Oct. 15, 2012 Use of balloon angioplasty and placement of stents to widen clogged arteries have become standard medical procedure. Further advancing this treatment, drug-eluting devices are now delivering medication directly to the site where it can be most effective. While this technique has met with success in coronary arteries, its use in peripheral arteries is still under study.
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.
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- Fabrizio Fanelli, Alessandro Cannavale, Emanuele Boatta, Mario Corona, Pierleone Lucatelli, Andrea Wlderk, Carlo Cirelli, Filippo Maria Salvatori. Lower Limb Multilevel Treatment With Drug-Eluting Balloons:6-Month Results From the DEBELLUM Randomized Trial. Journal of Endovascular Therapy, 2012; 19 (5): 571 DOI: 10.1583/JEVT-12-3926MR.1
- Ramon L. Varcoe. Commentary: Drug-Eluting Balloons:Are They the Magic Bullet? Journal of Endovascular Therapy, 2012; 19 (5): 581 DOI: 10.1583/JEVT-12-3926C.1
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