FAST(Femoral Artery Stenting Trial)

Final Results

FAST(Femoral Artery Stenting Trial)

Final Results

Hans KrankenbergHans Krankenberg(on behalf of the FAST Investigators)(on behalf of the FAST Investigators)Hamburg University Cardiovascular CenterHamburg University Cardiovascular Center

Prof. Schofer, Prof. Mathey & PartnersProf. Schofer, Prof. Mathey & PartnersHamburg, GermanyHamburg, Germany

Institution Investigators Enrollment

Berlin, Germany H. Steinkamp 60

Bad Krozingen, Germany T. Zeller 57

Hamburg, Germany H. Krankenberg 39

Leipzig, Germany D. Scheinert 28

Berlin, Germany K.L. Schulte 18

Tübingen, Germany G. Tepe 4

Vienna, Austria E. Minar 14

Bonheiden, Belgium P. Peeters 13

Dendermonde, Belgium M. Bosiers 5

Mirano, Italy B. Reimers 4

Bern, Switzerland F. Mahler 3

FASTParticipating Centers

FASTParticipating Centers

FASTPurposeFAST

Purpose

To assess the efficacy of nitinol stent implantation (Bard® Luminexx® 3 Vascular Stent [C.R. Bard, Inc.]) vs. stand-alone balloon angioplasty (PTA) in patients with superficial femoral artery (SFA) disease

Primary Endpoint::Binary restenosis (>50% stenosis on duplex Binary restenosis (>50% stenosis on duplex ultrasound)ultrasound) at 12 monthsat 12 months

To assess the efficacy of nitinol stent implantation (Bard® Luminexx® 3 Vascular Stent [C.R. Bard, Inc.]) vs. stand-alone balloon angioplasty (PTA) in patients with superficial femoral artery (SFA) disease

Primary Endpoint::Binary restenosis (>50% stenosis on duplex Binary restenosis (>50% stenosis on duplex ultrasound)ultrasound) at 12 monthsat 12 months

The The Bard® Luminexx® 3 Vascular Stent is not available in the U.S.

FASTHypothesis

FASTHypothesis

Assumptions: 12-month restenosis rate in the PTA arm:

45% 12-month restenosis rate in the nitinol

stent arm: 25% (relative reduction by 44%)

To establish this difference (45% vs. 25%) with statistical significance (2-sided error of 0.05, 80% power) and assuming a 15% drop-out rate, a total of 244 patients (122 per arm) would be required.

Assumptions: 12-month restenosis rate in the PTA arm:

45% 12-month restenosis rate in the nitinol

stent arm: 25% (relative reduction by 44%)

To establish this difference (45% vs. 25%) with statistical significance (2-sided error of 0.05, 80% power) and assuming a 15% drop-out rate, a total of 244 patients (122 per arm) would be required.

FAST Key Inclusion Criteria

FAST Key Inclusion Criteria

Clinical: Rutherford classification ≥ 2

Angiographic: Single de novo SFA lesion ≥ 1 cm from origin Target lesion length 1–10 cm

(visual estimate) Target lesion stenosis 70–100%

(visual estimate) Popliteal artery patent At least one infrapopliteal artery patent

(for distal run-off)

FASTTrial Profile

FASTTrial Profile

244 244 PatientsPatients

PTAPTA(n = 121)(n = 121)

RR

Intention-to-Treat

Analysis

PTAPTA(n = 108)(n = 108)

StentStent(n = 136)(n = 136)

CrossoverCrossover(n = (n = 1313 [ [11%11%])])

On-TreatmentAnalysis

Luminexx® 3 (C.R. Bard)

StentStent(n = 123)(n = 123)

12/03–3/05:12/03–3/05:

0

20

40

60

80

PTA(n=121)

Stent(n=123)

[mm

]FAST

Lesion CharacteristicsFAST

Lesion CharacteristicsLesion length

(visual estimate)Lesion length

(visual estimate)

