A European Respiratory Society task force, working to GRADE across four PICO questions and one narrative question, has updated the treatment guideline for pulmonary arterial hypertension around two decisions: where sotatercept sits, and when to repeat right heart catheterisation.
On the first, the task force recommends add-on sotatercept - an activin signalling inhibitor, a genuinely different pathway from the endothelin, nitric oxide and prostacyclin routes - for patients already receiving pulmonary arterial hypertension drugs who are at intermediate-low, intermediate-high or high risk of death at follow-up. The certainty of evidence is graded high, from randomised trials. At low risk the task force declines to recommend either way, because the evidence is of low certainty and few such patients were enrolled. Treatment should be in a pulmonary hypertension centre with regular follow-up.
On the second, right heart catheterisation during follow-up is suggested - the weaker word - for the same above-low-risk groups, and only when a therapeutic consequence is expected. At low risk there is again no recommendation, with very low certainty.
The practical shape of this is that risk stratification at follow-up now determines two separate decisions, so the risk assessment itself has to be done properly and repeatedly rather than at diagnosis alone. What the guideline cannot address is availability: sotatercept is expensive and supplied through specialist channels, and an ERS document says nothing about its regulatory status or cost in India. Where it is not obtainable, the catheterisation recommendation still stands on its own and the risk assessment still guides escalation among the drugs that are.
- Repeat formal risk stratification at follow-up, not only at diagnosis; two separate recommendations now hang on it.
- Reserve the sotatercept recommendation for patients above low risk who are already on background therapy.
- Do not extrapolate to low-risk patients - the task force explicitly declined to make a recommendation there.
- Order follow-up right heart catheterisation when the result would change treatment, not routinely.
- Manage these patients in or with a pulmonary hypertension centre, as the guideline specifies.
The statistics, in plain English
The wording is the data here. Recommends signals a strong recommendation - most patients should receive it; suggests signals a conditional one, where the right choice depends on the individual. High certainty means further research is unlikely to change the estimate; very low certainty, applied to catheterisation in low-risk patients, means the panel effectively had nothing to go on. A refusal to make a recommendation is not a recommendation against: it means the question is open, which is different from the answer being no.
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