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Peer-reviewedCC BY 4.0JAMA Network Open

Roxadustat Treatment After PCI Among Patients With ST-Segment Elevation Myocardial Infarction

  • Weiwei Quan1
  • Yueying Wang1,2
  • Min Zhang3,4
  • Tianqi Zhu1
  • Jinzhou Zhu1
  • Xiaoqun Wang1
  • Zhengbin Zhu1
  • Run Du1
  • Fenghua Ding1
  • Jingwei Ni1
  • Shuo Feng1
  • Hongyang Xie1
5 more authors
  • Lili Liu1
  • Yuehua Fang1
  • Xuezheng Qu1
  • Ruiyan Zhang1
  • Xiaoxiang Yan1
4 affiliations
  1. 1Department of Cardiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
  2. 2Institute of Cardiovascular Diseases, Shanghai Jiao Tong University School of Medicine, Shanghai, China
  3. 3Department of Nuclear Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
  4. 4Collaboration Innovation Center for Molecular Imaging of Precision Medicine, Ruijin Center, Shanghai, China
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Abstract

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 [ ⁶⁸ Ga]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 [ ⁶⁸ Ga]Ga-DOTA-FAPI-04 PET and MRI. The primary efficacy analysis for infarct size was conducted in the modified intention-to-treat population.

Results: Among 158 randomized patients (mean [SD] age, 63.6 [11.0] years; 133 men [84.2%]; 79 randomized to each group), 148 (93.7%; 72 roxadustat and 76 control) had evaluable imaging for the primary outcome. For the primary end point, mean (SD) infarct size did not significantly differ between the roxadustat and control groups (23.3% [12.2%] vs 22.0% [12.2%]; mean difference, 1.3 percentage points; 95% CI, −2.7 to 5.3 percentage points; P = .51). Major adverse cardiovascular events occurred in 3 of 79 patients (3.8%) in the roxadustat group and 7 of 79 (8.9%) in the control group (hazard ratio, 0.42; 95% CI, 0.11-1.63; P = .21). In multiplicity-unadjusted secondary analyses, adjusted between-group differences at 12 months were 2.9 percentage points (95% CI, 0.4-5.3 percentage points; P = .02) for the change in left ventricular ejection fraction (mean [SD]: roxadustat, 3.4% [0.9%] vs control, 0.5% [0.9%]) and −4.5 mL/m ² (95% CI, −8.9 to −0.1 mL/m ² ; P = .045) for left ventricular end-diastolic volume index (mean [SD]: roxadustat, 1.2 [1.6] mL/m ² vs control, 5.7 [1.6] mL/m ² ). The incidence of prespecified safety end points did not differ between the roxadustat and control groups.

Conclusions and Relevance: In this randomized clinical trial of patients with STEMI, roxadustat administration after PCI did not significantly reduce infarct size at 30 days compared with control. Secondary ventricular remodeling findings were exploratory and require confirmation.

Trial Registration: ClinicalTrials.gov Identifier: NCT04803864

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Cite

BibTeXRIS
BibTeX
@article{quan2026roxadustat,
  title = {{Roxadustat Treatment After PCI Among Patients With ST-Segment Elevation Myocardial Infarction}},
  author = {Weiwei Quan and Yueying Wang and Min Zhang and Tianqi Zhu and Jinzhou Zhu and Xiaoqun Wang and Zhengbin Zhu and Run Du and Fenghua Ding and Jingwei Ni and Shuo Feng and Hongyang Xie and Lili Liu and Yuehua Fang and Xuezheng Qu and Ruiyan Zhang and Xiaoxiang Yan},
  journal = {JAMA Network Open},
  year = {2026},
  month = oct,
  doi = {10.1001/jamanetworkopen.2026.37953},
  url = {https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2855122},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Roxadustat Treatment After PCI Among Patients With ST-Segment Elevation Myocardial Infarction
AU  - Weiwei Quan
AU  - Yueying Wang
AU  - Min Zhang
AU  - Tianqi Zhu
AU  - Jinzhou Zhu
AU  - Xiaoqun Wang
AU  - Zhengbin Zhu
AU  - Run Du
AU  - Fenghua Ding
AU  - Jingwei Ni
AU  - Shuo Feng
AU  - Hongyang Xie
AU  - Lili Liu
AU  - Yuehua Fang
AU  - Xuezheng Qu
AU  - Ruiyan Zhang
AU  - Xiaoxiang Yan
PY  - 2026
DA  - 2026/10/09
JO  - JAMA Network Open
DO  - 10.1001/jamanetworkopen.2026.37953
UR  - https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2855122
AB  - 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 [ ⁶⁸ Ga]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 [ ⁶⁸ Ga]Ga-DOTA-FAPI-04 PET and MRI. The primary efficacy analysis for infarct size was conducted in the modified intention-to-treat population.  Results: Among 158 randomized patients (mean [SD] age, 63.6 [11.0] years; 133 men [84.2%]; 79 randomized to each group), 148 (93.7%; 72 roxadustat and 76 control) had evaluable imaging for the primary outcome. For the primary end point, mean (SD) infarct size did not significantly differ between the roxadustat and control groups (23.3% [12.2%] vs 22.0% [12.2%]; mean difference, 1.3 percentage points; 95% CI, −2.7 to 5.3 percentage points; P = .51). Major adverse cardiovascular events occurred in 3 of 79 patients (3.8%) in the roxadustat group and 7 of 79 (8.9%) in the control group (hazard ratio, 0.42; 95% CI, 0.11-1.63; P = .21). In multiplicity-unadjusted secondary analyses, adjusted between-group differences at 12 months were 2.9 percentage points (95% CI, 0.4-5.3 percentage points; P = .02) for the change in left ventricular ejection fraction (mean [SD]: roxadustat, 3.4% [0.9%] vs control, 0.5% [0.9%]) and −4.5 mL/m ² (95% CI, −8.9 to −0.1 mL/m ² ; P = .045) for left ventricular end-diastolic volume index (mean [SD]: roxadustat, 1.2 [1.6] mL/m ² vs control, 5.7 [1.6] mL/m ² ). The incidence of prespecified safety end points did not differ between the roxadustat and control groups.  Conclusions and Relevance: In this randomized clinical trial of patients with STEMI, roxadustat administration after PCI did not significantly reduce infarct size at 30 days compared with control. Secondary ventricular remodeling findings were exploratory and require confirmation.  Trial Registration: ClinicalTrials.gov Identifier: NCT04803864
SN  - 2574-3805
ER  -