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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?
Methods:
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.
Results:
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.
Conclusions:
The authors concluded that use of a paclitaxel-eluting balloon was associated with dramatic reduction in restenosis rates compared with historic controls.
Perspective:
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.
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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