title: Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study.
abstract: OBJECTIVE
  To report a prospective, single-arm, multicenter clinical study evaluating the Zilver PTX drug-eluting stent for treating the above-the-knee femoropopliteal segment (NCT01094678; http://www.clinicaltrials.gov ).
  
  
  METHODS
  The Zilver PTX drug-eluting stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. Patients with symptomatic (Rutherford category 2-6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment were eligible for enrollment. Between April 2006 and June 2008, 787 patients (578 men; mean age 66.6±9.5 years) were enrolled at 30 international sites.
  
  
  RESULTS
  Nine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1722 Zilver PTX stents; the mean lesion length was 99.5±82.1 mm. The 12-month Kaplan-Meier estimates included an 89.0% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularization. There were no paclitaxel-related adverse events reported. The 12-month stent fracture rate was 1.5%. The ankle-brachial index, Rutherford score, and walking distance/speed scores significantly improved (p<0.001) from baseline to 12 months.
  
  
  CONCLUSIONS
  These results indicate that the Zilver PTX drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment. At 1 year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy.
authors: Stanford University School of Medicine, Stanford, California 94305-5407, USA. mddake@stanford.edu
authors: Michael D
authors: MD
authors: Dake
authors: Dierk
authors: D
authors: Scheinert
authors: Gunnar
authors: G
authors: Tepe
authors: Jörg
authors: J
authors: Tessarek
authors: Fabrizio
authors: F
authors: Fanelli
authors: Marc
authors: M
authors: Bosiers
authors: Christof
authors: C
authors: Ruhlmann
authors: Zaza
authors: Z
authors: Kavteladze
authors: Aaron E
authors: AE
authors: Lottes
authors: Anthony O
authors: AO
authors: Ragheb
authors: Thomas
authors: T
authors: Zeller
mesh_terms: D000368:Aged; D000497:Alloys; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D002170:Canada; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003251:Constriction, Pathologic; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011150:Popliteal Artery / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D020127:Recovery of Function; D012008:Recurrence; D056910:Republic of Korea; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D000497:Alloys; D002317:Cardiovascular Agents; C013616:nitinol; D017239:Paclitaxel