44.544.5 45.245.2

PTA

75%

25%

Stenosis Total Occlusion

Stent

63%37%

Stenosis Total Occlusion

p = 0.053p = 0.053

Prevalence of stenoses vs.

total occlusions

Prevalence of stenoses vs.

total occlusions

65

70

75

80

85

90

95

100

PTA(n=91)

Stent(n=78)

[%]

8585.3.38787.0.0

% stenosis of non-occluded

lesions

% stenosis of non-occluded

lesions

p = 0.133

FAST 12-Month Results

FAST 12-Month Results

Binary Restenosis (1ry End Point) Binary Restenosis (1ry End Point)

38.6 37.8

31.7 33.0

0

10

20

30

40

I ntention to Treat On Treatment

(% )

PTA Stent

p = 0.554p = 0.377

39/10139/101 32/10132/101 34/9034/90 37/11237/112

0.70 (0.37-1.33)

0.94 (0.46-1.90)

0.53 (0.25-1.09)

FAST 12-Month Results – ITT

FAST 12-Month Results – ITT

Impact of treatment modality on 12-month restenosis in patient/lesion subgroups

Impact of treatment modality on 12-month restenosis in patient/lesion subgroups

0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0

Women

Men

Normal cholesterol

Hyperlipidemia

Smoker (ex/current)

Hypertension

Nondiabetics

Diabetics

Stenosis @ baseline

Total occlusion @ baseline

Lesion length ≤50mm

Lesion length >50mm

No distal vessel occluded

≥1 distal vessels occluded

Stent better PTA better

1.52 (0.49-4.73)

0.59 (0.29-1.20)

0.43 (0.16-1.15)

1.00 (0.47-2.10)

0.97 (0.45-2.13)

0.52 (0.22-1.26)

0.48 (0.17-1.34)

0.84 (0.42-1.69)

0.51 (0.17-1.52)

0.73 (0.35-1.54)

0.73 (0.29-1.85)

0.93 (0.45-1.91)

0.50 (0.18-1.36)

OR (95% CI)

No calcification

Calcification

FASTDifference in Restenosis Rates

@ 12 Months

FASTDifference in Restenosis Rates

@ 12 Months Absolute reduction in restenosis rate (RR) con-

ferred by stenting in selected patient subgroups Absolute reduction in restenosis rate (RR) con-

ferred by stenting in selected patient subgroups

-40%

-30%

-20%

-10%

0%

10%

20%

30%

RR

[S

ten

t] –

RR

[P

TA

]

Men Women Diabetics Smokers Total Occlusions

Mod./sev.Calcification

≥1 dist. ves. occluded

RR [PTA] 43.4% (76) 24.0% (25) 38.7% (31) 40.3% (72) 45.5% (22) 44.4% (45) 36.1% (36)

RR [Stent] 31.2% (61) 32.5% (40) 23.1% (39) 26.2% (65) 29.7% (37) 29.6% (44) 22.0% (41)

Point estimate with 95% CIPoint estimate with 95% CI

-15.6%-12.3%

+8.5%

-14.1% -15.7% -14.9% -14.2%

FAST 12-Month Results – ITT

FAST 12-Month Results – ITT

Stent fractures X-ray in 83/101 stent patients in whom

restenosis was assessed @ 12 months 10 stent fractures

Stent fractures X-ray in 83/101 stent patients in whom

restenosis was assessed @ 12 months 10 stent fractures

Binary Restenosis (% )

28.8

20.0

0

10

20

30

Stent OK(n=73)

Fracture(n=10)

Stent Integrity

12%

88%

OK (n=73)

Fracture (n=10)

p = 0.719

FAST 12-Month Results

FAST 12-Month Results

Target Lesion Revascularizations Target Lesion Revascularizations

18.3 18.6

14.9 15.0

0

5

10

15

20

I ntention to Treat On Treatment

(% )

PTA Stent

p = 0.479p = 0.595

21/11521/115 17/11417/114 19/10219/102 19/12719/127

–19%–19%

FAST12 Month Results – ITT

FAST12 Month Results – ITT

Absolute walking distance and ankle-brachial index at rest in patients who were able to undergo treadmill testing at both baseline and 12-month follow-up

Absolute walking distance and ankle-brachial index at rest in patients who were able to undergo treadmill testing at both baseline and 12-month follow-up

0

50

100

150

200

250

300

350

Baseline 12 Mos. Δ (Baseline-12 Mos.)

