Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation
Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation
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DOI：
10.1056/nejmoa1805374
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发表时间：
2018-12-13
影响因子：
158.5
通讯作者：
Mewton, N.
中科院分区：
文献类型：
--
作者：
Obadia, J. -F.;Messika-Zeitoun, D.;Mewton, N.
研究背景在慢性心力衰竭伴左心室射血分数降低的患者中，严重的继发性二尖瓣返流与不良预后相关。经皮二尖瓣修复术是否能改善这一患者人群的临床结局尚不清楚。（定义为有效舒张口面积> 20 mm（2）或舒张容积> 30 ml/次），左心室射血分数在15 - 40%之间，并伴有症状性心力衰竭，在1：1的比率，在接受药物治疗的基础上接受经皮二尖瓣修复术（干预组; 152例患者）或仅接受药物治疗（对照组; 152例患者）。主要疗效结局是12个月时任何原因导致的死亡或因心力衰竭而计划外住院的复合终点。（152例患者中的83例），51.3%对照组（152例患者中的78例）（比值比，1.16; 95%置信区间[CI]，0.73至1.84; P = 0.53）。干预组的全因死亡率为24.3%（37/152例患者），对照组为22.4%（34/152例患者）（风险比，1.11; 95%CI，0.69 - 1.77）。心力衰竭非计划性住院率为48.7%（74/152例患者）在干预组和47.4%对照组（152例患者中的72例）（风险比，1.13; 95%CI，0.81 ~ 1.56）。结论在重度二尖瓣返流患者中，接受经皮二尖瓣修复术并接受药物治疗的患者和仅接受药物治疗的患者1年时的死亡率或因心力衰竭而非计划住院率无显著差异。
BACKGROUNDIn patients who have chronic heart failure with reduced left ventricular ejection fraction, severe secondary mitral-valve regurgitation is associated with a poor prognosis. Whether percutaneous mitral-valve repair improves clinical outcomes in this patient population is unknown.METHODSWe randomly assigned patients who had severe secondary mitral regurgitation (defined as an effective regurgitant orifice area of > 20 mm(2) or a regurgitant volume of > 30 ml per beat), a left ventricular ejection fraction between 15 and 40%, and symptomatic heart failure, in a 1:1 ratio, to undergo percutaneous mitral-valve repair in addition to receiving medical therapy (intervention group; 152 patients) or to receive medical therapy alone (control group; 152 patients). The primary efficacy outcome was a composite of death from any cause or unplanned hospitalization for heart failure at 12 months.RESULTSAt 12 months, the rate of the primary outcome was 54.6% (83 of 152 patients) in the intervention group and 51.3% (78 of 152 patients) in the control group (odds ratio, 1.16; 95% confidence interval [CI], 0.73 to 1.84; P = 0.53). The rate of death from any cause was 24.3% (37 of 152 patients) in the intervention group and 22.4% (34 of 152 patients) in the control group (hazard ratio, 1.11; 95% CI, 0.69 to 1.77). The rate of unplanned hospitalization for heart failure was 48.7% (74 of 152 patients) in the intervention group and 47.4% (72 of 152 patients) in the control group (hazard ratio, 1.13; 95% CI, 0.81 to 1.56).CONCLUSIONSAmong patients with severe secondary mitral regurgitation, the rate of death or unplanned hospitalization for heart failure at 1 year did not differ significantly between patients who underwent percutaneous mitral-valve repair in addition to receiving medical therapy and those who received medical therapy alone.