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Biomarker guidance allows a more personalized allocation of patients for remote patient management in heart failure: results from the TIM-HF2 trial.
European Journal of Heart Failure ( IF 16.9 ) Pub Date : 2019-06-17 , DOI: 10.1002/ejhf.1530
Martin Möckel 1 , Kerstin Koehler 2 , Stefan D Anker 3 , Jörn Vollert 4 , Volker Moeller 2 , Magdalena Koehler 5 , Stefan Gehrig 4 , Jan C Wiemer 4 , Stephan von Haehling 6 , Friedrich Koehler 2
Affiliation  

AIMS The TIM-HF2 study showed less days lost due to unplanned cardiovascular hospitalization or all-cause death and improved survival in patients randomly assigned to remote patient management (RPM) instead of standard of care. METHODS AND RESULTS This substudy explored whether the biomarkers mid-regional pro-adrenomedullin (MR-proADM) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) could be used to identify low-risk patients unlikely to benefit from RPM, thereby allowing more efficient allocation of the intervention. For 1538 patients of the trial (median age 73 years, interquartile range 64-78 years, 30% female), baseline biomarkers were used to select subpopulations recommended for RPM with various safety endpoints (100%, 98%, 95% sensitivity), and efficacy of RPM was assessed. Both biomarkers were strongly associated with events. The primary endpoint of lost days increased from 1.0% (1.4%) in the lowest to 17.3% (17.6%) in the highest quintile of NT-proBNP (MR-proADM). After combining biomarkers to identify patients recommended for RPM with 95% sensitivity, in the most efficient scenario (excluding 27% of patients; NT-proBNP < 413.7 pg/mL and MR-proADM < 0.75 nmol/L), the effect of RPM on patients was highly similar to the original trial (ratio of lost days: 0.78, hazard ratio for all-cause death: 0.68). Number needed to treat for all-cause death was lowered from 28 to 21. Rates of emergencies and telemedical efforts were significantly lower among patients not recommended for RPM. Biomarker guidance would have saved about 150 h effort/year per 100 patients of the eligible population. CONCLUSIONS The combined use of MR-proADM and NT-proBNP may allow safe, more precise, effective and cost-saving allocation of patients with heart failure to RPM and warrants further prospective studies.

中文翻译:

生物标志物指导可对心力衰竭患者进行更个性化的分配,以进行远程患者管理:TIM-HF2试验的结果。

目的TIM-HF2研究显示,由于计划外的心血管疾病住院或全因死亡而导致的工作日损失减少,并且随机分配到远程患者管理(RPM)代替标准治疗的患者的生存期得到了改善。方法和结果本子研究探讨了是否可以使用生物标志物中部区域肾上腺髓质素原(MR-proADM)和N末端前B型钠尿肽(NT-proBNP)来鉴定不太可能受益于RPM的低危患者,从而可以更有效地分配干预措施。对于1538名试验患者(中位年龄73岁,四分位间距为64-78岁,女性为30%),使用基线生物标志物选择推荐用于RPM的亚群,这些亚群具有各种安全性终点(100%,98%,95%敏感性),并评估了RPM的有效性。两种生物标志物均与事件密切相关。损失天数的主要终点从最低的五分之一(NT-proBNP(MR-proADM))的1.0%(1.4%)增加到最高的五分之一的17.3%(17.6%)。在结合生物标记物以95%的敏感性鉴定推荐用于RPM的患者后,在最有效的情况下(不包括27%的患者; NT-proBNP <413.7 pg / mL和MR-proADM <0.75 nmol / L),RPM对患者与原始试验高度相似(损失天数比:0.78,全因死亡的风险比:0.68)。不推荐使用RPM的患者中,用于全因死亡的治疗人数从28降低到21。紧急情况和远程医疗工作的比率显着降低。每100名合格人群中,生物标志物指导每年可节省约150小时的精力。结论MR-proADM和NT-proBNP的联合使用可以确保安全,
更新日期:2019-11-18
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