title: A randomized, controlled, multicenter trial to evaluate the safety and efficacy of Zotarolimus- vs. Paclitaxel-eluting stents in de novo occlusive lesions in coronary arteries: five-year results from the ZOMAXX I trial.
abstract: BACKGROUND
  The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent (ZoMaxx(™) ) when compared with a paclitaxel-eluting coronary stent (Taxus(™) Express(2™) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. Angiographic analysis at the primary endpoint of 9 months has been reported previously. The purpose of this follow-on analysis was to describe the clinical results of the ZoMaxx and Taxus cohorts of the ZOMAXX I trial after 5 years.
  
  
  RESULTS
  In the ZOMAXX I trial, 199 patients received a ZoMaxx stent and 197 patients received a Taxus stent at 29 investigative sites in Europe, Australia, and New Zealand. The two groups were generally well matched with respect to both clinical and lesional characteristics, including the incidence of diabetes (ZoMaxx 22% vs. Taxus 26%; P = 0.29), reference vessel diameter (ZoMaxx 2.79 ± 0.43 mm vs. Taxus 2.81 ± 0.46 mm; P = 0.65), and lesion length (ZoMaxx 14.9 ± 5.7 mm vs. Taxus 14.6 ± 5.5; P = 0.61). Through 5 years of follow-up, a total of 21 patients had died, six patients had withdrawn, nine had been lost to follow-up, and 13 missed their 5-year visit, leaving a total of 347 patients for analysis (169 ZoMaxx and 178 Taxus). At the 5-year time point, there were no significant differences in any clinical metric including ischemia-driven target lesion revascularization (TLR; ZoMaxx 10.6% vs. Taxus 7.1%; P = 0.29), Q-wave myocardial infarction (ZoMaxx 1.5% vs. Taxus 1.0%; P = 0.99), definite/probable stent thrombosis (ZoMaxx 1.5% vs. Taxus 3.0%; P = 0.34), and cardiac death (ZoMaxx 3.0% vs. Taxus 1.0%; P = 0.28).
  
  
  CONCLUSIONS
  After 5 years, the differences in clinical outcome between patients treated with ZoMaxx vs. Taxus stents did not reach statistical significance. However, the nominally higher rate of ischemia-driven TLR (10.6 vs. 7.1%) and the previously reported higher rate of restenosis after 9 months suggest that the ZoMaxx stent afforded less neointimal inhibition when compared with Taxus. © 2013 Wiley Periodicals, Inc.
authors.affiliation: Institut Cardio-vasculaire, Paris-Sud, Massy, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: Carlo
authors.initials: C
authors.lastname: Dimario
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.forename: David O
authors.initials: DO
authors.lastname: Williams
authors.forename: John
authors.initials: J
authors.lastname: Ormiston
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: Robert
authors.initials: R
authors.lastname: Whitbourn
authors.forename: Jessie
authors.initials: J
authors.lastname: Coe
authors.forename: Lewis B
authors.initials: LB
authors.lastname: Schwartz
mesh_terms: D000368:Aged; D001315:Australia; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D058426:Neointima; D009520:New Zealand; D017239:Paclitaxel / Q000008:administration & dosage*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011474:Prosthesis Design; D012307:Risk Factors; D012720:Severity of Illness Index; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; C489443:zotarolimus; D017239:Paclitaxel; D020123:Sirolimus
keywords: drug delivery; percutaneous coronary intervention; restenosis