title: Comparison of SFA lesion treatment with Zilver PTX in diabetics vs. non-diabetics: 2-year clinical and functional results.
abstract: BACKGROUND
  Prospective single-arm study, aimed at evaluating safety and effectiveness at 12 and 24 months of the paclitaxel-eluting nitinol stent (Zilver PTX), and focused in particular on the treatment of complex lesions and/or diabetic patients.
  
  
  METHODS
  Between May 2010 and March 2012, 67 patients (78% males) were treated by Zilver PTX, because of stenosis or occlusions of the superficial femoral artery in one of two centers. The mean age of patients was 70.1±8 years. Thirty-two of 67 (48%) were diabetics, 14 (21%) active smokers and 11 (14.6%) had chronic renal failure (end stage renal disease). The average length of lesions was 104±60 mm. Occlusion was complete in 46.3% of cases, whereas severely calcified lesions were present in 30% of patients (18.8% in diabetics and 31.4% in non-diabetics). Twenty-six patients (39%) had type C or D lesions according to TASC 2.
  
  
  RESULTS
  One hundred-two stents were used (1.7±0.9 per patients); median 1 (range 1-4). All patients had successful stent placement. Primary patency, evaluated by Kaplan-Meier method was 88±0.06% at 12 months, and 68±0.1% at 24 months. In particular, the difference between diabetics (D) and non-diabetics (non-D) was not significant (P=0.07, Log-Rank). Patients turned from 4.2±1.3 to 1.6±1.3 Rutherford class. There were 5 deaths due to systemic comorbidities. There also were 3 major amputations, all of them also in the D group. Among the other patients, differences between D and non-D patients were not significant in terms of wound healing, bipedal stay and spontaneous ambulation. The mean follow-up length was 28±5 months (range 24-36 months). There was only one patient who had fracture and stent migration (1.5%). In 13 diabetic patients, tibial PTA was also associated. Additional treatment was required in 6 D and 1 non-D.
  
  
  CONCLUSIONS
  The use of Zilver PTX is safe and effective in the treatment of SFA lesions. In particular, both stent patency and functional results on the basis of both clinical and instrumental tools were similar in D and non-D, suggesting a particularly favorable activity of PTX in a subpopulation of diabetics. Further studies are required to confirm these results, which seem to be particularly promising in diabetic patients.
authors: Vascular Surgery Unit, MultiMedica Institute for Scientific Research, Sesto San Giovanni, Milan, Italy - saraoberto@libero.it.
authors: Sara
authors: S
authors: Oberto
authors: Vascular Surgery Unit, MultiMedica Institute for Scientific Research, Sesto San Giovanni, Milan, Italy.
authors: Francesco
authors: F
authors: Cetta
authors: Cardiovascular Unit, Monzino Heart Institute for Scientific Research, Milan, Italy.
authors: Piero
authors: P
authors: Trabattoni
authors: Cardiovascular Unit, Monzino Heart Institute for Scientific Research, Milan, Italy.
authors: Stefano
authors: S
authors: Zoli
authors: Cardiovascular Hemodynamic Unit, MultiMedica Institute for Scientific Research, Sesto San Giovanni, Milan, Italy.
authors: Davide
authors: D
authors: Tavano
authors: &quot;G. Natta&quot; Department of Chemistry, Materials and Chemical Engineering, Polytechnic University, Milan, Italy.
authors: Filippo
authors: F
authors: Rossi
authors: Diabetic Foot Unit, MultiMedica Institute for Scientific Research, Sesto San Giovanni, Milan, Italy.
authors: Giacomo
authors: G
authors: Clerici
authors: Cardiovascular Hemodynamic Unit, MultiMedica Institute for Scientific Research, Sesto San Giovanni, Milan, Italy.
authors: Flavio
authors: F
authors: Airoldi
authors: Cardiovascular Unit, Monzino Heart Institute for Scientific Research, Milan, Italy.
authors: Rita
authors: R
authors: Spirito
authors: Vascular Surgery Unit, MultiMedica Institute for Scientific Research, Sesto San Giovanni, Milan, Italy.
authors: Sergio
authors: S
authors: Losa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000671:Amputation, Surgical; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003925:Diabetic Angiopathies / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D054855:Drug-Eluting Stents; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007558:Italy; 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 / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011474:Prosthesis Design; D019233:Retreatment; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D000497:Alloys; D002317:Cardiovascular Agents; C013616:nitinol; D017239:Paclitaxel