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