Pulmonary-artery denervation halved clinical worsening in heart failure–related pulmonary hypertension

Design

Multicentre, randomised, open-label trial (PADN-HF-PH)

Population

264 patients with pulmonary hypertension due to left heart disease and heart failure, China

Primary outcome

Clinical worsening (death, transplant, HF hospitalisation, outpatient worsening or fall in 6MWD)

Effect

2-year estimate 25.7% vs 51.5%, HR 0.49 (95% CI 0.30–0.82)

A multicentre Chinese trial randomised 264 patients with pulmonary hypertension due to left heart disease and heart failure to pulmonary-artery denervation plus guideline-directed medical therapy, or medical therapy alone.

Over a median 338 days, the Kaplan–Meier estimated 2-year incidence of clinical worsening was 25.7% with denervation versus 51.5% without (HR 0.49, 95% CI 0.30–0.82). The composite included death, transplantation, heart failure hospitalisation, outpatient worsening and a fall in 6-minute walk distance. Procedural complications were limited to access-site haematomas.

Group 2 pulmonary hypertension has no proven targeted therapy, so a positive trial matters. But the design was open-label with no sham procedure, the composite includes subjective and functional components, and the device maker funded it. It needs a sham-controlled trial before it reaches routine care.

• Pulmonary-artery denervation is investigational; do not refer outside trials.
• Optimise guideline-directed medical therapy in heart failure–related pulmonary hypertension first — that is where the evidence is.
• Pulmonary vasodilators remain unproven and potentially harmful in group 2 pulmonary hypertension.
• Watch for a sham-controlled trial before treating this as established.

Why it matters

It is the first device or drug to show a hard-edged signal in group 2 pulmonary hypertension, a large group with nothing targeted to offer.

Don't overread it

Without a sham procedure, the walk-distance and outpatient-worsening parts of the composite are open to placebo effect.

The statistics, in plain English

An HR of 0.49 means about half the rate of worsening, but the 2-year figures are Kaplan–Meier projections from under a year of median follow-up, so they rest on fewer patients at the far end.

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