INSERM, Centre d'Investigations Cliniques 9501, Université de Lorraine, CHU de Nancy, Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu, 4 Rue du Morvan, 54500, Nancy, Vandoeuvre lès Nancy, France.
INI-CRCT (Cardiovascular and Renal Clinical Trialists) F-CRIN network, Nancy, France.
Clin Res Cardiol. 2017 Sep;106(9):722-733. doi: 10.1007/s00392-017-1116-z. Epub 2017 Apr 28.
Contradictory findings have been reported regarding the safety and efficacy of digitalis in patients recovering from acute myocardial infarction (MI). We studied the association of digitalis use with long-term and short-term prognosis in patients presenting with an acute MI complicated with heart failure (HF), left ventricular dysfunction, or both.
Using the High-Risk MI Database Initiative combining data from 4 major clinical trials, totaling 27,673 patients, we investigated the association between digitalis use at baseline (3093 patients with digitalis and 24,580 without) with the rate of all-cause death, sudden cardiac death, cardiovascular death, HF hospitalization and the combination of the latter two, over a mean follow-up time of 2.7 years. Patients with and without atrial fibrillation (AF) were studied separately. After a propensity score-based analysis, among patients without AF, those receiving digitalis experienced a higher rate of all-cause [hazard ratio (HR) 1.54, 95% confidence interval (CI) 1.42-1.67] and sudden cardiac death (HR 1.65, 95% CI 1.44-1.89), compared to those not receiving digitalis; similar results were found for the other 3 endpoints (all HR around 1.6). In contrast, in AF patients, digitalis had a milder effect on all outcomes (all HR ≤ 1.12), with significant association only for the composite endpoint (HR 1.10, 95% CI 1.00-1.21, p = 0.049); comparable results were obtained at 30 days. Finally, the detrimental effect associated with digitalis use appeared to be more pronounced in patients with ejection fraction ≥ 40%.
In MI survivors with HF and/or systolic dysfunction, digitalis was associated with a significant increased risk of death in patients without AF with mild to neutral associations for patients with AF. These findings raise concerns regarding the safety of digitalis in MI survivors with HF, especially for those without AF.
关于在急性心肌梗死（MI）后恢复的患者中使用洋地黄类药物的安全性和疗效，已有相互矛盾的研究结果。我们研究了在急性 MI 合并心力衰竭（HF）、左心室功能障碍或两者并存的患者中，洋地黄类药物的使用与长期和短期预后的关系。
利用合并了 4 项大型临床试验数据的高危 MI 数据库倡议，共纳入 27673 例患者，我们研究了基线时使用洋地黄类药物（3093 例使用洋地黄类药物和 24580 例未使用洋地黄类药物）与全因死亡率、心源性猝死、心血管死亡率、HF 住院率以及后两者的联合发生率之间的关系，平均随访时间为 2.7 年。分别对有和无心房颤动（AF）的患者进行了研究。在基于倾向评分的分析后，在无 AF 的患者中，与未使用洋地黄类药物的患者相比，使用洋地黄类药物的患者全因死亡（危险比 [HR] 1.54，95%置信区间 [CI] 1.42-1.67）和心源性猝死（HR 1.65，95%CI 1.44-1.89）的发生率更高；其他 3 个终点的结果相似（所有 HR 约为 1.6）。相比之下，在 AF 患者中，洋地黄类药物对所有结局的影响更轻微（所有 HR≤1.12），仅复合终点有显著相关性（HR 1.10，95%CI 1.00-1.21，p=0.049）；在 30 天时也得到了类似的结果。最后，在射血分数≥40%的患者中，洋地黄类药物的使用与死亡风险增加之间的关联似乎更为明显。
在 HF 和/或收缩功能障碍的 MI 幸存者中，洋地黄类药物与无 AF 的患者死亡风险显著增加相关，而在 AF 患者中则呈轻度到中性相关。这些发现引发了对 HF 后 MI 幸存者使用洋地黄类药物安全性的担忧，特别是对于无 AF 的患者。
