Five-year outcomes of self-expanding nitinol stent implantation for chronic total occlusion of the superficial femoral and proximal popliteal artery

Catheter Cardiovasc Interv. 2013 Sep 1;82(3):E251-6. doi: 10.1002/ccd.24935. Epub 2013 Apr 25.

Abstract

Objective: To investigate the 5-year patency rates and predictors of restenosis after self-expanding nitinol stent implantation for chronic total occlusion (CTO) in superficial femoral and proximal popliteal artery (SFPA) lesions.

Background: Outcomes and long-term patency rates after self-expanding nitinol stent for CTO in the SFPA lesions have not been clarified.

Methods: From January 2004 to December 2009, 861 serial arteriosclerosis obliterans patients, 1,017 limbs, underwent endovascular therapy with implantation of a self-expanding nitinol stent for SFPA lesions at four institutions in Japan. Of the cohort, 352 patients, 383 limbs, had self-expanding nitinol stents implanted for CTOs in the SFPA and were followed for 5 years. We retrospectively investigated patency rate and multivariate predictors associated with restenosis.

Results: Mean age was 72 ± 9 years and 31% were female patients. In total, 58% of the patients had diabetes mellitus and 25% were patients with critical limb ischemia. Occluded length was 194 ± 89 mm, mean total stent length was 198 ± 7 mm, and mean stent diameter was 7.1 ± 0.9 mm. Five-year primary and secondary patency rates were 51.8 and 79.5%, respectively, and the rates of freedom from bypass surgery, major or minor amputation, and all-cause death were 96.1, 96.2, and 78.4%, respectively. Female gender (odds ratio, 1.95; P = 0.0051) and mean stent diameter (odds ratio, 0.77; P = 0.0324) were factors strongly associated with restenosis.

Conclusions: Women and patients requiring small stents failed to maintain primary patency when treated with self-expanding nitinol stents for CTO lesions in the SFPA. Although primary patency was low, the secondary patency rate was acceptable.

Keywords: PVD-peripheral vascular disease; endovascular therapy; self-expandable nitinol stent.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Alloys*
  • Amputation, Surgical
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / instrumentation*
  • Arterial Occlusive Diseases / diagnosis
  • Arterial Occlusive Diseases / physiopathology
  • Arterial Occlusive Diseases / therapy*
  • Chronic Disease
  • Constriction, Pathologic
  • Female
  • Femoral Artery* / physiopathology
  • Humans
  • Japan
  • Kaplan-Meier Estimate
  • Limb Salvage
  • Logistic Models
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Odds Ratio
  • Popliteal Artery* / physiopathology
  • Prosthesis Design
  • Recurrence
  • Retrospective Studies
  • Risk Factors
  • Sex Factors
  • Stents*
  • Time Factors
  • Treatment Outcome
  • Vascular Patency

Substances

  • Alloys
  • nitinol