gb danzi sv-1 · 2005. 3. 31. · gb danzi poliambulanza hospital brescia - italy small vessel...
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GB DanziPoliambulanza Hospital
Brescia - Italy
Small Vessel Stenting
Controversy Between DES and BMS
Small Vessel Stenting
♥ It is estimated that about 30% of all PCIs are performed in vessels with a reference diameter <2.5 mm
♥ However, the best interventional approach for patients with lesions located in small vessels has yet to be determined
POBA Vs Stenting
ISAR-SMART 171 163 SEOUL Study 55 56SISA 145 144BESMART 197 198COAST (HC) 197 195SISCA 72 69Total 837 825Restenosis 233 (27.8%) 289 (35.0%)**P<=0.002
Stent Balloon
Small Vessels
♥ Different definitions of small vessel♥ Small number of patients♥ Prior to modern antiplatelet therapy♥ High rate of cross-over♥ Stent pre-mounted and hand-crimped♥ Bare metal stents or coated stents♥ Not dedicated stent available
POBA Vs Stenting: Confounding factors
Small Vessel Stenting
2,43
2,23
2,32
2,26
2,55
2,34
2,5
2,1
2,2
2,3
2,4
2,5
2,6
Reference Vessel Diameter
ISAR-SMARTSISA
COAST
SISCA
PIXEL D
BESMART
(mm
)
SEOUL
Small Vessel Stenting
35,7
21
30
15,7
35,7
9,7
28,8
0
10
20
30
40
50
Incidence of Restenosis
ISAR-SMARTSISA
COASTSISCA
PIXEL D
SEOUL
BESMART
%
Small Vessel Stenting
Small vessels require customised small vessel stents
To improve clinical outcome:♥ Thinner struts♥ Less metal ♥ Lower M:A ratio ♥ Improved conformability
To improve performance:♥ Improved deliverability and flexibility
European Pixel Study
On-line QCA1:1 Randomization
Angiographic FU(6 Months)
Direct stenting176 patients
Pre-dilatation174 patients
350 patients
Garcia E, EURO-PCR 2003
European Pixel Study
Patients (n°) 174 176Diabetes mellitus 23% 28%Vessel size (mm) 2.25±0.32 2.26±0.34Lesion length (mm) 10.8±4.7 10.8±4.7Restenosis 25.0% 15.7%MACE at 6 Mo 9.1% 6.2% TLR at 6 Mo 4.3% 3.4%
Pre-dilation Direct stenting
Garcia E, EURO-PCR 2003
♥ 7 Centers in Europe and ASIA
♥ End Point: MACE at 30 and 180 days
TSUNAMI SV Registry
Patients (n°) 103Lesions (n°) 122Diabetes mellitus 42%Vessel size (mm) 2.01±0.32Lesion length (mm) 10.1±5.1MACE in-Hospital 0MACE at 1 Mo 0MACE at 6 Mo 5.8% TLR at 6 Mo 4.8%
TSUNAMI SV Registry
2.4%7.5%
15.5%
34.6%
25.0%
39.6%
Small Medium Large
%
Sirolimus Control
2.4%7.5%
15.5%
34.6%
25.0%
39.6%
Small Medium Large
%
Sirolimus Control
SIRIUS - Vessel Size Sub-AnalysisSIRIUSSIRIUS - Vessel Size Sub-AnalysisIn-Segment RestenosisIn-Segment Restenosis
P=0.002P=0.002
P<0.001P<0.001P=0.027P=0.027
2.3mm2.3mm 2.8mm2.8mm 3.25mm3.25mm
7.1%6.1%
17.6%
24.6%
19.7%
14.9%
Small Medium Large
%
Sirolimus Control
7.1%6.1%
17.6%
24.6%
19.7%
14.9%
Small Medium Large
%
Sirolimus Control
SIRIUS - Vessel Size Sub-AnalysisSIRIUSSIRIUS - Vessel Size Sub-AnalysisTVF (to 270 days)TVF (to 270 days)
P=0.047P=0.047
P=0.156P=0.156
P=0.396P=0.396
2.3mm2.3mm 2.8mm2.8mm 3.25mm3.25mm
1.8%3.0%
8.8%
23.1%
14.5%13.4%
Small Medium Large
%
Sirolimus Control
1.8%3.0%
8.8%
23.1%
14.5%13.4%
Small Medium Large
%
Sirolimus Control
SIRIUS - Vessel Size Sub-AnalysisSIRIUSSIRIUS - Vessel Size Sub-AnalysisTLR (to 270 days)TLR (to 270 days)
P=0.013P=0.013P=0.055P=0.055
P=0.032P=0.032
2.3mm2.3mm 2.8mm2.8mm 3.25mm3.25mm
38.5
27.8
15.210.2
6.7 6.8
0
10
20
30
40
50
<2.5 mm >2.5 - 3.0 mm >3.0 mm
Res
teno
sis
(%)
TAXUS IV - Restenosis
P<0.0001
P=0.10
P=0.0001
RVD (mm)
N=78 N=98 N=97 N=105 N=92 N=88
Control TAXUS™ Stent
Lemos PA, Am J Cardiol. 2004;93:633
Patients (n°) 91Lesions (n°) 112Diabetes mellitus 26%RVD (mm) 1.88±0.34Lesion length (mm) 12.3±9.3Angio at FU 68%Late loss (mm) 0.07±0.48Restenosis 10.7%MACE at 12 Mo 7.7%TLR at 12 Mo 5.5%
RESEARCH Registry
SES SMART Study
Patients (n°) 129 128Diabetes mellitus 19% 30%Vessel size (mm) 2.22 2.17Lesion length (mm) 13.1 10.7Restenosis 9.8% 53.1%*MACE at 8 Mo 9.3% 31.3%* TLR at 8 Mo 7.0% 21.1%*
Cypher-Bx Bx-Sonic
Ardissino D, ACC 2004
*P<0.001
Small Vessel Stenting
23
11,7
67,7
18,3
10,8
5,89,3
0
5
10
15
20
25
30
35
Incidence of MACE at Follow-Up
ISAR-SMARTSISA
COASTSISCA
PIXEL D
TSUNAMI S
V
RESEARCH
SES SMART
%
Small Vessel Stenting
20,1
11,2
3,35,5
17,8
9,6
4,87
0
5
10
15
20
25
30TVR at Follow-Up
ISAR-SMARTSISA
COASTSISCA
PIXEL D
TSUNAMI SV
RESEARCH
SES SMART
%
Small Vessel Stenting
12,5
9,17,7
10,312,3
10,811,8
10,1
13
0
5
10
15
20
25
Mean Lesion Length (mm)
ISAR-SMARTSISA
COAST
SISCA
PIXEL D
BESMART
(mm
)
TSUNAMI
RESEARCH
SES SMART
Small Vessel Stenting
♥ Bare metal stents specifically designed for the treatment of focal lesions involvingsmall coronary arteries represent an attractive therapeutic option
♥ The value of this approach should be tested in a head-to-head comparison with DES
♥ Diffuse disease in small vessel could represent a future challenging scenario for DES