fast f emoral a rtery s tenting t rial final results l.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
FAST ( F emoral A rtery S tenting T rial) Final Results PowerPoint Presentation
Download Presentation
FAST ( F emoral A rtery S tenting T rial) Final Results

Loading in 2 Seconds...

play fullscreen
1 / 17

FAST ( F emoral A rtery S tenting T rial) Final Results - PowerPoint PPT Presentation


  • 163 Views
  • Uploaded on

FAST ( F emoral A rtery S tenting T rial) Final Results. Hans Krankenberg (on behalf of the FAST Investigators) Hamburg University Cardiovascular Center Prof. Schofer, Prof. Mathey & Partners Hamburg, Germany. FAST Participating Centers. Institution Investigators Enrollment

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

FAST ( F emoral A rtery S tenting T rial) Final Results


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
fast f emoral a rtery s tenting t rial final results

FAST(Femoral Artery Stenting Trial)Final Results

Hans Krankenberg

(on behalf of the FAST Investigators)

Hamburg University Cardiovascular Center

Prof. Schofer, Prof. Mathey & Partners

Hamburg, Germany

fast participating centers
FASTParticipating Centers

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

fast purpose
FASTPurpose
  • 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 ultrasound)at 12 months

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

fast hypothesis
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.
fast key inclusion criteria
FASTKey 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)
fast trial profile

R

Crossover(n = 13 [11%])

PTA

(n = 108)

Stent

(n = 136)

FASTTrial Profile

12/03–3/05:

244 Patients

Luminexx® 3 (C.R. Bard)

PTA

(n = 121)

Stent

(n = 123)

Intention-to-TreatAnalysis

On-TreatmentAnalysis

fast lesion characteristics

Prevalence of stenoses vs. total occlusions

% stenosis of non-occluded lesions

87.0

85.3

p = 0.053

FASTLesion Characteristics

Lesion length (visual estimate)

45.2

44.5

p = 0.133

fast 12 month results
FAST12-Month Results
  • Binary Restenosis (1ry End Point)

p = 0.377

p = 0.554

39/101

32/101

34/90

37/112

fast 12 month results itt
FAST12-Month Results – ITT
  • Impact of treatment modality on 12-month restenosis in patient/lesion subgroups

OR (95% CI)

Women

1.52 (0.49-4.73)

Men

0.59 (0.29-1.20)

Normal cholesterol

0.43 (0.16-1.15)

Hyperlipidemia

1.00 (0.47-2.10)

Smoker (ex/current)

0.53 (0.25-1.09)

Hypertension

0.70 (0.37-1.33)

Nondiabetics

0.94 (0.46-1.90)

Diabetics

0.48 (0.17-1.34)

No calcification

0.97 (0.45-2.13)

0.52 (0.22-1.26)

Calcification

Stenosis @ baseline

0.84 (0.42-1.69)

Total occlusion @ baseline

0.51 (0.17-1.52)

Lesion length ≤50mm

0.73 (0.35-1.54)

Lesion length >50mm

0.73 (0.29-1.85)

No distal vessel occluded

0.93 (0.45-1.91)

≥1 distal vessels occluded

0.50 (0.18-1.36)

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

Stent better

PTA better

fast difference in restenosis rates @ 12 months
Absolute reduction in restenosis rate (RR) con-ferred by stenting in selected patient subgroups

+8.5%

-12.3%

-14.1%

-14.2%

-14.9%

-15.6%

-15.7%

FASTDifference in Restenosis Rates@ 12 Months

30%

Point estimate with 95% CI

20%

10%

0%

RR [Stent] – RR [PTA]

-10%

-20%

-30%

-40%

fast 12 month results itt11
FAST12-Month Results – ITT
  • Stent fractures
    • X-ray in 83/101 stent patients in whom restenosis was assessed @ 12 months
    • 10 stent fractures

p = 0.719

fast 12 month results12

–19%

–19%

FAST12-Month Results
  • Target Lesion Revascularizations

p = 0.595

p = 0.479

21/115

17/114

19/102

19/127

fast 12 month results itt13
FAST12 Month Results – ITTFAST12 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

p=0.936

p=0.089

p=0.015

p=0.007

p=0.386

p=0.161

0.90

0.88

0.75

0.68

185

150

110

100

0.21

52

0.15

20

fast 12 month results itt14
FAST12 Month Results – ITTFAST12 Month Results – ITTFAST12 Month Results – ITT
  • Absolute walking distance in patients who were able to undergo treadmill testing at both baseline and 12-month follow-up

p=0.936

p=0.089

p=0.015

185

150

110

100

52

20

*medians and interquartile ranges

fast 12 month results itt15
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

*negative numbers denote improvement

fast 12 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

*negative numbers denote improvement

fast conclusions
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 tendencytowards 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.