Published Online
on January 26, 2009

A more recent version of this article appeared on February 10, 2009

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Submitted on July 1, 2008
Accepted on November 7, 2008

Randomized Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents. Two-Year Clinical Follow-Up From the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III Trial

Gregg W. Stone MD^*, Mark Midei MD, William Newman MD, Mark Sanz MD, James B. Hermiller MD, Jerome Williams MD, Naim Farhat MD, Ronald Caputo MD, Nicholas Xenopoulos MD, Robert Applegate MD, Paul Gordon MD, Roseann M. White MA, Krishnankutty Sudhir MD, PhD, Donald E. Cutlip MD, John L. Petersen MD, for the SPIRIT III Investigators

From the Columbia University Medical Center and Cardiovascular Research Foundation, New York, NY (G.W.S.); St Joseph Medical Center, Towson, Md (M.M.); Wake Medical Center, Raleigh, NC (W.N.); St Patrick Hospital, Missoula, Mont (M.S.); The Heart Center of Indiana, Indianapolis (J.B.H.); Presbyterian Hospital, Charlotte, NC (J.W.); EMH Regional Medical Center, Elyria, Ohio (N.F.); St Joseph's Hospital Health Center, Syracuse, NY (R.C.); Jewish Hospital, Louisville, Ky (N.X.); Wake Forest University Baptist Medical Center, Winston-Salem, NC (R.A.); Miriam Hospital, Providence, RI (P.G.); Abbott Vascular, Santa Clara, Calif (R.M.W., K.S.); Harvard Clinical Research Institute, Boston, Mass (D.E.C.); and Duke Clinical Research Institute, Durham, NC (J.L.P.).

^* To whom correspondence should be addressed. E-mail: gs2184{at}columbia.edu.

Background—In the prospective randomized Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial, an everolimus-eluting stent (EES) compared with a widely used paclitaxel-eluting stent (PES) resulted in a statistically significant reduction in angiographic in-segment late loss at 8 months and noninferior rates of target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) at 1 year. The safety and efficacy of EES after 1 year have not been reported.

Methods and Results—A total of 1002 patients with up to 2 de novo native coronary artery lesions (reference vessel diameter, 2.5 to 3.75 mm; lesion length 28 mm) were randomized 2:1 to EES versus PES. Antiplatelet therapy consisted of aspirin indefinitely and a thienopyridine for 6 months. Between 1 and 2 years, patients treated with EES compared with PES tended to have fewer episodes of protocol-defined stent thrombosis (0.2% versus 1.0%; P=0.10) and myocardial infarctions (0.5% versus 1.7%; P=0.12), with similar rates of cardiac death (0.3% versus 0.3%; P=1.0) and target vessel revascularization (2.9% versus 3.0%; P=1.0). As a result, at the completion of the 2-year follow-up, treatment with EES compared with PES resulted in a significant 32% reduction in target vessel failure (10.7% versus 15.4%; hazard ratio, 0.68; 95% confidence interval, 0.48 to 0.98; P=0.04) and a 45% reduction in major adverse cardiac events (cardiac death, myocardial infarction, or target lesion revascularization; 7.3% versus 12.8%; hazard ratio, 0.55; 95% confidence interval, 0.36 to 0.83; P=0.004). Among the 360 patients who discontinued clopidogrel or ticlopidine after 6 months, stent thrombosis subsequently developed in 0.4% of EES patients versus 2.6% of PES patients (P=0.10).

Conclusions—Patients treated with EES rather than PES experienced significantly improved event-free survival at a 2-year follow-up in the SPIRIT III trial, with continued divergence of the hazard curves for target vessel failure and major adverse cardiac events between 1 and 2 years evident. The encouraging trends toward fewer stent thrombosis episodes after 6 months in EES-treated patients who discontinued a thienopyridine and after 1 year in all patients treated with EES rather than PES deserve further study.

Key words: angioplasty • restenosis • stents • thrombosis

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