A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of Single-use Ring-shaped Pulmonary Artery Radiofrequency Ablation Catheter and Pulmonary Artery RF Ablation Generator for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure

doi:10.1056/nejmoa2609056

PADN-PH-LHD

Paziente / Popolazione Intervento / Esposizione Confronto Esito

In 264 patients with pulmonary hypertension due to heart failure, pulmonary artery denervation reduced clinical worsening compared with medical therapy alone.

N

264pazienti

Disegno

phase 3 device trial, prospective, multicentre (up to 39 centres in China), randomised 1:1, open-label with blinded outcome assessment; pulmonary artery denervation plus guideline-directed medical therapy vs guideline-directed medical therapy alone (no sham procedure); primary analysis when the last enrolled patient reaches 6 months; follow-up to 3 years; control patients may cross over to PADN at 12 months

Esito

Clinical worsening — first occurrence of any of: intravenous inotropes, diuretics or vasodilators for worsening heart failure; rehospitalisation for heart failure; 6-minute walk distance decrease >10 % or >30 m from baseline; referral for heart or heart–lung transplantation; all-cause death — assessed when the last enrolled patient has ≥6 months of follow-up

Rilevanza

2Importante — uno dei diversi pilastri.

RisultatoKaplan-Meier estimated 2-year clinical worsening 25.7% vs 51.5% (HR 0.49, 95% CI 0.30-0.82; P = 0.006) over a median follow-up of 338 days. Access-site haematoma in 2 of 134 denervation patients and 1 of 130 controls, with no other procedural complications; adverse events during follow-up were similar in both groups.

Zhang H, Wang L, Liang X, et al. N Engl J Med. 2026; published online 30 August. 10.1056/nejmoa2609056

Discussione e critica

A halving of clinical worsening from a single catheter procedure, in a group with no treatment of its own: pulmonary hypertension from left heart disease is where the pulmonary vasodilators have repeatedly failed, so a positive device trial here is genuinely new. Three things bound it. The median follow-up is 338 days while the estimate quoted is at two years, so the curve's second half rests on few patients; the control arm received a procedure-free comparison, which in a composite carrying outpatient worsening and a walk-distance decline is the weakest part of the design; and the trial is Chinese, single-country, sponsored by the device maker. The effect is large enough to matter and the confirmation should be blinded.