Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis.

IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL New England Journal of Medicine Pub Date : 2024-10-28 DOI:10.1056/NEJMoa2405880
Philippe Généreux, Allan Schwartz, J Bradley Oldemeyer, Philippe Pibarot, David J Cohen, Philipp Blanke, Brian R Lindman, Vasilis Babaliaros, William F Fearon, David V Daniels, Adnan K Chhatriwalla, Clifford Kavinsky, Hemal Gada, Pinak Shah, Molly Szerlip, Thom Dahle, Kashish Goel, William O'Neill, Tej Sheth, Charles J Davidson, Raj R Makkar, Heather Prince, Yanglu Zhao, Rebecca T Hahn, Jonathon Leipsic, Björn Redfors, Stuart J Pocock, Michael Mack, Martin B Leon
{"title":"Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis.","authors":"Philippe Généreux, Allan Schwartz, J Bradley Oldemeyer, Philippe Pibarot, David J Cohen, Philipp Blanke, Brian R Lindman, Vasilis Babaliaros, William F Fearon, David V Daniels, Adnan K Chhatriwalla, Clifford Kavinsky, Hemal Gada, Pinak Shah, Molly Szerlip, Thom Dahle, Kashish Goel, William O'Neill, Tej Sheth, Charles J Davidson, Raj R Makkar, Heather Prince, Yanglu Zhao, Rebecca T Hahn, Jonathon Leipsic, Björn Redfors, Stuart J Pocock, Michael Mack, Martin B Leon","doi":"10.1056/NEJMoa2405880","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>For patients with asymptomatic severe aortic stenosis and preserved left ventricular ejection fraction, current guidelines recommend routine clinical surveillance every 6 to 12 months. Data from randomized trials examining whether early intervention with transcatheter aortic-valve replacement (TAVR) will improve outcomes in these patients are lacking.</p><p><strong>Methods: </strong>At 75 centers in the United States and Canada, we randomly assigned, in a 1:1 ratio, patients with asymptomatic severe aortic stenosis to undergo early TAVR with transfemoral placement of a balloon-expandable valve or clinical surveillance. The primary end point was a composite of death, stroke, or unplanned hospitalization for cardiovascular causes. Superiority testing was performed in the intention-to-treat population.</p><p><strong>Results: </strong>A total of 901 patients underwent randomization; 455 patients were assigned to TAVR and 446 to clinical surveillance. The mean age of the patients was 75.8 years, the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.8% (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after surgery), and 83.6% of patients were at low surgical risk. A primary end-point event occurred in 122 patients (26.8%) in the TAVR group and in 202 patients (45.3%) in the clinical surveillance group (hazard ratio, 0.50; 95% confidence interval, 0.40 to 0.63; P<0.001). Death occurred in 8.4% of the patients assigned to TAVR and in 9.2% of the patients assigned to clinical surveillance, stroke occurred in 4.2% and 6.7%, respectively, and unplanned hospitalization for cardiovascular causes occurred in 20.9% and 41.7%. During a median follow-up of 3.8 years, 87.0% of patients in the clinical surveillance group underwent aortic-valve replacement. There were no apparent differences in procedure-related adverse events between patients in the TAVR group and those in the clinical surveillance group who underwent aortic-valve replacement.</p><p><strong>Conclusions: </strong>Among patients with asymptomatic severe aortic stenosis, a strategy of early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes. (Funded by Edwards Lifesciences; EARLY TAVR ClinicalTrials.gov number, NCT03042104.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":null,"pages":null},"PeriodicalIF":96.2000,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"New England Journal of Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1056/NEJMoa2405880","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0

Abstract

Background: For patients with asymptomatic severe aortic stenosis and preserved left ventricular ejection fraction, current guidelines recommend routine clinical surveillance every 6 to 12 months. Data from randomized trials examining whether early intervention with transcatheter aortic-valve replacement (TAVR) will improve outcomes in these patients are lacking.

