title: Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions. Clinical and angiographic results of the ENDEAVOR II Trial.
abstract: OBJECTIVE
  The use of the Endeavor stent might reduce restenosis and stent thrombosis at 9 months.
  
  
  METHODS
  Patients (n =1,197) treated for single coronary artery stenosis were enrolled in a prospective, randomized, double-blind study and randomly assigned to receive the Endeavor zotarolimus-eluting phosphorylcholine polymer-coated stent (n= 598) or the same bare metal stent but without the drug or the polymer coating (n=599).
  
  
  RESULTS
  The 2 groups were well matched in baseline characteristics. Diabetes was present in 20.1% of patients; the mean reference vessel diameter was 2.75 mm; and the mean lesion length was 14.2 mm. The primary end point of target vessel failure at 9 months was reduced from 15.1% with the bare metal stent to 7.9% with the Endeavor (P=0.0001), and the rate of major adverse cardiac events was reduced from 14.4% with the bare metal stent to 7.3% with the Endeavor (P=0.0001). Target lesion revascularization was 4.6% with Endeavor compared with 11.8% with the bare metal stent (P=0.0001). The rate of stent thrombosis was 0.5% with the Endeavor, which was not significantly different from 1.2% with the bare metal stent. In 531 patients submitted to angiographic follow-up, late loss was reduced from 1.03+/-0.58 to 0.61+/-0.46 (P<0.001) in stent and from 0.72+/-0.61 to 0.36+/-0.46 (P<0.001) in segment. The rate of in-segment restenosis was reduced from 35% to 13.2% with Endeavor (P<0.0001). There was no excessive edge stenosis, aneurysm formation, or late acquired malposition by intravascular ultrasound imaging. Differences in clinical outcome were maintained at 12 and 24 months (P<0.0001).
  
  
  CONCLUSIONS
  Compared with bare metal stents, the Endeavor stent is safe and reduces the rates of clinical and angiographic restenosis at 9, 12, and 24 months.
authors.affiliation: Clinique Pasteur, Toulouse, France.
authors.forename: J
authors.initials: J
authors.lastname: Fajadet
authors.forename: W
authors.initials: W
authors.lastname: Wijns
authors.forename: G-J
authors.initials: GJ
authors.lastname: Laarman
authors.forename: K-H
authors.initials: KH
authors.lastname: Kuck
authors.forename: J
authors.initials: J
authors.lastname: Ormiston
authors.forename: T
authors.initials: T
authors.lastname: Münzel
authors.forename: J J
authors.initials: JJ
authors.lastname: Popma
authors.forename: P J
authors.initials: PJ
authors.lastname: Fitzgerald
authors.forename: R
authors.initials: R
authors.lastname: Bonan
authors.forename: R E
authors.initials: RE
authors.lastname: Kuntz
mesh_terms: D000368:Aged; D001315:Australia; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging* / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D004867:Equipment Design; D005060:Europe; D005260:Female; D006801:Humans; D007557:Israel; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D010139:Pacific Islands; D010767:Phosphorylcholine; D011446:Prospective Studies; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015607:Stents; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D010767:Phosphorylcholine; C489443:zotarolimus; D020123:Sirolimus