Department of Cardiovascular Diseases, University of Zagreb School of Medicine, Zagreb, Croatia.
Brigham and Women's Hospital, Boston, Massachusetts.
JACC Heart Fail. 2018 Aug;6(8):689-697. doi: 10.1016/j.jchf.2018.05.005. Epub 2018 Jul 11.
This study assessed the relationship between atrial fibrillation (AF) and outcomes in the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) trial, to evaluate whether AF modified the treatment response to spironolactone and whether spironolactone influenced post-randomization AF.
AF is common in heart failure with preserved ejection fraction (HFpEF) and likely contributes to increased risk of adverse outcomes.
A total 1,765 patients enrolled in TOPCAT trial in North and South America were divided into 3 groups: no known AF, history of AF without AF at enrollment, and AF found on the electrocardiogram (ECG) at enrollment. We assessed outcomes and treatment response to spironolactone in all groups, and the association between post-randomization AF and outcomes in patients free of AF at baseline. The primary outcome of the TOPCAT trial was a composite of cardiovascular mortality, aborted cardiac arrest, or heart failure hospitalization.
A total of 760 patients (43%) had a history of AF (18%) or AF on ECG at enrollment (25%). The highest adjusted risk was associated with AF at enrollment (primary outcome, hazard ratio: 1.34; 95% confidence interval: 1.09 to 1.65; p = 0.006; and an increased early risk of secondary outcomes). Neither history of AF nor AF at enrollment modified the beneficial treatment effect of spironolactone. Post-randomization AF, which occurred in 6.3% of patients, was not influenced by spironolactone treatment, but was associated with an increased early risk of the primary outcome (hazard ratio: 2.32; 95% confidence interval: 1.59 to 3.40; p < 0.0001) and secondary outcomes.
AF at enrollment was associated with increased cardiovascular risk in HFpEF patients in the TOPCAT study. Post-randomization AF, which was associated with an increased risk of morbidity and mortality, was not influenced by spironolactone. (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist [TOPCAT]; NCT00094302).
本研究旨在评估心房颤动（AF）与 TOPCAT 试验结局的关系，以评估 AF 是否改变螺内酯的治疗反应，以及螺内酯是否影响随机分组后的 AF。
AF 在射血分数保留的心力衰竭（HFpEF）中很常见，并且可能导致不良结局风险增加。
共纳入 1765 名来自南北美洲的 TOPCAT 试验患者，分为 3 组：无已知 AF、入组时无 AF 但有 AF 病史，以及入组时心电图（ECG）发现 AF。我们评估了所有组的结局和螺内酯治疗反应，以及基线时无 AF 的患者随机分组后 AF 与结局的关系。TOPCAT 试验的主要结局是心血管死亡、心搏骤停未遂或心力衰竭住院的复合终点。
共有 760 名患者（43%）有 AF 病史（18%）或入组时 ECG 发现 AF（25%）。最高调整风险与入组时的 AF 相关（主要结局，风险比：1.34；95%置信区间：1.09 至 1.65；p = 0.006；以及二级结局的早期风险增加）。AF 病史或入组时的 AF 均未改变螺内酯的治疗效果。随机分组后发生的 AF 占 6.3%，不受螺内酯治疗的影响，但与主要结局的早期风险增加相关（风险比：2.32；95%置信区间：1.59 至 3.40；p < 0.0001）和次要结局。
在 TOPCAT 研究中，入组时的 AF 与 HFpEF 患者的心血管风险增加相关。与发病率和死亡率增加相关的随机分组后 AF 不受螺内酯的影响。（螺内酯治疗射血分数保留的心力衰竭[TOPCAT]；NCT00094302）。
