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The SOS (Stenting Of Saphenous vein grafts)
Randomized, Controlled Trial of a Paclitaxel-Eluting Stent Vs. a
Similar Bare Metal Stent in Saphenous Vein Graft Lesions
The SOS (Stenting Of Saphenous vein grafts)
Randomized, Controlled Trial of a Paclitaxel-Eluting Stent Vs. a
Similar Bare Metal Stent in Saphenous Vein Graft Lesions
Emmanouil S. Brilakis, MD, PhDDirector, Cardiac Catheterization Laboratory
VA North Texas Healthcare System
On behalf of the SOS investigators
Emmanouil S. Brilakis, MD, PhDDirector, Cardiac Catheterization Laboratory
VA North Texas Healthcare System
On behalf of the SOS investigators
I, Emmanouil Brilakis DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
I, Emmanouil Brilakis DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
Disclosure Statement of Financial InterestDisclosure Statement of Financial InterestDisclosure Statement of Financial InterestDisclosure Statement of Financial Interest
• Veteran Affairs, VISN-17
• Clark R. Gregg fund, Harris Methodist Foundation, Fort Worth, Texas
• Veteran Affairs, VISN-17
• Clark R. Gregg fund, Harris Methodist Foundation, Fort Worth, Texas
FundingFunding
SOS designSOS design
• DESIGN: Prospective, randomized, multi-center trial comparing the Taxus™ paclitaxel-eluting stent (PES) with a similar Express2™ bare metal stent (BMS) in saphenous vein graft (SVG) lesions
• OBJECTIVE: To compare the 12-month angiographic and 24-month clinical outcomes between PES and BMS in SVG lesions
• PRINCIPAL INVESTIGATOR: Emmanouil S. Brilakis, MD, PhD. VA North Texas Healthcare System, Dallas, Texas
SOS: sample size determinationSOS: sample size determination
• 31 patients needed per group to have 80% power (2-sided alpha 0.05) to detect a 66% reduction in binary angiographic restenosis assuming 50% restenosis in BMS group and 1 lesion treated per pt
• Target enrollment: 40 patients per group to account for losses during follow-up
SOS: Patient flowSOS: Patient flow80 patients (112 lesions) enrolled between
2005 and 2007 in 5 clinical sites in USA and Europe
Died: 1 ptDeclined: 5 pts
Angiographic follow-up at 12 months
33 pts47 lesions
Clinical follow-up at 24 months
Clinical follow-up at 24 months
Angiographic follow-up at 12 months
33 pts43 lesions
BMS39 pts
55 lesions
PES41 pts
57 lesions
Died: 4 ptsEmergent CABG: 1 ptDeclined: 3 pts
Died: 1 pt Died: 1 pt
median follow-up: 18 months
Iowa City VAMC•James Rossen, MD
Michael E. DeBakey VAMC•Biswajit Kar, MD
VA North Texas HCSCoordinating Ctr•Emmanouil Brilakis, MD, PhD•Subhash Banerjee, MD •Christopher Lichtenwalter, MD•James de Lemos, MD•Owen Obel, MD•Michele Roesle, RN
Little Rock VAMC•Joe K. Bissett, MD•Rajesh Sachdeva, MD
SOS trial centers
Collaborators:Peter Berger, MDPanayotis Fasseas, MD
Onassis Cardiac Surgery CtrAthens, Greece•Vassilios Voudris, MD•Panagiotis Karyofillis, MD
BMS n = 39
PES n = 41
P Value
Age (yrs) 67± 9 66 ± 9 0.71
Men (%) 100 100 1.0
White (%) 90 98 0.19
Diabetes (%) 44 44 0.98
Current smoker (%) 23 29 0.53
Hypertension (%) 95 93 0.69
Hyperlipidemia (%) 95 98 0.53
Baseline characteristics IBaseline characteristics I
BMS n = 39
PES n = 41
P Value
Years since CABG 12 ± 6 11 ± 6 0.84
Presentation 0.53
- Stable angina (%) 33 29
- ACS (%) 57 63
BMI (kg/m2) 29 ± 4 30 ± 5 0.32
Prior MI (%) 59 56 0.79
Normal ejection fraction (%)
61 51 0.53
Baseline characteristics IIBaseline characteristics II
BMS n = 39
PES n = 41
P Value
SVG recipient vessel 0.37
- LAD/diagonal (%) 30 27
- Circumflex/OM (%) 30 44
- RCA/PDA (%) 40 29
Lesion location 0.80
- Aortic anastomosis (%) 27 26
