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Selective C-reactive protein apheresis in ST-elevation myocardial infarction: Design and rationale of the randomized
Sebastian J Reinstadler1, Andreas Kronbichler2, Martin Reindl1
1University Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Innsbruck, Austria.
Insights
This study investigates if C-reactive protein (CRP) apheresis can reduce heart attack damage. The CRP-STEMI trial tests CRP apheresis alongside standard care for ST-elevation myocardial infarction (STEMI) patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomedical Engineering
Background:
- ST-elevation myocardial infarction (STEMI) treatment via percutaneous coronary intervention (PCI) often leads to incomplete myocardial salvage.
- Inflammation, particularly C-reactive protein (CRP), plays a role in infarct expansion, increasing risks of heart failure and mortality.
- The potential benefit of selective CRP apheresis in reducing infarct size in STEMI patients requires investigation.
Purpose of the Study:
- To evaluate the efficacy of selective CRP apheresis as an adjunct to standard care in reducing infarct size in STEMI patients undergoing PCI.
- To determine if CRP apheresis can mitigate myocardial damage following acute myocardial infarction.
Main Methods:
- The CRP-STEMI trial is a randomized, multicenter study involving 202 STEMI patients undergoing PCI within 12 hours of symptom onset.
- Patients are randomized to receive either standard care plus CRP apheresis (days 1-3 post-PCI) or standard care alone.
- Infarct size, the primary endpoint, is assessed using late gadolinium-enhanced cardiac magnetic resonance imaging at 5 ± 2 days post-PCI.
Main Results:
- The CRP-STEMI trial is the first randomized study to assess the impact of CRP apheresis on infarct size in STEMI patients.
- The study aims to provide data on the effectiveness of this novel therapeutic approach.
Conclusions:
- CRP-STEMI is pioneering research into CRP apheresis for acute STEMI.
- Findings will elucidate the role of CRP reduction in improving outcomes for heart attack patients.
Background:
Despite the effectiveness of primary percutaneous coronary intervention (PCI) in treating ST-elevation myocardial infarction (STEMI), myocardial salvage is often incomplete, resulting in large infarct size and an increased risk of heart failure and mortality. Inflammation is involved in this process, with C-reactive protein (CRP) potentially contributing to infarct expansion. Whether selective CRP apheresis in addition to standard care can reduce infarct size in STEMI remains to be determined.
Trial Design:
Selective C-reactive protein apheresis in ST-elevation myocardial infarction (CRP-STEMI) is an investigator-initiated, randomized, open-label (outcome assessor blinded), multicenter trial investigating whether selective CRP apheresis using the PentraSorb-CRP system, in addition to standard care, can reduce infarct size in STEMI patients undergoing PCI within 12 hours of symptom onset. The trial will enroll 202 patients at 5 tertiary care centers in Austria and Germany, randomized 1:1 to either the intervention group (standard care + CRP apheresis) or the control group (standard care). In the intervention group, CRP apheresis will be performed on days 1, 2, and 3 post-PCI. The primary endpoint is infarct size as assessed by late gadolinium enhanced cardiac magnetic resonance at 5 ± 2 days after PCI.
Outlook:
CRP-STEMI is the first randomized trial to investigate whether selective CRP apheresis, as an adjunct to standard care, can effectively reduce infarct size in acute STEMI patients.
Trial Registration:
CRP-STEMI, NCT04939805, is registered at https://clinicaltrials.gov/study/NCT04939805.
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