Paclitaxel-eluting balloons are associated with favourable functional and clinical outcomes at two years in patients with femoropopliteal arterial disease requiring percutaneous revascularisation, according to a study published in the Journal of the American College of Cardiology: Cardiovascular Interventions in March 2013.
The authors of the study, led by Antonio Micari, Palermo, Italy, wrote that percutaneous transluminal angioplasty with paclitaxel-eluting balloons for femoropopliteal arterial disease has provided favourable results at one year.
“This was an independent, non-industry-supported prospective multicentre study aimed to appraise in detail fatal and nonfatal outcomes after femoropopliteal angioplasty with the In.Pact Admiral balloon (Medtronic),” they said. The Italian Multicentre Registry also included centres in Mercogliano, Cotignola, Lecce, Bari, and Rapallo.
Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions ≤15mm long and with 3- to 7-mm reference vessel diameter were prospectively enrolled in a multicentre registry. Endpoints included primary patency, major adverse events (the composite of death, amputation, or target lesion revascularisation), changes in Rutherford class, ankle brachial index, absolute claudication distance, and quality of life after ≥24 months.
A total of 105 patients (114 lesions) treated with paclitaxel-eluting balloons (135) and provisional stenting were enrolled, and final procedural success was obtained in all. Follow-up after 27±3 months was obtained in 98 (93.3%) patients, showing that primary patency was maintained in 71 (72.4%), and major adverse events had occurred in 17 (17.5%), with death in two (2.2%), amputation in one (1%), and target lesion revascularisation in 14 (14.3%). There were persistently significant benefits in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life (all p<0.001). Secondary patency rate was achieved in 89 cases (84.7%).
The authors concluded that their findings “signal that a stent-less therapy approach with IN.PACT Admiral paclitaxel-eluting balloon and optimal angioplasty provides favourable outcomes and is likely to leave more interventional options open for the future”.