作者
Reinoud E Knops, Louise RA Olde Nordkamp, Peter-Paul HM Delnoy, Lucas VA Boersma, Jürgen Kuschyk, Mikhael F El-Chami, Hendrik Bonnemeier, Elijah R Behr, Tom F Brouwer, Stefan Kääb, Suneet Mittal, Anne-Floor BE Quast, Lonneke Smeding, Willeke van der Stuijt, Anouk de Weger, Koen C de Wilde, Nick R Bijsterveld, Sergio Richter, Marc A Brouwer, Joris R de Groot, Kirsten M Kooiman, Pier D Lambiase, Petr Neuzil, Kevin Vernooy, Marco Alings, Tim R Betts, Frank ALE Bracke, Martin C Burke, Jonas SSG de Jong, David J Wright, Jan GP Tijssen, Arthur AM Wilde
发表日期
2020/8/6
期刊
New England Journal of Medicine
卷号
383
期号
6
页码范围
526-536
出版商
Massachusetts Medical Society
简介
Background
The subcutaneous implantable cardioverter–defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies.
Methods
We conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD. The primary end point was the composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD) was 1.45. A superiority analysis was prespecified if noninferiority was established. Secondary end points included death and appropriate shocks.
Results
A total of 849 patients (426 in the subcutaneous ICD …
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