Imperial College London, National Heart and Lung Institute, Hammersmith Hospital Campus, B Block, 2nd floor, NHLI - Cardiovascular Science, Du Cane Road, W12 0NN London, UK.
Eur Heart J. 2017 Jun 7;38(22):1738-1746. doi: 10.1093/eurheartj/ehx028.
Primary prevention implantable cardioverter defibrillators (ICDs) are established therapy for reducing mortality in patients with left ventricular systolic dysfunction and ischaemic heart disease (IHD). However, their efficacy in patients without IHD has been controversial. We undertook a meta-analysis of the totality of the evidence.
We systematically identified all RCTs comparing ICD vs. no ICD in primary prevention. Eligible RCTs were those that recruited patients with left ventricular dysfunction, reported all-cause mortality, and presented their results stratified by the presence of IHD (or recruited only those with or without). Our primary endpoint was all-cause mortality. We identified 11 studies enrolling 8567 participants with left ventricular dysfunction, including 3128 patients without IHD and 5439 patients with IHD. In patients without IHD, ICD therapy reduced mortality by 24% (HR 0.76, 95% CI 0.64 to 0.90, P = 0.001). In patients with IHD, ICD implantation (at a dedicated procedure), also reduced mortality by 24% (HR 0.76, 95% CI 0.60 to 0.96, P = 0.02).
Until now, it has never been explicitly stated that the patients without IHD in COMPANION showed significant survival benefit from adding ICD therapy (to a background of CRT). Even before DANISH, meta-analysis of patients without ischaemic heart disease already showed reduced mortality. DANISH is consistent with these data. With a significant 24% mortality reduction in both aetiologies, it may no longer be necessary to distinguish between them when deciding on primary prevention ICD implantation.
植入式心脏复律除颤器（ICD）是降低左心室收缩功能障碍和缺血性心脏病（IHD）患者死亡率的既定治疗方法。然而，其在非 IHD 患者中的疗效一直存在争议。我们对所有证据进行了荟萃分析。
我们系统地确定了所有比较 ICD 与非 ICD 在一级预防中的 RCT。合格的 RCT 是那些招募左心室功能障碍患者、报告全因死亡率并按 IHD 存在情况对结果进行分层（或仅招募有或无 IHD 的患者）的 RCT。我们的主要终点是全因死亡率。我们确定了 11 项研究，共纳入 8567 名左心室功能障碍患者，其中 3128 名无 IHD，5439 名有 IHD。在无 IHD 的患者中，ICD 治疗可降低 24%的死亡率（HR 0.76，95%CI 0.64 至 0.90，P=0.001）。在有 IHD 的患者中，ICD 植入（在专门的程序中）也降低了 24%的死亡率（HR 0.76，95%CI 0.60 至 0.96，P=0.02）。
到目前为止，从未明确表明 COMPANION 中无 IHD 的患者从添加 ICD 治疗（在 CRT 的基础上）中获得显著的生存获益。甚至在 DANISH 之前，对无缺血性心脏病患者的荟萃分析已经显示死亡率降低。DANISH 与这些数据一致。两种病因的死亡率均显著降低 24%，在决定进行一级预防 ICD 植入时，可能不再需要区分它们。
