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经导管二尖瓣修复术治疗继发性二尖瓣反流相关肺动脉高压:COAPT 试验。

Pulmonary Hypertension in Transcatheter Mitral Valve Repair for Secondary Mitral Regurgitation: The COAPT Trial.

机构信息

Cardiovascular Research Foundation, New York, New York.

Cardiovascular Research Foundation, New York, New York.

出版信息

J Am Coll Cardiol. 2020 Dec 1;76(22):2595-2606. doi: 10.1016/j.jacc.2020.09.609.

Abstract

BACKGROUND

Pulmonary hypertension worsens prognosis in patients with heart failure (HF) and secondary mitral regurgitation (SMR).

OBJECTIVES

This study sought to determine whether baseline pulmonary hypertension influences outcomes of transcatheter mitral valve repair (TMVr) in patients with HF with SMR.

METHODS

In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, 614 patients with HF with moderate-to-severe or severe SMR were randomized to TMVr with the MitraClip plus guideline-directed medical therapy (GDMT) (n = 302) versus GDMT alone (n = 312). Baseline pulmonary artery systolic pressure (PASP) estimated from echocardiography was categorized as substantially increased (≥50 mm Hg) versus not substantially increased (<50 mm Hg).

RESULTS

Among 528 patients, 184 (82 TMVr, 102 GDMT) had PASP of ≥50 mm Hg (mean: 59.1 ± 8.8 mm Hg) and 344 (171 TMVr, 173 GDMT) had PASP of <50 mm Hg (mean: 36.3 ± 8.1 mm Hg). Patients with PASP of ≥50 mm Hg had higher 2-year rates of death or HF hospitalization (HFH) compared to those with PASP of <50 mm Hg (68.8% vs. 49.1%; adjusted hazard ratio: 1.52; 95% confidence interval: 1.17 to 1.97; p = 0.002). Rates of death or HFH were reduced by TMVr versus GDMT alone, irrespective of baseline PASP (p = 0.45). TMVr reduced PASP from baseline to 30 days to a greater than GDMT alone (adjusted least squares mean: -4.0 vs. -0.9 mm Hg; p = 0.006), a change that was associated with reduced risk of death or HFH between 30 days and 2 years (adjusted hazard ratio: 0.91 per -5 mm Hg PASP; 95% confidence interval: 0.86 to 0.96; p = 0.0009).

CONCLUSIONS

Elevated PASP is associated with a worse prognosis in patients with HF with severe SMR. TMVr with the MitraClip reduced 30-day PASP and 2-year rates of death or HFH compared with GDMT alone, irrespective of PASP.

摘要

背景

肺动脉高压会使心力衰竭(HF)和继发性二尖瓣反流(SMR)患者的预后恶化。

目的

本研究旨在确定基线肺动脉高压是否会影响 HF 合并 SMR 患者行经导管二尖瓣修复术(TMVr)的结局。

方法

在 COAPT(经皮二尖瓣夹合术治疗伴有功能性二尖瓣反流的心力衰竭患者的心血管结局评估)试验中,614 例 HF 合并中重度或重度 SMR 的患者被随机分配至 TMVr 联合二尖瓣夹合术加指南指导的药物治疗(GDMT)(n=302)与 GDMT 单药治疗(n=312)。通过超声心动图估计的基线肺动脉收缩压(PASP)分为显著升高(≥50mmHg)和未显著升高(<50mmHg)。

结果

在 528 例患者中,184 例(TMVr 组 82 例,GDMT 组 102 例)PASP≥50mmHg(平均:59.1±8.8mmHg),344 例(TMVr 组 171 例,GDMT 组 173 例)PASP<50mmHg(平均:36.3±8.1mmHg)。与 PASP<50mmHg 的患者相比,PASP≥50mmHg 的患者 2 年死亡率或 HF 住院率更高(68.8%比 49.1%;校正风险比:1.52;95%置信区间:1.17 至 1.97;p=0.002)。与 GDMT 单药治疗相比,TMVr 可降低死亡率或 HF 住院率,无论基线 PASP 如何(p=0.45)。TMVr 可降低基线至 30 天的 PASP,且降幅大于 GDMT 单药治疗(校正最小二乘均数:-4.0mmHg 比-0.9mmHg;p=0.006),这一改变与 30 天至 2 年的死亡率或 HF 住院率降低相关(校正风险比:每降低 5mmHg PASP 死亡或 HF 住院风险降低 0.91;95%置信区间:0.86 至 0.96;p=0.0009)。

结论

在 HF 合并严重 SMR 的患者中,升高的 PASP 与预后不良相关。TMVr 联合二尖瓣夹合术可降低 30 天 PASP 和 2 年死亡率或 HF 住院率,与 GDMT 单药治疗相比,无论 PASP 如何。

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