MonashHeart, Monash Health, Monash Medical Centre, Clayton, Victoria, Australia.
Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California.
Am J Cardiol. 2014 Apr 1;113(7):1117-23. doi: 10.1016/j.amjcard.2013.12.011. Epub 2014 Jan 14.
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.
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。