German multicenter real-world registry of stenting for superficial femoral artery disease: clinical results and predictive factors for revascularization

J Endovasc Ther. 2014 Aug;21(4):463-71. doi: 10.1583/13-4625R.1.


Purpose: 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 ( 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).

Conclusion: 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.

Keywords: angioplasty; gender; lesion length; peripheral artery disease; reocclusion; restenosis; stent; superficial femoral artery; target lesion revascularization.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Aged
  • Alloys
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / instrumentation*
  • Constriction, Pathologic
  • Female
  • Femoral Artery*
  • Germany
  • Humans
  • Intermittent Claudication / diagnosis
  • Intermittent Claudication / therapy*
  • Ischemia / diagnosis
  • Ischemia / therapy*
  • Kaplan-Meier Estimate
  • Logistic Models
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Odds Ratio
  • Peripheral Arterial Disease / diagnosis
  • Peripheral Arterial Disease / therapy*
  • Prospective Studies
  • Prosthesis Design
  • Recurrence
  • Registries
  • Risk Factors
  • Sex Factors
  • Stents*
  • Time Factors
  • Treatment Outcome


  • Alloys
  • nitinol

Associated data