Results from the PADN-5 study, investigating the efficacy and safety of pulmonary artery denervation in the treatment of combined postcapillary and precapillary and pulmonary hypertension (CpcPH) related to left heart failure, have been presented at the Technology and Heart Failure Therapeutics (THT) conference (20–22 March, Boston, USA).
The trial enrolled 98 patients with CpcPH related to left heart failure who met the inclusion criteria of being on a maximum tolerated dose of heart failure medications, achieving clinical stability, and being off pulmonary arterial hypertension (PAH)-targeting drugs for at least three months.
Forty-eight patients were in the treatment group (pulmonary artery denervation plus standard heart failure drug therapy) while 50 patients were in the control group (sham operation plus Sildenafil plus standard heart failure drug therapy).
The results of the study showed that the incidence of clinical deterioration at six months, one year and three years was significantly lower in the study group than in the control group, and the incidence of readmission due to heart failure, cardiac death, and all-cause mortality at one and three years after surgery was also significantly lower in the study group than in the control group.
Other endpoints such as N-terminal pro b-type natriuretic peptide (NT-proBNP) and six-minute walk distance (6MWD) were also considerably improved in the study group than in the control group at six months and three years postoperatively, as were pulmonary vascular resistance (PVR) and pulmonary capillary wedge pressure (PCWP) measured by right heart catheterisation (RHC) at six months postoperatively.
The three-year follow-up results of the PADN-5 study showed the long-term benefits of pulmonary artery denervation for patients with CpcPH. In contrast to Sildenafil plus a standard drug therapy for heart failure, pulmonary artery denervation plus a standard drug therapy for heart failure significantly reduced the incidence of clinical deterioration, whether at six months, one year or three years postoperatively. In addition, pulmonary artery denervation was effective in improving haemodynamic parameters, increasing exercise tolerance among patients, and improving their cardiac function and clinical prognosis.
In a press release, Pulnovo Medical, said: “As the first sham randomised controlled study to explore pulmonary artery denervation in heart failure combined with CpcPH, PADN-5 achieved exciting and ground-breaking outcomes—pulmonary artery denervation showed great long-term effects over a three-year follow-up period and consistently outperformed the control group.”