Mori Yuichiro, Inoue Kosuke, Sato Hiroyuki, Tsushima Takahiro, Fukuma Shingo
Department of Human Health Sciences, Graduate School of Medicine, Kyoto University, 54, Shogoin-Kawahara-cho, Sakyo-Ku, Kyoto-shi, Kyoto 6068507, Japan.
Department of Social Epidemiology, Graduate School of Medicine, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto-shi, Kyoto 6068315, Japan.
Eur Heart J Open. 2024 Jul 4;4(4):oeae054. doi: 10.1093/ehjopen/oeae054. eCollection 2024 Jul.
In patients with advanced heart failure requiring dobutamine infusion, it is usually recommended to initiate beta-blockers after weaning from dobutamine. However, beta-blockers are sometimes initiated under dobutamine infusion in a real-world scenario. The association between such early beta-blocker initiation with clinical outcomes is unknown. Therefore, this study investigates the association between initiating beta-blockers under dobutamine infusion and survival outcomes.
This observational study with a multicentre inpatient-care database emulated a pragmatic randomized controlled trial (RCT) of the beta-blocker initiation strategy. First, 1151 patients on dobutamine and not on beta-blockers on the day of heart failure admission (Day 0) were identified. Among 1095 who met eligibility criteria, patients who were eventually initiated beta-blockers under dobutamine infusion by Day 7 (early initiation strategy) were 1:1 matched to those who were not initiated (conservative strategy). The methods of cloning, censoring, and weighting were applied to emulate the target trial. Patients were followed up for up to 30 days. The primary outcome was all-cause death. Among 780 matched patients (median age, 81 years), the adjusted hazard ratio was 1.11 (95% confidence interval 0.75-1.64, = 0.59) for the early initiation strategy. The estimated 30-day all-cause mortalities in the early initiation strategy and the conservative strategy were 19.3% (10.6-30.7) and 16.2% (9.2-25.3), respectively. The results were consistent when we used different days to determine strategies (i.e. 5 and 9) instead of 7 days.
The present observational study emulating a pragmatic RCT found no positive or negative association between beta-blocker initiation under dobutamine infusion and overall survival.
在需要静脉输注多巴酚丁胺的晚期心力衰竭患者中,通常建议在多巴酚丁胺撤药后开始使用β受体阻滞剂。然而,在实际临床中,有时会在多巴酚丁胺输注期间就开始使用β受体阻滞剂。这种早期开始使用β受体阻滞剂与临床结局之间的关联尚不清楚。因此,本研究旨在调查在多巴酚丁胺输注期间开始使用β受体阻滞剂与生存结局之间的关联。
这项基于多中心住院患者护理数据库的观察性研究模拟了一项关于β受体阻滞剂起始策略的实用随机对照试验(RCT)。首先,确定了1151例在心力衰竭入院当天(第0天)接受多巴酚丁胺治疗且未使用β受体阻滞剂的患者。在1095例符合纳入标准的患者中,最终在第7天之前在多巴酚丁胺输注期间开始使用β受体阻滞剂的患者(早期起始策略)与未开始使用的患者(保守策略)按1:1进行匹配。采用克隆、删失和加权的方法来模拟目标试验。对患者进行长达30天的随访。主要结局是全因死亡。在780例匹配患者(中位年龄81岁)中,早期起始策略的校正风险比为1.11(95%置信区间0.75-1.64,P = 0.59)。早期起始策略和保守策略的估计30天全因死亡率分别为19.3%(10.6-30.7)和16.2%(9.2-25.3)。当我们使用不同天数(即5天和9天)而非7天来确定策略时结果一致。
这项模拟实用RCT的观察性研究发现,在多巴酚丁胺输注期间开始使用β受体阻滞剂与总体生存之间不存在正相关或负相关。