依维莫司洗脱生物可吸收支架治疗冠状动脉疾病。
Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease.
机构信息
From Cleveland Clinic, Cleveland (S.G.E.), the Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati (D.J.K.), and Mercy St. Vincent's Medical Center, Toledo (A. Kini) - all in Ohio; Wellmont Holston Valley Medical Center, Kingsport, TN (D.C.M.); St. Joseph's Hospital Health Center, Liverpool, NY (R.P.C.); Scottsdale Healthcare, Scottsdale, AZ (D.G.R.); Scripps Clinic, La Jolla (P.S.T.), and Abbott Vascular, Santa Clara (R.M., Z.Z., C.S.) - both in California; Baptist Medical Center, Jacksonville, FL (M.R.L.); Mount Sinai Medical Center (A. Kabour), Columbia University Medical Center (S.O.M., G.W.S.), and the Cardiovascular Research Foundation (G.W.S.) - all in New York; and the Beth Israel Deaconess Medical Center, Boston (J.J.P.).
出版信息
N Engl J Med. 2015 Nov 12;373(20):1905-15. doi: 10.1056/NEJMoa1509038. Epub 2015 Oct 12.
BACKGROUND
In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes.
METHODS
In this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt-chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year.
RESULTS
Target-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95% confidence interval, -0.5 to 3.9; P=0.007 for noninferiority and P=0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P=0.29), target-vessel myocardial infarction (6.0% and 4.6%, respectively; P=0.18), or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively; P=0.50). Device thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in 0.7% of patients in the Xience group (P=0.13).
CONCLUSIONS
In this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt-chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. (Funded by Abbott Vascular; ABSORB III ClinicalTrials.gov number, NCT01751906.).
背景
在接受金属药物洗脱冠状动脉支架治疗的冠状动脉疾病患者中，晚期靶病变失败等不良事件部分可能与金属支架框架在冠状动脉壁中的持续存在有关。生物可吸收血管支架的发展旨在尝试改善长期结果。
方法
在这项大型多中心随机试验中，2008 例稳定或不稳定型心绞痛患者以 2:1 的比例随机分配接受依维莫司洗脱生物可吸收血管支架（Absorb）（1322 例）或依维莫司洗脱钴铬（Xience）支架（686 例）。主要终点为 1 年时的靶病变失败（心脏死亡、靶血管心肌梗死或缺血驱动的靶病变血运重建），同时进行非劣效性（边缘值为 4.5%的风险差异）和优效性检验。
结果
Absorb 组 1 年时的靶病变失败率为 7.8%，Xience 组为 6.1%（差异 1.7%；95%置信区间为-0.5 至 3.9；非劣效性 P=0.007，优效性 P=0.16）。Absorb 组和 Xience 组的心脏死亡发生率（分别为 0.6%和 0.1%，P=0.29）、靶血管心肌梗死发生率（分别为 6.0%和 4.6%，P=0.18）或缺血驱动的靶病变血运重建发生率（分别为 3.0%和 2.5%，P=0.50）无显著差异。Absorb 组 1 年内器械血栓形成率为 1.5%，Xience 组为 0.7%（P=0.13）。
结论
在这项大规模随机试验中，与依维莫司洗脱钴铬支架相比，使用依维莫司洗脱生物可吸收血管支架治疗非复杂的阻塞性冠状动脉疾病，在 1 年时的靶病变失败方面，非劣效性在预设范围内。（由 Abbott Vascular 资助；ABSORB III ClinicalTrials.gov 编号，NCT01751906。）
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