| Title | Pulmonary Artery Denervation for Pulmonary Arterial Hypertension A Sham-Controlled Randomized PADN-CFDA Trial |
| Authors | Zhang, Hang Wei, Yongyue Zhang, Caojin Yang, Zhenwen Kan, Jing Gu, Heping Fan, Fenling Gu, Hong Wang, Qiguang Xie, Dujiang Zhang, Gangcheng Guo, Xiaomei Yin, Yuehui Jin, Bowen Zhou, Hongmei Yang, Ziyang Wang, Zhouming Xin, Yu Zhang, Chen Meng, Lili Wang, Xiaoyu Sun, Jingping Zhao, Chunxia Zhang, Juan Yan, Xiaoyan Chen, Feng Yao, Cheng Stone, Gregg W. Chen, Shao-Liang |
| Affiliation | Nanjing Med Univ, Div Cardiol, Nanjing Hosp 1, Nanjing, Peoples R China Nanjing Med Univ, Sch Publ Hlth, Nanjing, Peoples R China Guangdong Prov Peoples Hosp, Div Cardiol, Guangzhou, Peoples R China Tianjin Med Univ, Div Pulm Vasc Dis, Gen Hosp, Tianjin, Peoples R China Zhengzhou Univ, Div Cardiol, Hosp 1, Zhengzhou, Peoples R China Xi An Jiao Tong Univ, Div Pulm Vasc Dis, Affiliated Hosp 1, Xian, Peoples R China Capital Med Univ, Beijing Anzhen Hosp, Div Congenital Heart Dis, Beijing, Peoples R China Gen Hosp Northern Theater Command, Div Pulm Vasc Dis, Shenyang, Peoples R China Wuhan Univ, Div Pulm Vasc Dis, Zhongnan Hosp, Wuhan, Peoples R China Div Cardiol, Tongji Hosp, Huazhong Univ Sci & Technol, Wuhan, Peoples R China Chongqing Med Univ, Div Cardiol, Hosp 2, Chongqing, Peoples R China Wuhan Asia Heart Hosp, Div Pulm Vasc Dis, Wuhan, Peoples R China Nanjing Med Univ, Cardiac Imaging Ctr, Nanjing, Peoples R China Peking Univ, Clin Res Inst, Beijing, Peoples R China Icahn Sch Med Mt Sinai, Zena & Michael A Wiener Cardiovasc Inst, New York, NY 10029 USA |
| Keywords | SYMPATHETIC-NERVE ACTIVITY CONTRIBUTES THERAPY FAILURE |
| Issue Date | 12-Dec-2022 |
| Publisher | JACC-CARDIOVASCULAR INTERVENTIONS |
| Abstract | BACKGROUND 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. OBJECTIVES The aim of this study was to determine the treatment effects of PADN in patients with group 1 PAH. METHODS 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. RESULTS 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: 16.7-0.9 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. CONCLUSIONS 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) (c) 2022 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc- nd/4.0/). |
| URI | http://hdl.handle.net/20.500.11897/671381 |
| ISSN | 1936-8798 |
| DOI | 10.1016/j.jcin.2022.09.013 |
| Indexed | SCI(E) |
| Appears in Collections: | 医学部待认领 |