Ab

so

lute

Wa

lkin

g D

ista

nc

e (

m)

PTA (n=75) Stent (n=61)

p=0.936 p=0.089 p=0.015

110 100

185

150

52

20

0,0

0,2

0,4

0,6

0,8

1,0

1,2

Baseline 12 Mos. Δ (Baseline-12 Mos.)

An

kle

-Bra

ch

ial I

nd

ex

PTA (n=75) Stent (n=61)

p=0.007 p=0.386 p=0.161

0.680.75

0.880.90

0.210.15

FAST12 Month Results – ITT

FAST12 Month Results – ITT

Absolute Walking Distance*

0

50

100

150

200

250

300

350

Baseline 12 Months Δ (Baseline-12Months)

(m)

PTA (n=75) Stent (n=61)

FAST12 Month Results – ITT

FAST12 Month Results – ITT

Absolute walking distance in patients who were able to undergo treadmill testing at both baseline and 12-month follow-up

Absolute walking distance in patients who were able to undergo treadmill testing at both baseline and 12-month follow-up

FAST12 Month Results – ITT

FAST12 Month Results – ITT

p=0.936 p=0.089 p=0.015

110 100

185

150

5220

FAST12 Month Results – ITT

FAST12 Month Results – ITT

**medians and interquartile rangesmedians and interquartile ranges

FAST12 Month Results – ITT

FAST12 Month Results – ITT

Change in Rutherford Category from baseline to 12 months in patients who were able to undergo treadmill testing at both baseline and 12-month follow-up

Change in Rutherford Category from baseline to 12 months in patients who were able to undergo treadmill testing at both baseline and 12-month follow-up

24

1719

32

25

13

18

23

0

10

20

30

+1 0 -1 -2 -3

Change in Rutherford Category*

No.

of

Pati

en

ts

PTA (n=75) Stent (n=61)

**negative numbers denote improvementnegative numbers denote improvement

FAST12 Month Results – OT

FAST12 Month Results – OT

Change in Rutherford Category from baseline to 12 months in patients who were able to undergo treadmill testing at both baseline and 12-month follow-up

Change in Rutherford Category from baseline to 12 months in patients who were able to undergo treadmill testing at both baseline and 12-month follow-up

24

1518

28

25

1519

27

0

10

20

30

+1 0 -1 -2 -3

Change in Rutherford Category*

No.

of

Pati

en

ts

PTA (n=75) Stent (n=61)

**negative numbers denote improvementnegative numbers denote improvement

FASTConclusions

FASTConclusions

The Femoral Artery Stenting Trial failed to demonstrate the hypothesized difference in 12-month restenosis between Luminexx® nitinol stenting and stand-alone PTA in the treatment of patients with short superficial femoral artery lesions.

However, stent implantation was associated with a tendency towards markedly lower restenosis rates in a wide variety of patient subgroups.

Prospective randomized trials in specific patient cohorts, such as diabetics, patients with total occlusions, or patients with impaired distal run-off, are warranted.

The Femoral Artery Stenting Trial failed to demonstrate the hypothesized difference in 12-month restenosis between Luminexx® nitinol stenting and stand-alone PTA in the treatment of patients with short superficial femoral artery lesions.

However, stent implantation was associated with a tendency towards markedly lower restenosis rates in a wide variety of patient subgroups.

Prospective randomized trials in specific patient cohorts, such as diabetics, patients with total occlusions, or patients with impaired distal run-off, are warranted.