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
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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/Design: 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 ≤28 mm and vessel diameter ≥2.75 mm to ≤4.0 mm which compares TAXUS Element to the TAXUS Express 2 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. Discussion: 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.
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Heterogeneity of treatment effects might remain undetected in a traditional RCT design.
“Furthermore, heterogeneity of treatment effects might remain undetected in a traditional RCT design.78”
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Retracted
- Authors
- Allocco, D. J., Cannon, L. A., Britt, A., Heil, J. E., Nersesov, A., Wehrenberg, S., Dawkins, K. D., & Kereiakes, D. J.
- Affiliations
- Boston Scientific (United States) (US)
- Cardiac And Vascular Research Center Of Northern Michigan (US)
- Christ Hospital (US)
- Corresponding author
- Kereiakes, Dean J
- Venue
- Trials
- Published
- 2010-01-07
- Volume
- 11
- Issue
- 1
- Pages
- 1-1
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC2826324
- OpenAlex
- W2139043704
- Cited by
- 159
- References
- 28
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 6 · 2022: 8 · 2021: 34 · 2020: 11 · 2019: 7 · 2018: 7 · 2017: 12 · 2016: 10 · 2015: 10 · 2014: 19 · 2013: 7 · 2012: 8
- FWCI
- 9.77
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- University of Connecticut
- Boston Scientific Corporation
- Cordis
- Topics
- Health Sciences › Medicine › Surgery › Coronary Interventions and Diagnostics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Keywords
- paclitaxel-eluting stents, de novo coronary lesions, percutaneous coronary intervention, restenosis
- MeSH terms
- Australia, Bayes Theorem, Cardiovascular Agents, Chromium Alloys, Coronary Artery Disease, Data Interpretation, Statistical, Humans, New Zealand, Platelet Aggregation Inhibitors, Platinum, Prospective Studies, Prosthesis Design, Research Design, Severity of Illness Index, Singapore, Time Factors, United States, Stents, Angioplasty, Balloon, Coronary, Single-Blind Method, Treatment Outcome, Coronary Angiography, Paclitaxel, Drug-Eluting Stents
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