美国范德比尔特大学医学中心JoAnn Lindenfeld团队研究了心力衰竭的血流动力学指导治疗（GIDEHF）对患者临床预后的影响。相关论文于2021年8月27日发表在《柳叶刀》杂志上。
先前的研究表明，使用植入式肺动脉压监测仪的血流动力学指导治疗可减少中度症状（纽约心脏协会功能III级）慢性心力衰竭和过去一年住院治疗的心力衰竭患者的住院率，且与射血分数无关。目前尚不清楚这些益处是否适用于轻度（NYHA功能II级）或重度（NYHA功能IV级）心衰症状的患者，或近期无心衰住院治疗的钠尿肽升高的患者。该试验旨在评估使用远程肺动脉压监测的血流动力学指导管理是否可降低心衰患者（包括钠尿肽升高但近期无心力衰竭住院的患者）的各种症状严重程度（NYHA功能级II-IV）的心衰事件和死亡率。
心衰血流动力学指导治疗（GIDE-HF）试验随机组是在美国和加拿大的118个中心进行的一项多中心、单盲研究。成功植入肺动脉压监测器后，研究组将所有射血分数、NYHA功能性II-IV级慢性心力衰竭、最近因心力衰竭住院或利钠肽升高（基于先验阈值）的患者按1：1随机分配至基于肺动脉压的血流动力学指导的心衰治疗组或常规护理对照组。主要终点是在所有随机分配的患者中评估的12个月时全因死亡率和总心衰事件（心衰住院和紧急心衰住院）的组合。对所有患者进行安全性评估。
2018年3月15日至2019年12月20日，研究组共招募了1022名患者，其中1000名患者成功植入，随访于2021年1月8日完成。血流动力学指导治疗组（治疗组）497例患者中有253例发生主要终点事件（0.563/患者-年），对照组503例患者中有289例（0.640/患者-年），危险比为0.88。预先指定的疫情敏感性分析使用时间变量比较疫情之前和大流行期间的事件，表明由于试验疫情期间主要终点事件率的变化，存在治疗交互作用，因此需要进行疫情前的影响分析。
在疫情前影响分析中，干预组共发生177起主要终点事件（0.553例/患者-年），对照组发生224起（0.682例/患者-年），组间差异显著。但在疫情期间，这种主要终点事件的差异几乎消失，与疫情前相比，对照组减少了21%（0.536例/患者-年），但干预组几乎没有变化（0.597例/患者-年），两组之间没有差异。血流动力学指导治疗并没有降低心力衰竭事件的累积发生率，但在疫情前的影响分析中显著降低。1022名患者中有1014名（99%）未发生器械或系统相关并发症。
研究结果表明，在整体研究分析中，与对照组相比，血流动力学指导的心衰管理并未降低死亡或心衰事件综合结局的发生率，但疫情前影响分析表明有临床获益。
附：英文原文
Title: Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial
Author: JoAnn Lindenfeld, Michael R Zile, Akshay S Desai, Kunjan Bhatt, Anique Ducharme, Douglas Horstmanshof, Selim R Krim, Alan Maisel, Mandeep R Mehra, Sara Paul, Samuel F Sears, Andrew J Sauer, Frank Smart, Marcel Zughaib, Paige Castaneda, Jean Kelly, Nessa Johnson, Poornima Sood, Greg Ginn, John Henderson, Philip B Adamson, Maria Rosa Costanzo
Issue&Volume: 2021-08-27
Abstract:
Background
Previous studies have suggested that haemodynamic-guided management using an implantable pulmonary artery pressure monitor reduces heart failure hospitalisations in patients with moderately symptomatic (New York Heart Association [NYHA] functional class III) chronic heart failure and a hospitalisation in the past year, irrespective of ejection fraction. It is unclear if these benefits extend to patients with mild (NYHA functional class II) or severe (NYHA functional class IV) symptoms of heart failure or to patients with elevated natriuretic peptides without a recent heart failure hospitalisation. This trial was designed to evaluate whether haemodynamic-guided management using remote pulmonary artery pressure monitoring could reduce heart failure events and mortality in patients with heart failure across the spectrum of symptom severity (NYHA funational class II–IV), including those with elevated natriuretic peptides but without a recent heart failure hospitalisation.
Methods
The randomised arm of the haemodynamic-GUIDEed management of Heart Failure (GUIDE-HF) trial was a multicentre, single-blind study at 118 centres in the USA and Canada. Following successful implantation of a pulmonary artery pressure monitor, patients with all ejection fractions, NYHA functional class II–IV chronic heart failure, and either a recent heart failure hospitalisation or elevated natriuretic peptides (based on a-priori thresholds) were randomly assigned (1:1) to either haemodynamic-guided heart failure management based on pulmonary artery pressure or a usual care control group. Patients were masked to their study group assignment. Investigators were aware of treatment assignment but did not have access to pulmonary artery pressure data for control patients. The primary endpoint was a composite of all-cause mortality and total heart failure events (heart failure hospitalisations and urgent heart failure hospital visits) at 12 months assessed in all randomly assigned patients. Safety was assessed in all patients. A pre-COVID-19 impact analysis for the primary and secondary outcomes was prespecified. This study is registered with ClinicalTrials.gov, NCT03387813.
Findings
Between March 15, 2018, and Dec 20, 2019, 1022 patients were enrolled, with 1000 patients implanted successfully, and follow-up was completed on Jan 8, 2021. There were 253 primary endpoint events (0·563 per patient-year) among 497 patients in the haemodynamic-guided management group (treatment group) and 289 (0·640 per patient-year) in 503 patients in the control group (hazard ratio [HR] 0·88, 95% CI 0·74–1·05; p=0·16). A prespecified COVID-19 sensitivity analysis using a time-dependent variable to compare events before COVID-19 and during the pandemic suggested a treatment interaction (pinteraction=0·11) due to a change in the primary endpoint event rate during the pandemic phase of the trial, warranting a pre-COVID-19 impact analysis. In the pre-COVID-19 impact analysis, there were 177 primary events (0·553 per patient-year) in the intervention group and 224 events (0·682 per patient-year) in the control group (HR 0·81, 95% CI 0·66–1·00; p=0·049). This difference in primary events almost disappeared during COVID-19, with a 21% decrease in the control group (0·536 per patient-year) relative to pre-COVID-19, virtually no change in the treatment group (0·597 per patient-year), and no difference between groups (HR 1·11, 95% CI 0·80–1·55; p=0·53). The cumulative incidence of heart failure events was not reduced by haemodynamic-guided management (0·85, 0·70–1·03; p=0·096) in the overall study analysis but was significantly decreased in the pre-COVID-19 impact analysis (0·76, 0·61–0·95; p=0·014). 1014 (99%) of 1022 patients had freedom from device or system-related complications.
Interpretation
Haemodynamic-guided management of heart failure did not result in a lower composite endpoint rate of mortality and total heart failure events compared with the control group in the overall study analysis. However, a pre-COVID-19 impact analysis indicated a possible benefit of haemodynamic-guided management on the primary outcome in the pre-COVID-19 period, primarily driven by a lower heart failure hospitalisation rate compared with the control group.
DOI: 10.1016/S0140-6736(21)01754-2
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01754-2/fulltext
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