CORONARY STENT safety update & ROLE OF ENDOTHELIAL PROGENITOR CELL CAPTURING STENTS
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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 problemScope 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 Second generation drug-eluting stentsstents
Update on endothelial progenitor cell capturing stents
Scope of the problem
Second generation drug-eluting stents
Update on endothelial Update on endothelial progenitor cell capturing stentsprogenitor cell capturing stents
accelerated endothelializationby EPC-“capturing”
immediately after Stent Implantation
Endothelialization of the Stent Struts:
0
10
20
30
40
50
Genous BMS
(%)
p=0.07
mean
mean
In rabbit iliac model
BMSGenous7-days
Anti-CD34 coating
Confocal
SES-anti-CD34 SES alone
3 days
14 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 2
ASIA PACIFICAustralia 6Hong Kong 1Malaysia 9Singapore 2
144 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 days 6 months 12 months
Cardiac Death 0.6 % 1.3 % 1.9 %
MI 1.2 % 1.5 % 1.6 %
Q-wave 0.2 % 0.2 % 0.2 %
Non Q-wave 1.0 % 1.3 % 1.4 %
TLR (Clinically Driven) 0.2 % 2.9 % 5.0 %
PCI 0.2 % 2.6 % 4.6 %
CABG 0.0 % 0.3 % 0.4 %
MACE 1.9 % 5.8 % 8.5 %Acute stent thrombosis 0.2 %
Sub-acute stent thrombosis 0.4 %
Late stent thrombosis 0.3 %
Acute stent thrombosis 0.0 %
Sub-acute stent thrombosis 0.2 %
Late stent thrombosis 0.8 %
30 days 6 months 12 months
Cardiac Death 0.8 % 2.5 % 3.6 %
MI 0.6 % 1.3 % 1.3 %
Q-wave 0.1 % 0.1 % 0.1 %
Non Q-wave 0.5 % 1.2 % 1.2 %
TLR (Clinically Driven) 0.2 % 3.2 % 4.9 %
PCI 0.2 % 2.8 % 4.5 %
CABG 0.0 % 0.4 % 0.5 %
MACE 1.6 % 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 thrombosis 0.2 %
Sub-acute stent thrombosis 0.3 %
Late stent thrombosis 0.4 %
30 days 6 months 12 months
Cardiac Death 0.6 % 1.2 % 1.7 %
MI 1.1 % 1.3 % 1.4 %
Q-wave 0.1 % 0.1 % 0.2 %
Non Q-wave 0.9 % 1.2 % 1.2 %
TLR (Clinically Driven) 0.2 % 3.0 % 5.2 %
PCI 0.2 % 2.6 % 4.7 %
CABG 0.0 % 0.4 % 0.5 %
MACE 1.8 % 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 thrombosis 0.4 %
Sub-acute stent thrombosis 0.7 %
Late stent thrombosis 0.2 %
30 days 6 months 12 months
Cardiac Death 0.5 % 2.2 % 3.3 %
MI 1.6 % 2.7 % 2.5 %
Q-wave 0.4 % 0.5 % 0.5 %
Non Q-wave 1.3 % 2.2 % 2.0 %
TLR (Clinically Driven) 0.4 % 2.5 % 4.2 %
PCI 0.4 % 2.5 % 4.2 %
CABG 0.0 % 0.0 % 0.0 %
MACE 2.5 % 7.4 % 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
Genous(e-HEALING)
Cypher(LEADERS)
BioMatrix(LEADERS)
Taxus(SYNTAX)
Inclusion criteria all comers all comers all 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 criteria all comers all comers all comers3-VD / Left
main
Number of patients 3196 850 857 903
Duration of follow-up 12 months 9 months 9 months 12 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 criteria all comers all comers all comers3-VD / Left
main
Number of patients 3196 850 857 903
Duration of follow-up 12 months 9 months 9 months 12 months
Cardiac death 1.9 % 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 criteria all comers all comers all comers3-VD / Left
main
Number of patients 3196 850 857 903
Duration of follow-up 12 months 9 months 9 months 12 months
Cardiac death 1.9 % 1 2.5 % 1.6 % 4.3 % (any)
