Randomized%20Comparison%20of%20Genous%20Stent%20Versus%20Chromium-Cobalt%20stent%20for%20Treatment%20of%20ST-Elevation%20Myocardial%20Infarction.%20%20%206-month%20Clinical,%20Angiographic%20and%20IVUS%20Follow-up.%20GENIUS-STEMI%20trial.

1
Randomized Comparison of Genous Stent Versus
Chromium-Cobalt stent for Treatment of
ST-Elevation Myocardial Infarction. 6-month
Clinical, Angiographic and IVUS
Follow-up.GENIUS-STEMI trial.

• P. Cervinka, M. Bystron, R. Špacek, M. Kvašnák,
  J. Jakabcin
• Masaryk hospital and University of J.E. Purkyne
• Ústí nad Labem, Czech Republic

(Orlando, 28th March,2008)
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GENIUS-STEMI

• Presenter Disclosure Information

ltAssoc. Prof . Pavel Cervinka, MD, PhD, FESC,
FSCAI
No relationships to disclose
3
GENIUS-STEMI

• Acute coronary syndromes
• (STEMI or UAP/NSTEMI )

Plaque rupture/errosion thrombosis
4
GENIUS-STEMI

• Concerns about DES thrombosis in patients with
  STEMI

5
GENIUS-STEMI

• EPC Capture Coating Technology (GENOUSTM stent)

• OrbusNeich has succesfully applied EPC capture
  technology to 316L
• stainless steel
• Antibodies (murine monoclonal antihuman CD34)
  immobilizied on the stent
• surface are directed towards cell surface
  antigens on EPC
• By recruiting the bodys own EPCs to the site
  of vascular injury/stent, an
• acceleration of the normal endothelisation
  process would occur

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GENIUS-STEMI

• Scanning electron micrographs (SEMs) 1 hour

EPC capture stent
Bare stent
almost complete cellular coverage
sparse cellular coverage
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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-month outcome with chromium-cobalt
stents. The use of EPC capture stent may result
in more rapid healing process and improve
clinical outcome.
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GENIUS-STEMI

• Single center, Prospective, Randomized
  (envelope)
• No sponsor

Ústí nad Labem

• Medical ethics committee of our institution
  approved
• the study protocol

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GENIUS-STEMI

• Method

Between August and December 2007, 100
consecutive patients with STEMI and single vessel
disease were randomly assigned (sealed envelope)
to receive either EPC capture stent (N50)
(GenousTM stent) or chromium-cobalt stent
(N50) (either DriverTM or Coroflex BlueTM)
Dual antiplatelet treatment was administered
for 30 days in both groups. A 6-month
clinical, angiographic and IVUS follow-ups were
assessed in both groups.
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GENIUS-STEMI

• Endpoints

• 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

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GENIUS-STEMI

• Definitions

• Deaths - cardiac or noncardiac
• - undetermined causes reported as
  cardiac
• Myocardial infarction
• Q wave MI new, pathological Q waves
  in2 contiguous leads with post-PCI increase
• CK double the upper limit of normal
  and CK-MBgt10 of CK level
• Non-Q-wave MI elevation of CK level
  to double the upper limit of normal,
• CK-MBgt10 of CK level and no
  Q-waves
• TLR reinterventions inside the stent or within
  5mm proximal or distal to the stent
• Stent thrombosis (according to the Academic
  Research Consorcium)
• - early (0-30 days) - late
  (31-360days) - very late (gt361 days)
• - definite ACSangiographic or
  autopsy evidence of thrombus or occlusion
• - probable unexplained deaths within
  30 days of the procedure or acute MI
• involving
  the target-vessel teritory without angiography
• - possible all unexplained
  deathsgt30 days after the procedure

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GENIUS-STEMI

• Statistical analysis (NCSSPASS)

Continuous variables are expressed as the mean
SD Categorical variables as percentages
Continuous variables were compared by means of
the Students t- t. Categorical variables were
compared by the means of the ?2 t. A
two-tailed value of plt0.05 was considered to be
statistically significant
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GENIUS-STEMI

• Study flow chart

2007 400 P-PCI
100 patients included
(Randomization)
50 GenousTM
50 CrCo
ASA 100mg/dayclopidogrel 75mg/day 30 days
GPIIb/IIIa inhibitors and thromboaspiration at
the discretion of the physician
6-month clinical, angio and IVUS FU
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GENIUS-STEMI
1)Pre-PCI angiography -at least 2 orthogonal
projections -QCA (Quantcore, Siemens-PieMedical
Im.)
2) Length and diameter of the stent -
according to the QCA - longer stent than the
lesion (ratio 1.11 at nom. pr.) (predilatation
with a small, short balloon)
3) Stent implantation - low pressure (lt10 atms)
4) Postdilatation - short, non-compliant balloon
- high-pressure (15 atms) - avoid injury at the
edges
5) Final optimal angio - at least 2 orthogonal
projections
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GENIUS-STEMI

• 6 month FU

Excercise stress test)
Angiography - at least 2 orthogonal
projections (same as in the end of index
procedure) - QCA (Quantcore, Siemens-PieMedical
Im.)
IVUS
motorized pull-back 0.5mm/s
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GENIUS-STEMI

• Baseline demographic, clinical and angiographic
  charcteristics

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GENIUS-STEMI

• Procedural characteristics

Genous
Cr-Co P value
N50
N50 Stenosis ()
5.24.5
3.93.7 NS MLD (mm)
3.560.42
3.620.39 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 GP IIb/IIIa inhibitors () 32
22
NS Thromboaspiration () 17
25
NS
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GENIUS-STEMI

• 6-month clinical outcome

GenousTM
CrCo
P0.03
P0.04
24
4
4
PNS
PNS
10
2
2
PNS
14
6
4
4
6
0
4
2
MACE CV Deaths MI
TLR ST
(Non hierachical)
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GENIUS-STEMI

• 6 month angio and IVUS data

Genous Cr-Co
P value
ANGIO DATA
N44
N47 Late lumen loss (mm)
0.890.59 0.790.47
NS Restenosis (gt50)
20 13
NS (QCA Pie Medical Im) IVUS

N41 N42 mean in-stent
NIH (mm3) 49.748
40.022.8 NS
(Volcano, pull back 0.5mm/s) (QIVA Pie
Medical Im)
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GENIUS-STEMI

• Stent thrombosis in GenousTM group

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 Alive
P.U. 26 3
Y Y LAD 45 1
3/23 32 dPCIG Y
Alive
J.T. 47 2
Y Y
RCA 52 2 3.5/2318 52 dPOBA
N Alive
ARC definition 3x definite 3x late
ASA
ASAclopidogrel
32
48
52
P-PCI Day 30
Day 60
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GENIUS-STEMI
Patient Age TIMI Thrombus
iGP IIb/IIa Vessel EF Stent
Days Treatment Dual T Stát.
J.T. 47 2 Y
Y RCA 52 2 3.5/2318 52
dPOBA N Alive
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GENIUS-STEMI

• Studies with EPCs capture stent

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 (N16) (N63)
(N99) (N80) (N100)
(N3196/5000) (N120) (N236))

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GENIUS-STEMI

• Conclusions

The use of EPC capture stents in the setting of
STEMI is feasible and save. However, the rate
of MACE at 6-month FU was significantly higher in
GenousTM group when compare to CrCo
stents. Warrisome is the rate of late stent
thrombosis in EPCs capture stent group. Larger
randomized trials are mandatory.
Caveats Small, single center trial Underpowered
for MACE No core lab
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Thank you for your attention