Effect of Stenting Plus Medical Therapy vs Medical Therapy Alone on Risk of Stroke and Death in Patients With Symptomatic Intracranial Stenosis

医学 冲程(发动机) 随机对照试验 狭窄 内科学 外科 机械工程 工程类
作者
Peng Gao,Tao Wang,Daming Wang,David S Liebeskind,Huaizhang Shi,Tianxiao Li,Zhenwei Zhao,Yuyang Cai,Wei Wu,Wei He,Jianqun Yu,Bingjie Zheng,Haibo Wang,Yangfeng Wu,Adam A. Dmytriw,Timo Krings,Colin P. Derdeyn,Liqun Jiao,Liqun Jiao,Daming Wang,Timo Krings,David S Libeskind,Huaizhang Shi,Tianxiao Li,Zhenwei Zhao,Wei Wu,Yuyang Cai,Wei He,Shiying Huang,Long Yin,Yun Gu,Hongqi Zhang,Feng Li,Louis R. Caplan,Osama O. Zaidat,Simon Chun Ho Yu,Qinjian Sun,Jie Lu,Yijun Bao,Kun Yang,Haiqing Song,Wenhuo Chen,Haitao Chi,Shouchun Wang,Jin Zhang,Fei Chen,Shenmao Li,Xiaobo Zhang,Hong Sui,Weiwu Hu,Long Li,Yao Feng,Peng Gao,Tao Wang,Haibo Wang,Yidan Zhu,Bingjie Zheng,Peng Qi,Kunpeng Chen,Yingkun He,Jianqun Yu,Wenping Gong,Juan Du,Yongqiang Cui,Yachong Chen
出处
期刊:JAMA [American Medical Association]
卷期号:328 (6): 534-534 被引量:93
标识
DOI:10.1001/jama.2022.12000
摘要

Importance

Prior randomized trials have generally shown harm or no benefit of stenting added to medical therapy for patients with symptomatic severe intracranial atherosclerotic stenosis, but it remains uncertain as to whether refined patient selection and more experienced surgeons might result in improved outcomes.

Objective

To compare stenting plus medical therapy vs medical therapy alone in patients with symptomatic severe intracranial atherosclerotic stenosis.

Design, Setting, and Participants

Multicenter, open-label, randomized, outcome assessor–blinded trial conducted at 8 centers in China. A total of 380 patients with transient ischemic attack or nondisabling, nonperforator (defined as nonbrainstem or non–basal ganglia end artery) territory ischemic stroke attributed to severe intracranial stenosis (70%-99%) and beyond a duration of 3 weeks from the latest ischemic symptom onset were recruited between March 5, 2014, and November 10, 2016, and followed up for 3 years (final follow-up: November 10, 2019).

Interventions

Medical therapy plus stenting (n = 176) or medical therapy alone (n = 182). Medical therapy included dual-antiplatelet therapy for 90 days (single antiplatelet therapy thereafter) and stroke risk factor control.

Main Outcomes and Measures

The primary outcome was a composite of stroke or death within 30 days or stroke in the qualifying artery territory beyond 30 days through 1 year. There were 5 secondary outcomes, including stroke in the qualifying artery territory at 2 years and 3 years as well as mortality at 3 years.

Results

Among 380 patients who were randomized, 358 were confirmed eligible (mean age, 56.3 years; 263 male [73.5%]) and 343 (95.8%) completed the trial. For the stenting plus medical therapy group vs medical therapy alone, no significant difference was found for the primary outcome of risk of stroke or death (8.0% [14/176] vs 7.2% [13/181]; difference, 0.4% [95% CI, −5.0% to 5.9%]; hazard ratio, 1.10 [95% CI, 0.52-2.35];P = .82). Of the 5 prespecified secondary end points, none showed a significant difference including stroke in the qualifying artery territory at 2 years (9.9% [17/171] vs 9.0% [16/178]; difference, 0.7% [95% CI, −5.4% to 6.7%]; hazard ratio, 1.10 [95% CI, 0.56-2.16];P = .80) and 3 years (11.3% [19/168] vs 11.2% [19/170]; difference, −0.2% [95% CI, −7.0% to 6.5%]; hazard ratio, 1.00 [95% CI, 0.53-1.90];P > .99). Mortality at 3 years was 4.4% (7/160) in the stenting plus medical therapy group vs 1.3% (2/159) in the medical therapy alone group (difference, 3.2% [95% CI, −0.5% to 6.9%]; hazard ratio, 3.75 [95% CI, 0.77-18.13];P = .08).

