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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients With Native Coronary Artery Disease

A Randomized Controlled Trial

David E. Kandzari, MD, FACC^_*,_*, Martin B. Leon, MD, FACC, Jeffrey J. Popma, MD, FACC, Peter J. Fitzgerald, MD, FACC^||, Charles O’Shaughnessy, MD, FACC^#, Michael W. Ball, MD, FACC^_**, Mark Turco, MD, FACC, Robert J. Applegate, MD, FACC, Paul A. Gurbel, MD, FACC, Mark G. Midei, MD, FACC, Sejal S. Badre, MS, Laura Mauri, MD, MSc, FACC, Kweli P. Thompson, MD^¶, LeRoy A. LeNarz, MD^¶, Richard E. Kuntz, MD, FACC^¶ for the ENDEAVOR III Investigators

^_* Duke Clinical Research Institute, Durham, North Carolina
Baptist Medical Center and Wake Forest University, Winston-Salem, North Carolina
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
Harvard Clinical Research Institute and Brigham and Women’s Hospital, Boston, Massachusetts
^|| Stanford University Medical Center, Palo Alto, California
^¶ Medtronic, Inc., Santa Rosa, California
^# North Ohio Heart Center, Elyria, Ohio
^_** St. Vincent’s Hospital, Indianapolis, Indiana
Washington Adventist Hospital, Takoma Park, Maryland
Sinai Center for Thrombosis Research, Baltimore, Maryland
St. Joseph’s Medical Center, Towson, Maryland.

Manuscript received March 24, 2006; revised manuscript received August 7, 2006, accepted August 7, 2006.

^_* Reprint requests and correspondence: Dr. David E. Kandzari, Room 7063, Duke Clinical Research Institute, 2400 Pratt Street, Durham, North Carolina 27705. (Email: david.kandzari{at}duke.edu).

OBJECTIVES: This trial examined the relative clinical efficacy, angiographic outcomes, and safety of zotarolimus-eluting coronary stents (ZES) with a phosphorylcholine polymer versus sirolimus-eluting stents (SES).

BACKGROUND: Whether a cobalt-based alloy stent coated with the novel antiproliferative agent, zotarolimus, and a phosphorylcholine polymer may provide similar angiographic and clinical benefit compared with SES is undetermined.

METHODS: A prospective, multicenter, 3:1 randomized trial was conducted to evaluate the safety and efficacy of ZES (n = 323) relative to SES (n = 113) in 436 patients undergoing elective percutaneous revascularization of de novo native coronary lesions with reference vessel diameters between 2.5 mm and 3.5 mm and lesion length 14 mm and 27 mm. The primary end point was 8-month angiographic in-segment late lumen loss.

RESULTS: Angiographic in-segment late lumen loss was significantly higher among patients treated with ZES compared with SES (0.34 ± 0.44 mm vs. 0.13 ± 0.32 mm, respectively; p < 0.001). In-hospital major adverse cardiac events were significantly lower among patients treated with ZES (0.6% vs. 3.5%, p = 0.04). In-segment binary angiographic restenosis was also higher in the ZES cohort (11.7% vs. 4.3%, p = 0.04). Total (clinically and non-clinically driven) target lesion revascularization rates at 9 months were 9.8% and 3.5% for the ZES and SES groups, respectively (p = 0.04). However, neither clinically driven target lesion revascularization (6.3% zotarolimus vs. 3.5% sirolimus, p = 0.34) nor target vessel failure (12.0% zotarolimus vs. 11.5% sirolimus, p = 1.0) differed significantly.

CONCLUSIONS: Compared with SES, treatment with a phosphorylcholine polymer-based ZES is associated with significantly higher late lumen loss and binary restenosis at 8-month angiographic follow-up.

(The Endeavor III CR; http://clinicaltrials.gov/ct/show/ NCT00265668 [ClinicalTrials.gov] ?order=1?)

Abbreviations and Acronyms   CK = creatine kinase   IVUS = intravascular ultrasound   MACE = major adverse cardiac events   MLD = minimal lumen diameter   SES = sirolimus-eluting stent   ZES = zotarolimus-eluting stent

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