Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8).

Methods

Phase 3 randomised clinical trial.

第三阶段随机临床试验。

Three tertiary hospitals in Shiraz, Iran.

伊朗设拉子的三家三级医院。

420 patients with a first ST segment elevation acute myocardial infarction and left ventricular ejection fraction <40% were enrolled and randomised in a 1:2 ratio to receive intervention or standard care.

共有420名首次发生ST段抬高型急性心肌梗死且左心室射血分数<40%的患者被纳入研究，并按1:2的比例随机分为接受干预治疗组和标准治疗组。

intervention

Intracoronary infusion of allogenic Wharton's jelly derived mesenchymal stem cells within 3-7 days of acute myocardial infarction in addition to standard care.

在急性心肌梗死后的3-7天内，通过冠状动脉输注异体脐带血源间充质干细胞，辅以标准治疗。

Methods

The primary endpoint was incidenceof heart failure.

主要终点事件是心力衰竭的发生率。

Secondary endpoints included readmission to hospital for heart failure, all cause mortality, cardiovascular mortality, and readmission to hospital for myocardial infarction.

次要终点包括因心力衰竭再次入院、全因死亡率、心血管死亡率以及因心肌梗死再次入院的情况。

Changes in left ventricular ejection fraction within six months post-myocardial infarction were compared between groups.

在心肌梗死后的六个月内，比较了两组之间左心室射血分数的变化。

Results

A total of 396 patients (136 in the intervention group and 260 in the control group) were included in the final analysis, with a median follow-up of 33.2 months.

最终分析纳入了396名患者（干预组136名，对照组260名），中位随访时间为33.2个月。

Intracoronary infusion of mesenchymal stem cells had a preventive effect for incidenceof heart failure (2.77 v 6.48 per 100 person years; hazard ratio0.43, 95% confidence interval0.21 to 0.89; P=0.024), readmission to hospital for heart failure (0.92 v 4.20 per 100 person years; 0.22, 0.06 to 0.74; P=0.015), and a composite endpoint of cardiovascular mortality and readmission for myocardial infarction or heart failure (2.80 v 7.16 per 100 person years; 0.39, 0.19 to 0.82; P=0.012).

冠状动脉内输注间充质干细胞对心力衰竭的发生率有预防效果（2.77比6.48每100人年；风险比0.43，95%置信区间0.21至0.89；P=0.024），对心力衰竭再入院（0.92比4.20每100人年；0.22，0.06至0.74；P=0.015），以及心血管死亡和心肌梗死或心力衰竭再入院的复合终点（2.80比7.16每100人年；0.39，0.19至0.82；P=0.012）。

The intervention did not have a statistically significant effect on readmission to hospital for myocardial infarction (1.23 v 3.06 per 100 person years; hazard ratio0.40, 0.14 to 1.19; P=0.10), all cause mortality (1.81 v 1.66 per 100 person years; 1.10, 0.40 to 3.02; P=0.86), or cardiovascular mortality (0.91 v 1.33 per 100 person years; 0.68, 0.18 to 2.57; P=0.57).

干预措施对心肌梗死再入院（1.23比3.06每100人年；风险比0.40，95%置信区间0.14至1.19；P=0.10）、全因死亡率（1.81比1.66每100人年；1.10，95%置信区间0.40至3.02；P=0.86）或心血管死亡率（0.91比1.33每100人年；0.68，95%置信区间0.18至2.57；P=0.57）没有统计学显著性影响。

Left ventricular ejection fraction in the intervention group showed a significantly greater improvement from baseline at six months compared with the control group (β=5.88, 95% confidence interval4.00 to 7.76; P<0.001).

干预组在六个月时左心室射血分数从基线开始显著改善，与对照组相比（β=5.88，95%置信区间4.00至7.76；P<0.001）。

Conclusions

Intracoronary infusion of Wharton's jelly derived mesenchymal stem cells significantly reduced the risk of incidenceof heart failure, readmission to hospital for heart failure, and the composite endpoint of cardiovascular mortality and readmission to hospital for heart failure or myocardial infarction in patients after an acute myocardial infarction, suggesting that this technique may serve as a valuable adjunctive procedure after myocardial infarction to prevent the development of heart failure and reduce the risk of future adverse events.

冠状动脉内输注由华通胶衍生的间充质干细胞显著降低了急性心肌梗死患者心力衰竭的发生率、因心力衰竭再次入院的风险以及心血管死亡和因心力衰竭或心肌梗死再次入院的复合终点事件风险，表明这种技术可能作为心肌梗死后预防心力衰竭发展和降低未来不良事件风险的有价值的辅助程序。

trial_registration

ClinicalTrials.gov NCT05043610.

ClinicalTrials.gov NCT05043610。