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

Abstract

BackgroundPaclitaxel-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/DesignThe 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 ≤28 mm and vessel diameter ≥2.75 mm to ≤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 ≤20 mm and vessel diameter ≥2.25 mm to <2.75 mm that compares TAXUS Element with a matched historical bare metal Express stent control.DiscussionThe 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.

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

“…Although the polymer and drug are similar to those of prior TAXUS PES platforms, the platinum chromium alloy has increased bend fatigue resistance, greater conformability, and increased radial strength versus 316L stainless steel (Table 1). Because platinum chromium is denser than 316L stainless steel (9), radiopacity is enhanced despite thinner struts (10,11).…”

“…Staged PCI or subsequent planned coronary artery bypass graft procedures were not allowed. Other inclusion and exclusion criteria have been reported (11).…”

“…The TAXUS Element stent is laser-cut from 81-m platinum chromium alloy. Controlled slow release of paclitaxel, incorporated at 1 g/mm 2 into poly(styrene-b-isobutylene-bstyrene) polymer is provided with release kinetics similar to those of the previous generation TAXUS Express (2,6) and Liberté (3) 316L stainless steel stent systems (11). Study design.…”

“…Study design. The PERSEUS WH trial design has been reported previously (11). The PERSEUS WH trial is a prospective, randomized (3:1), singleblind controlled trial powered to evaluate noninferiority of the TAXUS Element compared with the TAXUS Express 2 PES.…”

“…The PERSEUS WH trial is a prospective, randomized (3:1), singleblind controlled trial powered to evaluate noninferiority of the TAXUS Element compared with the TAXUS Express 2 PES. Eligible subjects with a single, native vessel, de novo target lesion of Ն50% diameter stenosis with length Յ28 mm and reference vessel diameter Ն2.75 to Յ4.0 mm were enrolled between July 16, 2007, andOctober 1, 2008, at 90 clinical sites (11). Randomization to treatment group was stratified for the presence or absence of medically-treated diabetes.…”