A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: design and statistical methods of the PERSEUS clinical program.
BACKGROUND
Paclitaxel-eluting stents decrease angiographic and clinical restenosis following percutaneous coronary intervention compared to bare metal stents. TAXUS Element is a third-generation paclitaxel-eluting stent which incorporates a novel, thinner-strut, platinum-enriched metal alloy platform. The stent is intended to have enhanced radiopacity and improved deliverability compared to other paclitaxel-eluting stents. The safety and efficacy of the TAXUS Element stent are being evaluated in the pivotal PERSEUS clinical trials.


METHODS
The PERSEUS trials include two parallel studies of the TAXUS Element stent in single, de novo coronary atherosclerotic lesions. The PERSEUS Workhorse study is a prospective, randomized (3:1), single-blind, non-inferiority trial in subjects with lesion length < or = 28 mm and vessel diameter > or = 2.75 mm to < or = 4.0 mm which compares TAXUS Element to the TAXUS Express2 paclitaxel-eluting stent system. The Workhorse study employs a novel Bayesian statistical approach that uses prior information to limit the number of study subjects exposed to the investigational device and thus provide a safer and more efficient analysis of the TAXUS Element stent. PERSEUS Small Vessel is a prospective, single-arm, superiority trial in subjects with lesion length < or = 20 mm and vessel diameter > or = 2.25 mm to <2.75 mm that compares TAXUS Element with a matched historical bare metal Express stent control.


CONCLUSIONS
The TAXUS PERSEUS clinical trial program uses a novel statistical approach to evaluate whether design and metal alloy iterations in the TAXUS Element stent platform provide comparable safety and improved procedural performance compared to the previous generation Express stent. PERSEUS trial enrollment is complete and primary endpoint data are expected in 2010. PERSEUS Workhorse and Small Vessel are registered at http://www.clinicaltrials.gov, identification numbers NCT00484315 and NCT00489541.
Allocco
Dominic J
DJ
Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760, USA.
Cannon
Louis A
LA
Britt
Amy
A
Heil
John E
JE
Nersesov
Andrey
A
Wehrenberg
Scott
S
Dawkins
Keith D
KD
Kereiakes
Dean J
DJ
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D001315:Australia; D001499:Bayes Theorem; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002858:Chromium Alloys; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D003627:Data Interpretation, Statistical; D054855:Drug-Eluting Stents; D006801:Humans; D009520:New Zealand; D017239:Paclitaxel / Q000008:administration & dosage*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D010984:Platinum; D011446:Prospective Studies; D011474:Prosthesis Design; D012107:Research Design; D012720:Severity of Illness Index; D012846:Singapore; D016037:Single-Blind Method; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D002317:Cardiovascular Agents; D002858:Chromium Alloys; D010975:Platelet Aggregation Inhibitors; D010984:Platinum; D017239:Paclitaxel