Drug-Eluting Balloons Studied in Infrapopliteal Arteries

August 29, 2011—In the Journal of American College of Cardiology, Andrej Schmidt, MD, et al have published findings from a study that investigated the efficacy of drug-eluting balloons in the treatment of long infrapopliteal lesions with regard to the short-term restenosis rate and midterm clinical result (2011;58:1105–1109). The investigators noted that restenosis rates of long-segment tibial artery disease are very high, and a restenosis rate of 69% at 3 months after standard balloon angioplasty was recently demonstrated.

As detailed by the investigators, infrapopliteal angioplasty was performed with a paclitaxel-eluting balloon (In.Pact Amphirion, Medtronic, Inc., Minneapolis, MN). Clinical and angiographic follow-up was performed at 3 months to detect binary restenosis, and further clinical assessment was performed over a 12-month period. In 104 patients, 109 limbs were treated for critical limb ischemia (82.6%) or severe claudication (17.4%). Mean lesion length of the arteries treated was 176 ± 88 mm.

Angiography in 84 treated arteries at 3 months showed restenosis in 27.4% of patients (19.1% had restenosis > 50%, and 8.3% were totally occluded) and usually occurred focally. Of all angiographically followed-up arteries, the entire treated segment was restenosed or reoccluded in only 9.5%. During a follow-up period of 378 ± 65 days, one patient was lost and 17 died. Of the 91 limbs remaining in the analysis, clinical improvement was present in 83 (91.2%). Complete wound healing occurred in 74.2%, whereas major amputation occurred in four patients, resulting in a limb salvage rate of 95.6% for patients with critical limb ischemia.

The investigators concluded that the early restenosis rate of long-segment infrapopliteal disease is significantly lower after treatment with drug-eluting balloons compared with historical data using uncoated balloons. They advised that randomized trials are required to show whether this difference will lead to improvement in clinical outcomes.

In an accompanying editorial, Michael R. Jaff, DO, noted that the study investigators are among the most prolific of clinical vascular researchers of the modern era and that this study continues their distinguished contribution (2011;58:1110–1111). Dr. Jaff stated that the investigators have demonstrated for the first time impressive results of endovascular intervention using an angioplasty balloon coated with paclitaxel and urea, a novel spacer. However, Dr. Jaff observed that the study is limited in size and scope. Also, there is a need to demonstrate the comparative cost effectiveness of the technology. He commented, “For any endovascular technology to represent a true breakthrough, not only must the treatment promote improvement in functional capacity and limb salvage, but also strategies to prolong overall survival must be even more effective. Without the latter, the relevance of patent limb arteries wanes.”