First Experience With Drug-Eluting Balloons in Infrapopliteal Arteries: Restenosis Rate and Clinical Outcome

Study Questions:

What is the efficacy of drug-eluting balloons for treatment of infrapopliteal arterial stenosis?


The authors reported the outcome of infrapopliteal angioplasty performed with a paclitaxel-eluting balloon (In.Pact Amphirion; Medtronic) in 104 patients. Clinical and angiographic follow-up was performed at 3 months, with additional clinical follow-up at 1 year.


A total of 109 limbs were treated in 104 patients. Most patients were treated for critical limb ischemia (82.6%) and some for severe claudication (17.4%). The average lesion length was 176 mm. Binary restenosis among patients undergoing angiographic follow-up demonstrated a restenosis rate of 27.4%. Most restenosis was focal, and restenosis of the entire segment or reocclusion was seen only in 9.5% of the treated vessels. Of the 91 limbs that could be evaluated at 1 year (one patient was lost to follow-up and 17 died), clinical improvement was present in 83 (91.2%). Complete wound healing was seen in 74.2%, and limb salvage rate was 96% for patients with critical limb ischemia.


The authors concluded that use of a paclitaxel-eluting balloon was associated with dramatic reduction in restenosis rates compared with historic controls.


Endovascular therapy for infrapopliteal arterial disease is plagued by high restenosis rates, and this study demonstrates dramatically low restenosis rates in this arterial bed with drug-eluting balloons. Further research is needed to assess if the superiority of the drug-eluting balloons over plain balloon angioplasty is maintained in blinded randomized trials, and if this reduction in restenosis translates into a meaningful clinical benefit.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Stable Ischemic Heart Disease, Interventions and Imaging, Angiography, Nuclear Imaging, Chronic Angina

Keywords: Follow-Up Studies, Coronary Restenosis, Werner Syndrome, Lost to Follow-Up, Sirolimus, Constriction, Pathologic, Angioplasty, Angioplasty, Balloon, Coronary, Paclitaxel, Coronary Angiography, Limb Salvage, Wound Healing, Popliteal Artery

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