Treatment of femoropopliteal in-stent restenosis with paclitaxel-eluting stents

Thomas Zeller, Michael D. Dake, Gunnar Tepe, Klaus Brechtel, Elias Noory, Ulrich Beschorner, Patricia L. Kultgen, Aljoscha Rastan

Research output: Contribution to journalArticle

99 Scopus citations

Abstract

Objectives This study sought to evaluate the outcomes of drug-eluting stent treatment for femoropopliteal in-stent restenosis (ISR). Background ISR after femoropopliteal interventions is an increasing problem. Although the role of drug-eluting stents in the treatment of coronary ISR is well defined, no published studies have examined drug-eluting stents in the treatment of femoropopliteal ISR. Methods This study examines 108 patients with 119 ISR lesions who were enrolled in the ZILVERPTX single-arm study, a prospective, multicenter clinical trial of 787 patients. All patients were treated with paclitaxel-eluting nitinol stents. Results Mean patient age was 68.3 ± 9.4 years; 61.1% of patients were men. Mean lesion length was 133.0 ± 91.7 mm; 33.6% of lesions were >150 mm long and 31.1% of lesions were totally occluded. Procedural success was achieved in 98.2% of lesions with 2.1 ± 1.2 stents placed per lesion. Primary patency was 95.7% at 6 months and 78.8% at 1 year. Freedom from target lesion revascularization was 96.2% at 6 months, 81.0% at 1 year, and 60.8% at 2 years. Forty patients experienced major adverse events, exclusively target lesion revascularization. Before treatment, 81.1% of patients had Rutherford scores ≲γ≥ 3; at 2 years, 60.9% of patients had Rutherford scores ≲λ≤ 1. Both ankle brachial index and walking impairment questionnaire scores significantly improved following treatment. The 1-year fracture rate of stents used in ISR lesions was 1.2%. No significant risk factors associated with loss of patency were identified. Conclusions Treatment of femoropopliteal ISR with paclitaxel-eluting stents results in favorable acute, midterm, and long-term outcomes. (Zilver PTX Global Registry [ZILVER-PTX]; NCT01094678).

Original languageEnglish (US)
Pages (from-to)274-281
Number of pages8
JournalJACC: Cardiovascular Interventions
Volume6
Issue number3
DOIs
StatePublished - Mar 2013
Externally publishedYes

Keywords

  • Drug-eluting stent(s)
  • Femoral artery
  • In-stent restenosis
  • Paclitaxel
  • Peripheral occlusive artery disease
  • Revascularization

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Zeller, T., Dake, M. D., Tepe, G., Brechtel, K., Noory, E., Beschorner, U., Kultgen, P. L., & Rastan, A. (2013). Treatment of femoropopliteal in-stent restenosis with paclitaxel-eluting stents. JACC: Cardiovascular Interventions, 6(3), 274-281. https://doi.org/10.1016/j.jcin.2012.12.118