From Hopital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque (J.-F.O.), Pharmacy Department and Laboratoire Mateis (X.A.), and Hopital Cardiovasculaire Louis Pradel, Clinical Investigation Center and Heart Failure Department, INSERM 1407 (C.B., G.S., N. Mewton), Hospices Civils de Lyon and Claude Bernard University, Lyon, Assistance Publique-Hôpitaux de Paris (APHP), Hôpital Bichat (D.M.-Z., B.I., A.V.), and APHP, Hôpital Européen Georges Pompidou (N.K.), Paris, Centre Hospitalier Universitaire (CHU) Rennes, Hôpital Pontchaillou, Rennes (G.L., E.D.), Assistance Publique-Hôpitaux de Marseille (APHM), Hôpital de la Timone (G.B.), and Hôpital Saint Joseph (N. Michel), Marseille, CHU Nantes, Hôpital Guillaume et René Laennec, Nantes (N.P., J.-N.T., P.G.), Institut Jacques Cartier, Massy (T.L., B.C.), Clinique du Millénaire (C.P.) and CHU Montpellier, Hôpital Arnaud-de-Villeneuve (F.L.), Montpellier, CHU Angers, Angers (F.R.), CHU Toulouse, Hôpital Rangueil, Toulouse (D.C.), Centre Cardiologique du Nord, Saint-Denis (M.N.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg (P.O.), Centre Hospitalier Régional Universitaire (CHRU) de Tours, Hôpital Trousseau, Tours (C.S.E.), APHP, Hôpital Henri Mondor, Créteil (E.T.), CHU Bordeaux, Hôpital Haut-Lévêque, Pessac (L.L.), CHRU Brest, Hôpital de La Cavale Blanche, Brest (M.G.), and Service de Biostatistique-Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Centre National de la Recherche Scientifique (CNRS), and Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Villeurbanne (F.B., D.M.-B.) - all in France; and the University of Ottawa Heart Institute, Division of Cardiology, Ottawa, Canada (D.M.-Z.).
N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27.
In 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.
We randomly assigned patients who had severe secondary mitral regurgitation (defined as an effective regurgitant orifice area of >20 mm 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.
At 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).
Among 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. (Funded by the French Ministry of Health and Research National Program and Abbott Vascular; MITRA-FR ClinicalTrials.gov number, NCT01920698 .).
在左心室射血分数降低的慢性心力衰竭患者中，严重的继发性二尖瓣反流与预后不良相关。经皮二尖瓣修复术是否能改善此类患者的临床结局尚不清楚。
我们以 1:1 的比例随机分配 152 例严重继发性二尖瓣反流（定义为有效反流口面积>20mm 或每搏反流容积>30ml）、左心室射血分数在 15%至 40%之间且有症状性心力衰竭的患者，一组患者除了接受药物治疗之外还进行经皮二尖瓣修复术（干预组，152 例患者），另一组患者仅接受药物治疗（对照组，152 例患者）。主要疗效终点为 12 个月时因任何原因死亡或因心力衰竭计划外住院的复合终点。
12 个月时，干预组的主要终点发生率为 54.6%（83/152 例），对照组为 51.3%（78/152 例）（比值比，1.16；95%置信区间[CI]，0.73 至 1.84；P=0.53）。干预组因任何原因死亡的发生率为 24.3%（37/152 例），对照组为 22.4%（34/152 例）（风险比，1.11；95%CI，0.69 至 1.77）。干预组因心力衰竭计划外住院的发生率为 48.7%（74/152 例），对照组为 47.4%（72/152 例）（风险比，1.13；95%CI，0.81 至 1.56）。
在严重继发性二尖瓣反流患者中，经皮二尖瓣修复术联合药物治疗与单纯药物治疗相比，1 年时死亡或因心力衰竭计划外住院的发生率无显著差异。（由法国卫生部和研究国家计划以及 Abbott Vascular 资助；MITRA-FR ClinicalTrials.gov 编号，NCT01920698）。
