Yang Pei, Li Xiaokang, Wang Lijin, Wu Xinlei, Wang Chiyao, Li Tian, Wang Haiyan
Department of Structural Heart Disease, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Jiajiang Integrated Warehouse, Leshan, Sichuan, China.
Front Cardiovasc Med. 2023 Jan 13;9:1059420. doi: 10.3389/fcvm.2022.1059420. eCollection 2022.
In 2014, the PARADIGM-HF trial (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) has shown that sacubitril/valsartan can reduce the risk of hospitalization and death from cardiovascular causes more effectively than enalapril (an ACEI) in heart failure patients with reduced ejection fraction (HFrEF). Similarly, the PARADIGM-HF trial (Comparison of Sacubitril-Valsartan vs. Enalapril on Effect on NT-proBNP in Patients Stabilized from an Acute Heart Failure Episode) came to similar conclusions and extended the PARADIGM-HF trial results in 2019. Since then, numerous new studies have provided further insight in HFrEF, sacubitril/valsartan can reduce N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, increase left ventricular ejection fraction (LVEF), reverse ventricular remodeling, and reduce other non-fatal manifestations of clinical deterioration as compared to ACEI/ARB. However, few trials have compared the effects of these drugs in patients shortly after AMI. Therefore, it is necessary to further explore the clinical efficacy and safety of sacubitril/valsartan vs. valsartan in patients with AMI.
We conducted an open-label, prospective, randomized controlled trial to determine the superiority in ameliorating ventricular remodeling and preventing of heart failure in patients with AMI after percutaneous coronary intervention (PCI), 148 patients were randomly assigned (85 to sacubitril/valsartan and 63 to valsartan).
LAV, LVDV, and LVSV were all decreased in the sacubitril/valsartan group when compared with before treatment, but there was no difference between the sacubitril/valsartan group and the valsartan group. In addition, compared with before treatment in the sacubitril/valsartan group, the heart global work index (GWI) and the global work efficiency (GWE) increased, while the heart global wasted work (GWW) decreased. Patients in the sacubitril/valsartan group have similar MACE and adverse side effects to those in the valsartan group.
Sacubitril/valsartan has the same performance as valsartan in inhibiting ventricular remodeling and preventing heart failure after PCI in patients with AMI, and its clinical application is safe. It provides a clinical foundation for the application of sacubitril/valsartan in patients with AMI.
2014年,PARADIGM-HF试验(血管紧张素受体脑啡肽酶抑制剂与血管紧张素转换酶抑制剂对心力衰竭患者全球死亡率和发病率影响的前瞻性比较)表明,在射血分数降低的心力衰竭(HFrEF)患者中,沙库巴曲缬沙坦比依那普利(一种血管紧张素转换酶抑制剂)能更有效地降低心血管原因导致的住院和死亡风险。同样,PARADIGM-HF试验(沙库巴曲缬沙坦与依那普利对急性心力衰竭发作后病情稳定患者NT-proBNP影响的比较)也得出了类似结论,并在2019年扩展了PARADIGM-HF试验结果。从那时起,大量新研究进一步深入了解了HFrEF,与血管紧张素转换酶抑制剂/血管紧张素受体拮抗剂相比,沙库巴曲缬沙坦可降低N末端B型利钠肽原(NT-proBNP)水平,提高左心室射血分数(LVEF),逆转心室重构,并减少临床恶化的其他非致命表现。然而,很少有试验比较这些药物在急性心肌梗死(AMI)后不久的患者中的效果。因此,有必要进一步探讨沙库巴曲缬沙坦与缬沙坦在AMI患者中的临床疗效和安全性。
我们进行了一项开放标签、前瞻性、随机对照试验,以确定在接受经皮冠状动脉介入治疗(PCI)的AMI患者中,沙库巴曲缬沙坦在改善心室重构和预防心力衰竭方面的优势,148例患者被随机分配(85例接受沙库巴曲缬沙坦,63例接受缬沙坦)。
与治疗前相比,沙库巴曲缬沙坦组的左心房容积(LAV)、左心室舒张末期容积(LVDV)和左心室收缩末期容积(LVSV)均降低,但沙库巴曲缬沙坦组与缬沙坦组之间无差异。此外,与沙库巴曲缬沙坦组治疗前相比,心脏整体做功指数(GWI)和整体做功效率(GWE)增加,而心脏整体无用功(GWW)降低。沙库巴曲缬沙坦组患者的主要不良心血管事件(MACE)和不良副作用与缬沙坦组相似。
沙库巴曲缬沙坦在抑制AMI患者PCI后心室重构和预防心力衰竭方面与缬沙坦表现相同,且临床应用安全。这为沙库巴曲缬沙坦在AMI患者中的应用提供了临床依据。