MI 1.6 % 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 criteria all comers all comers all comers3-VD / Left
main
Number of patients 3196 850 857 903
Duration of follow-up 12 months 9 months 9 months 12 months
Cardiac death 1.9 % 1 2.5 % 1.6 % 4.3 % (any)
MI 1.6 % 1 4.6 % 5.7 % 4.8 %
TLR Clinically Driven 5.0 % 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 criteria all comers all comers all comers3-VD / Left
main
Number of patients 3196 850 857 903
Duration of follow-up 12 months 9 months 9 months 12 months
Cardiac death 1.9 % 1 2.5 % 1.6 % 4.3 % (any)
MI 1.6 % 1 4.6 % 5.7 % 4.8 %
TLR Clinically Driven 5.0 % 1 4.9 % 4.3 % 13.7 %
MACE 8.5 % 1 10.5 % 2 9.2 % 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
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 criteria all comers all comers all comers3-VD / Left
main
Number of patients 3196 850 857 903
Duration of follow-up 12 months 9 months 9 months 12 months
Cardiac death 1.9 % 1 2.5 % 1.6 % 4.3 % (any)
MI 1.6 % 1 4.6 % 5.7 % 4.8 %
TLR Clinically Driven 5.0 % 1 4.9 % 4.3 % 13.7 %
MACE 8.5 % 1 10.5 % 2 9.2 % 2 17.2 % 3
Stent thrombosis 1.0 % 4 2.2 % 4 2.7 % 4 3.4 % 4
Recommended dual antiplatelet therapy 4 weeks 12 months 12 months 12 months
Study flow chartStudy flow chart
2007:2007: 400 P-PCI400 P-PCI
100 patients included100 patients included
(Randomization)
50 GenousTM 50 CrCo
6-month clinical, angio and IVUS FU
ASA 100mg/day+clopidogrel 75mg/day 30 days; GPIIb/IIIa inhibitors
and thromboaspiration at the discretion of the physician
6-month clinical outcome6-month clinical outcome
0
5
10
15
20
25
30
MACE CV Deaths MI TLR ST
P=0.03
P=NS
P=0.04
P=NSP=NS
(Non hierachical)
GenousTM CrCo
24
10
4 4 6 2
14
4 6 0
4 4
2 2
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)
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
Single center trial – (Università degli Studi di Napoli - Federico II)
PI: F. Piscione 195 consecutive patients underwent PCI with
either Genous or DES (SES or PES) implantations in the period May – July 2006.
Dual anti-platelet therapy for 1 month post-Genous implant and 9 months post DES implant.
Clinical follow-up (average FU 10.1 ± 3.2 months).
Follow-up major adverse clinical events (MACE): cardiac death, MI, target vessel re-PTCA, CABG.
Age
Diabetes 32 34
Smoke 32.7 50
Dislipidemia 46 63
Familyhistory
38.2 33.4
Pre PTCA
Pre CABG
10.9
9.1
15.4
3.8
p
0.047
NS
NS
NS
NS
NS
NS
Pre EF 45 NS
Genous DES
Hypertension 70 80.6 NS
(n=100) (n=95)
Male 0.048
65.56±10.8
60.11±10.8 84 67.7
51
(%) (%)
CX (%) 16.3 26.2
PTCA Multivessel (%)
24.5 26.2RCA (%)
LAD (%) 57 43
p
NS
NS
NS
NS
3
73
NS
NS
22.67±9 Lesion length (mm)
3
57 44.6
Genous DES
26.9±12 0.049
Multiple stenting (%) 98.5 95.4
NS
IIb/IIIa (%)
TIMI grade post
62
Direct stenting (%) 43.8 72.3 0.002
1 1 2 24
7,8
11,8
7,85,8
22
0
10
20
30
MI Re-PCI Death Stentthrombosis
MACE
GenousDES
% p=0.045
p=0.013
p=0.017
p=NS p=NS
Coronary stents have always faced a significant risk of early and late stent thrombosis
Whereas second-generation drug-eluting stents have improved early and subsequent outcomes, their biocompatibility is still at stake
Recent studies on EPC stents suggest the promising role of this device
The asymptotic coronary stent will likely be a bioabsorbable device with drug-elution and EPC capabilities