Division of Cardiology, Nanjing First Hospital of Nanjing Medical University, Nanjing, China.
School of Public Health, Nanjing Medical University, Nanjing, China.
JACC Cardiovasc Interv. 2022 Dec 12;15(23):2412-2423. doi: 10.1016/j.jcin.2022.09.013. Epub 2022 Sep 18.
World Health Organization (WHO) group 1 pulmonary arterial hypertension (PAH) is a progressive, debilitating disease. Previous observational studies have demonstrated that pulmonary artery denervation (PADN) reduces pulmonary artery pressures in PAH. However, the safety and effectiveness of PADN have not been established in a randomized trial.
The aim of this study was to determine the treatment effects of PADN in patients with group 1 PAH.
Patients with WHO group 1 PAH not taking PAH-specific drugs for at least 30 days were enrolled in a multicenter, sham-controlled, single-blind, randomized trial. Patients were assigned to receive PADN plus a phosphodiesterase-5 inhibitor or a sham procedure plus a phosphodiesterase-5 inhibitor. The primary endpoint was the between-group difference in the change in 6-minute walk distance from baseline to 6 months.
Among 128 randomized patients, those treated with PADN compared with sham had a greater improvement in 6-minute walk distance from baseline to 6 months (mean adjusted between-group difference 33.8 m; 95% CI: 16.7-50.9 m; P < 0.001). From baseline to 6 months, pulmonary vascular resistance was reduced by -3.0 ± 0.3 WU after PADN and -1.9 ± 0.3 WU after sham (adjusted difference -1.4; 95% CI: -2.6 to -0.2). PADN also improved right ventricular function, reduced tricuspid regurgitation, and decreased N-terminal pro-brain natriuretic peptide. Clinical worsening was less (1.6% vs 13.8%; OR: 0.11; 95% CI: 0.01-0.87), and a satisfactory clinical response was greater (57.1% vs 32.3%; OR: 2.79; 95% CI: 1.37-5.82) with PADN treatment during 6-month follow-up.
In patients with WHO group 1 PAH, PADN improved exercise capacity, hemodynamic status, and clinical outcomes during 6-month follow-up. (Safety and Efficacy of Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension [PADN-CFDA]; NCT03282266).
世界卫生组织（WHO）第 1 组肺动脉高压（PAH）是一种进行性、使人虚弱的疾病。先前的观察性研究表明，肺动脉去神经支配（PADN）可降低 PAH 中的肺动脉压力。然而，PADN 的安全性和有效性尚未在随机试验中得到证实。
本研究旨在确定 PADN 在 1 组 PAH 患者中的治疗效果。
入组了至少接受 30 天 PAH 特异性药物治疗的 WHO 第 1 组 PAH 患者，进行了一项多中心、假手术对照、单盲、随机试验。患者被分配接受 PADN 加磷酸二酯酶-5 抑制剂或假手术加磷酸二酯酶-5 抑制剂。主要终点是从基线到 6 个月时 6 分钟步行距离的组间变化差异。
在 128 名随机患者中，与假手术相比，接受 PADN 治疗的患者从基线到 6 个月时的 6 分钟步行距离改善更大（平均调整组间差异 33.8 m；95%CI：16.7-50.9 m；P<0.001）。从基线到 6 个月，PADN 后肺血管阻力降低了-3.0±0.3 WU，假手术后降低了-1.9±0.3 WU（调整差异-1.4；95%CI：-2.6 至-0.2）。PADN 还改善了右心室功能，减少了三尖瓣反流，并降低了 N 端脑利钠肽前体。在 6 个月的随访中，临床恶化较少（1.6%对 13.8%；比值比：0.11；95%CI：0.01-0.87），且治疗组的满意临床反应更大（57.1%对 32.3%；比值比：2.79；95%CI：1.37-5.82）。
在 WHO 第 1 组 PAH 患者中，PADN 在 6 个月的随访期间改善了运动能力、血液动力学状态和临床结局。（肺动脉高压患者肺动脉去神经支配的安全性和有效性研究[PADN-CFDA]；NCT03282266）。
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