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.
OBJECTIVE
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 microm), 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<or=28 mm in length in reference vessels>or=2.75 to <or=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).
Kereiakes
Dean J
DJ
Christ Hospital Heart and Vascular Center/The Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio 45219, USA. lindner@thechristhospital.com
Cannon
Louis A
LA
Feldman
Robert L
RL
Popma
Jeffrey J
JJ
Magorien
Raymond
R
Whitbourn
Robert
R
Dauber
Ira M
IM
Rabinowitz
Abram C
AC
Ball
Michael W
MW
Bertolet
Barry
B
Kabour
Ameer
A
Foster
Michael C
MC
Wang
John C
JC
Underwood
Paul
P
Dawkins
Keith D
KD
D000368:Aged; D002857:Chromium / Q000008:administration & dosage / Q000009:adverse effects; D002858:Chromium Alloys / Q000008:administration & dosage* / Q000009:adverse effects; D017023:Coronary Angiography / Q000592:standards*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects / Q000592:standards*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D010984:Platinum / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome
D002858:Chromium Alloys; D002857:Chromium; D010984:Platinum; D017239:Paclitaxel