Clinical Evaluation of a Paclitaxel-Eluting Balloon for Treatment of Femoropopliteal Arterial Disease: 12-Month Results From a Multicenter Italian Registry

Mar 19, 2012
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Authors:
Micari A, Cioppa A, Vadalà G, et al.
Citation:
JACC Cardiovasc Interv 2012;5:331-338.
Summary By:
Hitinder S. Gurm, MBBS, FACC

Study Questions:

What is the safety and efficacy of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease?

Methods:

The authors enrolled 105 patients treated with a PEB for femoropopliteal arterial disease in a prospective registry. Patients had Rutherford class 2-4 symptoms, the reference vessel diameter was 3-7 mm, and lesion/occlusion length was ≤15 cm. The study evaluated multiple endpoints including primary and secondary patency rate, target lesion revascularization, and changes in Rutherford class and ankle-brachial index (ABI).

Results:

Most (77%) lesions were located in the superficial femoral artery, and mean lesion length was 76.3 ± 38.3 mm. Approximately 30% of the lesions were total occlusions. The PEB was successfully used in all patients, and stenting was performed in only 12.3% of the lesions. Primary patency at 12 months was 84%, with a target lesion revascularization rate of 7.6%. There was significant improvement in quality of life, and 85% of the patients were Rutherford class 0 or 1 at 1 year. The average ABI increased from 0.56 ± 0.15 at baseline to 0.86 ± 0.15 at 12-month follow-up.

Conclusions:

The authors concluded that PEB treatment of femoropopliteal arterial disease resulted in a durable clinical result with high primary patency, low use of stents, and significant improvement in quality of life.

Perspective:

The unique mechanical stresses of the femoral-popliteal bed make it particularly unsuitable for stenting, and drug-eluting balloons have recently emerged as a possible strategy for treatment of this bed. This study adds to the growing body of data that has demonstrated consistently high primary patency rates with PEB for treatment of short femoral-popliteal lesions. PEBs are currently being evaluated in ongoing randomized controlled trials, but the preliminary data look promising, and it is likely that this therapy will emerge as the pre-eminent strategy for endovascular therapy of femoral arterial disease.

Keywords: Paclitaxel, Registries, Follow-Up Studies, Ankle Brachial Index, Stress, Mechanical, Femoral Artery, Stents


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