No abstract

No abstract

No abstract

for the ENDEAVOR II InvestigatorsBackground-The use of the Endeavor stent might reduce restenosis and stent thrombosis at 9 months. Methods and Results-Patients (nϭ1197) 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 (nϭ598) or the same bare metal stent but without the drug or the polymer coating (nϭ599). 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 (Pϭ0.0001), and the rate of major adverse cardiac events was reduced from 14.4% with the bare metal stent to 7.3% with the Endeavor (Pϭ0.0001). Target lesion revascularization was 4.6% with Endeavor compared with 11.8% with the bare metal stent (Pϭ0.0001). 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 1.03Ϯ0.58 to 0.61Ϯ0.46 (PϽ0.001) in stent and from 0.72Ϯ0.61 to 0.36Ϯ0.46 (PϽ0.001) in segment. The rate of in-segment restenosis was reduced from 35.0% to 13.2% with Endeavor (PϽ0.0001). 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 (PϽ0.0001). Conclusions-Compared