Original title: 2-Year Results of Paclitaxel-Eluting Balloons for Femoropopliteal Artery Disease. Evidence From a Multicenter Registry. Reference: Antonio Micari et al. J Am Coll Cardiol Intv 2013;6:282–9.
Paclitaxel-eluting balloons appear safe and effective for treating atherosclerotic lesions in the femoropopliteal region, leaving the stent only as a rescue strategy against a suboptimal outcome. However, the vast majority of the available information is based on angiographic results at six months but there is no data on the long-term primary patency or clinical outcomes.
This is a prospective and multicenter registry to evaluate the results of angioplasty in the femoropopliteal region with paclitaxel eluting balloon IN.PACT Admiral, (Medtronic, Frauenfeld, Switzerland). A total of 105 patients with atherosclerotic lesions of the superficial femoral artery or popliteal proximal with a reference diameter between 3 and 7 mm and a length not exceeding 150 mm were included. It required an adequate exit with at least one permeable infrapatellar artery and in the case of suboptimal results, (stenosis > 50% or dissection), a self-expanding stent implantation was allowed. The procedure was successful in all cases with a rescue stent implantation rate of 12.3%.
Primary patency at one year was 83.7% and 72.4% after two years. No significant differences were observed with regard to primary patency in patients who received stent versus those without, (69.2% versus 75.4%, P = 0.426), in the patients with occlusive versus non-occlusive lesions, heavily calcified lesions versus non-calcified and popliteal artery involvement versus superficial femoral disease only. Results appear to be influenced by the number of infrapatelar patency arteries and lesion length. At 27 ± 3 months mortality was 2.2%, amputation 1% and revascularization of lesion 14.3%. The ankle-brachial index showed a significant and sustained improvement over time, (0.88 at 27 ± 3 months versus 0.86 at 12 months versus 0.56 baseline; p <0.001), as well as maximal walking distance, (418 meters versus 316 meters versus 111 meters respectively; p <0.001).
Conclusion:
Paclitaxel eluting balloon angioplasty has favorable results in patients with atherosclerotic disease over the femoropopliteal region and allows therapeutic options for the future because permanent prosthesis is not necessary.
Commentary:
Excluding patients with critical ischemia or lesions larger than 150 mm were limitations of the study because of the frequency of patients with these characteristics in everyday practice. The evidence that only using a strategy of drug eluting balloon and stent implantation if suboptimal results, indicate this as the best choice in this territory is gradually gaining place.
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