Two-Year Independent Registry Results Support Medtronic's In.Pact Admiral Paclitaxel-Eluting Balloon for Femoropopliteal Artery Disease

March 25, 2013—Two-year data from an independent, prospective, multicenter registry aimed at assessing outcomes of femoropopliteal angioplasty with a paclitaxel-eluting balloon (PEB) (In.Pact Admiral, Medtronic, Inc., Minneapolis, MN) were recently published by Antonio Micari, MD, et al in the Journal of the American College of Cardiology: Cardiovascular Interventions (2013;6:282–289).

In the study, 105 consecutive patients with Rutherford class 2 to 4 disease caused by femoropopliteal lesions ≤ 15 mm long and with 3- to 7-mm reference vessel diameters were enrolled. Endpoints included primary patency, major adverse events (the composite of death, amputation, or target lesion revascularization), changes in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life after ≥ 24 months.

As summarized in the publication, the registry enrolled 105 patients (114 lesions) who were treated with PEBs and provisional stenting; final procedural success was achieved in all patients. Follow-up after 27 ± 3 months was obtained in 98 (93.3%) patients, showing that primary patency was maintained in 71 (72.4%) and that major adverse events had occurred in 17 (17.5%; death in 2, amputation in 1, target lesion revascularization in 14). Persistently significant benefits were seen in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life (all P < .001). Secondary patency was achieved in 89 cases (84.7%). Revascularization was performed with standard angioplasty but not adjunctive stenting. In comparing lesions receiving bailout stenting (14; 12.3%) with those that did not, no statistically signficant difference in patency rates was noted. 

The investigators found PEBs to be associated with favorable functional and clinical outcomes at 2 years. They further noted that in contrast to elective stenting, PEBs might best fit a long-term therapeutic strategy as needed for claudicant patients with unavoidable disease progression due to the therapy being less likely to impact future options for intervention.