Published Online
on June 25, 2007

A more recent version of this article appeared on July 17, 2007

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Submitted on January 9, 2007
Accepted on May 11, 2007

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

Hans Krankenberg MD^*, Michael Schlüter PhD, Hermann J. Steinkamp MD, Karlheinz Bürgelin MD, Dierk Scheinert MD, Karl-Ludwig Schulte MD, Erich Minar MD, Patrick Peeters MD, Marc Bosiers MD, Gunnar Tepe MD, Bernhard Reimers MD, Felix Mahler MD, Thilo Tübler MD, and Thomas Zeller MD

From the Hamburg University Cardiovascular Center, Prof Mathey, Prof Schofer, & Partners, Hamburg, Germany (H.K., M.S., T.T.); DRK-Kliniken Berlin Westend, Institut für Klinische Radiologie, Berlin, Germany (H.J.S.); University of Leipzig Heart Center, Leipzig, Germany (D.S.); Vascular Center Berlin, Evangelisches Krankenhaus Königin Elisabeth Herzberge, Berlin, Germany (K.-L.S.); Department of Angiology, Vienna Medical University, Vienna, Austria (E.M.); Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium (P.P.); Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium (M.B.); Department of Diagnostic Radiology, University of Tübingen, Tübingen, Germany (G.T.); Department of Cardiology, Ospedale di Mirano, Mirano, Italy (B.R.); Inselspital, University of Bern, Bern, Switzerland (F.M.); and Department of Angiology, Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany (K.B., T.Z.).

^* To whom correspondence should be addressed. E-mail: krankenberg{at}herz-hh.de.

Background--Endoluminal treatment of superficial femoral artery lesions is a matter of controversy. The present study was designed to investigate the impact of nitinol stenting of superficial femoral artery lesions with a maximum length of 10 cm on restenosis and clinical outcomes at 1 year.

Methods and Results--Two hundred forty-four patients (168 men; 66±9 years) with a single superficial femoral artery lesion and chronic limb ischemia were randomized to implantation of a single Bard Luminexx 3 stent (123 patients) or stand-alone percutaneous transluminal angioplasty (PTA) (121 patients). Mean lesion length was 45 mm. Technical success (residual stenosis <50% for PTA, <30% for stenting) was achieved in 96 patients assigned to PTA (79%) and 117 patients assigned to stenting (95%); 13 PTA group patients (11%) "crossed over" to stenting. At 1 year, the primary end point of ultrasound-assessed binary restenosis was reached in 39 of 101 PTA group patients (38.6%) and 32 of 101 stent group patients (31.7%; absolute treatment difference, -6.9%; 95% CI, -19.7% to 6.2%; P=0.377). Target lesion revascularization rates at 1 year were 18.3% and 14.9%, respectively (absolute treatment difference, -3.3%; 95% CI, -13.0% to 6.4%; P=0.595). No statistically significant difference between treatment groups was observed at 12 months in the improvement by at least 1 Rutherford category of peripheral arterial disease.

Conclusions--In the present study of patients with short superficial femoral artery lesions, the hypothesized absolute difference of 20% in binary restenosis at 1 year between the implantation of a single Luminexx nitinol stent and stand-alone PTA could not be demonstrated. A smaller difference requiring a larger trial might have been missed.

Key words: angioplasty • peripheral vascular disease • restenosis • stents

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