Pulmonary hypertension arising from left heart disease has no approved targeted therapy, and pulmonary vasodilators have generally disappointed or harmed. This multicentre Chinese trial randomised 264 such patients on guideline-directed medical therapy to pulmonary-artery denervation plus medical therapy, or medical therapy alone.
Over a median 338 days, the estimated two-year incidence of clinical worsening, a composite of death, transplantation, heart failure hospitalisation, outpatient worsening or a fall in six-minute walk distance, was 25.7% with denervation against 51.5% without (hazard ratio 0.49, 95% CI 0.30-0.82, P = 0.006). Procedural complications were limited to three access-site haematomas across both groups.
Treat this as promising rather than practice-changing. The trial was open-label, and a composite that includes outpatient worsening and walk distance is susceptible to expectation when neither patients nor treating clinicians are blinded to whether a procedure was performed. Median follow-up was under a year while the headline figure is a two-year estimate. It is a real signal in a condition with nothing else, and it needs a sham-controlled trial before it changes referral patterns.
- Clinical worsening 25.7% vs 51.5% at two years (HR 0.49)
- Open-label, with a partly subjective composite endpoint
- Median follow-up 338 days against a two-year headline estimate
- A genuine signal in a condition with no targeted therapy; not yet a referral
The statistics, in plain English
A hazard ratio of 0.49 means events accrued at about half the rate; the interval, 0.30 to 0.82, stays below 1.0 so the effect is unlikely to be chance. The weakness is bias, not precision. In an unblinded trial, endpoints such as outpatient worsening and six-minute walk distance can shift on expectation alone, and they sit inside the composite alongside hard events like death. That is why a sham-controlled trial is the necessary next step.
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