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INTERVENCIONISMO CARDIACO Manel Sabaté H. Clínic, Barcelona - ICP vs. Cirugía en enfermedad de 3 v y/o TCI: Syntax 2 años - ICP en TCI: ISAR-Left Main; Main Compare; LeMans Registry - SPIRIT IV, COMPARE trials. - NEVO II - Tratamiento de la enfermedad multivaso y/o TCI: - Stent farmacoactivos de 2ª generación:TRANSCRIPT
INTERVENCIONISMO CARDIACO
Manel SabatéH. Clínic, Barcelona
Intervencionismo Cardiaco 2008-09
- Tratamiento de la enfermedad multivaso y/o TCI:- ICP vs. Cirugía en enfermedad de 3 v y/o TCI:
Syntax 2 años- ICP en TCI: ISAR-Left Main; Main Compare;
LeMans Registry- Stent farmacoactivos de 2ª generación:
- SPIRIT IV, COMPARE trials.- NEVO II
Intervencionismo Cardiaco 2008-09
- Tratamiento de la enfermedad multivaso y/o TCI:- ICP vs. Cirugía en enfermedad de 3 v y/o TCI:
Syntax 2 años- ICP en TCI: ISAR-Left Main; Main Compare;
LeMans Registry- Stent farmacoactivos de 2ª generación:
- SPIRIT IV, COMPARE trials.- NEVO II
71% enrolled
(N=3,075)
All Pts with de novo 3VD and/or LM disease (N=4,337)
Treatment preference (9.4%) Referring MD or pts. refused
informed consent (7.0%) Inclusion/exclusion (4.7%) Withdrew before consent (4.3%) Other (1.8%) Medical treatment (1.2%)TAXUS
n=903PCI
n=198CABG
n=1077CABGn=897
no f/un=428
5yr f/un=649
PCIall captured w/
follow up
CABG2500
750 w/ f/uvsvs
Total enrollment N=3075
Stratification: LM and Diabetes
Two Registry ArmsRandomized Armsn=1800
Two Registry ArmsN=1275
Randomized ArmsN=1800
Heart Team (surgeon & interventionalist)
PCIN=198
CABGN=1077
Amenable for only one treatment approach
TAXUS*
N=903 CABG
N=897 vsvs
Amenable for bothtreatment options
Stratification: LM and Diabetes
LM33.7%
3VD66.3%
LM34.6%
3VD65.4%
23 US Sites62 EU Sites +SYNTAX Trial DesignSYNTAX Trial Design
**TAXUS ExpressTAXUS Express
Patient Characteristics (II)Patient Characteristics (II)Randomized CohortRandomized Cohort
Patient-basedCABGN=897
TAXUSN=903 P value
Total SYNTAX Score 29.1 ±11.4 28.4 ±11.5 0.19Diffuse disease or small vessels, % 10.7 11.3 0.69No. lesions, mean ± SD 4.4 ±1.8 4.3 ±1.8 0.443VD only, % 66.3 65.4 0.70Left main, any, % 33.7 34.6 0.70 Left Main only 3.1 3.8 0.46 Left Main + 1 vessel 5.1 5.4 0.78 Left Main + 2 vessel 12.0 11.5 0.72 Left Main + 3 vessel 13.5 13.9 0.78Total occlusion, % 22.2 24.2 0.33Bifurcation, % 73.3 72.4 0.67Trifurcation, % 10.6 10.7 0.92
Average Number of Stents Implanted per Patient
0
1
2
3
4
5
Avg
. # s
tent
s or
lesi
ons
treat
ed
4.6
3.5 3.7
Average Total Stented Length
0
20
40
60
80
100
71
Ave
rage
tota
l ste
nt le
ngth
(mm
) 86.1
73
MAIN-COMPARE trialn=858 (n=660-SES; n=189 PES)
Lee JY et al. J Am Coll Cardiol 2009; 54:853–9
ISAR-LEFT MAIN trial
Mehili J et al. J Am Coll Cardiol 2009;53:1760–8
Le Mans Registry
Buszman PE et al. J Am Coll Cardiol 2009;54:1500–11
Intervencionismo Cardiaco 2008-09
- Tratamiento de la enfermedad multivaso y/o TCI:- ICP vs. Cirugía en enfermedad de 3 v y/o TCI:
Syntax 2 años- ICP en TCI: ISAR-Left Main; Main Compare;
LeMans Registry- Stent farmacoactivos de 2ª generación:
- SPIRIT IV, COMPARE trials.- NEVO II
SPIRIT IV trial
SPIRIT IV trial
SPIRIT IV trial
SPIRIT IV trial
Eligible Patients for PCI
Guide-wire passage± Predilatation
Operator blinded1:1 Randomisation
Taxus Liberte Xience V
Expected MACE 9% versus 14 % (delta 5%)Power 85%1800 patients
Eligible Patients for PCI
Guide-wire passage± Predilatation
Operator blinded1:1 Randomisation
Taxus Liberte Xience V
Expected MACE 9% versus 14 % (delta 5%)Power 85%1800 patients
Study Outline: COMPARE trial
Clinical events were adjudicated by an independent CECTarget vessel revascularizations were analysed by an independent QCA core lab.
