title: Elutax paclitaxel-eluting balloon followed by bare-metal stent compared with Xience V drug-eluting stent in the treatment of de novo coronary stenosis: a randomized trial.
abstract: BACKGROUND
  Paclitaxel-eluting balloons (PEBs) are a promising alternative to drug-eluting stent (DES) in the treatment of coronary stenoses. The aim of our study was to compare the 9-month restenosis rates of a strategy of predilatation with PEB followed by bare-metal CoCr stent (PEB + BMS group) versus implantation of everolimus DES (DES group).
  
  
  METHODS
  This randomized, single-center study planned to enroll 366 patients with stable angina (183 patients per arm) undergoing percutaneous coronary intervention of a de novo, native coronary artery stenosis ≤ 15 mm in length. Primary end point, in a noninferiority study design, was 9-month binary angiographic restenosis. A frequency-domain optical coherence tomography substudy investigated the percentage of uncovered stent struts per lesion, the percentage of malapposed/uncovered struts per lesion, and the percentage of net volume obstruction at 9-month follow-up among the first consecutive 30 patients enrolled in the PEB + BMS group.
  
  
  RESULTS
  The study was prematurely halted after enrollment of 125 patients, 59 in the PEB + BMS group and 66 in the DES group, because of excess of ischemia-driven target lesion revascularization in the PEB + BMS group. When all the enrolled patients completed their follow-up, IDLTR rates were 14% in the PEB + BMS versus 2% in DES group (P = .001). Binary restenosis, either in-stent or in-segment, was significantly higher in the PEB + BMS compared with DES group (17% vs 3% [P = .01] and 25% vs 4% [P = .009] respectively). Frequency-domain optical coherence tomography demonstrated important neointimal regrowth in the PEB + BMS group, similar to historical BMS data.
  
  
  CONCLUSIONS
  In the treatment of de novo coronary stenosis, a strategy of predilatation with PEB before BMS implantation was significantly inferior to implantation of an everolimus DES stent in terms of 9-month target lesion revascularization. Frequency-domain optical coherence tomography data confirm the lack of efficacy of this strategy.
authors.affiliation: Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Liistro
authors.forename: Italo
authors.initials: I
authors.lastname: Porto
authors.forename: Paolo
authors.initials: P
authors.lastname: Angioli
authors.forename: Simone
authors.initials: S
authors.lastname: Grotti
authors.forename: Kenneth
authors.initials: K
authors.lastname: Ducci
authors.forename: Giovanni
authors.initials: G
authors.lastname: Falsini
authors.forename: Leonardo
authors.initials: L
authors.lastname: Bolognese
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D060050:Angina, Stable / Q000188:drug therapy*; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000453:epidemiology* / Q000628:therapy; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D003331:Coronary Vessels / Q000473:pathology*; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods*; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015607:Stents / Q000009:adverse effects*; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus