Study Indicates Drug-Eluting Balloons Very Effective in Infrapopliteal Arteries


September 15, 2011

September 15, 2011 — Very positive results were reported in the first account of a clinical study evaluating the effectiveness of angioplasty with drug-eluting balloons for critical limb ischemia (CLI) below the knee. It is the most severe form of peripheral artery disease (PAD). The data appeared in Journal of the American College of Cardiology (JACC) Sept. 6.  

The article is titled “First Experience with Drug-Eluting Balloons in Infrapoplital Arteries.” Andrej Schmidt, M.D., of Park Hospital Leipzig in Germany, led the study. He found that treating CLI with Medtronic’s In.Pact Amphirion paclitaxel-eluting balloon in arteries shows promising results for limb salvage rates and an encouragingly low rate of restenosis to about one year.

Individuals with CLI are a subgroup of PAD patients who often are very sick and at the highest risk of limb loss and mortality. In the 104 patients in the study population, there was a high prevalence of major comorbidities, including diabetes (71 percent), chronic kidney disease (46 percent) and coronary artery disease (46 percent).

Currently treated with bypass graft surgery and traditional balloon angioplasty, CLI patients have less than optimal outcomes; limb salvage rates are roughly 75 percent in patients that undergo surgical bypass grafting. Restenosis, or renarrowing of the artery, occurs in 70 percent of patients treated with traditional balloon angioplasty. Within one year of seeking treatment for CLI, 20 percent of patients will die.

Restenosis rates with standard angioplasty of long infrapopliteal lesions approaches 69 percent at three months, with high rates of long segment occlusions. Schmidt and colleagues report the first experience using a paclitaxel-eluting balloon for these lesions in 104 patients with either critical limb ischemia or severe claudication.

The three-month binary restenosis rate was 27 percent, and the restenotic segments were usually short. At one year, there was clinical improvement in 91percent of treated limbs, with complete wound healing in 74 percent.

In this trial, the use of a drug-eluting balloon was associated with much lower rates of restenosis than has been historically seen with infrapopliteal disease.

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