Jing Kan1, MD; Hang Zhang1, MD; Dujiang Xie1, MD; Yongyue Wei2, PhD; Juan Zhang1, MD; Caojin Zhang3, MD; Zhenwen Yang4, MD; Heping Gu5, MD; Fenling Fan6, MD; Hong Gu7, MD; Qiguang Wang8, MD; Gangcheng Zhang9, MD; Xiaomei Guo10, MD; Yuehui Yin11, MD; Xiang Wang12, MD; Bowen Jin13, MD; Hongmei Zhou13, MD; Ziyang Yang3, MD; Zhouming Wang4, MD; Yu Xin5, MD; Chen Zhang7, MD; Lili Meng8, MD; Xiaoyu Wang6, MD; Chunxia Zhao10, MD; Xiaoyan Yan14, PhD; Feng Chen12, PhD; Cheng Yao14, PhD; Gregg W. Stone15, MD; Shao-Liang Chen1, MD
1. Division of Cardiology, Nanjing First Hospital of Nanjing Medical University, Nanjing, People’s Republic of China; 2. Center for Public Health and Epidemic Preparedness & Response, Health Science Center, Peking University, Shanghai, People’s Republic of China; 3. Division of Cardiology, Guangdong Provincial Peoples Hospital, Guangzhou, People’s Republic of China; 4. Division of Pulmonary Vascular Disease, General Hospital of Tianjin Medical University, Tianjin, People’s Republic of China; 5. Division of Cardiology, First Hospital of Zhengzhou University, Zhengzhou, People’s Republic of China; 6. Division of Pulmonary Vascular Disease, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, People’s Republic of China; 7. Division of Congenital Heart Disease, Beijing Anzhen Hospital of Capital Medical University, Beijing, People’s Republic of China; 8. Division of Pulmonary Vascular Disease, General Hospital of Northern Theater of Command, Shenyang, People’s Republic of China; 9. Division of Pulmonary Vascular Disease, Zhongnan Hospital of Wuhan University, Wuhan, People’s Republic of China; 10. Division of Cardiology, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, People’s Republic of China; 11. Division of Cardiology, Second Hospital of Chongqing Medical University, Chongqing, People’s Republic of China; 12. Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, People’s Republic of China; 13. Division of Pulmonary Vascular Disease, Wuhan Asia Heart Hospital, Wuhan, People’s Republic of China; 14. Peking University Clinical Research Institute, Beijing, People’s Republic of China; 15. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA
Background: Long-term clinical outcomes after pulmonary artery denervation (PADN) in patients with Group 1 pulmonary arterial hypertension (PAH) have not been reported.
Aims: We aimed to investigate the effect of PADN on 1-year outcomes in patients with PAH.
Methods: In the multicentre PADN-CFDA trial, 128 patients with Group 1 PAH were randomly assigned to PADN plus a phosphodiesterase-5 inhibitor (PDE-5i) versus a sham PADN procedure plus a PDE-5i. The principal endpoint of interest for the present study was clinical worsening at 1 year after randomisation, the composite of worsening of PAH (increase in WHO functional class, need for additional PAH treatments or PAH-related hospitalisation), atrial septostomy, listing for lung transplantation, or all-cause death.
Results: One-year clinical follow-up was available in all patients. At 1 year, clinical worsening had occurred in 3 (4.8%) patients in the PADN plus PDE-5i group and in 15 patients (23.1%) in the sham plus PDE-5i group (adjusted hazard ratio: 0.17; 95% confidence interval [CI]: 0.05-0.60; p=0.006), driven by significantly increased rates of PAH-related hospitalisations, worsening functional class and the requirement for additional PAH treatments in the sham group. Results were consistent in high-risk, intermediate-risk and low-risk patients (pinteraction=0.186). Patients treated with PADN plus PDE-5i had an improvement in the between-group change in the six-minute walking distance (6MWD) from baseline to 1 year of 81.2 m (95% CI: 50.3-112.2; p<0.001) compared with PDE-5i treatment alone.
Conclusions: In this multicentre sham-controlled randomised trial, PADN treatment for Group 1 PAH significantly reduced clinical worsening and improved the 6MWD during 1-year follow-up in patients treated with a PDE-5i.
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clinical trialsOther abdominal visceral interventionpulmonary hypertension
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