title: Primary nitinol stenting in femoropopliteal occlusive disease: a meta-analysis of randomized controlled trials.
abstract: OBJECTIVE
  To determine the efficacy and safety of balloon angioplasty (BA) with optional stenting vs. routine stenting with current open cell nitinol stents for femoropopliteal occlusive disease by analyzing the overall results from all available randomized controlled trials.
  
  
  METHODS
  A bibliographic search of electronic medical databases (MEDLINE, Embase, ISI Web of Knowledge, and the Cochrane Central Register of Controlled Trials) was conducted to identify relevant articles from 1960 to July 2011. Of the 701 published articles retrieved, 17 clinical trials randomized patients with symptomatic femoropopliteal occlusive disease to either primary BA or primary stenting. Of these, 4 RCTs involved the use of currently employed high flexibility nitinol stents. Thirteen other trials that employed obsolete, steel, or coated stents were excluded. The technical success rate, the target lesion revascularization (TLR) rate, and the binary restenosis rate at 12 months were primary efficacy endpoints; mortality was the primary safety endpoint. The results are reported as the odds ratio (OR) with 2-tailed 95% confidence intervals (95% CI).
  
  
  RESULTS
  The study population was made up of 627 patients (416 men; mean age 67±10 years) and 665 lesions (361 assigned to the primary stenting and 304 to BA). The mean length of the treated lesion was similar in both groups (74.6±45.7 mm in the stenting group vs. 66.7±41.3 mm in the BA group). Technical success was significantly higher in the stenting group compared to BA (95.8% vs. 64.2%; OR 0.31, 95% CI 0.09 to 0.92, p<0.001). Follow-up ranged from 12 to 24 months. Based on 3 studies, the TLR at 12 months favored the stent group (OR 2.47, 95% CI 0.72 to 8.49, p=0.065), but the difference did not reach statistical significance. However, the 12-month binary restenosis rate was significantly lower in the primary stenting group (OR 3.02, 95% CI 1.3 to 6.71, p<0.001). With respect to the safety endpoint, mortality was similar in both groups (OR 0.83, 95% CI 0.39 to 1.77, p<0.001).
  
  
  CONCLUSIONS
  This meta-analysis supports the use of the primary stenting, mainly for long lesions, as a first-line endovascular treatment for symptomatic disease in the femoropopliteal segment, contrary to indications for use in current clinical guidelines.
authors.affiliation: Angiology and Vascular Surgery Department, Hospital Universitario Getafe, Madrid, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Acin
authors.forename: Joaquin
authors.initials: J
authors.lastname: de Haro
authors.forename: Silvia
authors.initials: S
authors.lastname: Bleda
authors.forename: Cesar
authors.initials: C
authors.lastname: Varela
authors.forename: Leticia
authors.initials: L
authors.lastname: Esparza
mesh_terms: D000368:Aged; D000497:Alloys; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001157:Arterial Occlusive Diseases / Q000401:mortality / Q000628:therapy*; D003251:Constriction, Pathologic; D019317:Evidence-Based Medicine; D005260:Female; D005263:Femoral Artery; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011150:Popliteal Artery; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000497:Alloys; C013616:nitinol