title: A randomized, controlled, multi-center trial comparing the safety and efficacy of zotarolimus-eluting and paclitaxel-eluting stents in de novo lesions in coronary arteries: final results of the ZoMaxx II trial.
abstract: OBJECTIVE
  The purpose of this prospective, randomized, single-blind controlled clinical trial was to compare the effectiveness of a zotarolimus-eluting stent (ZoMaxx™) with a paclitaxel-eluting coronary stent (Taxus™ Express(2)™) in patients with angina pectoris and a single native coronary artery lesion between 10-28 mm in length and 2.5-3.75mm in diameter.
  
  
  METHODS
  Patients were enrolled at 75 international institutions between June 2005 and November 2006.
  
  
  RESULTS
  1099 (1672 originally planned) patients received 557 ZoMaxx and 542 Taxus stents: cohorts were well-matched for diabetes (27% vs. 27%), reference vessel diameter (2.73 ± 0.46mm vs. 2.74 ± 0.45mm) and lesion length (14.8 ± 6.7mm vs. 14.3 ± 6.4mm). Nine month clinical and angiographic follow-up was available in 1052/1099 (96%) and 649/836 (78%) patients, respectively. The safety profiles for the two stents (myocardial infarction (MI), cardiac death and/or target vessel revascularization (TVR)) were similar (ZoMaxx 8.7% vs. Taxus 6.9%, p=NS). The primary endpoint of 9-month TVR occurred more frequently after treatment with ZoMaxx (6.8%) as compared with Taxus (4.2%), therefore the primary clinical endpoint was not met. However, the 9-month in-segment late lumen loss for ZoMaxx (0.29 ± 0.47mm) and Taxus (0.22 ± 0.41mm, p=NS) were similar, thus satisfying the primary angiographic endpoint. Secondary endpoints of the rates of in-segment and in-stent binary restenosis were also similar (5.9% vs. 5.8%, 7.8% vs. 7.9%, respectively).
  
  
  CONCLUSIONS
  At 9months, the ZoMaxx stent failed to achieve the primary endpoint of non-inferiority in TVR to the Taxus stent, but safety endpoints were equal between the two stent systems.
authors.affiliation: Columbia University Medical Center, New York, NY, USA.
authors.forename: William A
authors.initials: WA
authors.lastname: Gray
authors.forename: Alan C
authors.initials: AC
authors.lastname: Yeung
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Fitzgerald
authors.forename: David O
authors.initials: DO
authors.lastname: Williams
authors.forename: Hubertus
authors.initials: H
authors.lastname: Heuer
authors.forename: Charles D
authors.initials: CD
authors.lastname: O'Shaughnessy
authors.forename: Paul A
authors.initials: PA
authors.lastname: Overlie
authors.forename: J Tift
authors.initials: JT
authors.lastname: Mann
authors.forename: Louis A
authors.initials: LA
authors.lastname: Cannon
authors.forename: James B
authors.initials: JB
authors.lastname: Hermiller
authors.forename: Timothy D
authors.initials: TD
authors.lastname: Henry
authors.forename: Robert
authors.initials: R
authors.lastname: Whitbourn
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Stuckey
authors.forename: Mark G
authors.initials: MG
authors.lastname: Midei
authors.forename: Jessie
authors.initials: J
authors.lastname: Coe
authors.forename: Lewis B
authors.initials: LB
authors.lastname: Schwartz
mesh_terms: D000787:Angina Pectoris / Q000000981:diagnostic imaging / Q000188:drug therapy; D015331:Cohort Studies; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000188:drug therapy; D003331:Coronary Vessels / Q000187:drug effects* / Q000473:pathology*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D006801:Humans; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011859:Radiography; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: C489443:zotarolimus; D017239:Paclitaxel; D020123:Sirolimus