CORONARY STENT safety update & ROLE OF ENDOTHELIAL PROGENITOR CELL CAPTURING STENTS

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CORONARY STENT safety update & ROLE OF ENDOTHELIAL PROGENITOR CELL CAPTURING STENTS. Giuseppe Biondi Zoccai, MD , FSICI-GISE University of Turin , Turin , Italy. Learnging goals. Scope of the problem Second generation drug-eluting stents - PowerPoint PPT Presentation

Transcript of CORONARY STENT safety update & ROLE OF ENDOTHELIAL PROGENITOR CELL CAPTURING STENTS

  • Giuseppe Biondi Zoccai, MD, FSICI-GISE

    University of Turin, Turin, Italy

  • Scope of the problem

    Second generation drug-eluting stents

    Update on endothelial progenitor cell capturing stents

  • Scope of the problem

    Second generation drug-eluting stents

    Update on endothelial progenitor cell capturing stents

  • 25% Stent Thrombosis !

  • Scope of the problem

    Second generation drug-eluting stents

    Update on endothelial progenitor cell capturing stents

  • Scope of the problem

    Second generation drug-eluting stents

    Update on endothelial progenitor cell capturing stents

  • accelerated endothelializationby EPC-capturingimmediately after Stent ImplantationEndothelialization of the Stent Struts:

  • ConfocalSES-anti-CD34SES alone3 days14 days

  • LATIN AMERICAVenezuela 1

    MIDDLE EASTEgypt 6Lebanon 1Saudi Arabia 1Syria 3Turkey 3

    EUROPEAustria 8Belgium 3Cyprus 2Denmark 2France 8Germany 11Greece 6Ireland 1Italy 26Netherlands 5Portugal 3Spain 8Switzerland 1United Kingdom 9

    NORTH AFRICATunisia 2ASIA PACIFICAustralia 6Hong Kong 1Malaysia 9Singapore 2144 SITES

    Czech Republic 5 Finland 1Hungary 2Poland 2Romania 1 Russian Federation 5

  • Patients treated on or before Feb 22, 2007 All events reported before Aug 12, 2008; all events adjudicated by CEC Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR

    30 days6 months12 monthsCardiac Death0.6 %1.3 %1.9 %MI1.2 %1.5 %1.6 %Q-wave0.2 %0.2 %0.2 %Non Q-wave1.0 %1.3 %1.4 %TLR (Clinically Driven)0.2 %2.9 %5.0 %PCI0.2 %2.6 %4.6 %CABG0.0 %0.3 %0.4 %MACE1.9 %5.8 %8.5 %

    Acute stent thrombosis0.2 %Sub-acute stent thrombosis0.4 %Late stent thrombosis0.3 %

  • Patients treated on or before Feb 22, 2007 All events reported before Aug 12, 2008; all events adjudicated by CEC Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR

    Acute stent thrombosis0.0 %Sub-acute stent thrombosis0.2 %Late stent thrombosis0.8 %

    30 days6 months12 monthsCardiac Death0.8 %2.5 %3.6 %MI0.6 %1.3 %1.3 %Q-wave0.1 %0.1 %0.1 %Non Q-wave0.5 %1.2 %1.2 %TLR (Clinically Driven)0.2 %3.2 %4.9 %PCI0.2 %2.8 %4.5 %CABG0.0 %0.4 %0.5 %MACE1.6 %6.9 %9.9 %

  • Patients treated on or before Feb 22, 2007 All events reported before Aug 12, 2008; all events adjudicated by CEC Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR

    Acute stent thrombosis0.2 %Sub-acute stent thrombosis0.3 %Late stent thrombosis0.4 %

    30 days6 months12 monthsCardiac Death0.6 %1.2 %1.7 %MI1.1 %1.3 %1.4 %Q-wave0.1 %0.1 %0.2 %Non Q-wave0.9 %1.2 %1.2 %TLR (Clinically Driven)0.2 %3.0 %5.2 %PCI0.2 %2.6 %4.7 %CABG0.0 %0.4 %0.5 %MACE1.8 %5.5 %8.2 %

