (95% CI, 0.48-1.26) P=.31 RR 0.68 (95% CI, 0.36-1.28) P=.23 20 10 11.6 RR 1.46 (95% CI, 0.47-4.57) P=.52 13.3 0 TLR Taxus Cypher Mehilli et al., J Am Coll Cardiol 2009
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 [0.57-1.15] 0.78 [0.39-1.57] 1.13 [0.62-2.04] 1.03 [0.75-1.42] 0.78 [0.40-1.52] 2.43 [1.31-4.51] 0.81 [0.48-1.37] 1.20 [0.62-2.34] 0.57 [0.17-1.90] 0 1 2 3 4 5
PCI: High-Risk Patients - Left Main Coronary Artery Disease - LEFT MAIN 2, n= 650 80% distally located lesions 35% two-stent stenting technique Mehilli et al., J Am Coll Cardiol 2013
PCI: High-Risk Patients - LEFT MAIN 2: Stent Thrombosis - 4 % Probable stent thrombosis Definite stent thrombosis 2 0 0.6 0.6 0.3 Resolute n=324 Xience n=326 0.0 Mehilli et al., J Am Coll Cardiol 2013
PCI: High-Risk Patients - LEFT MAIN 2: Revascularization - 25 % 20 RR 1.26 (95% CI 0.78-2.06) P=.35 15 10 11.7 10.7 9.4 8.8 Resolute Xience 5 0 1.0 0.6 TLR Repeat PCI Bypass surgery Mehilli et al., J Am Coll Cardiol 2013
FAME, n= 1005 PCI: High-Risk Patients - Functional Revascularization - Tonino et al., New Engl J Med 2009
PCI: High-Risk Patients - Complete Functional Revascularization - SYNTAX Randomized and Nested registry N=2636 Farooq et al., J Am Coll Cardiol 2013
PCI: High-Risk Patients - Complete Functional Revascularization - PCI (Taxus stent) CABG surgery Farooq et al., J Am Coll Cardiol 2013
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
Technically and Clinically Successful PCI Excellent Drug-Eluting Stents + Temporary Drug-Eluting Vascular Scaffold = LESS is MORE Complete Functional Revascularization
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
FREEDOM trial N=1900 Very High-Risk Subsets Diabetic Patients Farkouh et al., New Engl J Med 2012
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
Complex Lesions Do Benefit From DES Restenotic Lesions
ISAR-DESIRE 3 PCI: High-Risk Patients - In-DES Restenosis - 402 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
ISAR-DESIRE 3 PCI: High-Risk Patients - In-DES Restenosis - Target Lesion Revascularization Byrne, Neumann, Mehilli Kastrati, Lancet 2012
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
PCI: High-Risk Patients - Unprotected Left Main Coronary Artery Disease - ca. 260.hr ISAR-LEFT MAIN Mehilli Schömig, J Am Coll Cardiol 2009
PCI: High-Risk Patients - Unprotected Left Main Coronary Artery Disease - ISAR-LEFT MAIN 3-year MACE Mehilli Schömig, J Am Coll Cardiol 2009
PCI: High-Risk Patients - Unprotected Left Main Coronary Artery Disease - ISAR-LEFT MAIN 3-year cardiac death Mehilli Schömig, J Am Coll Cardiol 2009
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
PCI: High-Risk Patients - Unprotected Left Main Coronary Artery Disease - ISAR-LEFT MAIN 2 650 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
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
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
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
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
Clinical impact of extending DAPT after PCI in the DES era: a meta-analysis of RCTs Stroke and Bleeds: extending DAPT vs. control DAPT