- Body (%) 66 67
- Distal anastomosis (%) 7 7
Procedural description IProcedural description I
BMS n = 39
PES n = 41
P Value
Number of SVGs treated 1.15 ± 0.37 1.12 ± 0.33 0.68
Number of lesions treated 1.41 ± 0.64 1.39 ± 0.70 0.89
Number of stents/lesion 1.13 ± 0.34 1.09 ± 0.29 0.50
Predilatation (%) 29 33 0.63
Embolic protection (%) 56 51 0.56
Max balloon diameter, mm 3.20 ± 0.48 3.30 ± 0.52 0.40
Max inflation pressure, atm 17 ± 3 17 ± 3 0.37
Stent length, mm 18 ± 6 18 ± 6 0.90
Procedural description IIProcedural description II
BMS n = 39
PES n = 41
P Value
Heparin (%) 79 83 0.69
GP IIb/IIIa inhibitors (%) 13 10 0.66
Contrast, mL 257 ± 105 262 ± 98 0.84
Fluoroscopy, min 20 ± 9 21 ± 11 0.64
Post PCI MI (%) 7 6 0.87
Procedural success (%) 97 95 0.59
Procedural description IIIProcedural description III
Late LossLate Loss
mm
± 1.03
BMS (47 lesions), PES (43 lesions)
Diff (95% CI)-0.87 (-0.51, -1.22)P<0.0001
Diff (95% CI)-0.81 (-0.48, -1.46)P<0.0001
± 0.57
± 0.98
± 0.54
Binary angiographic restenosisBinary angiographic restenosis
%
Primary study endpoint
relative risk: 0.1895% CI: 0.07, 0.48
p < 0.0001
0
25
50
75
100
0 1 2 3 4Minimum lumen diameter (mm)
%
BMSPES
Before intervention
Cumulative frequency distribution curves
0
25
50
75
100
0 1 2 3 4Minimum lumen diameter (mm)
%
BMSPES
Before intervention
After interventionAfter intervention(in-stent minimum lumen diameter)
Cumulative frequency distribution curves
0
25
50
75
100
0 1 2 3 4
BMSPES
%
After intervention
Follow-upBMS
In-stent minimum lumen diameter (mm)
Follow-upPES
Cumulative frequency distribution curves
BMS n = 39
PES n = 41
P Value
Death (%) 5 12 0.27
Myocardial infarction (%) 31 15 0.10
TLR (%) 28 5 0.003
TVR (%) 31 15 0.08
Any revascularization (%) 41 20 0.02
Target vessel failure (%) 46 22 0.03
Overall MACE (%) 49 37 0.20
ARC definite/probable stent thrombosis (%)
13 2 0.07
Clinical outcomes
median follow-up: 1.5 years
0
10
20
30
40
50
60
0 1 2
Hazard ratio, 1.56 P=0.27
No. at riskBMS
PES
39
41
37
40
31
34
22
19
12
12
0.5 1.5
Years from stenting
Death from any cause%
of
Pat
ien
ts
COPDMI
Lung CASBO
Stroke
MI unknown
BMS
PES
No. at risk
BMS
PES
39
41
30
39
23
30
15
15
10
8
Myocardial infarction
0
10
20
30
40
50
60
% o
f P
atie
nts
Years from stenting
PES
BMS
Hazard ratio, 0.67 P=0.10
0 1 20.5 1.5
0
10
20
30
40
50
60
Hazard ratio, 0.38 P=0.003
0 1 2
No. at riskBMS
PES
39
41
33
40
23
32
13
17
8
10
0.5 1.5
Years from stenting
Target lesion revascularization%
of
Pat
ien
ts
PES
BMS
No. at riskNo. at risk
BMSBMS
PESPES3939
41412828
38381919
27271111
131366
77
Target vessel failureCardiac death, MI, TVR
Years from stenting
00
1010
2020
3030
4040
5050
6060
% o
f P
atie
nts
00 11 220.50.5 1.51.5
Hazard ratio, 0.65 P=0.03
BMS
PES
5850
98
82
6889
7464
0
20
40
60
80
100
6 months 12 months 18 months 24 months
PES BMS
Clopidogrel useClopidogrel use
P=NS
% o
f P
atie
nts
In saphenous vein graft lesions, compared to a similar bare metal stent, the Taxus™ PES resulted in:
• Significant reduction in 12-month binary angiographic restenosis, target lesion revascularization and target vessel failure
• Trends for lower target vessel revascularization, myocardial infarction
• No difference in mortality and stent thrombosis
In saphenous vein graft lesions, compared to a similar bare metal stent, the Taxus™ PES resulted in:
• Significant reduction in 12-month binary angiographic restenosis, target lesion revascularization and target vessel failure
• Trends for lower target vessel revascularization, myocardial infarction
• No difference in mortality and stent thrombosis
ConclusionsConclusions