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Twelve-month results of a prospective, multicentre trial to assess the everolimus-eluting coronary stent system (PROMUS Element): The PLATINUM PLUS all-comers randomised trial

Lookup NU author(s): Professor Azfar Zaman



This is the authors' accepted manuscript of an article that has been published in its final definitive form by EuroPCR, 2017.

For re-use rights please refer to the publisher's terms and conditions.


© Europa Digital & Publishing 2017. All rights reserved. Aims: The aim of the study was to compare the safety and efficacy of the platinum-chromium-based everolimus-eluting stent (EES) with a cobalt-chromium EES. Methods and results: We performed a prospective, multicentre, single-blind non-inferiority all-comers study randomising patients with stable or unstable coronary artery disease (2:1) to treatment with the platinum-chromium EES (n=1,952) or the control cobalt-chromium EES (n=1,028) in Europe (PLATINUM PLUS trial). The primary endpoint was target vessel failure (TVF) at 12 months, a composite of target vessel-related cardiac death, myocardial infarction (MI), and ischaemia-driven target vessel revascularisation (TVR). Among 2,980 patients, 33% presented with acute coronary syndromes, and 48% with multivessel disease. At 12 months, the intention-to-treat analysis determined that the platinum-chromium EES was non-inferior to the cobalt-chromium EES for the primary endpoint (86 [4.6%] patients vs. 32 [3.2%], absolute difference 1.4%, 95% confidence interval [CI]:-0.1-2.9; upper limit of the one-sided 95% CI: 2.57%; non-inferiority p=0.012; superiority analysis: hazard ratio [HR] 1.44, 95% CI: 0.96-2.16, p=0.08). In the per protocol analysis, however, the primary endpoint was significantly more common in the platinumchromium EES (HR 1.64, 95% CI: 1.05-2.55, p=0.03). There were no significant differences in the rates of cardiac death (1.1% vs. 1.0%, p=0.78), MI (1.6% vs. 0.8%, p=0.09), or ischaemia-driven TLR (2.0% vs. 1.6%, p=0.49). The rates of ARC definite or probable stent thrombosis were comparable between platforms (0.8% vs. 0.5%, p=0.44). Conclusions: At one year, the platinum-chromium EES satisfied the pre-specified criteria for non-inferiority relative to the control cobalt-chromium EES in this all-comers trial.

Publication metadata

Author(s): Fajadet J, Neumann F-J, Hildick-Smith D, Petronio S, Zaman A, Spence M, Wohrle J, Elhadad S, Roberts D, Hovasse T, Valdes M, Silber S

Publication type: Article

Publication status: Published

Journal: EuroIntervention

Year: 2017

Volume: 12

Issue: 13

Pages: 1595-1604

Online publication date: 20/01/2017

Acceptance date: 02/04/2016

Date deposited: 08/03/2018

ISSN (print): 1774-024X

ISSN (electronic): 1969-6213

Publisher: EuroPCR


DOI: 10.4244/20150112-07


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