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A Randomized Trial

Gregg W. Stone, MD; Mark Midei, MD; William Newman, MD; Mark Sanz, MD; James B. Hermiller, MD; Jerome Williams, MD; Naim Farhat, MD; Kenneth W. Mahaffey, MD; Donald E. Cutlip, MD; Peter J. Fitzgerald, MD, PhD; Poornima Sood, MD, MPhil; Xiaolu Su, MS; Alexandra J. Lansky, MD; for the SPIRIT III Investigators

JAMA. 2008;299(16):1903-1913.

Context  A thin, cobalt-chromium stent eluting the antiproliferative agent everolimus from a nonadhesive, durable fluoropolymer has shown promise in preliminary studies in improving clinical and angiographic outcomes in patients with coronary artery disease.

Objective  To evaluate the safety and efficacy of an everolimus-eluting stent compared with a widely used paclitaxel-eluting stent.

Design, Setting, and Patients  The SPIRIT III trial, a prospective, randomized, single-blind, controlled trial enrolling patients at 65 academic and community-based US institutions between June 22, 2005, and March 15, 2006. Patients were 1002 men and women undergoing percutaneous coronary intervention in lesions 28 mm or less in length and with reference vessel diameter between 2.5 and 3.75 mm. Angiographic follow-up was prespecified at 8 months in 564 patients and completed in 436 patients. Clinical follow-up was performed at 1, 6, 9, and 12 months.

Interventions  Patients were randomized 2:1 to receive the everolimus-eluting stent (n = 669) or the paclitaxel-eluting stent (n = 333).

Main Outcome Measures  The primary end point was noninferiority or superiority of angiographic in-segment late loss. The major secondary end point was noninferiority assessment of target vessel failure events (cardiac death, myocardial infarction, or target vessel revascularization) at 9 months. An additional secondary end point was evaluation of major adverse cardiac events (cardiac death, myocardial infarction, or target lesion revascularization) at 9 and 12 months.

Results  Angiographic in-segment late loss was significantly less in the everolimus-eluting stent group compared with the paclitaxel group (mean, 0.14 [SD, 0.41] mm vs 0.28 [SD, 0.48] mm; difference, –0.14 [95% CI, –0.23 to –0.05]; P  .004). The everolimus stent was noninferior to the paclitaxel stent for target vessel failure at 9 months (7.2% vs 9.0%, respectively; difference, –1.9% [95% CI, –5.6% to 1.8%]; relative risk, 0.79 [95% CI, 0.51 to 1.23]; P < .001). The everolimus stent compared with the paclitaxel stent resulted in significant reductions in composite major adverse cardiac events both at 9 months (4.6% vs 8.1%; relative risk, 0.56 [95% CI, 0.34 to 0.94]; P = .03) and at 1 year (6.0% vs 10.3%; relative risk, 0.58 [95% CI, 0.37 to 0.90]; P = .02), due to fewer myocardial infarctions and target lesion revascularization procedures.

Conclusions  In this large-scale, prospective randomized trial, an everolimus-eluting stent compared with a paclitaxel-eluting stent resulted in reduced angiographic late loss, noninferior rates of target vessel failure, and fewer major adverse cardiac events during 1 year of follow-up.

Trial Registration  clinicaltrials.gov Identifier: NCT00180479

Author Affiliations: Columbia University Medical Center and The Cardiovascular Research Foundation, New York, New York (Drs Stone and Lansky); St Joseph Medical Center, Towson, Maryland (Dr Midei); Wake Medical Center, Raleigh, North Carolina (Dr Newman); St Patrick Hospital, Missoula, Montana (Dr Sanz); The Heart Center of Indiana, Indianapolis (Dr Hermiller); Presbyterian Hospital, Charlotte, North Carolina (Dr Williams); EMH Regional Medical Center, Elyria, Ohio (Dr Farhat); Duke Clinical Research Institute, Durham, North Carolina (Dr Mahaffey); Harvard Clinical Research Institute, Boston, Massachusetts (Dr Cutlip); Stanford University Medical Center, Stanford, California (Dr Fitzgerald); and Abbott Vascular, Santa Clara, California (Dr Sood and Ms Su).

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