title: Stent placement versus balloon angioplasty for the treatment of obstructive lesions of the popliteal artery: a prospective, multicenter, randomized trial.
abstract: BACKGROUND
  Stenting has been shown to improve patency after femoral artery revascularization compared with balloon angioplasty. Limited data are available evaluating endovascular treatment for obstructive lesions of the popliteal artery.
  
  
  RESULTS
  This prospective, randomized, multicenter trial compared primary nitinol stent placement to percutaneous transluminal balloon angioplasty in patients with peripheral artery disease Rutherford-Becker class 2 to 5 who had a de novo lesion in the popliteal artery. The primary study end point was 1-year primary patency, defined as freedom from target-lesion restenosis (luminal narrowing of ≥50%) as detected by duplex ultrasound. Secondary end points included target-lesion revascularization rate and changes in Rutherford-Becker class. Provisional stent placement was considered target-lesion revascularization and loss of primary patency. Two hundred forty-six patients were included in this trial. The mean target-lesion length was 42.3 mm. One hundred ninety-seven patients were available for the1-year follow-up. The 1-year primary patency rate was significantly higher in the group with primary nitinol stent placement (67.4%) than in the percutaneous transluminal balloon angioplasty group (44.9%, P=0.002). Target-lesion revascularization rates were 14.7% and 44.1%, respectively (P=0.0001); however, when provisional nitinol stent placement was not considered target-lesion revascularization and loss in patency, no significant differences prevailed between the study groups (67.4% versus 65.7%, P=0.92 for primary patency). Approximately 73% of patients in the percutaneous transluminal balloon angioplasty group and 77% in the nitinol stent group showed an improvement of ≥1 Rutherford-Becker class (P=0.31).
  
  
  CONCLUSIONS
  Primary nitinol stent placement for obstructive lesions of the popliteal artery achieves superior acute technical success and higher 1-year primary patency only if provisional stenting is considered target-lesion revascularization. Provisional stenting as part of a percutaneous transluminal balloon angioplasty strategy has equivalent 1-year patency and should be preferred over primary stenting.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT00712309.
authors.affiliation: Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, D-79189 Bad Krozingen, Germany. aljoscha.rastan@universitaets-herzzentrum.de
authors.forename: Aljoscha
authors.initials: A
authors.lastname: Rastan
authors.forename: Hans
authors.initials: H
authors.lastname: Krankenberg
authors.forename: Iris
authors.initials: I
authors.lastname: Baumgartner
authors.forename: Erwin
authors.initials: E
authors.lastname: Blessing
authors.forename: Stefan
authors.initials: S
authors.lastname: Müller-Hülsbeck
authors.forename: Ernst
authors.initials: E
authors.lastname: Pilger
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.forename: Johannes
authors.initials: J
authors.lastname: Lammer
authors.forename: Martin
authors.initials: M
authors.lastname: Gißler
authors.forename: Elias
authors.initials: E
authors.lastname: Noory
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
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*; D001157:Arterial Occlusive Diseases / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D057510:Endovascular Procedures / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery; D011446:Prospective Studies; D015607:Stents; D015996:Survival Rate; D016896:Treatment Outcome; D014654:Vascular Patency / Q000502:physiology
chemical_list: D000497:Alloys; C013616:nitinol
keywords: angioplasty; arteries; peripheral vascular diseases; stents