| Institution: | 1. Division of Cardiology, Nanjing First Hospital of Nanjing Medical University, Nanjing, China;2. School of Public Health, Nanjing Medical University, Nanjing, China;3. Division of Cardiology, Guangdong Provincial People’s Hospital, Guangzhou, China;4. Division of Pulmonary Vascular Disease, General Hospital of Tianjin Medical University, Tianjin, China;5. Division of Cardiology, First Hospital of Zhengzhou University, Zhengzhou, China;6. Division of Pulmonary Vascular Disease, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China;7. Division of Congenital Heart Disease, Beijing Anzhen Hospital of Capital Medical University, Beijing, China;8. Division of Pulmonary Vascular Disease, General Hospital of Northern Theater of Command, Shenyang, China;9. Division of Pulmonary Vascular Disease, Zhongnan Hospital of Wuhan University, Wuhan, China;10. Division of Cardiology, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China;11. Division of Cardiology, Second Hospital of Chongqing Medical University, Chongqing, China;12. Division of Pulmonary Vascular Disease, Wuhan Asia Heart Hospital, Wuhan, China;13. Cardiac Imaging Center of Nanjing Medical University, Nanjing, China;14. Peking University Clinical Research Institute, Beijing, China;15. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA |
| Abstract: | BackgroundWorld 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.ObjectivesThe aim of this study was to determine the treatment effects of PADN in patients with group 1 PAH.MethodsPatients 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.ResultsAmong 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.ConclusionsIn 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) |
