Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.
Toronto General Hospital, Peter Munk Cardiac Center, Ted Rogers Program in Cardiotoxicity Prevention, University of Toronto, Toronto, Canada.
JACC Cardiovasc Imaging. 2018 Aug;11(8):1098-1105. doi: 10.1016/j.jcmg.2018.03.019. Epub 2018 Jun 13.
This study sought to evaluate the hypothesis that global longitudinal strain (GLS) guidance of cardioprotective therapy would improve cardiac function of at-risk patients undergoing potentially cardiotoxic chemotherapy, compared with usual care.
The conventional criteria for diagnosis of chemotherapy-related cardiac dysfunction (CTRCD) are dependent on the recognition of heart failure symptoms and/or changes in left ventricular ejection fraction. However, the measurement variability of left ventricular ejection fraction necessitates broad diagnostic ranges, with the consequence of low sensitivity for CTRCD. Observational data have shown GLS to be a robust and sensitive marker to predict CTRCD and thereby guide the initiation of cardioprotective therapy, but these data are insufficient to justify changing the diagnostic criteria for CTRCD.
The SUCCOUR (Strain sUrveillance of Chemotherapy for improving Cardiovascular Outcomes) trial is an international multicenter prospective randomized controlled trial. Patients who are taking cardiotoxic chemotherapy (n = 320) with at least 1 risk factor will be randomly allocated into GLS- and ejection fraction-guided strategies. All participants will be followed over 3 years for the primary endpoint (change in 3-dimensional ejection fraction) and other secondary endpoints.
Among the first 185 patients (age 54 ± 13 years; 93% women) from 23 international sites, 88% had breast cancer, 9% had lymphoma, and 3% had other cancers. Heart failure risk factors were prevalent: 34% had hypertension and 10% had diabetes mellitus. The most common chemotherapy regimen during this study was the combination of anthracycline and trastuzumab. The baseline 3-dimensional left ventricular ejection fraction was 61 ± 4%, and GLS was 20.3 ± 2.5%. Of 93 patients followed up in the first year of the study, 10 had to withdraw for noncardiac reasons. Of 40 patients randomized to the GLS-guided arm, 15 have been started on cardioprotective therapy, whereas 4 of 46 patients in the ejection fraction-guided arm have been started on therapy.
The SUCCOUR trial will be the first randomized controlled trial of GLS and will provide evidence to inform guidelines regarding the place of GLS for surveillance for CTRCD. (Strain sUrveillance of Chemotherapy for improving Cardiovascular Outcomes [SUCCOUR]; ANZ Clinical Trials ACTRN12614000341628).
本研究旨在评估以下假设，即与常规护理相比，通过全球纵向应变（GLS）指导心脏保护性治疗可改善接受潜在致心脏毒性化疗的高危患者的心脏功能。
化疗相关性心脏功能障碍（CTRCD）的传统诊断标准取决于心力衰竭症状的识别和/或左心室射血分数的变化。然而，左心室射血分数的测量变异性需要广泛的诊断范围，从而导致 CTRCD 的敏感性较低。观察性数据显示，GLS 是预测 CTRCD 和指导心脏保护性治疗开始的一种强大而敏感的标志物，但这些数据不足以证明改变 CTRCD 的诊断标准是合理的。
SUCCOUR（化疗监测改善心血管结局研究）试验是一项国际多中心前瞻性随机对照试验。纳入至少存在 1 种风险因素且正在接受致心脏毒性化疗的 320 例患者，将其随机分配至 GLS 指导策略和射血分数指导策略组。所有患者将在 3 年内接受随访，以评估主要终点（三维射血分数的变化）和其他次要终点。
在来自 23 个国际研究中心的前 185 例患者（年龄 54 ± 13 岁，93%为女性）中，88%患有乳腺癌，9%患有淋巴瘤，3%患有其他癌症。心力衰竭的危险因素较为常见：34%患有高血压，10%患有糖尿病。本研究期间最常见的化疗方案是蒽环类药物联合曲妥珠单抗。基线时的三维左心室射血分数为 61 ± 4%，GLS 为 20.3 ± 2.5%。在研究的第一年接受随访的 93 例患者中，有 10 例因非心脏原因退出。在随机分配至 GLS 指导组的 40 例患者中，有 15 例开始接受心脏保护性治疗，而在射血分数指导组的 46 例患者中，有 4 例开始接受治疗。
SUCCOUR 试验将是 GLS 的首个随机对照试验，将为指南提供关于 GLS 监测 CTRCD 地位的循证依据。（化疗监测改善心血管结局研究[SUCCOUR]；ANZ 临床试验 ACTRN12614000341628）。
