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.
BACKGROUND
The use of the Endeavor stent might reduce restenosis and stent thrombosis at 9 months.


RESULTS
Patients (n = 1197) 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). 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 35.0% to 13.2% with Endeavor (P < 0.0001). There was no excessive edge stenosis, aneurysm formation, or late acquired malapposition 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.
Fajadet
Jean
J
Clinique Pasteur, Toulouse, France.
Wijns
William
W
Laarman
Gert-Jan
GJ
Kuck
Karl-Heinz
KH
Ormiston
John
J
Münzel
Thomas
T
Popma
Jeffrey J
JJ
Fitzgerald
Peter J
PJ
Bonan
Raoul
R
Kuntz
Richard E
RE
D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002214:Capsules; D006328:Cardiac Catheterization; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000601:surgery*; D004311:Double-Blind Method; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015607:Stents
D000900:Anti-Bacterial Agents; D002214:Capsules; C489443:zotarolimus; D020123:Sirolimus