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CLINICAL RESEARCH: CLINICAL TRIAL

Clinical and Angiographic Outcomes After Treatment of De Novo Coronary Stenoses With a Novel Platinum Chromium Thin-Strut Stent

Primary Results of the PERSEUS (Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System) Trial

Dean J. Kereiakes, MD^_*,_*, Louis A. Cannon, MD, Robert L. Feldman, MD, Jeffrey J. Popma, MD, Raymond Magorien, MD^||, Robert Whitbourn, MBBS^¶, Ira M. Dauber, MD^#, Abram C. Rabinowitz, MD^_**, Michael W. Ball, MD, Barry Bertolet, MD, Ameer Kabour, MD, Michael C. Foster, MD^||||, John C. Wang, MD^¶¶, Paul Underwood, MD^## and Keith D. Dawkins, MD^##

^_* Christ Hospital Heart and Vascular Center/The Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio
Cardiac and Vascular Research Center of Northern Michigan, Northern Michigan Regional Hospital, Petoskey, Michigan
Mediquest Research at Munroe Regional Medical Center, Ocala, Florida
Beth Israel Deaconess Medical Center, Boston, Massachusetts
^|| Ohio State University Medical Center, Columbus, Ohio
^¶ St. Vincent's Hospital (Melbourne), Fitzroy, Victoria, Australia
^# Swedish-HealthOne Medical Center, Englewood, Colorado
^_** TexSan Heart Hospital, San Antonio, Texas
St. Vincent's Hospital, Indianapolis, Indiana
North Mississippi Medical Center, Tupelo, Mississippi
St. Vincent Mercy Medical Center, Toledo, Ohio
^|||| Sisters of Charity Providence Hospital, Columbia, South Carolina
^¶¶ Union Memorial Hospital, Baltimore, Maryland
^## Boston Scientific Corporation, Natick, Massachusetts

Manuscript received February 25, 2010; revised manuscript received March 30, 2010, accepted April 7, 2010.

^_* Reprint requests and correspondence: Dr. Dean J. Kereiakes, The Christ Hospital Heart and Vascular Center and The Carl and Edyth Linder Center for Research and Education at The Christ Hospital, 2123 Auburn Avenue, Suite 424, Cincinnati, Ohio 45219 (Email: lindner{at}thechristhospital.com).

Objectives: The aim of this study was to evaluate the safety and efficacy of the novel platinum chromium TAXUS Element paclitaxel-eluting stent (PES) compared with the TAXUS Express PES (Boston Scientific, Natick, Massachusetts) in treating coronary artery stenoses.

Background: The TAXUS Element is a novel thin-strut (81 µm), platinum chromium alloy PES designed to improve radial strength, radiopacity, and deliverability, while safely providing comparable restenosis benefit compared with a previous-generation PES.

Methods: The PERSEUS (Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System) Workhorse (WH) trial is a prospective, randomized (3:1), controlled, multicenter study of the TAXUS Element (vs. TAXUS Express) PES for the treatment of de novo coronary atherosclerotic lesions 28 mm in length in reference vessels 2.75 to 4.0 mm in diameter. The primary end point was the 12-month rate of target lesion failure, and the secondary end point was 9-month angiographic in-segment percentage diameter stenosis. The study was powered to demonstrate noninferiority to TAXUS Express for both end points.

Results: The intent-to-treat analysis included 1,262 patients (320 TAXUS Express, 942 TAXUS Element). The TAXUS Element was noninferior to TAXUS Express with respect to both the incidence of target lesion failure (5.57% vs. 6.14%, respectively; difference: 0.57%; 95% credible interval: 1.85%; Bayesian posterior probability of noninferiority = 0.9996) and percentage diameter stenosis (ln[%DS] 3.09 vs. 3.12, respectively; difference: 0.03; 95% credible interval: 0.11; Bayesian posterior probability of noninferiority = 0.9970). No differences in clinical outcomes to 12 months were observed between stent treatments, and stent thrombosis was infrequent (0.3% Express, 0.4% Element).

Conclusions: At 1 year, the TAXUS Element is comparable in efficacy to the TAXUS Express PES. Furthermore, no safety concerns related to the novel platinum chromium alloy or stent design were observed. (A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions; NCT00484315)

Key Words: chromium • drug-eluting stent • paclitaxel • platinum • restenosis

Abbreviations and Acronyms   DS = diameter stenosis   FDA = Food and Drug Administration   MACE = major adverse cardiac events   MI = myocardial infarction   MLD = minimal lumen diameter   PES = paclitaxel-eluting stent   QCA = quantitative coronary angiography   TLF = target lesion failure   TLR = target lesion revascularization   TVR = target vessel revascularization

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