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MINERVA CARDIOANGIOLOGICA

A Journal on Heart and Vascular Diseases


Official Journal of the Italian Society of Angiology and Vascular Pathology
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ORIGINAL ARTICLES  INNOVATIONS IN ENDOVASCULAR INTERVENTIONS


Minerva Cardioangiologica 2007 February;55(1):1-18

language: English

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

Fajadet J., Wijns W., Laarman G.-J., Kuck K.-H., Ormiston J., Münzel T., Popma J. J., Fitzgerald P. J., Bonan R., Kuntz R. E., for the Endeavor II Investigators

1 Clinique Pasteur, Toulouse, France
2 Cardiovascular Center, Aalst, Belgium
3 OLV Gasthuis, Amsterdam, The Netherlands
4 Krankenhaus Sankt Georg, Hamburg, Germany
5 Mercy Hospital, Auckland, New Zealand
6 Universitätsklinikum Hamburg-Eppendorf, Germany
7 Brigham and Women’s Hospital, Boston, MA, USA
8 Stanford University, Stanford, CA, USA
9 Medtronic Vascular, Santa Rosa, CA, USA
10 Harvard Medical School, Boston, MA, USA


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Aim. 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 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.

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