Baylor Scott & White Heart Hospital Plano, Plano, Texas, USA.
Advanced Heart Failure and Cardiac Transplantation Section, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee, USA.
J Am Coll Cardiol. 2021 Mar 2;77(8):1029-1040. doi: 10.1016/j.jacc.2020.12.047.
In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, transcatheter mitral valve repair (TMVr) resulted in fewer heart failure hospitalizations (HFHs) and lower mortality at 24 months in patients with heart failure (HF) with mitral regurgitation (MR) secondary to left ventricular dysfunction compared with guideline-directed medical therapy (GDMT) alone.
This study determined if these benefits persisted to 36 months and if control subjects who were allowed to cross over at 24 months derived similar benefit.
This study randomized 614 patients with HF with moderate-to-severe or severe secondary MR, who remained symptomatic despite maximally tolerated GDMT, to TMVr plus GDMT versus GDMT alone. The primary effectiveness endpoint was all HFHs through 24-month follow-up. Patients have now been followed for 36 months.
The annualized rates of HFHs per patient-year were 35.5% with TMVr and 68.8% with GDMT alone (hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.37 to 0.63; p < 0.001; number needed to treat (NNT) = 3.0; 95% CI: 2.4 to 4.0). Mortality occurred in 42.8% of the device group versus 55.5% of control group (HR: 0.67; 95% CI: 0.52 to 0.85; p = 0.001; NNT = 7.9; 95% CI: 4.6 to 26.1). Patients who underwent TMVr also had sustained 3-year improvements in MR severity, quality-of-life measures, and functional capacity. Among 58 patients assigned to GDMT alone who crossed over and were treated with TMVr, the subsequent composite rate of mortality or HFH was reduced compared with those who continued on GDMT alone (adjusted HR: 0.43; 95% CI: 0.24 to 0.78; p = 0.006).
Among patients with HF and moderate-to-severe or severe secondary MR who remained symptomatic despite GDMT, TMVr was safe, provided a durable reduction in MR, reduced the rate of HFH, and improved survival, quality of life, and functional capacity compared with GDMT alone through 36 months. Surviving patients who crossed over to device treatment had a prognosis comparable to those originally assigned to transcatheter therapy. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation [COAPT]; NCT01626079).
在 COAPT（经导管二尖瓣修复术治疗左心室功能障碍导致功能性二尖瓣反流心力衰竭患者的心血管结局评估）试验中，与单独接受指南指导的药物治疗（GDMT）相比，经导管二尖瓣修复术（TMVr）可降低心力衰竭（HF）伴二尖瓣反流（MR）患者的心力衰竭住院率（HFHs）和 24 个月时的死亡率，这些患者对 GDMT 的耐受性达到最大。
本研究旨在确定这些益处是否持续到 36 个月，以及在 24 个月时允许交叉的对照组是否获得类似的益处。
本研究将 614 名 HF 伴中度至重度或重度继发性 MR 的患者随机分为 TMVr 加 GDMT 组和 GDMT 组，这些患者尽管接受了 GDMT，但仍有症状。主要有效性终点是 24 个月随访期间所有 HFHs 的发生情况。目前，患者已随访 36 个月。
TMVr 组和 GDMT 组患者的 HFHs 年发生率分别为 35.5%和 68.8%（风险比[HR]：0.49；95%置信区间[CI]：0.37 至 0.63；p<0.001；需要治疗的人数（NNT）为 3.0；95% CI：2.4 至 4.0）。设备组的死亡率为 42.8%，对照组为 55.5%（HR：0.67；95% CI：0.52 至 0.85；p=0.001；NNT 为 7.9；95% CI：4.6 至 26.1）。接受 TMVr 的患者也持续 3 年改善了 MR 严重程度、生活质量指标和功能能力。在 58 名被分配到 GDMT 组但交叉并接受 TMVr 治疗的患者中，与继续接受 GDMT 组相比，死亡或 HFH 的复合发生率降低（校正 HR：0.43；95% CI：0.24 至 0.78；p=0.006）。
在 HF 伴中度至重度或重度继发性 MR 且对 GDMT 仍有症状的患者中，与 GDMT 相比，TMVr 安全有效，可持久降低 MR，降低 HFH 发生率，改善生存、生活质量和功能能力，36 个月时的结果与单独接受 GDMT 治疗的患者相比无显著差异。交叉至器械治疗的存活患者的预后与最初接受经导管治疗的患者相当。（经导管二尖瓣修复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]；NCT01626079）。
