Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease
Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease
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DOI：
10.1056/nejmoa1509038
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发表时间：
2015-11-12
影响因子：
158.5
通讯作者：
Stone, Gregg W.
中科院分区：
文献类型：
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作者：
Ellis, Stephen G.;Kereiakes, Dean J.;Stone, Gregg W.
背景在接受金属药物洗脱冠状动脉支架的冠心病患者中，不良事件如晚期靶病变失败可能部分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已被开发，试图改善长期outcomes. METHODS在这个大型，多中心，随机试验，2008例稳定或不稳定型心绞痛患者随机分配在2：1的比例接受依维莫司洗脱生物可吸收血管（Absorb）支架（1322例）或依维莫司洗脱钴铬（Xience）支架（686例）。主要终点，检验了非劣效性（边际，风险差异为4.5个百分点）和优效性，是靶病变失败（心源性死亡，靶血管心肌梗死，Absorb组和Xience组分别有7.8%和6.1%的患者在1年时发生了靶病变失败。（差异，1.7个百分点; 95%置信区间，-0.5至3.9;非劣效性P = 0.007，优效性P = 0.16）。Absorb组和Xience组在心源性死亡（分别为0.6%和0.1%; P = 0.29）、靶血管心肌梗死（分别为6.0%和4.6%; P = 0.18）或缺血驱动的靶病变血运重建（分别为3.0%和2.5%; P = 0.50）的发生率方面无显著差异。Absorb组中1.5%的患者和Xience组中0.7%的患者在1年内发生器械血栓形成（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，依维莫司洗脱生物可吸收血管支架治疗非复杂性阻塞性冠状动脉疾病，在1年时靶病变失败方面在预定的非劣效性界值内。（由Abbott Vascular资助; ABSORB III ClinicalTrials.gov编号，NCT 01751906。）
BACKGROUNDIn 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.METHODSIn 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.RESULTSTarget-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).CONCLUSIONSIn 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.)