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(Circulation. 2009;119:680-686.)
© 2009 American Heart Association, Inc.

Interventional Cardiology

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.).

Correspondence to Gregg W. Stone, MD, Columbia University Medical Center, Cardiovascular Research Foundation, 111 E 59th St, 11th Floor, New York, NY 10022. E-mail gs2184{at}columbia.edu

Received July 1, 2008; accepted November 7, 2008.

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.

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