Cikes Maja, Planinc Ivo, Claggett Brian, Cunningham Jonathan, Milicic Davor, Sweitzer Nancy, Senni Michele, Gori Mauro, Linssen Gerard, Shah Sanjiv J, Packer Milton, Pfeffer Marc, Zile Michael R, Anand Inder, Chiang Lu-May, Lam Carolyn S P, Redfield Margaret, Desai Akshay S, McMurray John J V, Solomon Scott D
Department for Cardiovascular Diseases, University Hospital Centre Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia.
Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.
JACC Heart Fail. 2022 May;10(5):336-346. doi: 10.1016/j.jchf.2022.01.018. Epub 2022 Apr 6.
In this study, the authors sought to assess the relationship between AFF and outcomes, the treatment response to sacubitril/valsartan and first-detected AFF in patients with HFpEF enrolled in the PARAGON-HF trial.
Atrial fibrillation and flutter (AFF) are common in heart failure with preserved ejection fraction (HFpEF) and increase the risk of adverse outcomes.
A total of 4,776 patients formed 3 groups: those with AFF according to electrocardiography (ECG) at enrollment (n = 1,552; 33%), those with history of AFF but without AFF on ECG at enrollment (n = 1,005; 21%), and those without history of AFF or AFF on ECG at enrollment (n = 2,219, 46%). We assessed outcomes, treatment response to sacubitril/valsartan in each group, and the risk associated with first-detected AFF in patients without any known AFF. The primary outcome was a composite of total heart failure hospitalizations and cardiovascular death.
History of AFF and AFF at enrollment were associated with higher risk of the primary outcome (risk ratio [RR]: 1.36 [95% CI: 1.12-1.65] and RR: 1.31 [1.11-1.54], respectively), than no AFF. Neither history of AFF nor AFF at enrollment modified the treatment effect of sacubitril/valsartan. Post randomization AFF occurred in 12% of patients without previous AFF and was associated with 2.8-fold higher risk of the primary outcome, but it was not influenced by sacubitril/valsartan.
History of AFF and AFF on ECG at enrollment were associated with a higher risk of the primary outcome. First-detected AFF was not influenced by sacubitril/valsartan, yet it was associated with increased risk of all subsequent outcomes and may represent a potential target for future HFpEF trials. (Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction [PARAGON-HF]; NCT01920711).
在本研究中，作者试图评估射血分数保留的心力衰竭（HFpEF）患者中，房颤和房扑（AFF）与预后的关系、对沙库巴曲缬沙坦的治疗反应以及首次检测到的AFF情况。
房颤和房扑（AFF）在射血分数保留的心力衰竭（HFpEF）中很常见，并增加不良预后的风险。
总共4776名患者分为3组：入组时心电图（ECG）显示有AFF的患者（n = 1552；33%）、有AFF病史但入组时ECG无AFF的患者（n = 1005；21%）以及入组时无AFF病史或ECG无AFF的患者（n = 2219，46%）。我们评估了每组的预后、对沙库巴曲缬沙坦的治疗反应以及无任何已知AFF的患者首次检测到AFF的相关风险。主要结局是心力衰竭住院总数和心血管死亡的复合结局。
有AFF病史和入组时存在AFF与主要结局的较高风险相关（风险比[RR]：分别为1.36[95%CI：1.12 - 1.65]和RR：1.31[1.11 - 1.54]），高于无AFF。有AFF病史和入组时存在AFF均未改变沙库巴曲缬沙坦的治疗效果。随机分组后，12%既往无AFF的患者出现AFF，且与主要结局的风险高2.8倍相关，但不受沙库巴曲缬沙坦影响。
有AFF病史和入组时ECG显示有AFF与主要结局的较高风险相关。首次检测到的AFF不受沙库巴曲缬沙坦影响，但与所有后续结局的风险增加相关，可能是未来HFpEF试验的一个潜在靶点。（与缬沙坦相比，LCZ696对射血分数保留的心力衰竭患者发病率和死亡率的疗效和安全性[PARAGON - HF]；NCT01920711）
