title: PLATINUM QCA: a prospective, multicentre study assessing clinical, angiographic, and intravascular ultrasound outcomes with the novel platinum chromium thin-strut PROMUS Element everolimus-eluting stent in de novo coronary stenoses.
abstract: OBJECTIVE
  Assess clinical, angiographic, and intravascular ultrasound results in lesions treated with the PROMUS Element platinum chromium everolimus-eluting stent (EES).
  
  
  RESULTS
  Patients (N=100) with one de novo target lesion ≤ 34 mm long and reference vessel diameter (RVD) ≥ 2.25-≤ 4.25 mm were enrolled at 14 sites. The primary endpoint was the 30-day composite of cardiac death, myocardial infarction, target lesion revascularisation (TLR), or definite/probable stent thrombosis (ST). The efficacy endpoint of 9 month in-stent late loss in workhorse lesions (defined as RVD ≥ 2.5-≤ 4.25 mm, lesion ≤ 24 mm) was compared to a performance goal based on historical results with TAXUS Express paclitaxel-eluting stents. Post-procedure incomplete stent apposition (ISA) was compared to a performance goal based on results with the PROMUS/XIENCE V EES in SPIRIT III. Mean age was 61.8 ± 9.9 years; 77.0% were male; 19% had medically treated diabetes. Baseline RVD was 2.72 ± 0.53 mm; lesion length was 15.4 ± 7.0 mm. The primary endpoint occurred in one patient (periprocedural ST with TLR) with no additional major clinical events through one year. Nine-month in-stent late loss in workhorse lesions (0.17 ± 0.25 mm, N=73) and post-procedure ISA (5.7%, 5/88) were below performance goals (p<0.001).
  
  
  CONCLUSIONS
  Through one year, PROMUS Element EES had an acceptable safety and efficacy profile with low in-stent late loss and post-procedure ISA.
authors.affiliation: MonashHEART, Southern Health, Monash Medical Centre, Clayton, Victoria, Australia. ian.meredith@myheart.id.au
authors.forename: Ian T
authors.initials: IT
authors.lastname: Meredith
authors.forename: Robert
authors.initials: R
authors.lastname: Whitbourn
authors.forename: Douglas
authors.initials: D
authors.lastname: Scott
authors.forename: Seif
authors.initials: S
authors.lastname: El-Jack
authors.forename: Robaayah
authors.initials: R
authors.lastname: Zambahari
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Paul S
authors.initials: PS
authors.lastname: Teirstein
authors.forename: Ruth M
authors.initials: RM
authors.lastname: Starzyk
authors.forename: Dominic J
authors.initials: DJ
authors.lastname: Allocco
authors.forename: Keith D
authors.initials: KD
authors.lastname: Dawkins
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D002857:Chromium; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010984:Platinum; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018084:Ultrasonography, Interventional
chemical_list: D002857:Chromium; D010984:Platinum; D000068338:Everolimus; D020123:Sirolimus