title: A multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in bifurcation lesions treated with a single-stenting technique: six-month angiographic and 12-month clinical results of the drug-eluting balloon in bifurcations trial.
abstract: BACKGROUND
  Percutaneous treatment of coronary bifurcation lesions remains hampered by suboptimal results, mainly in the side branch (SB), even with the use of drug-eluting stents (DES). Paclitaxel drug-eluting balloons (DEB) could provide an attractive alternative to treat bifurcations in combination with a provisional T-stenting technique in order to minimize SB restenosis. We compared angiographic and clinical outcomes of a provisional T-stenting technique with a DEB plus bare-metal stent (BMS) versus BMS versus paclitaxel DES.
  
  
  METHODS
  In this randomized, international, multicenter, single-blinded 3-arm study, 117 patients with coronary bifurcation lesions underwent treatment with: (A) DEB in both main branch (MB) and SB and BMS in MB; (B) BMS in MB and regular balloon angioplasty in SB; or (C) paclitaxel DES in MB and regular balloon in SB. All patients underwent provisional T-stenting with an identical stent platform in the MB. Paclitaxel was the drug for elution in groups A and C. The primary endpoint was 6-month angiographic late luminal loss. Secondary end points were 6-month binary restenosis and 12-month major adverse cardiac events (MACE: death, myocardial infarction, target vessel revascularization).
  
  
  RESULTS
  The procedure was successful in all cases. Late luminal loss, measured respectively in the proximal MB, distal MB and SB was 0.58 ± 0.65, 0.41 ± 0.60, and 0.19 ± 0.66 mm in group A; 0.60 ± 0.65, 0.49 ± 0.85, and 0.21 ± 0.57 mm in group B; and 0.13 ± 0.45, 0.19 ± 0.64, and 0.11 ± 0.43 mm in group C (P = 0.001). Binary restenosis rates per bifurcation and MACE rates were 24.2%, 28.6%, and 15% (P = 0.45) and 20%, 29.7%, and 17.5% (P = 0.40) in groups A, B, and C, respectively.
  
  
  CONCLUSIONS
  Pretreatment of both MB and SB with DEB failed to show angiographic and clinical superiority over conventional BMS, using a provisional T-stenting technique. Moreover DES showed superior angiographic results than DEB and BMS.
authors.affiliation: Department of Cardiology, University Medical Center Utrecht, Heidelberglaan 100, room E.01.207, 3584 CX, Utrecht, The Netherlands. p.stella@umcutrecht.nl
authors.forename: Pieter R
authors.initials: PR
authors.lastname: Stella
authors.forename: Anouar
authors.initials: A
authors.lastname: Belkacemi
authors.forename: Christophe
authors.initials: C
authors.lastname: Dubois
authors.forename: Hendrik
authors.initials: H
authors.lastname: Nathoe
authors.forename: Jo
authors.initials: J
authors.lastname: Dens
authors.forename: Christoph
authors.initials: C
authors.lastname: Naber
authors.forename: Tom
authors.initials: T
authors.lastname: Adriaenssens
authors.forename: Eric
authors.initials: E
authors.lastname: van Belle
authors.forename: Pieter
authors.initials: P
authors.lastname: Doevendans
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Agostoni
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000209:etiology / Q000401:mortality; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D054855:Drug-Eluting Stents; D005060:Europe; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D012307:Risk Factors; D016037:Single-Blind Method; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D008670:Metals; D017239:Paclitaxel