title: DANUBIO - a new drug-eluting balloon for the treatment of side branches in bifurcation lesions: six-month angiographic follow-up results of the DEBSIDE trial.
abstract: OBJECTIVE
  We aimed to evaluate the role of drug-eluting balloon SB inflation, using the novel DANUBIO balloon, after placement of a drug-eluting stent in the main branch in patients with bifurcation lesions.
  
  
  RESULTS
  Fifty-two patients with bifurcation lesions suitable for stenting were enrolled in the DEBSIDE trial at eight French centres between May 2012 and July 2013. Two patients were excluded from the trial because of significant protocol deviations. Systematic Nile PAX stent placement was followed by final drug-eluting balloon inflation, using the DANUBIO balloon, according to the size of the side branch. Clinical follow-up was scheduled at one, six, and twelve months and an angiographic control at six months. The primary endpoint was six-month late lumen loss (LLL) at the ostium of the side branch. Secondary endpoints were main branch (MB) LLL, binary restenosis of the SB and MB, and clinically driven revascularisation rates for both branches. The procedural success rate was 100%. Angiographic control at six months post-procedure was performed in 48 patients (96%). Two patients with no reported clinical events refused the angiographic control. At six-month follow-up the primary endpoint of side branch LLL was -0.04±0.34 mm and the secondary endpoint of MB LLL was 0.54±0.60 mm. There was only one myocardial infarction (2%) and no reported cardiac deaths. Only one patient (2%) had a non-clinically driven target lesion revascularisation (TLR) at the level of the side branch combined with a main branch revascularisation.
  
  
  CONCLUSIONS
  Systematic final inflation of a DANUBIO balloon in the side branch after placement of a Nile PAX stent in the main branch for the treatment of a bifurcation lesion is safe and effective and results in very low LLL and a low restenosis rate at the side branch ostium. The DEBSIDE clinical trial was registered at the United States National Institute of Health website (NCT01485081).
authors.affiliation: Clinique Saint-Hilaire, Rouen, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Berland
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefèvre
authors.forename: Philippe
authors.initials: P
authors.lastname: Brenot
authors.forename: Jean
authors.initials: J
authors.lastname: Fajadet
authors.forename: Pascal
authors.initials: P
authors.lastname: Motreff
authors.forename: Patrice
authors.initials: P
authors.lastname: Guerin
authors.forename: Patrick
authors.initials: P
authors.lastname: Dupouy
authors.forename: Christian
authors.initials: C
authors.lastname: Schandrin
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D054855:Drug-Eluting Stents; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel