- Design
- Phase 2, randomised, open-label, single centre
- Population
- 158 adults with STEMI undergoing primary PCI
- Primary outcome
- Infarct size (% LV) at 30 days on PET-MRI
- Effect
- 23.3% vs 22.0%; difference 1.3 points (95% CI −2.7 to 5.3), P=0.51
ROXAMI was a single-centre, open-label phase 2 trial in 158 adults with STEMI. Oral roxadustat, a HIF-prolyl hydroxylase inhibitor already used for renal anaemia, was started within two hours of primary PCI (100 mg three times a week for two weeks) and compared with standard care.
Infarct size at 30 days, measured by PET-MRI, was 23.3% of the left ventricle with roxadustat and 22.0% with control (difference 1.3 points, 95% CI −2.7 to 5.3). Major adverse events were 3.8% vs 8.9%, which was not significant. Exploratory 12-month results showed slightly better ejection fraction and less ventricular dilatation with roxadustat, but these were unadjusted for multiple testing.
This is another reperfusion-injury strategy that worked in animals and missed its primary endpoint in people. It should not be used for this purpose outside trials.
- Roxadustat is not a cardioprotective therapy after STEMI on current evidence.
- The primary endpoint, infarct size at 30 days, was neutral.
- Remodelling signals at 12 months were exploratory and need confirmation.
- Patients already on roxadustat for renal anaemia need no change on the basis of this trial.
Why it matters
Reperfusion injury remains an unsolved target, and another plausible mechanism has failed its first clinical test.
Don't overread it
The better ejection fraction at 12 months came from unadjusted secondary analyses in a small open-label trial.
The statistics, in plain English
The confidence interval for infarct size (−2.7 to 5.3 points) includes zero and leans slightly towards harm, so the trial gives no sign of benefit. The event hazard ratio of 0.42 has an interval from 0.11 to 1.63 — far too wide to conclude anything with only ten events.
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