Pulmonary-artery denervation reduced clinical worsening compared to medical therapy alone (25.7% vs 51.5%; HR 0.49; 95% CI 0.30-0.82; P=0.006).
RCT (n=264)
1:1
Yes
Does pulmonary-artery denervation added to guideline-directed medical therapy reduce clinical worsening in patients with pulmonary hypertension associated with left heart disease and heart failure?
Pulmonary-artery denervation significantly reduced the risk of clinical worsening compared to medical therapy alone in patients with pulmonary hypertension associated with left heart disease and heart failure.
Hazard Ratio: 0.49 (95% CI 0.3–0.82)
Absolute Event Rate: 25.7% vs 51.5%
p-value: p=0.006
BackgroundPulmonary hypertension that is caused by left heart disease and is associated with heart failure may be driven by sympathetic overactivation leading to increased pulmonary vascular resistance, right ventricular dysfunction, and poor outcomes. Pulmonary-artery denervation may reduce sympathetic activity, although its clinical effects on left heart disease–associated pulmonary hypertension are unknown. MethodsWe conducted a multicenter, randomized trial in China involving patients with pulmonary hypertension associated with left heart disease and heart failure. Patients were randomly assigned in a 1:1 ratio to receive pulmonary-artery denervation plus guideline-directed medical therapy or to receive medical therapy alone. The primary outcome was clinical worsening — a composite of death, heart or lung transplantation, hospitalization for heart failure, outpatient worsening of heart failure, or a decline in the 6-minute walk distance — through the latest follow-up. ResultsA total of 264 patients underwent randomization: 134 to receive pulmonary-artery denervation plus medical therapy and 130 to receive medical therapy alone. During a median follow-up of 338 days, the Kaplan–Meier estimated 2-year incidence of clinical worsening was 25.7% in the pulmonary-artery denervation group and 51.5% in the medical-therapy group (hazard ratio, 0.49; 95% confidence interval, 0.30 to 0.82; P=0.006). Access-site hematomas occurred in two patients in the pulmonary-artery denervation group and in one patient in the medical-therapy group; there were no other procedural complications. Adverse events during follow-up occurred with similar frequency in the two groups. ConclusionsAmong patients with pulmonary hypertension associated with left heart disease and heart failure receiving guideline-directed medical therapy, pulmonary-artery denervation resulted in fewer events of clinical worsening than medical therapy. (Funded by Pulnovo Medical and others; PADN-HF-PH ClinicalTrials.gov number, NCT05824923.)
““Despite major advances in pharmacologic and device-based therapies, pulmonary hypertension remains one of the strongest predictors of hospitalization, right ventricular failure, and death in patients with left heart disease and heart failure.””
The PADN-HF-PH trial, published in NEJM, showed pulmonary-artery denervation reduced clinical worsening in patients with pulmonary hypertension associated with left heart disease, a novel interventional approach for a difficult-to-treat condition.
Zhang et al. (2026) conducted an RCT in Pulmonary hypertension associated with left heart disease and heart failure (n=264). Pulmonary-artery denervation vs. Guideline-directed medical therapy alone was evaluated on Clinical worsening (composite of death, heart or lung transplantation, hospitalization for heart failure, outpatient worsening of heart failure, or a decline in the 6-minute walk distance) (HR 0.49, 95% CI 0.30-0.82, p=0.006). Pulmonary-artery denervation reduced clinical worsening compared to medical therapy alone (25.7% vs 51.5%; HR 0.49; 95% CI 0.30-0.82; P=0.006).
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