背景:肺动脉去神经(PADN)在不同风险负担的肺动脉高压(PAH)患者中的治疗效果尚不清楚。本研究旨在确定PADN在低和中高风险PAH患者中的有效性。
方法:总共,PADN-CFDA试验中包含的128例初治PAH患者分为低风险和中高风险患者。主要终点是从基线到6个月的6分钟步行距离(6MWD)变化的组间差异。
结果:在中高风险组中,与接受假手术加PDE-5i治疗的患者相比,接受PADN和PDE-5i治疗的患者从基线到6个月的6MWD改善更大.从基线到6个月,PADN加PDE-5i和假手术加PDE-5i后,肺血管阻力(PVR)降低了-6.1±0.6和-2.0±0.7木单位,分别,随着NT-proBNP在中高危人群中的显著降低。然而,6MWD无显著差异,PVR,在低危患者中,PADN加PDE-5i组和假手术加PDE-5i组之间的NT-proBNP。此外,通过PADN治疗,右心室功能同样得到改善,中介-,和高危人群。在6个月的随访期间,PADN加PDE-5i治疗的临床恶化较少。
结论:在肺动脉高压患者中,去肺动脉神经联合PDE-5i提高了运动能力,NT-proBNP,血液动力学,在6个月的随访中,中高危患者的临床结局。
The differential treatment effect of pulmonary artery denervation (PADN) in pulmonary arterial hypertension (PAH) patients with different risk burdens remains unclear. This study aimed to determine the effectiveness of PADN in low vs intermediate-high-risk PAH patients.
In total, 128 patients with treatment naive PAH included in the PADN-CFDA trial were categorized into low-risk and intermediate-high-risk patients. The primary endpoint was the between-group difference in the change in 6-min walk distance (6 MWD) from baseline to 6 months.
In the intermediate-high-risk group, those treated with PADN and PDE-5i had a greater improvement in 6 MWD from baseline to 6 months as compared to those treated with sham plus PDE-5i. From baseline to 6 months, pulmonary vascular resistance (PVR) was reduced by -6.1 ± 0.6 and -2.0 ± 0.7 Wood units following PADN plus PDE-5i and sham plus PDE-5i, respectively, along with the significant reduction of NT-proBNP in the intermediate-high-risk group. However, there were no significant differences in 6 MWD, PVR, and NT-proBNP between the PADN plus PDE-5i and sham plus PDE-5i groups among low-risk patients. Moreover, the right ventricular function was equally improved by PADN treatment across the low-, intermediate-, and high-risk groups. Clinical worsening was less with PADN plus PDE-5i treatment during the 6-month follow-up.
In patients with pulmonary arterial hypertension, pulmonary artery denervation plus PDE-5i improved exercise capacity, NT-proBNP, hemodynamic, and clinical outcomes during the 6-month follow-up among intermediate-high risk patients.