Roxadustat Treatment After PCI Among Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial

Importance: Preclinical studies suggest that stabilization of hypoxia-inducible factor (HIF) may attenuate reperfusion injury.

Objective

To determine whether oral roxadustat, a HIF-prolyl hydroxylase inhibitor, reduced infarct size when administered after reperfusion among patients with ST-segment elevation myocardial infarction (STEMI). Design, setting, and participants: This phase 2, open-label, randomized clinical trial-Effect of Roxadustat in Acute Myocardial Infarction (ROXAMI)-enrolled adults with STEMI undergoing primary percutaneous coronary intervention (PCI) at a single tertiary medical center between April 1, 2021, and March 31, 2024, with follow-up through 1 year.

Interventions

Oral roxadustat (100 mg, 3 times per week for 2 weeks), initiated within 2 hours after primary PCI, or standard care alone. Main outcomes and measures: The primary end point was infarct size as a percentage of the left ventricle at 30 days measured by late gadolinium enhancement on [68Ga]Ga-DOTA-FAPI-04 positron emission tomography (PET) and magnetic resonance imaging (MRI). Prespecified secondary end points included major adverse cardiovascular events, myocardial injury markers, echocardiographic parameters, and myocardial fibroblast activation parameters on [68Ga]Ga-DOTA-FAPI-04 PET and MRI. The primary efficacy analysis for infarct size was conducted in the modified intention-to-treat population.