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Indexed/Abstracted in: BIOSIS Previews, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 1,632
Michel J. BOSIERS 1, Koen DELOOSE 2, Patrick PEETERS 3, Giovanni TORSELLO 1, Thomas ZELLER 4, Dierk SCHEINERT 5, Andrej SCHMIDT 5, Lieven MAENE 6, Koen KEIRSE 7, Ramon VARCOE 8, Marc BOSIERS 2
1 Department of Vascular and Endovascular Surgery, University of Münster, Germany, and Department of Vascular Surgery, St. Franziskus-Hospital GmbH Münster, Germany; 2 Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium; 3 Department of Vascular Surgery, Imelda Hospital, Bonheiden, Belgium; 4 Department of Angiology, Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany; 5 Department of Interventional Angiology, Medical Faculty, University of Leipzig, Germany; 6 Department of Cardiovascular and Thoracic Surgery, OLV Clinic Aalst, Aalst, Belgium; 7 Department of Vascular Surgery, RZ Heilig Hart, Tienen, Belgium; 8 Department of Surgery, Prince of Wales Hospital, Sydney, Australia
BACKGROUND: The superiority of drug eluting stents versus bare metal stents or balloon angioplasty in the treatment of patients with critical limb ischemia and infrapopliteal lesions has been established. However, only shorter lesions were evaluated. This study was designed to evaluate the immediate and long-term (up to 12 months) outcome of the XIENCE PRIME Everolimus-Eluting Coronary Stent System (Abbott Vascular) in a controlled, prospective, multi center investigation for long lesions up to 10 cm.
METHODS: All patients with critical limb ischemia and long infrapopliteal lesions between 30mm and 100mm, who met the inclusion criteria, were included in this study. The primary endpoint was primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion based on quantitative analysis of contrast angiography
RESULTS: Between August 2011 and October 2013, 60 patients were enrolled in this study with a mean lesion length of 47.40 mm (2-100; ±25.06). The primary patency rate at 12 months was 75.4%. Freedom from target lesion revascularization was 84.9%. The amputation rate was rare (94.4% freedom of amputation). At the 12-month follow-up time point, a total of 36 out of 42 (85.7%) patients improved in their Rutherford classification with at least 1 class.
CONCLUSIONS: The use of Everolimus-eluting stents in longer infrapopliteal lesions in the treatment of critical limb ischemia is safe and effective with a comparable primary patency, freedom of TLR and amputation free survival as in short lesions.