Nitinol Stent Implantation Versus Percutaneous Transluminal Angioplasty in Superficial Femoral Artery Lesions up to 10 cm in Length

Autor: Bernhard Reimers, Thomas Zeller, Thilo Tübler, Marc Bosiers, Karl-Ludwig Schulte, Karlheinz Bürgelin, Hermann J. Steinkamp, Gunnar Tepe, Patrick Peeters, Hans Krankenberg, Dierk Scheinert, Felix Mahler, Erich Minar, Michael Schlüter
Rok vydání: 2007
Předmět:
Zdroj: Circulation. 116:285-292
ISSN: 1524-4539
0009-7322
DOI: 10.1161/circulationaha.107.689141
Popis: 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 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.
Databáze: OpenAIRE