Abstract：
OBJECTIVE: In chronic ischaemic heart failure, revascularisation strategies control symptoms but are less effective in improving left ventricular ejection fraction (LVEF). The aim of this trial is to investigate the safety of cardiac shockwave therapy (SWT) as a novel treatment option and its efficacy in increasing cardiac function by inducing angiogenesis and regeneration in hibernating myocardium.
METHODS: In this single-blind, parallel-group, sham-controlled trial (cardiac shockwave therapy for ischemic heart failure, CAST-HF; NCT03859466) patients with LVEF ≤40% requiring surgical revascularisation were enrolled. Patients were randomly assigned to undergo direct cardiac SWT or sham treatment in addition to coronary bypass surgery. The primary efficacy endpoint was the improvement in LVEF measured by cardiac magnetic resonance imaging from baseline to 360 days.
RESULTS: Overall, 63 patients were randomized, out of which 30 patients of the SWT group and 28 patients of the Sham group attained 1-year follow-up of the primary endpoint. Greater improvement in LVEF was observed in the SWT group (Δ from baseline to 360 days: SWT 11.3%, SD 8.8; Sham 6.3%, SD 7.4, P = .0146). Secondary endpoints included the 6-minute walking test, where patients randomized in the SWT group showed a greater Δ from baseline to 360 days (127.5 m, SD 110.6) than patients in the Sham group (43.6 m, SD 172.1) (P = .028) and Minnesota Living with Heart Failure Questionnaire score on day 360, which was 11.0 points (SD 19.1) for the SWT group and 17.3 points (SD 15.1) for the Sham group (P = .15). Two patients in the treatment group died for non-device-related reasons.
CONCLUSIONS: In conclusion, the CAST-HF trial indicates that direct cardiac SWT, in addition to coronary bypass surgery improves LVEF and physical capacity in patients with ischaemic heart failure.
METHODS: In this single-blind, parallel-group, sham-controlled trial (cardiac shockwave therapy for ischemic heart failure, CAST-HF; NCT03859466) patients with LVEF ≤40% requiring surgical revascularisation were enrolled. Patients were randomly assigned to undergo direct cardiac SWT or sham treatment in addition to coronary bypass surgery. The primary efficacy endpoint was the improvement in LVEF measured by cardiac magnetic resonance imaging from baseline to 360 days.
RESULTS: Overall, 63 patients were randomized, out of which 30 patients of the SWT group and 28 patients of the Sham group attained 1-year follow-up of the primary endpoint. Greater improvement in LVEF was observed in the SWT group (Δ from baseline to 360 days: SWT 11.3%, SD 8.8; Sham 6.3%, SD 7.4, P = .0146). Secondary endpoints included the 6-minute walking test, where patients randomized in the SWT group showed a greater Δ from baseline to 360 days (127.5 m, SD 110.6) than patients in the Sham group (43.6 m, SD 172.1) (P = .028) and Minnesota Living with Heart Failure Questionnaire score on day 360, which was 11.0 points (SD 19.1) for the SWT group and 17.3 points (SD 15.1) for the Sham group (P = .15). Two patients in the treatment group died for non-device-related reasons.
CONCLUSIONS: In conclusion, the CAST-HF trial indicates that direct cardiac SWT, in addition to coronary bypass surgery improves LVEF and physical capacity in patients with ischaemic heart failure.
摘要：
目标：在慢性缺血性心力衰竭中，血运重建策略可控制症状,但在改善左心室射血分数(LVEF)方面效果较差.该试验的目的是研究心脏冲击波疗法（SWT）作为一种新颖的治疗选择的安全性，及其通过诱导冬眠心肌中的血管生成和再生来增强心脏功能的功效。
方法：在这种单盲方法中，平行组，假对照试验(心脏冲击波治疗缺血性心力衰竭，CAST-HF；NCT03859466）需要手术血运重建的LVEF≤40％的患者入组。除冠状动脉搭桥手术外，患者还被随机分配接受直接心脏SWT或假治疗。主要疗效终点是通过心脏磁共振成像测量的LVEF从基线到360天的改善。
结果：总体而言，63例患者被随机分组，其中SWT组的30例患者和Sham组的28例患者获得了主要终点的1年随访。在SWT组中观察到更大的LVEF改善（从基线到360天的Δ：SWT11.3%，标准差8.8；假6.3%，标准差7.4，P=0.0146）。次要终点包括6分钟步行测试，在SWT组中随机分配的患者从基线到360天显示出更大的Δ（127.5m，SD110.6）比Sham组的患者（43.6m，SD172.1）（P=.028）和第360天的明尼苏达州心力衰竭生活问卷得分，SWT组为11.0分（SD19.1），Sham组为17.3分（SD15.1）（P=.15）。治疗组中有两名患者因非器械相关原因死亡。
结论：结论：CAST-HF试验表明直接心脏SWT，除了冠状动脉搭桥手术外，缺血性心力衰竭患者的LVEF和身体能力也得到了改善。
方法：在这种单盲方法中，平行组，假对照试验(心脏冲击波治疗缺血性心力衰竭，CAST-HF；NCT03859466）需要手术血运重建的LVEF≤40％的患者入组。除冠状动脉搭桥手术外，患者还被随机分配接受直接心脏SWT或假治疗。主要疗效终点是通过心脏磁共振成像测量的LVEF从基线到360天的改善。
结果：总体而言，63例患者被随机分组，其中SWT组的30例患者和Sham组的28例患者获得了主要终点的1年随访。在SWT组中观察到更大的LVEF改善（从基线到360天的Δ：SWT11.3%，标准差8.8；假6.3%，标准差7.4，P=0.0146）。次要终点包括6分钟步行测试，在SWT组中随机分配的患者从基线到360天显示出更大的Δ（127.5m，SD110.6）比Sham组的患者（43.6m，SD172.1）（P=.028）和第360天的明尼苏达州心力衰竭生活问卷得分，SWT组为11.0分（SD19.1），Sham组为17.3分（SD15.1）（P=.15）。治疗组中有两名患者因非器械相关原因死亡。
结论：结论：CAST-HF试验表明直接心脏SWT，除了冠状动脉搭桥手术外，缺血性心力衰竭患者的LVEF和身体能力也得到了改善。
