Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease
JACC Cardiovascular Interventions, 04/06/2012Micari A et al.
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.
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.
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.
MDLinx connects healthcare professionals and patients to tomorrow's important medical news, while providing the pharmaceutical and healthcare industries with highly targeted interactive marketing, education, content, and medical research solutions.