title: Long-term follow-up of the platinum chromium TAXUS Element (ION) stent: The PERSEUS Workhorse and Small Vessel trial five-year results.
abstract: BACKGROUND
  The TAXUS Element (ION) platinum chromium paclitaxel-eluting stent (PtCr-PES) incorporates a thin (81 μm) strut design with a similar polymer and drug dose density as prior PES. The pivotal PERSEUS trial program consisted of two studies: PERSEUS Workhorse (WH) and PERSEUS Small Vessel (SV). The PERSEUS WH trial demonstrated the PtCr-PES to be non-inferior to the predicate TAXUS Express PES (TE-PES) for target lesion failure (TLF) at 1 year and in-segment angiographic percent diameter stenosis at 9 months. The PERSEUS SV trial demonstrated the PtCr-PES to be superior to a historical bare metal stent (BMS) for angiographic late lumen loss at 9 months. Long-term (5-year) clinical outcomes following PtCr-PES have not been previously reported.
  
  
  METHODS
  PERSEUS WH was a prospective, Bayesian, 3:1 randomized (PtCr-PES vs. TE-PES) trial in patients with lesion length ≤28 mm and vessel diameter ≥2.75 to ≤4.0 mm. PERSEUS SV was a prospective, single-arm trial in patients with lesion length ≤20 mm and vessel diameter ≥2.25 to <2.75 mm comparing PtCr-PES to a matched historical BMS control.
  
  
  RESULTS
  Among randomized subjects in the PERSEUS WH study, clinical event rates at 5 years were similar between treatment groups, including TLF (12.9% TE-PES vs. 12.1% PtCr-PES; P = 0.66). In the PERSEUS SV study, 5-year rates of MACE, and TLF were significantly lower for PtCr-PES (vs. BMS) following adjustment for baseline characteristics and were primarily due to lower target lesion revascularization rates (27.2% BMS vs. 14.9% PtCr-PES; P = 0.049).
  
  
  CONCLUSIONS
  At 5 years, the PtCr-PES provides efficacy and safety that is comparable to the TE-PES and superior efficacy with similar safety when compared with BMS in smaller caliber vessels. Cumulative stent thrombosis rates remained low and similar through 5 years for both DES platforms.
authors: The Christ Hospital Heart and Vascular Center/the Lindner Center for Research and Education at the Christ Hospital, Cincinnati, Ohio.
authors: Dean J
authors: http://orcid.org/0000-0003-1086-127X
authors: DJ
authors: Kereiakes
authors: The Cardiac & Vascular Research Center, McLaren Northern Michigan Hospital, Cardiac and Vascular Research Center of Northern Michigan, Petoskey, Michigan.
authors: Louis A
authors: LA
authors: Cannon
authors: Department of Cardiology, Swedish-HealthOne Medical Center, Englewood, Colorado.
authors: Ira
authors: I
authors: Dauber
authors: The Heart Center Institution, St. Vincent's Hospital, Indianapolis, Indiana.
authors: Michael
authors: M
authors: Ball
authors: Director, Cardiac Catheterization Laboratory, North Mississippi Medical Center, Tupelo, Mississippi.
authors: Barry
authors: B
authors: Bertolet
authors: Cardiovascular Services, Sisters of Charity Providence Hospital, Columbia, South Carolina.
authors: Michael
authors: M
authors: Foster
authors: Interventional Cardiology, Boston Scientific Corporation, Marlborough, Massachusetts.
authors: Andrey Y
authors: AY
authors: Nersesov
authors: Interventional Cardiology, Boston Scientific Corporation, Marlborough, Massachusetts.
authors: Paul L
authors: PL
authors: Underwood
authors: Interventional Cardiology, Boston Scientific Corporation, Marlborough, Massachusetts.
authors: Dominic J
authors: DJ
authors: Allocco
authors: Interventional Cardiology, Boston Scientific Corporation, Marlborough, Massachusetts.
authors: Keith D
authors: KD
authors: Dawkins
mesh_terms: D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods* / Q000401:mortality; D001499:Bayes Theorem; D002857:Chromium / Q000737:chemistry; D017023:Coronary Angiography / Q000379:methods; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000401:mortality; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D018579:Patient Selection; D010984:Platinum / Q000737:chemistry; D011446:Prospective Studies; D011474:Prosthesis Design / Q000379:methods*; D011475:Prosthesis Failure; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method; D018709:Statistics, Nonparametric; D015996:Survival Rate; D020946:Taxus; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D002857:Chromium; D010984:Platinum; D017239:Paclitaxel
keywords: coronary artery disease; paclitaxel-eluting stent; platinum chromium; randomized controlled trial