医学
再狭窄
危险系数
靶病变
临床终点
置信区间
心肌梗塞
支架
血栓形成
内科学
依维莫司
药物洗脱支架
外科
经皮冠状动脉介入治疗
随机对照试验
心脏病学
作者
Pieter C. Smits,Chun Chin Chang,Bernard Chevalier,Nick E.J. West,Tommaso Gori,Emanuele Barbato,Giuseppe Tarantini,Viktor Kočka,Stephan Achenbach,Dariusz Dudek,Javier Escaned,Adrian Włodarczak,Mohamed Abdel‐Wahab,Giovanni Esposito,Jan G.P. Tijssen,Marie‐Claude Morice,Yoshinobu Onuma,Robert‐Jan van Geuns
出处
期刊:Eurointervention
[Europa Digital and Publishing]
日期:2020-10-01
卷期号:16 (8): 645-653
被引量:18
标识
DOI:10.4244/eij-d-19-01079
摘要
The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of a bioresorbable vascular scaffold (BVS).The COMPARE-ABSORB trial was an investigator-initiated, prospective randomised study. Patients at high risk of restenosis were randomly assigned to receive either a BVS or an everolimus-eluting stent (EES). A dedicated implantation technique was recommended for BVS. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically indicated target lesion revascularisation at one year. The enrolment was discontinued prematurely because of a high thrombosis and TVMI rate in the BVS arm. A total of 1,670 patients were recruited (BVS 848 patients and EES 822 patients). TLF occurred in 43 patients (5.1%) of the BVS group and 34 patients (4.2%) of the EES group (absolute difference 0.9%, 95% confidence interval [CI]: -1.2%-3.0%, p non-inferiority <0.001). Definite or probable device thrombosis (2.0% vs 0.6%, hazard ratio [HR] 3.32, 95% CI: 1.22-8.99, p=0.012) and TVMI (4.0% vs 2.1%, HR 1.96, 95% CI: 1.10-3.51, p=0.02) were significantly higher in the BVS group than in the EES group.In patients at high risk of restenosis, non-inferiority of BVS compared with EES in terms of TLF was met at one year. BVS carried a higher risk of device thrombosis and TVMI than EES.
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