A Prospective, Randomized Evaluation of a Novel Everolimus-Eluting Coronary Stent: The PLATINUM (A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of up to Two De Novo Cor

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• 作者：Gregg W. Stone MD ; ^{gs2184@columbia.edu} ; Paul S. Teirstein MD^† ; ; Ian T. Meredith MBBS ; PhD^‡ ; ; Bruno Farah MD^§ ; ; Christophe L. Dubois MD ; PhD ; Robert L. Feldman MD^¶ ; ; Joseph Dens MD ; PhD^# ; Nobuhisa Hagiwara MD ; Dominic J. Allocco MD^† ; † ; ; Keith D. Dawkins MD^† ; † ; ; PLATINUM Trial Investigators
• 关键词：angioplasty ; coronary artery disease ; restenosis
• 刊名：Journal of the American College of Cardiology
• 出版年：2011
• 出版时间：19 April 2011
• 年：2011
• 卷：57
• 期：16
• 页码：1700-1708
• 全文大小：824 K

文摘

Objectives

We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI).

Background

Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance.

Methods

A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority.

Results

The 12-month rate of TLF in the per-protocol population occurred in 2.9 % versus 3.4 % of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5 % , 95 % confidence interval: −1.3 % to 2.3 % , p_{noninferiority} = 0.001, p_superiority = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2 % vs. 3.5 % , p = 0.72), cardiac death or MI (2.5 % vs. 2.0 % , p = 0.56), TLR (1.9 % vs. 1.9 % , p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4 % vs. 0.4 % , p = 1.00).

Conclusions

In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI. (A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of up to Two De Novo Coronary Artery Lesions: NCT00823212)