A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial

医学 依维莫司 心肌梗塞 支架 心脏病学 内科学 临床终点 冠状动脉疾病 心绞痛 血管内超声 不稳定型心绞痛 药物洗脱支架 外科 临床试验 经皮冠状动脉介入治疗
作者
Patrick W. Serruys,Bernard Chevalier,Dariusz Dudek,Ángel Cequier,Didier Carrié,Andrés Iñíguez,Marcello Dominici,René J. van der Schaaf,Michael Haude,Luc Wasungu,Susan Veldhof,Lei Peng,Peter Stæhr,Maik J. Grundeken,Yutaka Ishibashi,Héctor M. García‐García,Yoshinobu Onuma
出处
期刊:The Lancet [Elsevier BV]
卷期号:385 (9962): 43-54 被引量:492
标识
DOI:10.1016/s0140-6736(14)61455-0
摘要

Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease, no data from comparisons with its metallic stent counterpart are available. In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent. Here we report secondary clinical and procedural outcomes after 1 year of follow-up.In a single-blind, multicentre, randomised trial, we enrolled eligible patients aged 18-85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience, Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. The co-primary endpoints of this study are vasomotion (change in mean lumen diameter before and after nitrate administration at 3 years) and difference between minimum lumen diameter (after nitrate administration) after the index procedure and at 3 years. Secondary endpoints were procedural performance assessed by quantitative angiography and intravascular ultrasound; composite clinical endpoints based on death, myocardial infarction, and coronary revascularisation; device and procedural success; and angina status assessed by the Seattle Angina Questionnaire and exercise testing at 6 and 12 months. Cumulative angina rate based on adverse event reporting was analysed post hoc. This trial is registered at ClinicalTrials.gov, number NCT01425281.Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the bioresorbable scaffold group (335 patients, 364 lesions) or the metallic stent group (166 patients, 182 lesions). Dilatation pressure and balloon diameter at the highest pressure during implantation or postdilatation were higher and larger in the metallic stent group, whereas the acute recoil post implantation was similar (0.19 mm for both, p=0.85). Acute lumen gain was lower for the bioresorbable scaffold by quantitative coronary angiography (1.15 mm vs 1.46 mm, p<0.0001) and quantitative intravascular ultrasound (2.85 mm(2)vs 3.60 mm(2), p<0.0001), resulting in a smaller lumen diameter or area post procedure. At 1 year, however, cumulative rates of first new or worsening angina from adverse event reporting were lower (72 patients [22%] in the bioresorbable scaffold group vs 50 [30%] in the metallic stent group, p=0.04), whereas performance during maximum exercise and angina status by SAQ were similar. The 1-year composite device orientated endpoint was similar between the bioresorbable scaffold and metallic stent groups (16 patients [5%] vs five patients [3%], p=0.35). Three patients in the bioresorbable scaffold group had definite or probable scaffold thromboses (one definite acute, one definite sub-acute, and one probable late), compared with no patients in the metallic stent group. There were 17 (5%) major cardiac adverse events in the bioresorbable scaffold group compared with five (3%) events in the metallic stent group, with the most common adverse events being myocardial infarction (15 cases [4%] vs two cases [1%], respectively) and clinically indicated target-lesion revascularisation (four cases [1%] vs three cases [2%], respectively).The everolimus-eluting bioresorbable scaffold showed similar 1-year composite secondary clinical outcomes to the everolimus-eluting metallic stent.Abbott Vascular.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
zzw完成签到,获得积分10
3秒前
Guochunbao完成签到,获得积分10
4秒前
哈哈哈完成签到 ,获得积分10
6秒前
科研通AI5应助蒋念寒采纳,获得10
6秒前
月亮褪色了完成签到 ,获得积分20
10秒前
萱棚完成签到 ,获得积分10
10秒前
11秒前
Cao完成签到 ,获得积分10
11秒前
ENG完成签到,获得积分10
13秒前
alick完成签到,获得积分10
15秒前
刘刘完成签到,获得积分10
16秒前
Tom完成签到,获得积分10
17秒前
Villanellel发布了新的文献求助10
18秒前
程艳完成签到 ,获得积分10
19秒前
MINGHUI完成签到,获得积分10
20秒前
20秒前
子车半烟完成签到,获得积分10
20秒前
22秒前
淳于安筠完成签到,获得积分10
22秒前
雨晴完成签到,获得积分10
25秒前
jbq发布了新的文献求助10
25秒前
joshar完成签到,获得积分10
25秒前
26秒前
量子星尘发布了新的文献求助10
28秒前
blueblue完成签到,获得积分10
30秒前
落后秋烟完成签到,获得积分10
32秒前
大橙子发布了新的文献求助10
33秒前
LMY完成签到 ,获得积分10
33秒前
Betty完成签到 ,获得积分10
33秒前
NexusExplorer应助jbq采纳,获得10
34秒前
渔渔完成签到 ,获得积分10
34秒前
35秒前
Tangyartie完成签到 ,获得积分10
35秒前
skbkbe完成签到 ,获得积分10
36秒前
陈俊雷完成签到 ,获得积分0
37秒前
阿苗完成签到,获得积分10
38秒前
神勇的天问完成签到 ,获得积分10
39秒前
39秒前
advance完成签到,获得积分10
39秒前
李cc发布了新的文献求助10
40秒前
高分求助中
【提示信息,请勿应助】关于scihub 10000
Les Mantodea de Guyane: Insecta, Polyneoptera [The Mantids of French Guiana] 3000
徐淮辽南地区新元古代叠层石及生物地层 3000
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
Handbook of Industrial Diamonds.Vol2 1100
Global Eyelash Assessment scale (GEA) 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 550
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 4038184
求助须知:如何正确求助?哪些是违规求助? 3575908
关于积分的说明 11373872
捐赠科研通 3305715
什么是DOI,文献DOI怎么找? 1819255
邀请新用户注册赠送积分活动 892662
科研通“疑难数据库(出版商)”最低求助积分说明 815022