Clinical Trials Center Cardiovascular Research Foundation New York NY.
Division of Cardiology, Department of Medicine Solna Karolinska Institutet, Karolinska University Hospital Stockholm Sweden.
J Am Heart Assoc. 2023 Feb 21;12(4):e028444. doi: 10.1161/JAHA.122.028444. Epub 2023 Feb 8.
Background Peripheral artery disease (PAD) and heart failure (HF) often coexist. Whether PAD influences outcomes of transcatheter mitral valve repair (TMVr) in patients with HF and severe secondary mitral regurgitation is unknown. The objectives are to assess the impact of PAD on outcomes of TMVr plus guideline-directed medical therapy (GDMT) versus GDMT alone in patients with HF and secondary mitral regurgitation. Methods and Results The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) randomized patients with HF with ≥moderate-to-severe secondary mitral regurgitation to TMVr with MitraClip implant plus GDMT versus GDMT alone. We evaluated the relationship between PAD and 2-year outcomes in and examined whether PAD modified the benefits of TMVr. Among 614 patients enrolled, 109 (17.8%) had PAD. By multivariable analysis, PAD was independently associated with 2-year mortality (adjusted hazard ratio [adjHR], 1.51 [95% CI, 1.07-2.15]) but not HF hospitalizations. Compared with GDMT alone, TMVr reduced the 2-year risk of death in patients without PAD (adjHR, 0.42 [95% CI, 0.30-0.60]) but not those with PAD (adjHR, 1.27 [95% CI, 0.72-2.27]; =0.001). In contrast, TMVr reduced HF hospitalizations consistently in patients with (adjHR, 0.65 [95% CI, 0.35-1.23]) and without (adjHR, 0.42 [95% CI, 0.31-0.57]) PAD (=0.22). Improvements in health status and exercise capacity at 2 years with TMVr compared with GDMT alone were similar in degree, irrespective of PAD status (=0.76 and 0.64, respectively). Conclusions In patients with HF and severe secondary mitral regurgitation, the reduced mortality with TMVr in the overall COAPT study population was not observed in the subgroup of patients with PAD. However, TMVr reduced HF hospitalizations and improved health status and exercise capacity consistently in patients with and without PAD. Registration Clinical Trial Name: Cardiovascular Outocmes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (The COAPT Trial); URL: https://www.clinicaltrials.gov/; Unique identifier: NCT01626079. https://clinicaltrials.gov/ct2/show/NCT01626079.
外周动脉疾病（PAD）和心力衰竭（HF）常同时存在。PAD 是否会影响 HF 伴严重继发性二尖瓣反流患者行经导管二尖瓣修复术（TMVr）的结局尚不清楚。目的是评估 PAD 对 HF 伴继发性二尖瓣反流患者行 TMVr 加指南指导的药物治疗（GDMT）与单纯 GDMT 的影响。
COAPT 试验（经皮二尖瓣夹合术治疗心力衰竭伴功能性二尖瓣反流患者的心血管结局评估）将 HF 伴≥中重度继发性二尖瓣反流的患者随机分为 TMVr 加 MitraClip 植入物加 GDMT 组与单纯 GDMT 组。我们评估了 PAD 与 2 年结局的关系，并探讨了 PAD 是否改变了 TMVr 的获益。在纳入的 614 例患者中，109 例（17.8%）患有 PAD。多变量分析显示，PAD 与 2 年死亡率独立相关（校正后的危险比 [adjHR]，1.51 [95%CI，1.07-2.15]），但与 HF 住院无关。与单纯 GDMT 相比，TMVr 降低了无 PAD 患者的 2 年死亡风险（adjHR，0.42 [95%CI，0.30-0.60]），但对有 PAD 患者的 2 年死亡风险无影响（adjHR，1.27 [95%CI，0.72-2.27]；=0.001）。相反，TMVr 一致降低了有（adjHR，0.65 [95%CI，0.35-1.23]）和无 PAD（adjHR，0.42 [95%CI，0.31-0.57]）患者的 HF 住院率（=0.22）。与单纯 GDMT 相比，TMVr 改善了 2 年时的健康状况和运动能力，程度相似（分别为 adjHR，0.76 和 0.64）。
在 HF 伴严重继发性二尖瓣反流的患者中，TMVr 在 COAPT 研究总体人群中降低死亡率的效果在 PAD 亚组中并未观察到。然而，TMVr 降低了 HF 住院率，改善了有和无 PAD 患者的健康状况和运动能力。
临床试验名称：经皮二尖瓣夹合术治疗心力衰竭伴功能性二尖瓣反流患者的心血管结局评估（COAPT 试验）；网址：https://www.clinicaltrials.gov/；唯一标识符：NCT01626079。https://clinicaltrials.gov/ct2/show/NCT01626079。
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