The iMODERN trial (“iFR Guided Multi-vessel Revascularization During Percutaneous Coronary Intervention for Acute Myocardial Infarction.”) trial is an ongoing multinational study. This study will provide important knowledge on the best practice for the assessment and treatment of multi-vessel disease involving ST-segment elevation myocardial infarction (STEMI) patients.
We spoke with Professor Robin Nijveldt, Cardiologist at Radboud University Medical Center in Nijmegen, the Netherlands about this ongoing prospective, randomized controlled, multicentre study.
Revascularization strategy: Immediate vs Delayed
It is estimated that in patients with acute ST-elevation myocardial infarction (STEMI), 40-60% of them have multi-vessel coronary artery disease. Although it is not currently recommended to revascularize non-infarct lesions during acute interventions, outcomes with doing so have not been investigated. Professor Nijveldt touched upon the findings of previous studies,
“The PRAMI study showed that if you treat non-culprit lesions that might improve outcome after all, but that study was compared with doing nothing at all.”
Nijveldt and his team aim to compare revascularization of non-culprit lesions in the acute setting to the deferred strategy. Nijveldt states their hypothesis,
“We think treatment of non-culprit lesions, if they are significant, will abolish all ischemic myocardium and will therefore help infarct healing and improve outcome as compared to the deferred strategy.”
iMODERN study design
1146 patients will be stratified by acute anterior infarcts during primary percutaneous coronary intervention (PCI). If they are found to have non-culprit lesions, they will be invited to join the study. The patients will then be randomized 1:1, to either an active or a deferred treatment arm. In the former, patients will receive complete, iFR-guided revascularization of every noninfarct coronary lesion >50% and iFR ≤0.89. In the latter, patients will undergo an adenosine stress perfusion CMR scan within 6 weeks after STEMI, with revascularization of the noninfarct coronary lesions with associated perfusion defects.
The primary end point is a composite of Major Adverse Cardiac Events (MACE), including all-cause death, recurrent MI and hospitalization for heart failure at 12 months follow-up.
We currently do not know if pressure guided revascularization of non-infarct lesions in the acute phase will improves outcomes, as those achieved using current guidelines. We may see changes to these guidelines, depending on the findings of Nijveldt’s team.
To participate in this trial visit the iMODERN site to learn more about enrolling patients.
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Author: Kelly Schoonderwoerd
Reference: iMODERN Clinicaltrials.gov