Femoral Artery Stenting Trial - FAST (Femoral Artery Stenting)

Jul 19, 2007
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Trial Sponsor:
C.R. Bard, Inc.
Date Presented:
01/01/2005
Date Published:
01/01/2007
Date Updated:
07/19/2007
Original Posted Date:
07/19/2007
References

Description:

The goal of the trial was to evaluate treatment with balloon dilatation compared with stenting among patients with superficial femoral artery (SFA) disease and chronic limb ischemia.

Study Design

Patients Enrolled: 244
Mean Follow Up: 12 months
Mean Patient Age: Mean age, 66 years
Female: 31

Patient Populations:

Rutherford classification ≥2; single de novo SFA lesion ≥1 cm from origin; and stenosis of 70%-100%

Exclusions:

Lesion extends into the proximal popliteal artery; previous SFA stenting

Primary Endpoints:

Binary restenosis (≥50% stenosis) assessed by ultrasound at 12 months

Secondary Endpoints:

Periprocedural complications at 30 days, binary restenosis at 6 months, major adverse coronary events at 6 and 12 months, and stent fractures at 12 months

Drug/Procedures Used:

Patients were randomized to treatment with balloon dilatation (percutaneous transluminal angioplasty [PTA]) (n = 121) or stenting (n = 123) with a self-expanding nitinol stent.

Principal Findings:

Among the 121 patients randomized to balloon dilatation, 11% (n = 13) crossed over and were treated with stenting. Mean lesion length was 45 cm. Procedure success, defined as residual stenosis <50% for="" pta="" and="">/30%>

The primary endpoint of binary restenosis on Doppler at 12 months did not differ between groups (31.7% of the stent group and 38.6% of the PTA group, p = 0.377). Target lesion revascularization by 1 year occurred in 14.9% of the stent group and 18.3% of the PTA group (p = 0.595). Change in ankle brachial index at 12 months did not differ between groups (0.21 for stent vs. 0.15 for PTA, p = 0.56). Change from baseline in walk distance at 12 months was smaller in the stent group than in the PTA group (20 m vs. 52 m, p = 0.028). Amputation was required in 1.8% (n = 2) of the stent group and none of the PTA group. Stent fractures had occurred by 1 year in 12% of patients.

Interpretation:

Among patients with SFA disease, treatment with stenting was not associated with a difference in binary restenosis at 12 months compared with balloon dilatation.

Randomized data are limited for the use of stenting in the SFA. Safety concerns with stent use in the SFA include stent fracture, which was high in the SIROCCO trials. The present trial had a 12% rate of stent fracture at 12 months. There was also no difference in the need for target lesion revascularization between the groups by 1 year.

The only other published randomized trial of nitinol stent compared with PTA in patients with SFA, a single-center study, did show a benefit of stenting, but patients in that trial were very different from the present study, with longer lesions and more use of multiple stents.

References:

Krankenberg H, Schlüter M, Steinkamp HJ, et al. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the Femoral Artery Stenting Trial (FAST). Circulation 2007;116:285-292.

Presented by Dr. Hans Krankenberg at TCT 2005, Washington, DC.

Keywords: Ankle Brachial Index, Dilatation, Femoral Artery, Constriction, Pathologic, Angioplasty, Peripheral Vascular Diseases, Stents


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