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 SystemOn 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.

Disclosure Statement of Financial InterestDisclosure Statement of Financial Interest

• Veteran Affairs, VISN-17• Clark R. Gregg fund, Harris Methodist

Foundation, Fort Worth, Texas

Funding

SOS 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 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 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 0.71Men (%) 100 100 1.0White (%) 90 98 0.19Diabetes (%) 44 44 0.98Current smoker (%) 23 29 0.53Hypertension (%) 95 93 0.69Hyperlipidemia (%) 95 98 0.53

Baseline characteristics I

BMS n = 39

PES n = 41

P Value

Years since CABG 12 ± 6 11 ± 6 0.84Presentation 0.53 - Stable angina (%) 33 29 - ACS (%) 57 63BMI (kg/m2) 29 ± 4 30 ± 5 0.32Prior MI (%) 59 56 0.79Normal ejection fraction (%) 61 51 0.53

Baseline 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 29Lesion location 0.80 - Aortic anastomosis (%) 27 26 - Body (%) 66 67 - Distal anastomosis (%) 7 7

Procedural description I

BMS n = 39

PES n = 41

P Value

Number of SVGs treated 1.15 ± 0.37 1.12 ± 0.33 0.68Number of lesions treated 1.41 ± 0.64 1.39 ± 0.70 0.89Number of stents/lesion 1.13 ± 0.34 1.09 ± 0.29 0.50Predilatation (%) 29 33 0.63Embolic protection (%) 56 51 0.56Max balloon diameter, mm 3.20 ± 0.48 3.30 ± 0.52 0.40Max inflation pressure, atm 17 ± 3 17 ± 3 0.37Stent length, mm 18 ± 6 18 ± 6 0.90

Procedural description II

BMS n = 39

PES n = 41

P Value

Heparin (%) 79 83 0.69GP IIb/IIIa inhibitors (%) 13 10 0.66Contrast, mL 257 ± 105 262 ± 98 0.84Fluoroscopy, min 20 ± 9 21 ± 11 0.64

Post PCI MI (%) 7 6 0.87Procedural success (%) 97 95 0.59

Procedural description III

Late 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 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 0.27Myocardial infarction (%) 31 15 0.10TLR (%) 28 5 0.003TVR (%) 31 15 0.08Any revascularization (%) 41 20 0.02Target vessel failure (%) 46 22 0.03Overall MACE (%) 49 37 0.20ARC definite/probable stent thrombosis (%) 13 2 0.07

Clinical outcomesmedian follow-up: 1.5 years

0

10

20

30

40

50

60

0 1 2

Hazard ratio, 1.56 P=0.27

No. at riskBMSPES

3941

3740

3134

2219

1212

0.5 1.5

Years from stenting

Death from any cause%

of P

atie

nts

COPDMI

Lung CASBO

StrokeMI unknown

BMS

PES

No. at riskBMSPES

3941

3039

2330

1515

108

Myocardial infarction

0

10

20

30

40

50

60

% o

f Pat

ient

s

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 riskBMSPES

3941

3340

2332

1317

810

0.5 1.5Years from stenting

Target lesion revascularization%

of P

atie

nts

PES

BMS

No. at riskNo. at riskBMSBMSPESPES

39394141

28283838

19192727

11111313

6677

Target vessel failureCardiac death, MI, TVR

Years from stenting

00

1010

2020

3030

4040

5050

6060

% o

f Pat

ient

s

00 11 220.50.5 1.51.5

Hazard ratio, 0.65 P=0.03

BMS

PES

5850

9882

6889

7464

0

20

40

60

80

100

6 months 12 months 18 months 24 monthsPES BMS

Clopidogrel use

P=NS

% o

f Pat

ient

s

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

Conclusions