沙库巴曲缬沙坦治疗后左心室射血分数与N末端B型利钠肽原联合用于预测射血分数降低的心力衰竭患者的预后
Combined Left Ventricular Ejection Fraction and N-Terminal pro-B-type Natriuretic Peptide after Sacubitril/Valsartan for Predicting Outcomes in Patients with Heart Failure with Reduced Ejection Fraction.
作者信息
Fang Ching-Chang, Jao Yeun Tarl Fresner Ng
机构信息
Department of Cardiology and Critical Care Medicine, Tainan Municipal Hospital, Tainan, Taiwan.
出版信息
Acta Cardiol Sin. 2023 Mar;39(2):297-308. doi: 10.6515/ACS.202303_39(2).20220926A.
BACKGROUND
The aim of this study was to determine whether a combined increase of ≥ 10% in left ventricular ejection fraction (LVEF) and decrease in N-terminal pro-B-type natriuretic peptide (NT pro-BNP) to < 1000 pg/mL after treatment with sacubitril/valsartan (SAC/VAL) in patients with heart failure with reduced ejection fraction (HFrEF) translated to better treatment outcomes in a real-world Taiwanese population.
METHODS
This is a single-center, prospective, non-randomized, observational study. Consecutive patients with HFrEF were treated with SAC/VAL and followed up for at least 12 months. The primary endpoint was a change in LVEF and reduction in NT pro-BNP at 12 months. The secondary outcomes were death and heart failure (HF) rehospitalization.
RESULTS
A total of 105 patients were analyzed after 12 months of SAC/VAL treatment. The mean age was 66.0 ± 11.6 years, and the mean LVEF and NT pro-BNP were 33.6 ± 6.7% and 4462.7 ± 5851.7 pg/mL respectively. The mean LVEF significantly increased to 50.5 ± 10.3% (p < 0.001), while NT pro-BNP decreased to 1270.3 ± 2368.2 pg/mL (p = 0.001) at 12 months, with the greatest changes occurring in the first 3 months of treatment (p < 0.001). Five patients died and 12 were rehospitalized for HF. None of the patients in the responder group died compared to 5 deaths in the non-responder group (p = 0.039). Combined ≥ 10% LVEF increase and NT pro-BNP of < 1000 pg/mL was an independent predictor of death and HF rehospitalization (p = 0.019).
CONCLUSIONS
SAC/VAL treatment resulted in significant improvements in LVEF, reduced NT pro-BNP level, death and HF hospitalization. Taken separately, an NT pro-BNP level of < 1000 pg/mL was a better predictor than ≥ 10% LVEF increase. Combining both variables predicted fewer deaths and HF rehospitalizations. Even with failure to reach the target dose, SAC/VAL still had significantly beneficial treatment outcomes in Taiwanese patients.
背景
本研究旨在确定射血分数降低的心力衰竭（HFrEF）患者接受沙库巴曲缬沙坦（SAC/VAL）治疗后，左心室射血分数（LVEF）联合增加≥10%且N末端B型利钠肽原（NT pro-BNP）降低至<1000 pg/mL是否能转化为台湾实际人群中更好的治疗效果。
方法
这是一项单中心、前瞻性、非随机、观察性研究。连续的HFrEF患者接受SAC/VAL治疗并随访至少12个月。主要终点是12个月时LVEF的变化和NT pro-BNP的降低。次要结局是死亡和心力衰竭（HF）再住院。
结果
SAC/VAL治疗12个月后共分析了105例患者。平均年龄为66.0±11.6岁，平均LVEF和NT pro-BNP分别为33.6±6.7%和4462.7±5851.7 pg/mL。12个月时，平均LVEF显著增加至50.5±10.3%（p<0.001），而NT pro-BNP降至1270.3±2368.2 pg/mL（p = 0.001），最大变化发生在治疗的前3个月（p<0.001）。5例患者死亡，12例因HF再次住院。反应者组无患者死亡，而非反应者组有5例死亡（p = 0.039）。LVEF联合增加≥10%且NT pro-BNP<1000 pg/mL是死亡和HF再住院的独立预测因素（p = 0.019）。
结论
SAC/VAL治疗使LVEF显著改善，NT pro-BNP水平降低，死亡和HF住院减少。单独来看，NT pro-BNP水平<1000 pg/mL比LVEF增加≥10%是更好的预测指标。联合这两个变量可预测更少的死亡和HF再住院。即使未达到目标剂量，SAC/VAL对台湾患者仍有显著有益的治疗效果。
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