title: Drug coated balloons below-the-knee: just too early?
abstract: Patients with infrapopliteal arterial disease are generally considered challenging due to the usual presence of multivessel atherosclerotic disease. Several treatment options have been used by different authors but none of them can be considered ideal. In the last few years drug coated balloons have gained popularity especially due to the extraordinary results in the femoro-popliteal region. Following the great success, physicians started to use this promising device also in the below-the-knee (BTK) region. The initial enthusiasm correlated to some studies is not confirmed by the largest randomized trial, IN.PACT Deep, comparing In.Pact DCB to standard PTA. This trial failed completely to show the superiority of drug coated balloon (DCB). The negative outcome was mainly correlated to safety issues with an amputation rate higher for the drug coated balloon when compared to the conventional balloon (8.8% DCB vs.3.6% PTA, P=0.08). A thorough evaluation has been performed to justify these negative outcomes, given the good results reported by other studies. But nowadays it is still difficult to find a clear explanation. Especially for this negative outcome and for the big difference, in term of results, between the different studies in the BTK region and also between the above and below the knee regions more trials are mandatory.
authors.affiliation: Vascular and Interventional Unit, Department of Radiological Sciences, "Sapienza" University of Rome, Rome, Italy - fabrizio.fanelli@uniroma1.it.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Fanelli
authors.forename: Alessandro
authors.initials: A
authors.lastname: Cannavale
mesh_terms: D000800:Angioplasty, Balloon / Q000295:instrumentation*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D001157:Arterial Occlusive Diseases / Q000188:drug therapy*; D020099:Coated Materials, Biocompatible; D016503:Drug Delivery Systems / Q000295:instrumentation*; D054855:Drug-Eluting Stents; D057510:Endovascular Procedures / Q000295:instrumentation*; D004867:Equipment Design; D006801:Humans; D007866:Leg / Q000098:blood supply; D017239:Paclitaxel / Q000008:administration & dosage*; D016491:Peripheral Vascular Diseases / Q000188:drug therapy*; D011150:Popliteal Artery; D013499:Surface Properties; D017211:Treatment Failure
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel