DEBELLUM: Drug-Eluting Balloon Angioplasty for Peripheral Arterial Disease Shows Promise
October 15, 2012 — The current issue of the Journal of Endovascular Therapy presents the 6-month results of the DEBELLUM randomized controlled trial (Drug-Eluting Balloon Evaluation for Lower Limb Multilevel Treatment), which tested the efficacy of a drug-eluting balloon (DEB) to reduce restenosis following treatment for peripheral artery disease.
Occlusions of the femoropopliteal or below-the-knee arteries can be treated with conventional balloon angioplasty to open the artery. Another option that has been the subject of several trials is the use of a DEB. It can deliver the drug paclitaxel, which inhibits the proliferation of cells, directly to the site of the opened occlusion or stent.
In the DEBELLUM trial, 50 patients were randomly assigned to either conventional angioplasty or the DEB procedure. These patients presented a total of 122 lesions in the femoropopliteal or below-the-knee arteries. Some patients in each group required insertion of a stent after balloon dilation.
Six months after the procedure, the group treated with the DEB showed better clinical outcomes than the group treated with conventional angioplasty. Late lumen loss, thrombosis, binary restenosis, target lesion revascularization, and amputation rates all were lower among the DEB group. Overall, the DEB group experienced better outcomes regardless of whether a stent had been placed.
The authors of an accompanying commentary cautioned that while the trial’s positive results are welcomed news, the procedure has yet to prove itself in the long term. How this technology can be used most effectively and most cost-efficiently has yet to be determined.
Full text of the article, “Lower Limb Multilevel Treatment With Drug-Eluting Balloons: 6-Month Results From the DEBELLUM Randomized Trial” and commentary article, Journal of Endovascular Therapy, Vol. 19, No. 5, 2012, are available at http://jevt.org/toc/enth/19/5.
