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心力衰竭射血分数降低患者中血压变异性与结局的关系:依普利酮治疗射血分数降低的心力衰竭伴轻微症状患者试验的观察结果。

Visit-to-visit blood pressure variation and outcomes in heart failure with reduced ejection fraction: findings from the Eplerenone in Patients with Systolic Heart Failure and Mild Symptoms trial.

机构信息

Department of Cardiovascular, Respiratory, Nephrological and Geriatric Sciences, 'Sapienza' University, Rome, Italy.

Université de Lorraine, INSERM, Centre d'Investigations Cliniques-Plurithématique 1433, and INSERM U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.

出版信息

J Hypertens. 2020 Mar;38(3):420-425. doi: 10.1097/HJH.0000000000002275.

Abstract

BACKGROUND

Visit-to-visit office blood pressure (BP) variability (BPV) has been associated with morbidity and mortality outcomes in several cardiovascular conditions. The aim of this study was to evaluate the association between BPV and outcomes in patients with heart failure and reduced ejection fraction and the effect of eplerenone on BPV.

METHODS AND RESULTS

We evaluated the associations between BPV, calculated as SBP coefficient of variation (SBP-CoV = SD/mean × 100%), and the primary composite endpoint of cardiovascular mortality or heart failure hospitalization (HFH), and its components, in 2549 patients from the Eplerenone in Patients with Systolic Heart Failure and Mild Symptoms trial. Lower SBP-CoV was independently associated with a higher risk of all the studied outcomes, while higher as well as lower SBP-CoV were associated with a higher risk of cardiovascular death. After a median follow-up period of 21 months the risk of the composite outcome of cardiovascular death or HFH was almost double in the lower SBP-CoV tertile as compared with the intermediate tertile [adjusted hazard ratio: 2.01, 95% confidence interval (1.62-2.51), P < 0.001]. The relationship between SBP-CoV and outcomes was not modified by eplerenone (P value for interaction = 0.48). An interaction was detected between mean SBP and SBP-CoV for the primary outcome (P = 0.048) and for HFH (P = 0.018). The effect modification was slight, but lower SBP-CoV was associated with worse outcomes in patients with both low and high SBP, while this interaction was less clear for patients with SBP in the 'normal' range.

CONCLUSION

In our patients with heart failure and reduced ejection fraction and mild symptoms, both a lower and higher SBP-CoV were associated with worse outcomes. SBP-CoV did not modify the benefit of eplerenone. Further studies are warranted to clarify the role of BPV in heart failure. CLINICALTRIALS.

GOV IDENTIFIER

NCT00232180.

摘要

背景

在几种心血管疾病中,就诊间诊室血压(BP)变异性(BPV)与发病率和死亡率结果相关。本研究的目的是评估心力衰竭和射血分数降低患者的 BPV 与结局之间的关联,以及依普利酮对 BPV 的影响。

方法和结果

我们评估了 BPV(计算为收缩压变异系数[SBP-CoV=SD/mean×100%])与心血管死亡率或心力衰竭住院(HFH)的主要复合终点及其组成部分之间的相关性,该研究纳入了来自依普利酮治疗射血分数降低的心力衰竭和轻度症状患者试验的 2549 名患者。较低的 SBP-CoV 与所有研究结果的较高风险独立相关,而较高和较低的 SBP-CoV 与心血管死亡的较高风险相关。中位随访 21 个月后,与中间 tertile 相比,下 tertile 的 SBP-CoV 复合结局(心血管死亡或 HFH)的风险几乎增加了一倍[调整后的危险比:2.01,95%置信区间(1.62-2.51),P<0.001]。依普利酮并未改变 SBP-CoV 与结局之间的关系(交互作用 P 值=0.48)。在主要结局(P=0.048)和 HFH(P=0.018)中,平均 SBP 和 SBP-CoV 之间存在交互作用。这种效应修饰是轻微的,但在 SBP 较低和较高的患者中,较低的 SBP-CoV 与较差的结局相关,而对于 SBP 处于“正常”范围的患者,这种交互作用则不太明显。

结论

在我们患有心力衰竭和射血分数降低且症状轻微的患者中,较低和较高的 SBP-CoV 均与较差的结局相关。SBP-CoV 并未改变依普利酮的获益。需要进一步研究以阐明 BPV 在心力衰竭中的作用。

临床试验。

注册号

NCT00232180。

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