Nitinol Stent Implantation Versus Percutaneous Transluminal Angioplasty in Superficial Femoral Artery Lesions up to 10 cm in Length: The Femoral Artery Stenting Trial (FAST)

Abstract

Conclusion: At 1 year, there is no difference in angiographic and clinical outcomes in patients with short superficial femoral artery (SFA) lesions treated with percutaneous balloon angioplasty (PTA) alone vs those treated with primary nitinol stenting. Summary: This is a randomized trial of SFA lesions with the maximum length of 10 cm treated with primary angioplasty or primary implantation of a Luminexx 3 stent (Bard Peripheral Vascular Inc, Tempe, Az). Primary outcomes were restenosis and clinical outcome at 1 year. There were 244 patients (168 men; 69 ± 9 years) with a single SFA lesion and chronic limb ischemia randomized to angioplasty alone or primary stenting. The mean length of lesions treated was 45 mm. Technical success was defined as a residual stenosis of <50% for PTA and <30% for stenting. Technical success was achieved in 79% of the 121 patients randomized to PTA alone and in 117 of the 123 patients (95%) randomized to stenting. There were 13 PTA group patients (11%) who crossed over to stenting. At 1 year, ultrasound-assessed stenosis was present in 39 of 101 PTA patients (38.6%) and 32 of 101 stent patients (32.7%), for an absolute treatment difference of –6.9% (95% confidence interval [CI], –19.7% to 6.2%; P = .377). Target lesion revascularization rates at 1 year for PTA alone were 18.3% and 14.9% for primary stenting for an absolute treatment difference of –3.3% (95% CI, –13.0% to 6.4%; P = .595). An assessment of clinical difference, as defined by improvement of at least one category in the Rutherford scale, found no significant difference between the two treatment groups at 12 months. Comment: The trial was designed to demonstrate a 20% absolute reduction in ultrasound-assessed restenosis in the stented vs angioplasty-only patients. A trial by Schillinger (N Eng J Med 2006;354:1879-88) using a different manufacturer’s stent, allowing multiple stent implantations, and treating lesions that averaged twice as long as those treated in this study, did show benefit in reduction of restenosis in the stented vs nonstented patients. A reasonable conclusion from these two studies is that angioplasty alone is less effective for longer SFA lesions and stenting adds little to treatment of shorter SFA lesions.