Clinic for Cardiology II - Electrophysiology, University Hospital Münster, Münster, Germany.
Stiftung Institut für Herzinfarktforschung (IHF), Ludwigshafen am Rhein, Germany.
Int J Cardiol. 2021 Sep 1;338:109-114. doi: 10.1016/j.ijcard.2021.05.047. Epub 2021 Jun 1.
Despite lacking supporting randomized trials, cardiac glycosides (CGs) are widely used in heart failure and/or atrial fibrillation. Moreover, several pro- and retrospective studies and registry-data have recently raised serious concerns in terms of efficacy and safety of CGs in this field. We have therefore examined the association between CGs and clinical outcome of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization (CRT-ICD) patients of the large German DEVICE registry.
Between 2007 and 2014, 3782 ICD and 1529 CRT-ICD patients were enrolled in the German DEVICE registry. Those two groups were analyzed independently according to medication with or without CGs. After adjustment for patient characteristics, CGs were not significantly associated with increased one-year mortality (HR 1.27, 95%-CI 0.91-1.76, p = 0.162), major adverse cardiac and cerebrovascular events (OR 1.36, 95%-CI 0.98-1.89, p = 0.063), ICD-shocks (OR 1.29, 95%-CI 0.95-1.74, p = 0.104) or the need for rehospitalization in ICD patients at one-year-follow-up. Similar findings were obtained in CRT-ICD patients. Regarding possible determinants for glycoside treatment, atrial fibrillation at enrollment was found to be most strongly associated with the prescription of glycosides in ICD (adjusted OR 3.25, 95%-CI 2.63-4.02) and CRT-ICD patients (adjusted OR 3.17, 95%-CI 2.39-4.19).
Overall harmful effects of CGs in ICD- and CRT-ICD patients could not be confirmed in DEVICE. Further large and randomized-controlled trials that investigate dose-dependent effects of CGs in addition to contemporary therapy of heart failure and atrial fibrillation are needed.
尽管缺乏支持性的随机临床试验，心脏糖苷（CGs）仍广泛用于心力衰竭和/或心房颤动。此外，最近一些前瞻性和回顾性研究和注册数据对 CG 在该领域的疗效和安全性提出了严重关切。因此，我们检查了大型德国 DEVICE 注册中心植入式心脏复律除颤器（ICD）和心脏再同步（CRT-ICD）患者中 CG 与临床结局之间的关联。
2007 年至 2014 年间，3782 例 ICD 和 1529 例 CRT-ICD 患者入组德国 DEVICE 注册中心。根据有无 CG 用药情况，将这两组患者独立进行分析。调整患者特征后，CG 与一年死亡率增加无关（HR 1.27，95%-CI 0.91-1.76，p=0.162）、主要不良心脑血管事件（OR 1.36，95%-CI 0.98-1.89，p=0.063）、ICD 电击（OR 1.29，95%-CI 0.95-1.74，p=0.104）或 ICD 患者一年随访时再住院需求。在 CRT-ICD 患者中也得到了类似的发现。关于糖苷治疗的可能决定因素，入组时的心房颤动被发现与 ICD（调整后的 OR 3.25，95%-CI 2.63-4.02）和 CRT-ICD 患者（调整后的 OR 3.17，95%-CI 2.39-4.19）中 CG 处方最密切相关。
在 DEVICE 中，无法证实 CG 在 ICD 和 CRT-ICD 患者中的总体有害影响。需要进一步进行大型、随机对照试验，以研究 CG 在心力衰竭和心房颤动的当代治疗基础上的剂量依赖性作用。