Primary Endpoint Result MACE (all death, non-fatal MI and TVR)
# Patients at Risk
Taxus
Xience P = 0.023 (log-rank test)
RR = 0.69 (0.50-0.95) 9.1 %
6.2 %
Taxus 903 868 865 860 853 849 842 838 833 825 823 822 819Xience 897 872 870 867 865 864 858 854 851 849 844 842 840
Δ 1.1%
Δ 2.9 %
Secondary Endpoint Result Stent Thrombosis
(Definite & probable according to ARC)
2.6 %
0.7 %
Taxus
Xience P = 0.002 (log-rank test)
RR = 0.26 (0.11-0.64)
The NEVO™ stent provides:
CoCr stent platform- Flexible, conformable, thin
struts, maximized vesselcoverage, open cell design
Reservoir Technology (RES-TECHNOLOGY™)
- Reduced contact between vessel wall
and polymer
Biodegradable polymer - Rapid endothelialization
- Inflammation scores on par with BMS- Tailored sirolimus release achieving
CYPHER®-like tissue levels
Sirolimus - Largest body of clinical evidence
NEVO™ Sirolimus-Eluting Stent : Cordis’ 1st RES TECHNOLOGY™ Stent
Bridge elements
Reservoirs
Ductile Hinges
Reservoirs minimize tissue/polymer contact areaby more than 75%
0
20
40
60
80
100
Surface Coated Stent NEVO™ Stent
75%Reduction
NEVO™: Reduced Relative Polymer Exposure
NEVO RES-I Study Overview
40 sites worldwideEurope, South America, Australia and New Zealand
394 subjects, stratified by diabetic status, and randomized 1:1
Single De Novo Native Coronary Artery LesionsReference Vessel Diameter: 2.5 - 3.5 mm
Lesion Length: ≤ 28 mm
Primary Endpoint: 6-month in-stent late lossSub-Study: IVUS subset (50 patients per arm)
Dual antiplatelet therapy for ≥ 6 months
NEVO™ Sirolimus-eluting Stent
(n = 202)
TAXUS® Liberté™ Paclitaxel-eluting Stent
(n = 192)
30 Day 6Months 1Year 2Year 3Year 4ear
Angiographic/ IVUS
5Year
Clinical/ MACE
87% Angiographic follow up; 97% 180 day clinical follow up
P<0.001 for superiority
P<0.001
Primary Endpoint
Late
Los
s (m
m)
±0.31
±0.48
±0.32
±0.42
n=185 n=166 n=166 n=166
Primary Endpoint: Late Lumen Loss at 6 Months
NEVO™
Taxus® Liberte™
TCT 09, Oral presentation, J. Ormiston
P = 0.19
P = 0.37
P = 0.75
No reports of Emergent CABG
% o
f pat
ient
s
8/198 13/189 1/198 3/189 4/198 5/189 5/198 8/189 3/198 6/187
P = 0.354
P = 0.33
6-Month MACE and Components
10
8
6
4
2
0
MACE Death MI Death or MI TLR
4.0
7.4
0.5
1.62.0
2.6 2.5
4.2
1.5
3.2
NEVO™
Taxus® Liberte™
EuroPCR 09, Oral presentation, Chr. Spaulding
Diabetic Subgroup Analysis:In-Stent Late Lumen Loss at 6 Months
Diabeticsn = 65
Non-Diabeticsn = 277
0.5
0.3
0.4
0.1
0.2
0.0
P = 0.03 P < 0.001
0.17
± 0.42
0.42
± 0.46
0.12
± 0.28
0.34
± 0.46
Late
loss
(mm
)
NEVO™
Taxus® Liberté™
EuroPCR 09, Oral presentation, Chr. Spaulding
Intervencionismo Cardiaco 2008-09CONCLUSIONES
- La cirugía presenta mejores resultados que la ICP en pacientes con enfermedad de 3 v y/o TCI a los 2 años de seguimiento a expensas de una mayor necesidad de nueva revascularización con ICP.
- Los pacientes con Syntax score bajo evolucionan de forma parecida entre ICP y cirugía coronaria.
- Los pacientes con enfermedad de tronco pueden beneficiarse de la ICP. Se requieren estudios multicéntricos diseñados a este objetivo.
- Los stent farmacoactivos de 2ª generación son más eficaces y más seguros que los de 1ª generación (Taxus™)