NEW YORK (Reuters Health) – For treatment of femoropopliteal artery disease, angioplasty using a paclitaxel-eluting balloon (PEB) is associated with a high sustained patency rate and a low rate of stenting and target lesion revascularization, clinicians from Italy have found.
They saw “consistent improvement” in clinical endpoints, functional status and associated quality of life in a group of patients followed for one year in a prospective Italian multicenter PEB registry. The low rate of target lesion revascularization over 12 months suggests that the use of PEBs offers “durable safety and effectiveness in this population,” they say.
Dr. Antonio Micari from the Cardiology Unit, Gruppo Villa Maria Care and Research, Maria Eleonora Hospital in Palermo, Italy and colleagues report their findings this month in JACC: Cardiovascular Interventions.
According to background information in the article, treatment of femoropopliteal artery disease by conventional percutaneous transluminal angioplasty is limited by high rates of restenosis (40% to 60%) in the first year.
While drug-eluting stents have been shown to reduce restenosis in the coronary arteries, they don’t seem to achieve this effect in peripheral arteries. And stents are not ideal for leg arteries given the high mechanical stress they must endure which increases the risk for stent fractures. The use of PEBs avoids or limits the use of stents and combines local drug delivery to help prevent restenosis.
Dr. Micari and colleagues now report 12-month outcomes for 105 patients (114 lesions) treated with the In.Pact Admiral PEB (Medtronic Inc.). Most patients had Rutherford class 2 or 3 femoropopliteal arterial disease at baseline (91.5%) and most lesions were in the superficial femoral artery (77.1%). The average length of the lesions was 76.3 mm and 29.8% of lesions were total occlusions. All patients were given dual antiplatelet therapy for 12 weeks (24 weeks if a stent was implanted).
The investigators report that all PEBs were successfully deployed in all target vessels and ultimately only 14 lesions (12.3%) required stenting, mainly to seal flow-limiting dissections. “There was a similar rate of primary patency and limited stenting in totally occluded lesions, which accounted for almost one-third of treated lesions,” the authors say.
At 12 months, 92 of 105 patients (87.6%) were evaluable. The primary patency rate was 83.7%, the target lesion revascularization rate was 7.6% and 85.6% of patients made it to Rutherford class 0 or 1. The mean ankle-brachial index at follow-up had improved to 0.86 from 0.56 at baseline.
The authors note that within three months of treatment, patients were able to walk more than triple the distance they could previously walk “and this functional benefit persisted to 12 months after the PEB procedure. These clinical benefits similarly were observed in patients with totally occluded lesions, providing an important signal regarding the effectiveness of the PEB in both stenotic and occluded superficial femoral artery,” they say.
As reported by Reuters Health, a recent study from Germany published in the New England Journal of Medicine also found PEB to be effective in preventing restenosis of the superficial femoral and popliteal arteries. (See Reuters Health story of Feb. 13, 2008.)
Dr. Micari and colleagues would like to see larger, controlled trials to further define the role of PEB for management of patients with femoropopliteal artery disease. The authors did not respond to request for comment.
Dr. Micari and several co-authors have disclosed financial relationships with Medtronic and other entities. A Medtronic employee provided help with the statistical analysis and a Medtronic consultant provided editorial assistance.
SOURCE:
J Am Coll Cardiol Intv 2012;5:331-335.
