AIMS The MITRA-FR trial showed that among symptomatic patients with severe secondary mitral regurgitation, percutaneous repair did not reduce the risk of death or hospitalization for heart failure at 12 months compared with guideline-directed medical treatment alone. We report the 24-month outcome from this trial. METHODS AND RESULTS At 37 centres, we randomly assigned 304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20 mm2 or regurgitant volume >30 mL), and left ventricular ejection fraction between 15% and 40% to undergo percutaneous valve repair plus medical treatment (intervention group, n = 152) or medical treatment alone (control group, n = 152). The primary efficacy outcome was the composite of all-cause death and unplanned hospitalization for heart failure at 12 months. At 24 months, all-cause death and unplanned hospitalization for heart failure occurred in 63.8% of patients (97/152) in the intervention group and 67.1% (102/152) in the control group [hazard ratio (HR) 1.01, 95% confidence interval (CI) 0.77-1.34]. All-cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (HR 1.02, 95% CI 0.70-1.50). Unplanned hospitalization for heart failure occurred in 55.9% of patients (85/152) in the intervention group and 61.8% (94/152) in the control group (HR 0.97, 95% CI 0.72-1.30). CONCLUSIONS In patients with severe secondary mitral regurgitation, percutaneous repair added to medical treatment did not significantly reduce the risk of death or hospitalization for heart failure at 2 years compared with medical treatment alone.

中文翻译：

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经皮修复或药物治疗继发性二尖瓣反流：2年时结局。

目的MITRA-FR试验显示，在有症状的继发性二尖瓣反流严重的患者中，与单独进行指导性药物治疗相比，经皮修复并不能降低12个月时因心力衰竭而死亡或住院的风险。我们报告了该试验的24个月结果。方法和结果在37个中心，我们随机分配了304例有症状的心力衰竭患者，这些患者患有严重的继发性二尖瓣反流（有效返流孔面积> 20 mm2或返流体积> 30 mL），并且左心室射血分数在15％至40％之间进行经皮瓣膜修复加药物治疗（干预组，n = 152）或仅药物治疗（对照组，n = 152）。主要疗效结果是全因死亡和12个月计划性心衰住院治疗的综合结果。在24个月时，干预组的63.8％（97/152）患者和对照组的67.1％（102/152）患者发生全因死亡和计划外的心衰[危险比（HR）1.01、95 ％置信区间（CI）0.77-1.34]。全因死亡率发生在干预组的34.9％（53/152）和对照组的34.2％（52/152）（HR 1.02，95％CI 0.70-1.50）中。干预组有55.9％（85/152）的患者计划外住院，对照组为61.8％（94/152）（HR 0.97，95％CI 0.72-1.30）。结论：对于严重的继发性二尖瓣关闭不全患者，