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

被引：55

作者：

Kereiakes, Dean J. ^{[1
]}

Cannon, Louis A. ^{[2
]}

Feldman, Robert L. ^{[3
]}

Popma, Jeffrey J. ^{[4
]}

Magorien, Raymond ^{[5
]}

Whitbourn, Robert ^{[6
]}

Dauber, Ira M. ^{[7
]}

Rabinowitz, Abram C. ^{[8
]}

Ball, Michael W. ^{[9
]}

Bertolet, Barry ^{[10
]}

Kabour, Ameer ^{[11
]}

Foster, Michael C. ^{[12
]}

Wang, John C. ^{[13
]}

Underwood, Paul ^{[14
]}

Dawkins, Keith D. ^{[14
]}

机构：

[1] Christ Hosp, Christ Hosp Heart & Vasc Ctr, Lindner Ctr Res & Educ, Cincinnati, OH 45219 USA

[2] No Michigan Reg Hosp, Cardiac & Vasc Res Ctr No Michigan, Petoskey, MI USA

[3] Mediquest Res Munroe Reg Med Ctr, Ocala, FL USA

[4] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA

[5] Ohio State Univ, Med Ctr, Columbus, OH 43210 USA

[6] St Vincents Hosp Melbourne, Fitzroy, Vic, Australia

[7] Swedish HealthOne Med Ctr, Englewood, CO USA

[8] TexSan Heart Hosp, San Antonio, TX USA

[9] St Vincent Hosp, Indianapolis, IN USA

[10] N Mississippi Med Ctr, Tupelo, MS USA

[11] St Vincent Mercy Med Ctr, Toledo, OH USA

[12] Sisters Char Providence Hosp, Columbia, SC USA

[13] Union Mem Hosp, Baltimore, MD USA

[14] Boston Sci Corp, Natick, MA USA

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2010年 / 56卷 / 04期

关键词：

chromium; drug-eluting stent; paclitaxel; platinum; restenosis; ARTERY-DISEASE; ATLAS PROGRAM; LIBERTE STENT; RESTENOSIS; LESIONS; RISK;

D O I：

10.1016/j.jacc.2010.04.011

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 mu m), 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 (In[%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) (J Am Coll Cardiol 2010; 56: 264-71) (c) 2010 by the American College of Cardiology Foundation

引用

页码：264 / 271

页数：8

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