One-Year Data Published for Medtronic Invatec's In.Pact Admiral Paclitaxel-Eluting Balloon

March 20, 2012—Twelve-month results from a multicenter Italian registry evaluating the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease were published by Antonio Micari, MD, et al in the Journal of the American College of Cardiology: Cardiovascular Interventions (2012;5:331–338).

The investigators concluded that PEB treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization.

The registry, which evaluated the In.Pact Admiral paclitaxel-eluting balloon (Medtronic Invatec, Frauenfeld, Switzerland), was presented in November 2011 at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco. At that time, Dr. Micari commented, “For years, the medical community has hoped for a therapy that could deliver patency while leaving nothing behind. The drug-eluting balloon fulfills this and constitutes a tremendous tool in the hands of physicians for the benefit of their patients.”

The background of the study is that conventional balloon angioplasty and stenting in this setting is associated with high restenosis rates within 12 months, but recent data suggest that PEB use may reduce restenosis. Therefore, the investigators undertook this study to measure 12-month outcomes following PEB use with provisional stenting.

As detailed in the Journal of the American College of Cardiology: Cardiovascular Interventions, this prospective registry enrolled 105 patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length ≤ 15 cm. Endpoints included primary patency rate, target lesion revascularization rate, and changes in Rutherford class and ankle-brachial index. Walking capacity, absolute claudication distance, and quality of life were also assessed.

In the registry, the baseline ankle-brachial index was 0.56 ± 0.15, and baseline Rutherford classification was class 2 or 3 for most patients (91.5%). Most lesions were located in the superficial femoral artery (77.1%). Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions.

The investigators found that the device was successfully used in all patients, and only 12.3% of lesions required stenting. At 12-month follow-up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle-brachial index was 0.86 ± 0.15. Quality of life and absolute claudication distance showed significant improvement from baseline to 12-month follow-up, reported the investigators.