Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease

JACC Cardiovascular Interventions, 04/06/2012

Paclitaxel–eluting balloon (PEB) treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization.

Methods

  • This prospective registry enrolled patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length 15 cm.
  • Endpoints included primary patency rate, target lesion revascularization, and changes in Rutherford class and ankle–brachial index.
  • Walking capacity, absolute claudication distance, and quality of life were also assessed.

Results

  • The registry enrolled 105 patients.
  • Baseline ankle–brachial index was 0.56 ± 0.15. Baseline Rutherford classification was class 2 or 3 for most patients (91.5%).
  • Most lesions were located in the superficial femoral artery (77.1%).
  • Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions.
  • The device was successfully used in all patients and only 12.3% of lesions required stenting.
  • At 12–month follow–up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle–brachial index was 0.86 ± 0.15.
  • Quality of life and absolute claudication distance showed significant improvement from baseline to 12–month follow–up.

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