  • Patients treated on or before Feb 22, 2007 All events reported before Aug 12, 2008; all events adjudicated by CEC Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR

    Acute stent thrombosis0.4 %Sub-acute stent thrombosis0.7 %Late stent thrombosis0.2 %

    30 days6 months12 monthsCardiac Death0.5 %2.2 %3.3 %MI1.6 %2.7 %2.5 %Q-wave0.4 %0.5 %0.5 %Non Q-wave1.3 %2.2 %2.0 %TLR (Clinically Driven)0.4 %2.5 %4.2 %PCI0.4 %2.5 %4.2 %CABG0.0 %0.0 %0.0 %MACE2.5 %7.4 %9.9 %

  • 1 All events reported before Aug 12, 2008; all events adjudicated by CEC; Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR2 MACE = Cardiac Death, MI TVR; The Lancet, 372: 1163 1173, 20083 MACE = any death, MI, TVR, Syntax Trial, presented at the ESC meeting in Munich, Sept. 20084 ARC definite + probable

    Genous(e-HEALING)Cypher(LEADERS)BioMatrix(LEADERS)Taxus(SYNTAX)Inclusion criteriaall comersall comersall comers3-VD / Left main

  • 1 All events reported before Aug 12, 2008; all events adjudicated by CEC; Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR2 MACE = Cardiac Death, MI TVR; The Lancet, 372: 1163 1173, 20083 MACE = any death, MI, TVR, Syntax Trial, presented at the ESC meeting in Munich, Sept. 20084 ARC definite + probable

    Genous(e-HEALING)Cypher(LEADERS)BioMatrix(LEADERS)Taxus(SYNTAX)Inclusion criteriaall comersall comersall comers3-VD / Left mainNumber of patients3196850857903Duration of follow-up12 months9 months9 months12 months

  • 1 All events reported before Aug 12, 2008; all events adjudicated by CEC; Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR2 MACE = Cardiac Death, MI TVR; The Lancet, 372: 1163 1173, 20083 MACE = any death, MI, TVR, Syntax Trial, presented at the ESC meeting in Munich, Sept. 20084 ARC definite + probable

    Genous(e-HEALING)Cypher(LEADERS)BioMatrix(LEADERS)Taxus(SYNTAX)Inclusion criteriaall comersall comersall comers3-VD / Left mainNumber of patients3196850857903Duration of follow-up12 months9 months9 months12 monthsCardiac death1.9 % 1 2.5 %1.6 % 4.3 % (any)

  • 1 All events reported before Aug 12, 2008; all events adjudicated by CEC; Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR2 MACE = Cardiac Death, MI TVR; The Lancet, 372: 1163 1173, 20083 MACE = any death, MI, TVR, Syntax Trial, presented at the ESC meeting in Munich, Sept. 20084 ARC definite + probable

    Genous(e-HEALING)Cypher(LEADERS)BioMatrix(LEADERS)Taxus(SYNTAX)Inclusion criteriaall comersall comersall comers3-VD / Left mainNumber of patients3196850857903Duration of follow-up12 months9 months9 months12 monthsCardiac death1.9 % 1 2.5 %1.6 % 4.3 % (any)MI1.6 % 1 4.6 %5.7 % 4.8 %

  • 1 All events reported before Aug 12, 2008; all events adjudicated by CEC; Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR2 MACE = Cardiac Death, MI TVR; The Lancet, 372: 1163 1173, 20083 MACE = any death, MI, TVR, Syntax Trial, presented at the ESC meeting in Munich, Sept. 20084 ARC definite + probable

