Pulmonary Artery Denervation for Pulmonary Arterial Hypertension: A Sham-Controlled Randomized PADN-CFDA Trial.
JACC Cardiovasc Interv
; 15(23): 2412-2423, 2022 12 12.
Article
en En
| MEDLINE
| ID: mdl-36121246
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 16.7-50.9 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.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).Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Desnervación
/
Inhibidores de Fosfodiesterasa 5
/
Hipertensión Arterial Pulmonar
Tipo de estudio:
Clinical_trials
/
Observational_studies
Límite:
Humans
Idioma:
En
Revista:
JACC Cardiovasc Interv
Asunto de la revista:
ANGIOLOGIA
/
CARDIOLOGIA
Año:
2022
Tipo del documento:
Article
País de afiliación:
China