Methods: At 75 centers in the United States and Canada, we randomly assigned, in a 1:1 ratio, patients with asymptomatic severe aortic stenosis to undergo early TAVR with transfemoral placement of a balloon-expandable valve or clinical surveillance. The primary end point was a composite of death, stroke, or unplanned hospitalization for cardiovascular causes. Superiority testing was performed in the intention-to-treat population.

Results: A total of 901 patients underwent randomization; 455 patients were assigned to TAVR and 446 to clinical surveillance. The mean age of the patients was 75.8 years, the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.8% (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after surgery), and 83.6% of patients were at low surgical risk. A primary end-point event occurred in 122 patients (26.8%) in the TAVR group and in 202 patients (45.3%) in the clinical surveillance group (hazard ratio, 0.50; 95% confidence interval, 0.40 to 0.63; P<0.001). Death occurred in 8.4% of the patients assigned to TAVR and in 9.2% of the patients assigned to clinical surveillance, stroke occurred in 4.2% and 6.7%, respectively, and unplanned hospitalization for cardiovascular causes occurred in 20.9% and 41.7%. During a median follow-up of 3.8 years, 87.0% of patients in the clinical surveillance group underwent aortic-valve replacement. There were no apparent differences in procedure-related adverse events between patients in the TAVR group and those in the clinical surveillance group who underwent aortic-valve replacement.

Conclusions: Among patients with asymptomatic severe aortic stenosis, a strategy of early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes. (Funded by Edwards Lifesciences; EARLY TAVR ClinicalTrials.gov number, NCT03042104.).

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
经导管主动脉瓣置换术治疗无症状重度主动脉瓣狭窄。
背景:对于无症状重度主动脉瓣狭窄且左心室射血分数保留的患者,现行指南建议每6至12个月进行一次常规临床监测。目前还缺乏随机试验数据来研究经导管主动脉瓣置换术(TAVR)的早期干预是否能改善这些患者的预后:在美国和加拿大的 75 个中心,我们以 1:1 的比例随机分配无症状重度主动脉瓣狭窄患者接受经胸放置球囊扩张瓣膜的早期 TAVR 或临床监测。主要终点是死亡、中风或因心血管原因意外住院的综合结果。在意向治疗人群中进行了优越性测试:共有901名患者接受了随机分配,其中455名患者被分配到TAVR,446名患者被分配到临床监测。患者的平均年龄为75.8岁,胸外科医师学会预测死亡率风险平均得分为1.8%(评分标准从0到100%,得分越高,术后30天内死亡的风险越大),83.6%的患者手术风险较低。TAVR组有122名患者(26.8%)发生了主要终点事件,临床监测组有202名患者(45.3%)发生了主要终点事件(危险比为0.50;95%置信区间为0.40至0.63;PC结论:在无症状重度主动脉瓣狭窄患者中,早期TAVR策略在降低死亡、中风或因心血管原因意外住院的发生率方面优于临床监测策略。(由 Edwards Lifesciences 资助;EARLY TAVR 临床试验项目编号:NCT03042104)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
New England Journal of Medicine
New England Journal of Medicine 医学-医学:内科
CiteScore
145.40
自引率
0.60%
发文量
1839
审稿时长
1 months
期刊介绍: The New England Journal of Medicine (NEJM) stands as the foremost medical journal and website worldwide. With an impressive history spanning over two centuries, NEJM boasts a consistent publication of superb, peer-reviewed research and engaging clinical content. Our primary objective revolves around delivering high-caliber information and findings at the juncture of biomedical science and clinical practice. We strive to present this knowledge in formats that are not only comprehensible but also hold practical value, effectively influencing healthcare practices and ultimately enhancing patient outcomes.
期刊最新文献
Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. Compared with What? Measuring AI against the Health Care We Have “Blessed Be the Fruit” — The Contemporary Rise of Pronatalism Chvostek’s Sign in Familial Hypoparathyroidism APOL1 Bi- and Monoallelic Variants and Chronic Kidney Disease in West Africans
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1