Department of Cardiology, Maastricht University Medical Center, CARIM, Maastricht, The Netherlands.
Circ Heart Fail. 2014 Jan;7(1):131-9. doi: 10.1161/CIRCHEARTFAILURE.113.000527. Epub 2013 Dec 18.
BACKGROUND: Therapy guided by N-terminal-pro-B-type natriuretic peptide (NT-proBNP) levels may improve outcomes in patients with chronic heart failure (HF), especially in younger patients with reduced left ventricular ejection fraction. It remains unclear whether treatment effects persist after discontinuation of the NT-proBNP-guided treatment strategy. METHODS AND RESULTS: Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure randomized 499 patients with HF aged≥60 years with left ventricular ejection fraction≤45% to intensified, NT-proBNP-guided versus standard, symptom-guided therapy into prespecified age groups (60-74 and ≥75 years) during 18 months. A total of 329 patients (92%) alive at 18 months agreed to long-term follow-up. HF medication was intensified to a larger extent in the NT-proBNP-guided group. During long-term, NT-proBNP-guided therapy did not improve hospital-free (primary end point: hazard ratio, 0.87; 95% confidence interval, 0.71-1.06; P=0.16) or overall survival (hazard ratio, 0.85; 95% confidence interval, 0.64-1.13; P=0.25) but did improve HF hospitalization-free survival (hazard ratio, 0.70; 95% confidence interval, 0.55-0.90; P=0.005). Patients aged 60 to 74 years had benefit from NT-proBNP-guided therapy on the primary end point and HF hospitalization-free survival, whereas patients aged≥75 years did not (P<0.10 for interaction). In landmark analysis, there was no regression to the mean after cessation of the NT-proBNP-guided strategy. More intensified HF medication at month 12 was associated with better long-term HF hospitalization-free and overall survival. CONCLUSIONS: Intensified, NT-proBNP-guided therapy did not improve the primary end point compared with symptom-guided therapy but did improve HF hospitalization-free survival. Within the subgroup of patients aged 60 to 74 years, it improved clinical outcome including the primary end point. These effects did not disappear after cessation of the NT-proBNP-guided strategy on the long-term. This is possibly attributable to a more intensified HF medical therapy in the NT-proBNP-guided group. CLINICAL TRIAL REGISTRATION: URL: http://www.isrctn.org. Unique identifier: ISRCTN43596477.
背景：根据 N 端脑利钠肽前体（NT-proBNP）水平进行治疗指导可能会改善慢性心力衰竭（HF）患者的预后，尤其是对于左心室射血分数降低的年轻患者。目前尚不清楚在停止 NT-proBNP 指导治疗策略后，治疗效果是否仍然存在。
方法和结果：在强化与标准医疗治疗对老年充血性心力衰竭患者的试验（Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure，TIME-CHF）中，将 499 名年龄≥60 岁、左心室射血分数≤45%的 HF 患者随机分为强化、NT-proBNP 指导组与标准、症状指导组，在 18 个月内按预先设定的年龄组（60-74 岁和≥75 岁）进行治疗。共有 329 名（92%）在 18 个月时存活的患者同意进行长期随访。NT-proBNP 指导组的 HF 药物治疗得到了更大程度的强化。在长期随访中，NT-proBNP 指导治疗并未改善无住院（主要终点：风险比，0.87；95%置信区间，0.71-1.06；P=0.16）或总生存（风险比，0.85；95%置信区间，0.64-1.13；P=0.25），但改善了 HF 无住院生存率（风险比，0.70；95%置信区间，0.55-0.90；P=0.005）。年龄在 60-74 岁的患者从 NT-proBNP 指导治疗中获益主要体现在主要终点和 HF 无住院生存率方面，而年龄≥75 岁的患者则没有（交互作用 P<0.10）。在 landmark 分析中，停止 NT-proBNP 指导策略后没有回归均值。在第 12 个月时更强化的 HF 药物治疗与长期 HF 无住院生存率和总生存率更好相关。
结论：与症状指导治疗相比，强化、NT-proBNP 指导治疗并未改善主要终点，但改善了 HF 无住院生存率。在年龄在 60-74 岁的患者亚组中，它改善了包括主要终点在内的临床结局。这些效果在长期随访中停止 NT-proBNP 指导策略后并未消失。这可能归因于 NT-proBNP 指导组的 HF 药物治疗更加强化。
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