    Genous(e-HEALING)Cypher(LEADERS)BioMatrix(LEADERS)Taxus(SYNTAX)Inclusion criteriaall comersall comersall comers3-VD / Left mainNumber of patients3196850857903Duration of follow-up12 months9 months9 months12 monthsCardiac death1.9 % 1 2.5 %1.6 % 4.3 % (any)MI1.6 % 1 4.6 %5.7 % 4.8 %TLR Clinically Driven5.0 % 1 4.9 %4.3 % 13.7 %

  • 1 All events reported before Aug 12, 2008; all events adjudicated by CEC; Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR2 MACE = Cardiac Death, MI TVR; The Lancet, 372: 1163 1173, 20083 MACE = any death, MI, TVR, Syntax Trial, presented at the ESC meeting in Munich, Sept. 20084 ARC definite + probable

    Genous(e-HEALING)Cypher(LEADERS)BioMatrix(LEADERS)Taxus(SYNTAX)Inclusion criteriaall comersall comersall comers3-VD / Left mainNumber of patients3196850857903Duration of follow-up12 months9 months9 months12 monthsCardiac death1.9 % 1 2.5 %1.6 % 4.3 % (any)MI1.6 % 1 4.6 %5.7 % 4.8 %TLR Clinically Driven5.0 % 1 4.9 %4.3 % 13.7 %MACE8.5 % 1 10.5 % 29.2 % 2 17.2 % 3

  • 1 All events reported before Aug 12, 2008; all events adjudicated by CEC; Worst MACE per patient = cardiac death, MI, CABG, and clinically driven TLR2 MACE = Cardiac Death, MI TVR; The Lancet, 372: 1163 1173, 20083 MACE = any death, MI, TVR, Syntax Trial, presented at the ESC meeting in Munich, Sept. 20084 ARC definite + probable

    Genous(e-HEALING)Cypher(LEADERS)BioMatrix(LEADERS)Taxus(SYNTAX)Inclusion criteriaall comersall comersall comers3-VD / Left mainNumber of patients3196850857903Duration of follow-up12 months9 months9 months12 monthsCardiac death1.9 % 1 2.5 %1.6 % 4.3 % (any)MI1.6 % 1 4.6 %5.7 % 4.8 %TLR Clinically Driven5.0 % 1 4.9 %4.3 % 13.7 %MACE8.5 % 1 10.5 % 29.2 % 2 17.2 % 3Stent thrombosis1.0 % 42.2 % 42.7 % 43.4 % 4Recommended dual antiplatelet therapy4 weeks12 months12 months12 months

  • Study flow chart 100 patients included(Randomization)50 GenousTM50 CrCo6-month clinical, angio and IVUS FUASA 100mg/day+clopidogrel 75mg/day 30 days; GPIIb/IIIa inhibitors and thromboaspiration at the discretion of the physician

  • 6-month clinical outcomeMACE CV Deaths MI TLR ST

    P=0.03P=NSP=0.04P=NSP=NS(Non hierachical)GenousTMCrCo24104462144604422

  • 6 month angio and IVUS data Genous Cr-Co P value

    ANGIO DATA N=44 N=47 Late lumen loss (mm) 0.890.59 0.790.47 NS Restenosis (>50%) 20 13 NS (QCA: Pie Medical Im)

    IVUS N=41 N=42 mean in-stent NIH (mm3) 49.748 40.022.8 NS (Volcano, pull back 0.5%mm/s) (QIVA Pie Medical Im)

  • Stent thrombosis in GenousTM groupP-PCI Day 30 Day 60 ASAASA+clopidogrel324852ARC definition: 3x definite; 3x latePatient Age TIMI Thrombus iGP IIb/IIa Vessel EF Stent Days Treatment Dual T Stt.

    J.J. 61 3 Y Y RCA 60 1; 2.75/23 48 dPOBA N AliveP.U. 26 3 Y Y LAD 45 1; 3/23 32 dPCI+G Y Alive J.T. 47 2 Y Y RCA 52 2; 3.5/23+18 52 dPOBA N Alive

  • Single center trial