Objectives: 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.
Background: 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. Methods 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.
Results: 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 ± 0.45 mm for PES versus 0.11 ± 0.36 mm for PtCr-EES (P < 0.001). In-stent % diameter stenosis was 22.20 ± 16.00% for PES versus 11.06 ± 13.86% for PtCr-EES (P < 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 (P = 0.06) and target vessel revascularization was 4.7% (6/127) for PES versus 2.7% (10/371) for PtCr-EES (P = 0.26). No stent thromboses occurred at 12 months in either group.
Conclusions: 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.
Trial registration: ClinicalTrials.gov NCT01285999.
Keywords: coronary artery disease; drug-eluting stents; everolimus; paclitaxel; platinum chromium; randomized controlled trial.
© 2015 Wiley Periodicals, Inc.