title: One-Year Outcomes of the Paclitaxel-Eluting, Self-Expanding Stentys Stent System in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia.
abstract: To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long.
  
  
  
  The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0-58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI).
  
  
  
  Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months.
  
  
  
  In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.
authors.affiliation: 1 Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium.
authors.forename: Marc
authors.initials: M
authors.lastname: Bosiers
authors.affiliation: 1 Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium.
authors.forename: Joren
authors.initials: J
authors.lastname: Callaert
authors.affiliation: 2 Department of Vascular Surgery, Heilig Hart Hospital, Tienen, Belgium.
authors.forename: Koen
authors.initials: K
authors.lastname: Keirse
authors.affiliation: 3 Department of Cardiovascular and Thoracic Surgery, University Hospital of Antwerp, Edegem, Belgium.
authors.forename: Jeroen M H
authors.initials: JMH
authors.lastname: Hendriks
authors.affiliation: 4 Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: Peeters
authors.affiliation: 4 Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Verbist
authors.affiliation: 5 Department of Cardiovascular and Thoracic Surgery, OLV Hospital, Aalst, Belgium.
authors.forename: Lieven
authors.initials: L
authors.lastname: Maene
authors.affiliation: 5 Department of Cardiovascular and Thoracic Surgery, OLV Hospital, Aalst, Belgium.
authors.forename: Roel
authors.initials: R
authors.lastname: Beelen
authors.affiliation: 1 Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium.
authors.forename: Koen
authors.initials: K
authors.lastname: Deloose
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000792:Angiography; D001530:Belgium; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003251:Constriction, Pathologic; D016638:Critical Illness; D054855:Drug-Eluting Stents; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D000069322:Self Expandable Metallic Stents; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D000497:Alloys; D002317:Cardiovascular Agents; C013616:nitinol; D017239:Paclitaxel
keywords: below-the-knee arteries; critical limb ischemia; drug-eluting stent; infrapopliteal arteries; lower limb; paclitaxel; peroneal artery; self-expanding stent; tibial artery