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P. Červinka, M. Bystroň, R. Špaček, M. Kvašňák, J. Jakabčin

Randomized Compariso n of Gen ous Stent Versus Chrom iu m-Cobalt s tent for Treatment of ST - E levation M yocardial I nfarction. 6- month Clinical , Angiographic and IVUS Follow - up . GENIUS-STEMI trial. P. Červinka, M. Bystroň, R. Špaček, M. Kvašňák, J. Jakabčin

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P. Červinka, M. Bystroň, R. Špaček, M. Kvašňák, J. Jakabčin

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  1. Randomized Comparisonof Genous Stent Versus Chromium-Cobalt stent for Treatment of ST-ElevationMyocardial Infarction. 6-monthClinical, Angiographicand IVUS Follow-up.GENIUS-STEMI trial. P. Červinka, M. Bystroň, R. Špaček, M. Kvašňák, J. Jakabčin Masaryk hospital and University of J.E. Purkyne Ústí nad Labem, Czech Republic (Orlando, 28th March,2008)

  2. GENIUS-STEMI • Presenter Disclosure Information <Assoc. Prof . Pavel Červinka, MD, PhD, FESC, FSCAI No relationships to disclose

  3. GENIUS-STEMI • Acutecoronarysyndromes • (STEMI or UAP/NSTEMI ) Plaque rupture/errosion + thrombosis

  4. GENIUS-STEMI • Concernsabout DES thrombosis in patientswith STEMI

  5. GENIUS-STEMI • EPC CaptureCoating Technology (GENOUSTMstent) • OrbusNeich has succesfullyapplied EPC capture technology to 316L • stainlesssteel • Antibodies (murinemonoclonalantihuman CD34) immobilizied on thestent • surface are directedtowards cell surfaceantigens on EPC • By recruitingthe body´s ownEPCs to thesiteofvascularinjury/stent, an • accelerationofthenormalendothelisationprocesswouldoccur

  6. GENIUS-STEMI • Scanningelectronmicrographs (SEMs): 1 hour EPC capture stent Bare stent almostcompletecellularcoverage sparsecellularcoverage

  7. GENIUS-STEMI • Purpose The objective of this trial was to assess the feasibility and safety of the use of EPC capture stent for treatment of STEMI and comparison of 30-day and 6-monthoutcome with chromium-cobalt stents. The use ofEPC capture stent mayresult in more rapid healingprocessandimproveclinicaloutcome.

  8. GENIUS-STEMI • Single center, Prospective, Randomized (envelope) • No sponsor Ústí nad Labem • Medicalethicscommitteeofourinstitutionapproved the study protocol

  9. GENIUS-STEMI • Method Between August and December 2007, 100 consecutivepatients with STEMI and single vessel disease were randomly assigned (sealedenvelope) to receive either EPC capture stent (N=50) (GenousTM stent) or chromium-cobalt stent (N=50) (eitherDriverTMorCoroflexBlueTM) Dual antiplatelet treatment was administered for 30 days in both groups. A 6-monthclinical, angiographicand IVUS follow-upswere assessed in both groups.

  10. GENIUS-STEMI • Endpoints MACEs’ (CV death, MI, clinicallydrivenTLR) at 6 month FU Late lumen lossat 6-month FU Neointimalhyperplasiainsidethestentat 6-month FU

  11. GENIUS-STEMI • Definitions • Deaths- cardiac or noncardiac - undetermined causes reported as cardiac • Myocardial infarction Q wave MI: new, pathological Q waves in≥2 contiguous leads with post-PCI increase CK double the upper limit of normal and CK-MB>10% of CK level Non-Q-wave MI: elevationof CK level to double theupper limit ofnormal, CK-MB>10% of CK leveland no Q-waves • TLR – reinterventionsinsidethestentorwithin 5mm proximalordistal to thestent • Stentthrombosis (according to theAcademicResearchConsorcium) - early (0-30 days) - late (31-360days) - verylate (>361 days) - definite: ACS+angiographicorautopsy evidence ofthrombusorocclusion - probable: unexplaineddeathswithin 30 daysoftheprocedureoracute MI involvingthetarget-vesselteritorywithoutangiography - possible: allunexplaineddeaths>30 daysaftertheprocedure

  12. GENIUS-STEMI • Statisticalanalysis (NCSS&PASS) Continuousvariables are expressed as themean±SD Categoricalvariables as percentages Continuousvariableswerecompared by meansofthe Student´s t- t. Categoricalvariableswerecompared by themeansof theΧ2 t. A two-tailedvalueof p<0.05 wasconsidered to be statisticallysignificant

  13. GENIUS-STEMI • Study flow chart 2007:400 P-PCI 100 patientsincluded (Randomization) 50 CrCo 50 GenousTM ASA 100mg/day+clopidogrel 75mg/day 30 days; GPIIb/IIIa inhibitors and thromboaspiration at the discretion of the physician 6-month clinical, angio and IVUS FU

  14. GENIUS-STEMI • Baselinedemographic, clinicalandangiographiccharcteristics

  15. GENIUS-STEMI • Proceduralcharacteristics GenousCr-Co P value N=50 N=50 Stenosis (%) 5.2±4.5 3.9±3.7 NS MLD (mm) 3.56±0.42 3.62±0.39 NS TIMI flow 0-1 (%) 0 0 NS 2 6 3 NS 3 94 97 NS Number of stents 1.20 1.26 NS Length of the stents (mm) 20.42 22.30 NS GPIIb/IIIa inhibitors (%) 32 22 NS Thromboaspiration (%) 17 25 NS

  16. GENIUS-STEMI • 6-monthclinicaloutcome GenousTM CrCo P=0.03 P=0.04 24 4 4 P=NS P=NS 10 2 2 P=NS 14 6 4 4 6 0 4 2 MACE CV Deaths MI TLR ST (Non hierachical)

  17. GENIUS-STEMI • 6 monthangioand IVUS data GenousCr-Co P value ANGIO DATAN=44 N=47 Late lumen loss (mm) 0.89±0.59 0.79±0.47 NS Restenosis (>50%) 20 13 NS (QCA: Pie Medical Im) IVUS N=41 N=42 mean in-stent NIH (mm3) 49.7±4840.0±22.8 NS (Volcano, pull back 0.5%mm/s) (QIVA Pie Medical Im)

  18. GENIUS-STEMI • Stentthrombosis in GenousTMgroup • PatientAge TIMI ThrombusiGPIIb/IIaVessel EF StentDaysTreatmentDual T Stát. • J.J. 61 3 Y Y RCA 60 1; 2.75/23 48 dPOBA N Alive • P.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 ARC definition: 3x definite; 3x late ASA ASA+clopidogrel 32 48 52 P-PCI Day 30 Day 60

  19. GENIUS-STEMI • PatientAge TIMI ThrombusiGPIIb/IIaVessel EF StentDaysTreatmentDual T Stát. • J.T. 47 2 Y Y RCA 52 2; 3.5/23+18 52 dPOBA N Alive

  20. GENIUS-STEMI • StudieswithEPCscapturestent 6 M FU 12 M FU LL 0.89mm NIH 50 mm3 MACE TLR LL 0.89mm LL 0.78mm NIH 31 mm3 AMI LL 0.63mm NIH 52 mm3 HEALING FIM HEALING II HEALING Iib Miglionico GENIUS e-HEALING CO et al. AMCR (N=16) (N=63) (N=99) (N=80) (N=100) (N=3196/5000) (N=120) (N=236))

  21. GENIUS-STEMI • Conclusions: The use of EPC capturestents in thesettingof STEMI isfeasibleandsave. However, therateof MACE at 6-month FU wassignificantlyhigher in GenousTMgroupwhencompare to CrCostents. Warrisomeistherateoflatestentthrombosis in EPCscapturestentgroup. Largerrandomizedtrials are mandatory. Caveats: Small, single center trial Underpoweredfor MACE No corelab

  22. ¨Thank you for your attention

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