title: German multicenter real-world registry of stenting for superficial femoral artery disease: clinical results and predictive factors for revascularization.
abstract: OBJECTIVE
  To investigate nitinol stent treatment of superficial femoral artery (SFA) lesions and the impact of different risk factors on the need for clinically driven target lesion revascularization (TLR) in a large, real-world population of claudicants.
  
  
  METHODS
  Patients presenting with symptomatic SFA stenosis >70% were consecutively enrolled in the 13-center MARIS prospective registry (ClinicalTrials.gov identifier NCT01067885). There was no restriction on lesion length, thus leading to the inclusion of a real-world as well as high-risk patient cohort. The 998 participating patients (657 men; mean age 67.4±9.2 years) had 1050 lesions treated with the same nitinol stent type. The mean lesion length was 9.5±9.6 cm (range 0.5-44; median 8.0); more than a third of the lesions (450, 42.9%) were total occlusions. The primary endpoint was the need for clinically driven target lesion revascularization (TLR) at 12 months.
  
  
  RESULTS
  Acute technical success was achieved in 1042 (99.2%) lesions. Restenosis occurred in 187 (23.7%) and reocclusion in 79 (10.0%) lesions at 12 months. The primary endpoint of TLR at 12 months was reached by 136 (17.2%) patients. The periprocedural complication rate was 5.4%. Independent predictors of TLR were female gender [odds ratio (OR) 0.5, 95% confidence interval (CI) 0.3 to 0.7, p<0.001] and lesion length >20 cm vs. 10 cm (OR 2.7, 95% CI 1.1 to 6.6, p=0.029) and 10-20 cm vs. 10 cm (OR 1.9, 95% CI 1.0 to 4.1, p=0.047).
  
  
  CONCLUSIONS
  Stent implantation in the SFA is safe and associated with favorable acute and midterm results in a real-world setting. Lesion length and female gender were identified as independent risk factors for TLR.
authors.affiliation: 1 Klinik für Angiologie, Herz- und Gefäßzentrum Bad Bevensen, Germany.
authors.forename: Hans
authors.initials: H
authors.lastname: Krankenberg
authors.forename: Thilo
authors.initials: T
authors.lastname: Tübler
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sixt
authors.forename: Matthias
authors.initials: M
authors.lastname: Fischer
authors.forename: Rainer
authors.initials: R
authors.lastname: Schmiedel
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Schulte
authors.forename: Jörn O
authors.initials: JO
authors.lastname: Balzer
authors.forename: Arne
authors.initials: A
authors.lastname: Kieback
authors.forename: Eduard
authors.initials: E
authors.lastname: Fiehn
authors.forename: Günther
authors.initials: G
authors.lastname: Wittenberg
authors.forename: Tammam
authors.initials: T
authors.lastname: Ali
authors.forename: Christiane
authors.initials: C
authors.lastname: Tiefenbacher
authors.forename: Thomas
authors.initials: T
authors.lastname: Jahnke
authors.forename: Hermann J
authors.initials: HJ
authors.lastname: Steinkamp
authors.forename: Karl
authors.initials: K
authors.lastname: Wegscheider
authors.forename: András
authors.initials: A
authors.lastname: Treszl
authors.forename: Maja
authors.initials: M
authors.lastname: Ingwersen
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
mesh_terms: D000368:Aged; D000497:Alloys; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D003251:Constriction, Pathologic; D005260:Female; D005263:Femoral Artery; D005858:Germany; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000628:therapy*; D007511:Ischemia / Q000175:diagnosis / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000628:therapy*; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012042:Registries; D012307:Risk Factors; D012737:Sex Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000497:Alloys; C013616:nitinol
keywords: angioplasty; gender; lesion length; peripheral artery disease; reocclusion; restenosis; stent; superficial femoral artery; target lesion revascularization