Published Online
on August 14, 2006

A more recent version of this article appeared on August 22, 2006

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Submitted on November 7, 2005
Revised on June 5, 2006
Accepted on June 14, 2006

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

Jean Fajadet MD, William Wijns MD, PhD^*, Gert-Jan Laarman MD, Karl-Heinz Kuck MD, John Ormiston MD, Thomas Münzel MD, PhD, Jeffrey J. Popma MD, Peter J. Fitzgerald MD, Raoul Bonan MD, Richard E. Kuntz MD, MSc, for the ENDEAVOR II Investigators

From the Clinique Pasteur, Toulouse, France (J.F.); Cardiovascular Center, Aalst, Belgium (W.W.); OLV Gasthuis, Amsterdam, the Netherlands (G.-J.L.); Krankenhaus Sankt Georg, Hamburg, Germany (K.-H.K.); Mercy Hospital, Auckland, New Zealand (J.O.); Universitätsklinikum, Hamburg-Eppendorf, Germany (T.M.); Brigham and Women’s Hospital, Boston, Mass (J.J.P); Stanford University, Stanford, Calif (P.F); Medtronic Vascular, Santa Rosa, Calif (R.B.); and Harvard Medical School, Boston, Mass (R.E.K).

^* To whom correspondence should be addressed. E-mail: william.wijns{at}olvz-aalst.be.

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

Methods and 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.

Key words: coronary disease • restenosis • revascularization • stents

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