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

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

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

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  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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)

  6. 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

  7. 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

  8. FAST12-Month Results • Binary Restenosis (1ry End Point) p = 0.377 p = 0.554 39/101 32/101 34/90 37/112

  9. 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

  10. 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%

  11. 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

  12. –19% –19% FAST12-Month Results • Target Lesion Revascularizations p = 0.595 p = 0.479 21/115 17/114 19/102 19/127

  13. 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 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

  14. FAST12 Month Results – ITT 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 p=0.936 p=0.089 p=0.015 185 150 110 100 52 20 *medians and interquartile ranges

  15. 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

  16. 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

  17. 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.

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