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比较新型铂铬依维莫司洗脱支架(Promus Element)与钴铬依维莫司洗脱支架(Xience V)治疗初发冠状动脉狭窄的 3 年结果(来自 PLATINUM 试验)。

Three-year results comparing platinum-chromium PROMUS element and cobalt-chromium XIENCE V everolimus-eluting stents in de novo coronary artery narrowing (from the PLATINUM Trial).

机构信息

MonashHeart, Monash Health, Monash Medical Centre, Clayton, Victoria, Australia.

Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California.

出版信息

Am J Cardiol. 2014 Apr 1;113(7):1117-23. doi: 10.1016/j.amjcard.2013.12.011. Epub 2014 Jan 14.

DOI:10.1016/j.amjcard.2013.12.011
PMID:24530167
Abstract

In the randomized PLATINUM trial, the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES; Boston Scientific, Natick, Massachusetts) was noninferior to the XIENCE V cobalt-chromium everolimus-eluting stent (CoCr-EES; Boston Scientific and Abbott Vascular, Santa Clara, California) for the primary end point of 1-year target lesion failure. This study reports the 3-year outcomes. Patients (n=1,530) with 1 or 2 de novo native coronary artery lesions (baseline vessel diameter≥2.50 mm to ≤4.25 mm and length≤24 mm) were randomized 1:1 to PtCr-EES versus CoCr-EES. Three-year follow-up was available in 93.9% (703 of 749) of patients with CoCr-EES and 96.7% (733 of 758) of patients with PtCr-EES. Comparing CoCr-EES with PtCr-EES, 3-year rates of death (4.3% vs 3.7%, hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.52 to 1.48, p=0.62), cardiac death (1.9% vs 1.2%, HR 0.63, 95% CI 0.27 to 1.45, p=0.27), myocardial infarction (2.5% vs 2.3%, HR 0.92, 95% CI 0.48 to 1.79, p=0.81), ischemia-driven target lesion revascularization (4.9% vs 3.5%, HR 0.72, 95% CI 0.43 to 1.20, p=0.21), and Academic Research Consortium definite or probable stent thrombosis (0.5% vs 0.7%, HR 1.23, 95% CI 0.33 to 4.57, p=0.76) were not significantly different. In conclusion, 3-year results of the PLATINUM randomized, controlled, clinical trial demonstrate comparable safety and efficacy outcomes of the PROMUS Element PtCr-EES and the XIENCE V CoCr-EES.

摘要

在随机的 PLATINUM 试验中, PROMUS Element 铂铬依维莫司洗脱支架(PtCr-EES;波士顿科学公司,马萨诸塞州纳提克)与 XIENCE V 钴铬依维莫司洗脱支架(CoCr-EES;波士顿科学公司和雅培血管公司,加利福尼亚州圣克拉拉)相比,在主要终点 1 年靶病变失败方面不劣于后者。本研究报告了 3 年的结果。将 1530 例 1 或 2 处新发的原发性冠状动脉病变(基线血管直径≥2.50mm 至≤4.25mm,长度≤24mm)患者随机分为 1:1 接受 PtCr-EES 或 CoCr-EES 治疗。CoCr-EES 组 93.9%(749 例中的 703 例)和 PtCr-EES 组 96.7%(758 例中的 733 例)患者可获得 3 年随访。与 CoCr-EES 相比,PtCr-EES 组 3 年死亡率(4.3% vs 3.7%,风险比[HR]0.88,95%置信区间[CI]0.52 至 1.48,p=0.62)、心源性死亡率(1.9% vs 1.2%,HR 0.63,95%CI 0.27 至 1.45,p=0.27)、心肌梗死(2.5% vs 2.3%,HR 0.92,95%CI 0.48 至 1.79,p=0.81)、缺血驱动的靶病变血运重建(4.9% vs 3.5%,HR 0.72,95%CI 0.43 至 1.20,p=0.21)和学术研究联合会明确或可能的支架血栓形成(0.5% vs 0.7%,HR 1.23,95%CI 0.33 至 4.57,p=0.76)无显著差异。总之,PLATINUM 随机对照临床试验的 3 年结果表明, PROMUS Element PtCr-EES 和 XIENCE V CoCr-EES 的安全性和疗效相当。

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