title: Lower limb multilevel treatment with drug-eluting balloons: 6-month results from the DEBELLUM randomized trial.
abstract: OBJECTIVE
  To report 6-month results of the DEBELLUM (Drug-Eluting Balloon Evaluation for Lower Limb MUltilevel TreatMent) randomized trial to evaluate the efficacy of a drug-eluting balloon (DEB) to reduce restenosis after treatment of multilevel lower limb occlusive disease vs. a conventional angioplasty balloon (AB).
  
  
  METHODS
  Between September 2010 and March 2011, 50 consecutive patients (37 men; mean age 66±4 years) with 122 lesions (96 stenoses and 26 occlusions) of the femoropopliteal (92, 75.4%) or below-the-knee (BTK) arteries (30, 24.6%) were enrolled and randomly assigned to the DEB (25 patients with 57 lesions) or AB (25 patients with 65 lesions) group. Twenty patients presented multilevel lesions. Mean lesion length was 7.5±3.5 cm. Thirty-one (62%) of the patients were Fontaine stage IIb, while 19 (38%) were stage III or IV. DEBs or ABs were used for dilation of de novo lesions or for postdilation after primary stenting (superficial femoral artery only). Patients requiring provisional stenting after angioplasty secondary to flow-limiting dissection or residual stenosis >50% were ineligible. Primary endpoint was late lumen loss at 6 months. Secondary endpoints were target lesion revascularization (TLR), amputation, and thrombosis.
  
  
  RESULTS
  Late lumen loss was lower in the DEB group (0.5±1.4 vs. 1.6±1.7 mm, p<0.01). TLR was necessary in 6.1% of the DEB group vs. 23.6% of the AB group (p=0.02). Comparing the DEB to AB groups, the thrombosis rates were 3.0% vs. 5.2% (p=0.6), and the amputation rates were 3.0% vs. 7.9% (p=0.36). The binary restenosis rates were 9.1% (3/33 limbs) in the DEB group vs. 28.9% (11/38 limbs) in the control group (p=0.03). The ankle-brachial index improved to a greater degree in the DEB group: 0.87±0.22 vs. 0.70±0.13 (p<0.05). The Fontaine stage improved in both groups but more so in patients treated with DEBs (p=0.04).
  
  
  CONCLUSIONS
  The DEBELLUM trial confirmed the ability of paclitaxel-eluting balloons to reduce restenosis vs. conventional balloons at 6 months after treatment of multilevel (femoropopliteal and BTK) arterial disease in patients affected by claudication and CLI. A lower TLR rate and better clinical outcomes appear to be associated with the use of DEBs regardless of stent placement.
authors.affiliation: Vascular and Interventional Radiology Unit, Department of Radiological Sciences, Sapienza University of Rome, Italy. fabrizio.fanelli@uniroma1.it
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Fanelli
authors.forename: Alessandro
authors.initials: A
authors.lastname: Cannavale
authors.forename: Emanuele
authors.initials: E
authors.lastname: Boatta
authors.forename: Mario
authors.initials: M
authors.lastname: Corona
authors.forename: Pierleone
authors.initials: P
authors.lastname: Lucatelli
authors.forename: Andrea
authors.initials: A
authors.lastname: Wlderk
authors.forename: Carlo
authors.initials: C
authors.lastname: Cirelli
authors.forename: Filippo Maria
authors.initials: FM
authors.lastname: Salvatori
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000628:therapy*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003251:Constriction, Pathologic; D004337:Drug Carriers; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D006801:Humans; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011150:Popliteal Artery / Q000000981:diagnostic imaging; D011446:Prospective Studies; D011859:Radiography; D012008:Recurrence; D012384:Rome; D012720:Severity of Illness Index; D015607:Stents; D013927:Thrombosis / Q000209:etiology / Q000628:therapy; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices
chemical_list: D002317:Cardiovascular Agents; D004337:Drug Carriers; D017239:Paclitaxel