(Orlando, 28th March,2008) Randomized Comparison of Gen ous Stent Versus Chromiu m-Cobalt s tent for Treatment of ST ST - - E E levation 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 Masaryk hospital and University of J.E. Purkyne Ústí nad Labem, Czech Republic
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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 - PowerPoint PPT Presentation
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(Orlando, 28th March,2008)
Randomized Comparison of Genous Stent Versus Chromium-Cobalt stent for Treatment
of STST--EElevationlevation Myocardial Infarction. 6-month Clinical, Angiographic and IVUS
Follow-up.GENIUS-STEMI trial.
Randomized Comparison of Genous Stent Versus Chromium-Cobalt stent for Treatment
of STST--EElevationlevation Myocardial Infarction. 6-month Clinical, Angiographic and IVUS
Follow-up.GENIUS-STEMI trial.
P. Červinka, M. Bystroň, R. Špaček, M. Kvašňák, J. JakabčinMasaryk hospital and University of J.E. Purkyne
Ústí nad Labem, Czech Republic
Presenter Disclosure Information
<Assoc. Prof . Pavel Červinka, MD, PhD, FESC, FSCAIAssoc. Prof . Pavel Červinka, MD, PhD, FESC, FSCAI
OrbusNeich has succesfully applied EPC capture technology to 316LOrbusNeich has succesfully applied EPC capture technology to 316L stainless steel stainless steel
Antibodies (murine monoclonal antihuman CD34) immobilizied on the stentAntibodies (murine monoclonal antihuman CD34) immobilizied on the stent surface are directed towards cell surface antigens on EPC surface are directed towards cell surface antigens on EPC
By recruiting the body´s own EPCs to the site of vascular injury/stent, anBy recruiting the body´s own EPCs to the site of vascular injury/stent, an acceleration of the normal endothelisation process would occuracceleration of the normal endothelisation process would occur
GENIUS-STEMIGENIUS-STEMI
Scanning electron micrographs (SEMs): 1 hourScanning electron micrographs (SEMs): 1 hour
The objective The objective of this trial was to assess the of this trial was to assess the feasibility and safety of the use of EPC capture feasibility and safety of the use of EPC capture stent for treatment of STEMI and comparison of stent for treatment of STEMI and comparison of 30-day 30-day and 6-month and 6-month outcome with chromium-outcome with chromium-
cobalt stents.cobalt stents.
The use of EPC The use of EPC capture capture stent may result in more stent may result in more rapid healing process and improve clinical rapid healing process and improve clinical
outcome.outcome.
PurposePurpose
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Single center, Prospective, Randomized (envelope)Single center, Prospective, Randomized (envelope)
No sponsorNo sponsor
Ústí nad LabemÚstí nad Labem
Medical ethics committee of our institution approvedMedical ethics committee of our institution approved the study protocolthe study protocol
GENIUS-STEMIGENIUS-STEMI
GENIUS-STEMIGENIUS-STEMI MethodMethod
Between Between AugustAugust and December 2007, and December 2007, 100 100 consecutive consecutive patients with STEMI and single vessel patients with STEMI and single vessel disease were randomly assigned disease were randomly assigned (sealed envelope) (sealed envelope) to to
receive either EPC capture stent (N=50) (Genousreceive either EPC capture stent (N=50) (GenousTMTM stent stent)) or chromium-cobalt stent or chromium-cobalt stent ((N=50)N=50)
(either Driver(either DriverTM TM or Coroflex Blue or Coroflex BlueTMTM))
Dual antiplatelet treatment was administered for 30 days Dual antiplatelet treatment was administered for 30 days in both groups.in both groups.
AA 6-month clinical, angiographic and IVUS follow-ups 6-month clinical, angiographic and IVUS follow-ups were were assessed in both groups. assessed in both groups.
GENIUS-STEMIGENIUS-STEMI
EndpointsEndpoints
MACEs’MACEs’ (CV death, MI, clinically driven TLR) at 6 month FU
Late lumen loss at 6-month FU
Neointimal hyperplasia inside the stent at 6-month FU
6 month angio and IVUS data6 month angio and IVUS data
Genous Genous Cr-Co Cr-Co P valueP value
ANGIO DATAANGIO DATA N=44N=44 N=47 N=47 Late lumen loss (mm) 0.89±0.59 0.79±0.47 NSLate lumen loss (mm) 0.89±0.59 0.79±0.47 NS Restenosis (>50%) 20 13 NSRestenosis (>50%) 20 13 NS (QCA: Pie Medical Im)(QCA: Pie Medical Im)
IVUS N=41 N=42 mean in-stent NIH mean in-stent NIH (mm(mm33) ) 49.749.7±±4848 40.0±22.8 NS 40.0±22.8 NS (Volcano, pull back 0.5%mm/s)(Volcano, pull back 0.5%mm/s)
(QIVA Pie Medical Im)(QIVA Pie Medical Im)
GENIUS-STEMIGENIUS-STEMI Stent thrombosis in GenousStent thrombosis in GenousTMTM group group
P-PCI Day 30 Day 60
ASA
ASA+clopidogrel
32 48 52
ARC definition: ARC definition: 3x definite; 3x late
Patient Age TIMI Thrombus iGP IIb/IIa Vessel EF Stent Days Treatment Dual T Stát.Patient Age TIMI Thrombus iGP IIb/IIa Vessel EF Stent Days Treatment Dual T Stát.
J.J. 61 3 Y Y RCA 60 1; 2.75/23 48 dPOBA N AliveJ.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 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 AliveJ.T. 47 2 Y Y RCA 52 2; 3.5/23+18 52 dPOBA N Alive
GENIUS-STEMIGENIUS-STEMI
Patient Age TIMI Thrombus iGP IIb/IIa Vessel EF Stent Days Treatment Dual T Stát.Patient Age TIMI Thrombus iGP IIb/IIa Vessel EF Stent Days Treatment Dual T Stát.
J.T. 47 2 Y Y RCA 52 2; 3.5/23+18 52 dPOBA N J.T. 47 2 Y Y RCA 52 2; 3.5/23+18 52 dPOBA N AliveAlive
GENIUS-STEMIGENIUS-STEMI SStudies with EPCs capture stenttudies with EPCs capture stent
6 M FU 12 M FU
MACE TLR
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))
LL 0.63mmNIH 52 mm3
LL 0.78mmNIH 31 mm3 AMI
LL 0.89mmNIH 50 mm3
LL 0.89mm
GENIUS-STEMIGENIUS-STEMI Conclusions:Conclusions:
The use of EPC capture stents in the setting of The use of EPC capture stents in the setting of STEMI is feasible and save. STEMI is feasible and save.
However, the rate of MACE at 6-month FU was However, the rate of MACE at 6-month FU was significantly higher in Genoussignificantly higher in GenousTMTM group when group when
compare to CrCo stents.compare to CrCo stents.
Warrisome is the rate of late stent thrombosis in Warrisome is the rate of late stent thrombosis in EPCs capture stent group.EPCs capture stent group.
Larger randomized trials are mandatory. Larger randomized trials are mandatory.
Caveats:Caveats:
Small, single center trialSmall, single center trial