gb danzi sv-1 · 2005. 3. 31. · gb danzi poliambulanza hospital brescia - italy small vessel...

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