title: 12-month primary patency rates of contemporary endovascular device therapy for femoro-popliteal occlusive disease in 6,024 patients: beyond balloon angioplasty.
abstract: BACKGROUND
  Endovascular approach to superficial femoral artery (SFA) disease, the most common cause of symptomatic peripheral arterial disease, remains fraught with high failure rates. Newer devices including second-generation nitinol stents, drug-coated stents, drug-coated balloons, covered stents, cryo-therapy, LASER, and directional atherectomy have shown promising results. Clinical equipoise still persists regarding the optimal selection of devices, largely attributable to the different inclusion criteria, study population, length of lesions treated, definition of "patency" and "restenosis," and follow-up methods in the pivotal trials.
  
  
  METHODS
  A prospective protocol was developed. We performed a literature search using PubMed from January 2006 to November 2013. Published articles including endovascular interventions in SFA or popliteal arteries with reported 12-month "primary patency" or "binary restenosis" rates as endpoints were included.
  
  
  RESULTS
  We identified 6,024 patients in 61 trials reporting 12-month primary patency rates in patients with femoropoliteal disease. Primary patency rates were (weighted average) 77.2% for nitinol stents, 68.8% for covered stents, 84% for drug eluting stents, 78.2% for drug eluting/coated balloon, 60.7% for cryoballoon, 51.1% for LASER atherectomy, 63.5% for directional atherectomy and 70.2% with a combination of endovascular devices.
  
  
  CONCLUSIONS
  The most frequently used endovascular devices yielded various 12-month primary patency rates ranging from 51% to 85%. The increased variation in inclusion criteria, length, and complexity of lesions between studies does not allow direct comparison between them. Larger randomized trials in specific patient populations comparing those modalities is needed before we can make safe recommendation of the superiority of one device over the other.
authors.affiliation: Citizens Memorial Hospital Heart and Vascular Institute, Bolivar, Missouri.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Marmagkiolis
authors.forename: Abdul
authors.initials: A
authors.lastname: Hakeem
authors.forename: Nishit
authors.initials: N
authors.lastname: Choksi
authors.forename: Malek
authors.initials: M
authors.lastname: Al-Hawwas
authors.forename: Mohan Mallikarjuna Rao
authors.initials: MM
authors.lastname: Edupuganti
authors.forename: Massoud A
authors.initials: MA
authors.lastname: Leesar
authors.forename: Mehmet
authors.initials: M
authors.lastname: Cilingiroglu
mesh_terms: D000800:Angioplasty, Balloon / Q000295:instrumentation; D002317:Cardiovascular Agents / Q000008:administration & dosage; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D054855:Drug-Eluting Stents; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005263:Femoral Artery / Q000503:physiopathology*; D006801:Humans; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000503:physiopathology*; D011474:Prosthesis Design; D012008:Recurrence; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible
keywords: peripheral arterial disease (PAD); peripheral transluminal angioplasty (PTA)