PLATINUM China: A prospective, randomized investigation of the platinum chromium everolimus‐eluting stent in de novo coronary artery lesions. Issue 1 (18th February 2015)

• Record Type: Journal Article
• Authors: Gao, Runlin; Han, Yaling; Yang, Yuejin; Zhang, Jian; Hou, Yuqing; Wang, Haichang; Li, Hui; Fang, Quan; Yu, Bo; Xu, Bo; Allocco, Dominic J.; Dawkins, Keith D.
• Is Part Of: Catheterization and cardiovascular interventions. Volume 85:Issue 1(2015:Jan. 01)
• Page Start: 716
• Page End: 723
• Publication Date: 2015-02-18
• Subjects: Heart -- Diseases -- Diagnosis -- Periodicals; Cardiac catheterization -- Periodicals; 616.1207572
• DOI: 10.1002/ccd.25859
• Languages: English
• ISSNs: 1522-1946

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="ccd25859-sec-0001" sec-type="section"> <title>Objectives</title> <p>The PLATINUM China clinical trial evaluated the safety and effectiveness of the thin‐strut, everolimus‐eluting, platinum‐chromium PROMUS™ Element™ stent (PtCr‐EES) (Boston Scientific, Marlborough, MA) for the treatment of patients in China.</p> </sec> <sec id="ccd25859-sec-0002" sec-type="section"> <title>Background</title> <p>Clinical outcomes from the PtCr‐EES have not been evaluated in patients from China, nor has it been directly compared with the second‐generation stainless steel paclitaxel‐eluting TAXUS Liberté stent (PES) in a randomized head‐to‐head trial.</p> <p> <bold>Methods</bold> In this prospective, multicenter, single‐blind, superiority trial, patients with a single de novo atherosclerotic coronary artery lesion were randomized 1:3 to receive either the PES or PtCr‐EES. The primary endpoint was in‐stent late loss at 9 months.</p> </sec> <sec id="ccd25859-sec-0003" sec-type="section"> <title>Results</title> <p>Among 127 PES and 373 PtCr‐EES patients (71.2% male; mean age 57.3 years), the primary endpoint of 9‐month in‐stent late loss was 0.40 ± 0.45mm for PES versus 0.11 ± 0.36 mm for PtCr‐EES (<italic>P</italic> < 0.001). In‐stent % diameter stenosis was 22.20±16.00% for PES versus 11.06±13.86% for PtCr‐EES (<italic>P</italic><0.001) at 9 months. The 1‐year rate of death/MI was 1.6% (2/127) for PES versus 0% (0/371) for PtCr‐EES (<italic>P</italic>=0.06) and target vessel revascularization was 4.7% (6/127) for PES versus 2.7% (10/371) for PtCr‐EES (<italic>P</italic>=0.26). No stent thromboses occurred at12 months in either group.</p> </sec> <sec id="ccd25859-sec-0004" sec-type="section"> <title>Conclusions</title> <p>In the largest prospective angiographic evaluation conducted to date with this stent, the PROMUS Element PtCr‐EES was superior to the TAXUS Liberté PES for the primary endpoint of late loss at 9 months, with low rates of clinical events at 1 year. Clinical follow‐up will continue to 2 years. © 2015 Wiley Periodicals, Inc.</p> </sec> </abstract>