1. PLATINUM QCA: A prospective, multicenter trial assessing clinical, angiographic, and intravascular ultrasound outcomes (9 months) with the novel platinum-chromium thin-strut PROMUS Element everolimus-eluting stent in de novo coronary stenoses.
- Author
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El-Jack S., Whitbourne R., Dawkins K.D., Allocco D.J., Zambahari R., Scott D., Meredith I.T., El-Jack S., Whitbourne R., Dawkins K.D., Allocco D.J., Zambahari R., Scott D., and Meredith I.T.
- Abstract
Background: Everolimus-eluting stents (EES) reduce restenosis following percutaneous coronary intervention as compared to earlier generation paclitaxel-eluting stents (PES). The next generation PROMUS Element EES (Boston Scientific Corporation, Natick, MA, USA) consists of a novel platinum-chromium alloy thin-strut radiopaque stent with improved radial strength and low recoil. We report for the first time results of the PLATINUM QCA trial which collected clinical outcomes, quantitative coronary angiography (QCA) data, and intravascular ultrasound (IVUS) data in lesions treated with PROMUS Element. Method(s): Subjects with a de novo target lesion length <=34 mm in a vessel of >2.25 mm to <4.25 mm diameter were treated in this prospective, single-arm, multicenter trial. The primary endpoint was the 30-day composite rate of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and definite or probable stent thrombosis (ST). The efficacy endpoint of 9-month in-stent late loss by QCA was compared to a prespecified performance goal based on historical results with TAXUS Express PES. Additional endpoints include 9-month percent diameter stenosis and binary restenosis (QCA); 9-month percent net volume obstruction and incomplete apposition (IVUS); and clinical endpoints of all-cause death, cardiac death, MI, revascularization, and ST at 9 and 12 months. Result(s): Subjects (n=100) were enrolled at 14 clinical sites in Australia, New Zealand, Malaysia, and Singapore. Mean age was 62 years, 23%) of patients were female, and 19%) of patients had medically treated diabetes mellitus. Lesions treated were in the left anterior descending (35%), the left circumflex (30%), and the right coronary (35%) arteries. Technical success (successful study stent delivery and deployment to the target lesion without balloon rupture or embolization) was 100%) (108/108). Clinical procedural success (mean lesion diameter stenosis <30% with TIMI3 flow and no in-hospital c
- Published
- 2010