Conclusions and Relevance

Among patients with transient ischemic attack or ischemic stroke due to symptomatic severe intracranial atherosclerotic stenosis, the addition of percutaneous transluminal angioplasty and stenting to medical therapy, compared with medical therapy alone, resulted in no significant difference in the risk of stroke or death within 30 days or stroke in the qualifying artery territory beyond 30 days through 1 year. The findings do not support the addition of percutaneous transluminal angioplasty and stenting to medical therapy for the treatment of patients with symptomatic severe intracranial atherosclerotic stenosis.

Trial Registration

ClinicalTrials.gov Identifier:NCT01763320
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
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
1秒前
2秒前
2秒前
彭于晏应助hyyyyy123采纳,获得10
2秒前
3秒前
orixero应助wuhu采纳,获得10
4秒前
5秒前
8秒前
打打应助江小霜采纳,获得10
8秒前
ytolll完成签到,获得积分10
9秒前
大盆完成签到 ,获得积分10
9秒前
Pissenlit发布了新的文献求助10
10秒前
11秒前
可爱的函函应助daheeeee采纳,获得10
11秒前
13秒前
14秒前
缘知浮生完成签到 ,获得积分10
14秒前
14秒前
迷你的孤晴完成签到 ,获得积分20
15秒前
15秒前
kk应助yyyyou采纳,获得10
15秒前
ztlooo完成签到,获得积分10
16秒前
科研通AI2S应助哈哈哈采纳,获得30
16秒前
17秒前
莫华龙发布了新的文献求助10
17秒前
霸气赛君发布了新的文献求助10
17秒前
关显锋发布了新的文献求助10
18秒前
囚徒发布了新的文献求助10
18秒前
21秒前
wuhu完成签到,获得积分10
23秒前
飞云之下发布了新的文献求助10
23秒前
23秒前
关显锋完成签到,获得积分10
23秒前
喜悦贞发布了新的文献求助30
23秒前
蘼芜君关注了科研通微信公众号
24秒前
慕青应助潇湘采纳,获得10
24秒前
Helena发布了新的文献求助10
26秒前
所所应助飞云之下采纳,获得10
27秒前
完美世界应助qwqw采纳,获得30
27秒前
28秒前
高分求助中
Sraffa and applied economics: are there classical supply curves? 1000
Heun’s Differential Equations 600
《Fundamentals of Power Supply Design》Robert A. Mammano 510
Wind Effects on Structures: An Introduction to Wind Engineering and Wind Forces in Engineering (2nd Edition) 300
Against the Grain: The Vayda Tradition in Human Ecology and Ecological Anthropology 300
High Wire: How China Regulates Big Tech and Governs Its Economy 260
lingnan science journal vol. 16 250
热门求助领域 (近24小时)
化学 材料科学 医学 生物 有机化学 工程类 生物化学 纳米技术 物理 内科学 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 电极 光电子学 量子力学
热门帖子
关注 科研通微信公众号,转发送积分 2248175
求助须知:如何正确求助?哪些是违规求助? 1897516
关于积分的说明 4730486
捐赠科研通 1686678
什么是DOI,文献DOI怎么找? 855863
版权声明 544914
科研通“疑难数据库(出版商)”最低求助积分说明 452962