title: Stent placement vs. balloon angioplasty for popliteal artery treatment: two-year results of a prospective, multicenter, randomized trial.
abstract: OBJECTIVE
  To investigate the 2-year technical and clinical results of primary nitinol stent placement in comparison with percutaneous transluminal angioplasty (PTA) in the treatment of de novo lesions of the popliteal artery.
  
  
  METHODS
  The ETAP study (Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions: balloon angioplasty vs. primary stenting; www.ClinicalTrials.gov identifier NCT00712309) is a prospective, randomized trial that enrolled 246 patients (158 men; mean age 72 years) who were randomly assigned to receive a nitinol stent (n=119) or PTA (n=127) for lesions averaging 42.3 mm in length. The results of the primary study endpoint were published. Secondary outcome measures and endpoints included primary patency (freedom from duplex-detected target lesion restenosis), target lesion revascularization (TLR), secondary patency, changes in ankle-brachial index and Rutherford class, and event-free survival (freedom from target limb amputation, TLR, myocardial infarction, and death).
  
  
  RESULTS
  In total, 183 patients (89 stent and 94 PTA) were available for the 2-year analysis. The primary patency rate was significantly higher in the stent group (64.2%) than in the PTA group (31.3%, p=0.0001). TLR rates were 22.4% and 59.5%, respectively (p=0.0001). When provisional stent placement in the PTA arm was not considered as TLR and loss in patency, the differences prevailed between the study groups but were not significant (64.2% vs. 56.1% for primary patency, respectively; p=0.44). A significant improvement in ABI and Rutherford category was observed at 2 years in both groups.
  
  
  CONCLUSIONS
  In treatment of obstructive popliteal artery lesions, provisional stenting reveals equivalent patency in comparison to primary stenting. However, the 2-year results of this trial suggest the possibility of a shift toward higher patency rates in favor of primary stenting.
authors.affiliation: Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany aljoscha.rastan@universitaets-herzzentrum.de.
authors.forename: Aljoscha
authors.initials: A
authors.lastname: Rastan
authors.affiliation: Herz-und Gefässzentrum Bad Bevensen, Germany.
authors.forename: Hans
authors.initials: H
authors.lastname: Krankenberg
authors.affiliation: Universität Bern, Switzerland.
authors.forename: Iris
authors.initials: I
authors.lastname: Baumgartner
authors.affiliation: SRH Klinikum Karlsbad Langensteinbach, Karlsbad, Germany.
authors.forename: Erwin
authors.initials: E
authors.lastname: Blessing
authors.affiliation: Ev.-Luth. Diakonissenkrankenhaus, Flensburg, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Müller-Hülsbeck
authors.affiliation: Universitätsklinik für Innere Medizin, Graz, Austria.
authors.forename: Ernst
authors.initials: E
authors.lastname: Pilger
authors.affiliation: Universitätsklinik Leipzig, Germany.
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.affiliation: Medizinische Universität, Vienna, Austria.
authors.forename: Johannes
authors.initials: J
authors.lastname: Lammer
authors.affiliation: Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Beschorner
authors.affiliation: Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Elias
authors.initials: E
authors.lastname: Noory
authors.affiliation: Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.affiliation: Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000800:Angioplasty, Balloon / Q000379:methods; D055109:Ankle Brachial Index; D001317:Austria; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D058729:Peripheral Arterial Disease / Q000473:pathology / Q000628:therapy*; D011150:Popliteal Artery / Q000473:pathology; D011446:Prospective Studies; D015607:Stents; D013557:Switzerland; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D000497:Alloys; C013616:nitinol
keywords: balloon angioplasty; occlusion; peripheral artery disease; popliteal artery; randomized trial; restenosis; stenosis; stent