Columbia University Medical Center, New York Presbyterian Hospital, New York, New York.
Medstar Health Research Institute, Washington, DC.
J Am Coll Cardiol. 2020 Sep 15;76(11):1305-1314. doi: 10.1016/j.jacc.2020.07.035.
The presence of tricuspid regurgitation (TR) may affect prognosis in patients with mitral regurgitation (MR).
This study sought to determine the impact of TR on outcomes in patients with heart failure and severe secondary MR randomized to guideline-directed medical therapy (GDMT) or edge-to-edge repair with the MitraClip in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial.
A total of 614 patients with symptomatic heart failure with moderate to severe (3+) or severe (4+) secondary MR were randomized to maximally tolerated GDMT plus MitraClip or GDMT alone; 599 had core laboratory evaluable echocardiograms. Patients were divided into 2 groups by baseline TR severity: none/trace/mild TR (≤Mild TR) (n = 501 [83.6%]) and moderate/severe TR (≥Mod TR) (n = 98 [16.4%]). Two-year composite endpoints of death or heart failure hospitalization (HFH) and the individual endpoints were analyzed.
Patients with ≥Mod TR were more likely to be New York Heart Association functional class III/IV (p < 0.0001) and have a Society of Thoracic Surgeons score of ≥8 (p < 0.0001), anemia (p = 0.02), chronic kidney disease (p = 0.003), and higher N-terminal pro-B-type natriuretic peptide (p = 0.02) than those with ≤Mild TR. Patients with ≥Mod TR had more severe MR (p = 0.0005) despite smaller left ventricular volumes (p = 0.005) and higher right ventricular systolic pressure (p < 0.0001). At 2 years, the composite rate of death or HFH was higher in patients with ≥Mod TR compared with ≤Mild TR treated with GDMT alone (83.0% vs. 64.3%; hazard ratio: 1.74; 95% confidence interval: 1.24 to 2.45; p = 0.001) but not following MitraClip (48.2% vs. 44.0%; hazard ratio: 1.14; 95% confidence interval: 0.71 to 1.84; p = 0.59). Rates of death or HFH, as well as death and HFH alone, were reduced by MitraClip compared with GDMT, irrespective of baseline TR grade (p = 0.16, 0.29, and 0.21 respectively).
Patients with severe secondary MR who also had ≥Mod TR had worse clinical and echocardiographic characteristics and worse clinical outcomes compared to those with ≤Mild TR. Within the COAPT trial, MitraClip improved outcomes in patients with and without ≥Mod TR severity compared with GDMT alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079).
三尖瓣反流（TR）的存在可能会影响二尖瓣反流（MR）患者的预后。
本研究旨在确定 COAPT 试验中接受指南指导的药物治疗（GDMT）或 MitraClip 边缘对边缘修复的心力衰竭和严重继发性 MR 患者中 TR 对结局的影响。
共有 614 名有症状的心力衰竭伴中度至重度（3+）或重度（4+）继发性 MR 的患者被随机分配至最大耐受 GDMT 加 MitraClip 或 GDMT 单药治疗；599 名患者有核心实验室评估的超声心动图。根据基线 TR 严重程度将患者分为两组：无/TR/轻度 TR（≤轻度 TR）（n=501 [83.6%]）和中度/重度 TR（≥中度 TR）（n=98 [16.4%]）。分析了 2 年复合终点（死亡或心力衰竭住院[HFH]）和单个终点。
与≤轻度 TR 患者相比，≥中度 TR 患者更可能处于纽约心脏协会功能 III/IV 级（p<0.0001）和胸外科医生协会评分≥8（p<0.0001），贫血（p=0.02），慢性肾脏病（p=0.003）和更高的 N 末端 pro-B 型利钠肽（p=0.02）。尽管左心室容积较小（p=0.005）和右心室收缩压较高（p<0.0001），但≥中度 TR 患者的 MR 更严重（p=0.0005）。与单独接受 GDMT 治疗的≤轻度 TR 患者相比，≥中度 TR 患者在 2 年时死亡或 HFH 的复合发生率更高（83.0%比 64.3%；风险比：1.74；95%置信区间：1.24 至 2.45；p=0.001），但 MitraClip 后无差异（48.2%比 44.0%；风险比：1.14；95%置信区间：0.71 至 1.84；p=0.59）。与 GDMT 相比，MitraClip 降低了死亡或 HFH、死亡和 HFH 的发生率，无论基线 TR 分级如何（p=0.16、0.29 和 0.21）。
与≤轻度 TR 患者相比，严重继发性 MR 且同时伴有≥中度 TR 的患者具有更差的临床和超声心动图特征以及更差的临床结局。在 COAPT 试验中，与单独接受 GDMT 相比，MitraClip 改善了伴或不伴≥中度 TR 严重程度的患者的结局。（心力衰竭伴功能性二尖瓣反流患者的 MitraClip 经皮治疗的心血管结局评估[COAPT]；NCT01626079）。
