title: Non-polymer-based paclitaxel-coated coronary stents for the treatment of patients with de novo coronary lesions: angiographic follow-up of the DELIVER clinical trial.
abstract: BACKGROUND
  Paclitaxel, a microtubule-stabilizing compound with potent antitumor activity, has been shown to inhibit smooth muscle cell proliferation and migration. The DELIVER trial was a prospective, randomized, blinded, multicenter clinical evaluation of the non-polymer-based paclitaxel-coated ACHIEVE stent compared with the stainless steel Multi-Link (ML) PENTA stent.
  
  
  RESULTS
  A total of 1043 patients with focal de novo coronary lesions, <25 mm in length, in 2.5- to 4.0-mm vessels were randomized (ACHIEVE n=524; ML PENTA n=519). Angiographic follow-up was performed in a subset of 442 patients (ACHIEVE n=228; ML PENTA n=214). Prespecified end points were a 40% reduction in target-vessel failure at 9 months (primary clinical end point) and a 50% reduction in binary restenosis at 8 months (major secondary end point). Baseline clinical characteristics were comparable between the groups. Patients in ACHIEVE had more type C lesions and a larger reference diameter. At follow-up, stent late loss was 0.81 versus 0.98 mm (P=0.003), stent binary restenosis was 14.9% versus 20.6% (P=0.076), and target-vessel failure was 11.9% versus 14.5% (P=0.12) for ACHIEVE and ML PENTA, respectively.
  
  
  CONCLUSIONS
  The ACHIEVE paclitaxel-coated stent decreased neointimal proliferation compared with the bare-metal PENTA stent; however, this reduction was insufficient to meet the prespecified primary end point of target-vessel failure and the secondary end point of binary restenosis.
authors.affiliation: Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, 55 E 59th St, 6th Floor, New York, NY 10022-1112, USA. alansky@crf.org
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: Ricardo A
authors.initials: RA
authors.lastname: Costa
authors.forename: Gary S
authors.initials: GS
authors.lastname: Mintz
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Tsuchiya
authors.forename: Mark
authors.initials: M
authors.lastname: Midei
authors.forename: David A
authors.initials: DA
authors.lastname: Cox
authors.forename: Charles
authors.initials: C
authors.lastname: O'Shaughnessy
authors.forename: Robert A
authors.initials: RA
authors.lastname: Applegate
authors.forename: Louis A
authors.initials: LA
authors.lastname: Cannon
authors.forename: Michael
authors.initials: M
authors.lastname: Mooney
authors.forename: Anthony
authors.initials: A
authors.lastname: Farah
authors.forename: Mark A
authors.initials: MA
authors.lastname: Tannenbaum
authors.forename: Steven
authors.initials: S
authors.lastname: Yakubov
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.forename: S Chiu
authors.initials: SC
authors.lastname: Wong
authors.forename: Barry
authors.initials: B
authors.lastname: Kaplan
authors.forename: Ecaterina
authors.initials: E
authors.lastname: Cristea
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: William D
authors.initials: WD
authors.lastname: Knopf
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neill
mesh_terms: D003131:Combined Modality Therapy; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000175:diagnosis / Q000628:therapy*; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use; D015607:Stents; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel