Department of Cardiology, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, United Kingdom.
Department of Cardiology, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, United Kingdom.
Am Heart J. 2023 Dec;266:149-158. doi: 10.1016/j.ahj.2023.09.008. Epub 2023 Sep 28.
For patients with nonischemic cardiomyopathy (NICM), current guidelines recommend implantable cardioverter defibrillators (ICD) when left ventricular ejection fraction (LVEF) is ≤35%, but the DANISH trial failed to confirm that ICDs reduced all-cause mortality for such patients. Circumstantial evidence suggests that scar on CMR is predictive of sudden and arrhythmic death in this population. The presence of myocardial scar identified by cardiac magnetic resonance imaging (CMR) in patients with NICM and an LVEF ≤35% might identify patients at higher risk of sudden arrhythmic death, for whom an ICD is more likely to reduce all-cause mortality.
METHODS/DESIGN: The BRITISH trial is a prospective, multicenter, randomized controlled trial aiming to enrol 1,252 patients with NICM and an LVEF ≤35%. Patients with a nonischemic scar on CMR will be randomized to either: (1) ICD, with or without cardiac resynchronization (CRT-D), or (2) implantable loop recorder (ILR) or cardiac resynchronization (CRT-P). Patients who are screened for the trial but are found not to be eligible, predominantly due to an absence of scar or those who decline to be randomized will be enrolled in an observational registry. The primary endpoint is all-cause mortality, which we plan to assess at 3 years after the last participant is randomized. Secondary endpoints include clinical outcomes, appropriate and inappropriate device therapies, symptom severity and well-being, device-related complications, and analysis of the primary endpoint by subgroups with other risk markers.
The BRITISH trial will assess whether the use of CMR-defined scar to direct ICD implantation in patients with NICM and an LVEF ≤35% is associated with a reduction in mortality.
对于非缺血性心肌病（NICM）患者，当左心室射血分数（LVEF）≤35%时，目前的指南建议植入式心脏复律除颤器（ICD），但 DANISH 试验未能证实 ICD 可降低此类患者的全因死亡率。间接证据表明，CMR 上的瘢痕在该人群中与猝死和心律失常性死亡相关。在 LVEF≤35%的 NICM 患者中，通过心脏磁共振成像（CMR）识别的心肌瘢痕的存在可能会识别出心律失常性猝死风险较高的患者，对于这些患者，ICD 更有可能降低全因死亡率。
方法/设计：BRITISH 试验是一项前瞻性、多中心、随机对照试验，旨在招募 1252 名 LVEF≤35%的 NICM 患者。CMR 上有非缺血性瘢痕的患者将被随机分为：（1）ICD，带或不带心脏再同步（CRT-D），或（2）植入式环路记录器（ILR）或心脏再同步（CRT-P）。因无瘢痕或拒绝随机分组而筛选试验但不符合条件的患者将被纳入观察性登记。主要终点是全因死亡率，我们计划在最后一名参与者随机分组后 3 年评估。次要终点包括临床结局、适当和不适当的设备治疗、症状严重程度和幸福感、设备相关并发症以及使用其他风险标志物对主要终点进行亚组分析。
BRITISH 试验将评估使用 CMR 定义的瘢痕来指导 LVEF≤35%的 NICM 患者 ICD 植入是否与死亡率降低相关。
