title: MISAGO 2: one-year outcomes after implantation of the Misago self-expanding nitinol stent in the superficial femoral and popliteal arteries of 744 patients.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of the Misago self-expanding rapid-exchange nitinol stent system for the treatment of femoropopliteal occlusive disease in a prospective multicenter observational trial (ClinicalTrials.gov; identifier NCT01118117).
  
  
  METHODS
  Between April and October 2008, the registry enrolled 744 patients (496 men; 69 ± 10 years) who had symptomatic ≥ 70% stenosis or occlusion of the superficial femoral or popliteal arteries treated with the Misago stent. Mean length of the 750 lesions was 63.9 mm; 282 (37.6%) vessels were completely occluded. Primary study endpoints were the need for target lesion revascularization (TLR) and event-free survival rates for the assessment of efficacy and safety, respectively. At 6 and 12 months post intervention, clinical symptoms of recurrent ischemia and/or claudication, Rutherford category, and ankle-brachial index (ABI) at rest were assessed.
  
  
  RESULTS
  In the study period, 945 stents were successfully deployed in the 750 lesions. The overall TLR rate was 10.1% among 671 (90.3%) patients evaluated at 1 year [3.1% among 709 (95.3%) patients at 6 months]. Event-free survival at 12 months was 84.9%. Mean ABIs improved by ≥ 0.1 in three quarters of the patients (76.0%) over 12 months. The Rutherford grade improved or remained stable in the majority of patients (95.5%) after 1 year. Stent fractures (13 grade 1, 2 grade 2) in 3.1% of stents examined radiographically (n=484) at 1 year were not related to any clinical events. Primary patency was recorded in 574 (87.6%) patients evaluated at 1 year post procedure.
  
  
  CONCLUSIONS
  The Misago rapid-exchange nitinol stent showed promising efficacy and safety results, with a low stent fracture rate, in patients with femoropopliteal disease, making it a safe and reliable treatment option.
authors.affiliation: Charité Berlin, Vascular Center Berlin, Ev. Hospital Königin Elisabeth Herzberge, Berlin, Germany. k.schulte@keh-berlin.de
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Schulte
authors.forename: Ivan
authors.initials: I
authors.lastname: Kralj
authors.forename: Hans Martin
authors.initials: HM
authors.lastname: Gissler
authors.forename: Luis Alberto
authors.initials: LA
authors.lastname: Bagnaschino
authors.forename: Ivo
authors.initials: I
authors.lastname: Buschmann
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Pernès
authors.forename: Patrick
authors.initials: P
authors.lastname: Haage
authors.forename: Peter
authors.initials: P
authors.lastname: Goverde
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Beregi
authors.forename: Martin
authors.initials: M
authors.lastname: Válka
authors.forename: Jaroslav
authors.initials: J
authors.lastname: Boudny
authors.forename: Thomas
authors.initials: T
authors.lastname: Geibel
authors.forename: Marek
authors.initials: M
authors.lastname: Velkoborsky
authors.forename: Markus
authors.initials: M
authors.lastname: Zähringer
authors.forename: Christian
authors.initials: C
authors.lastname: Paetzel
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Fanelli
authors.forename: Stefan
authors.initials: S
authors.lastname: Müller-Hülsbeck
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.forename: Ralf
authors.initials: R
authors.lastname: Langhoff
mesh_terms: D000368:Aged; D000497:Alloys; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D016009:Chi-Square Distribution; D002677:Chile; D003251:Constriction, Pathologic; D018572:Disease-Free Survival; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D007511:Ischemia / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D007557:Israel; D015993:Life Tables; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D012008:Recurrence; D012042:Registries; D012720:Severity of Illness Index; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D000497:Alloys; C013616:nitinol