Integrating High-Sensitivity Troponin T and Sacubitril/Valsartan Treatment in HFpEF: The PARAGON-HF Trial,JACC: Heart Failure

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Integrating High-Sensitivity Troponin T and Sacubitril/Valsartan Treatment in HFpEF: The PARAGON-HF Trial
JACC: Heart Failure ( IF 10.3 ) Pub Date : 2021-07-07 , DOI: 10.1016/j.jchf.2021.04.009
Mauro Gori ₁ , Michele Senni ₁ , Brian Claggett ₂ , Jiankang Liu ₂ , Aldo P Maggioni ₃ , Michael Zile ₄ , Margaret F Prescott ₅ , Dirk J Van Veldhuisen ₆ , Faiez Zannad ₇ , Burkert Pieske ₈ , Carolyn S P Lam ₉ , Jean Rouleau ₁₀ , Pardeep Jhund ₁₁ , Milton Packer ₁₂ , Marc A Pfeffer ₂ , Martin Lefkowitz ₅ , Victor Shi ₅ , John J V McMurray ₁₁ , Scott D Solomon ₂

Affiliation

Cardiology Division, Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo, Italy.
Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.
National Association of Hospital Cardiologists Research Center, Florence, Italy.
Medical University of South Carolina and the Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, South Carolina, USA.
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
INSERM Centre d'Investigation Clinic 1433 and Universite de Lorraine, Centre Hospitalier Regional et Universitaire, Nancy, France.
Department of Internal Medicine and Cardiology, Charité University Medicine, Campus Virchow Klinikum, and German Heart Center Berlin, and German Center for Cardiovascular Research Partner Site, Berlin, Germany.
National Heart Center Singapore and Duke-National University of Singapore, Singapore.
Institut de Cardiologie de Montréal, Universite de Montréal, Montréal, Québec, Canada.
British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Scotland.
Baylor University Medical Center, Dallas, Texas, USA, and Imperial College, London, United Kingdom.

This study examined the relationship among high-sensitivity troponin-T (hs-TnT), outcomes, and treatment with sacubitril/valsartan in patients with heart failure (HF) and preserved ejection fraction (HFpEF). hs-TnT is a marker of myocardial injury in HF. The PARAGON-HF trial randomized 4,796 patients with HFpEF to sacubitril/valsartan or valsartan. We compared the risk of the composite outcome of cardiovascular death (CVD) and total HF hospitalization (HHF) according to hs-TnT. We also assessed the effect of allocated treatment on hs-TnT. hs-TnT was available in 1,141 patients (24%) at run-in (median value: 17 ng/L) and 1,260 (26%) at randomization, with 58.3% having hs-TnT >14 ng/L (upper limit of normal). During a median follow-up of 34 months, there were 393 outcome events (82 CVD, 311 HHF). Adjusting for demographics, comorbidities, left ventricular ejection fraction (LVEF), and N-terminal pro B-type natriuretic peptide (NT-proBNP), log-hs-TnT at randomization was an independent predictor of the composite outcome (HR: 1.38; 95% CI: 1.19-1.59; < 0.001). Compared with valsartan, sacubitril/valsartan significantly reduced hs-TnT by 9% at week 16 ( 0.001). Patients whose hs-TnT decreased from randomization to 16 weeks to at or below the median value of 17 ng/L subsequently had a lower risk of CVD/HHF compared with those with persistently elevated hs-TnT 0.046). Patients with higher baseline hs-TnT (>17 ng/L) appeared to have a greater benefit from sacubitril/valsartan treatment when accounting for other potential effect modifiers ( interaction = 0.07). Higher baseline hs-TnT was associated with increased risk of CVD/HHF, whereas hs-TnT decrease at 16 weeks led to lower subsequent risk of CVD/HHF compared with those who had persistently elevated values. Sacubitril/valsartan significantly reduced hs-TnT compared with valsartan. hs-TnT may be helpful in identifying patients with HFpEF who are more likely to benefit from sacubitril/valsartan.

中文翻译：

在 HFpEF 中整合高敏肌钙蛋白 T 和沙库巴曲/缬沙坦治疗：PARAGON-HF 试验

本研究探讨了心力衰竭 (HF) 和射血分数保留 (HFpEF) 患者的高敏肌钙蛋白 -T (hs-TnT)、结局和沙库巴曲/缬沙坦治疗之间的关系。 hs-TnT 是心衰时心肌损伤的标志物。 PARAGON-HF 试验将 4,796 名 HFpEF 患者随机分配至沙库巴曲/缬沙坦组或缬沙坦组。我们根据 hs-TnT 比较了心血管死亡 (CVD) 和心衰住院总人数 (HHF) 的复合结局风险。我们还评估了分配治疗对 hs-TnT 的影响。 1,141 名患者 (24%) 在导入时（中位值：17 ng/L）和 1,260 名患者（26%）在随机分组时可获得 hs-TnT，其中 58.3% 的 hs-TnT >14 ng/L（上限为 14 ng/L）普通的）。在中位 34 个月的随访期间，发生了 393 起结果事件（82 起 CVD，311 起 HHF）。调整人口统计学、合并症、左心室射血分数 (LVEF) 和 N 末端 B 型钠尿肽原 (NT-proBNP) 后，随机化时的 log-hs-TnT 是复合结果的独立预测因子（HR：1.38； 95% CI：1.19-1.59；< 0.001）。与缬沙坦相比，沙库巴曲/缬沙坦在第 16 周时使 hs-TnT 显着降低 9% (0.001)。与 hs-TnT 持续升高 (0.046) 的患者相比，hs-TnT 从随机分组到 16 周降低至中值 17 ng/L 或以下的患者随后发生 CVD/HHF 的风险较低。考虑到其他潜在的效果调节剂（交互作用 = 0.07），基线 hs-TnT 较高（>17 ng/L）的患者似乎从沙库巴曲/缬沙坦治疗中获得更大的益处。基线 hs-TnT 较高与 CVD/HHF 风险增加相关，而与那些值持续升高的人相比，hs-TnT 在 16 周时降低会导致后续 CVD/HHF 风险降低。与缬沙坦相比，沙库巴曲/缬沙坦显着降低 hs-TnT。 hs-TnT 可能有助于确定哪些 HFpEF 患者更有可能从沙库巴曲/缬沙坦中获益。

更新日期：2021-07-07

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