Acute coronary syndromes (ACS) are frequently associated with multivessel coronary artery disease (CAD), and current guidelines recommend complete revascularization beyond the culprit lesion. Angiography-guided PCI is the standard approach, but anatomical assessment does not always reflect the functional significance of intermediate lesions, while FFR-guided strategies are limited by the need for pressure wires and hyperemia. Murray-law-based quantitative flow ratio (μFR) is a wire-free angiography-derived physiological index that may improve decision-making for revascularization in ACS patients.
The Core-μFR is an investigator-driven, multicenter, randomized, open-label and prospective trial designed to evaluate whether μFR can act as a gatekeeper for complete revascularization in patients with ACS and multivessel disease by identifying non-culprit lesions that truly require PCI.
Patients with ACS (either STEMI or NSTE-ACS) undergoing primary PCI will be considered eligible if they present multivessel CAD on visual assessment with the intention to treat the non-culprit vessel in a staged procedure within the same hospitalization. After the pPCI, eligible patients will be randomized to either group A or group B and μFR will be performed in a blinded fashion with the operator unaware of the functional result. Patients in group A will undergo a staged PCI of all NCVs guided by coronary angiography, as per standard of care. In group B, μFR will be used as a gatekeeper for staged revascularization. Operators will only be informed whether at least one non-culprit vessel is μFR-positive, without disclosure of the specific vessel involved or the μFR values. If at least one non-culprit vessel has μFR ≤0.80, patients will undergo angiography-guided PCI of all non-culprit vessels previously deemed suitable for treatment by visual assessment. If μFR is \>0.80 in all non-culprit vessels, staged PCI will be deferred and the patient will be discharged without further revascularization. Finally, to test the functional reproducibility, a blinded post-hoc μFR assessment will be performed on the baseline angiograms of the staged procedures in all the patients undergoing complete revascularization. Clinical follow-up will be performed at 30 days and 1 year from randomization.
Patients presenting with ACS within 72 hours of successful culprit PCI
at least 50% diameter stenosis by visual assessment
a vessel diameter of at least 2.5 mm
amenable to successful PCI
Cardiogenic shock or severe heart failure (NYHA class ≥III)
Severely impaired renal function: creatinine >2 mg/dl or estimated glomerular filtration rate (eGFR) <30 ml/min/1,73 m²
Allergy to iodine-containing contrast agents which cannot be adequately pre-medicated
Pregnancy or intention to become pregnant during the trial
Parallel
Angiography-guided PCI
Procedure/Surgerystaged PCI of all NCVs will be performed as per standard of care
μFR based-PCI
Procedure/Surgerystaged PCI will be deferred if the μFR \> 0.80 in all the NCVs or performed if the μFR is ≤ 0.80 in at least one NCVs
Primary efficacy endpoint
Number of stents implanted and number of procedures
Primary safety endpoint
MACE (major adverse cardiovascular event) defined as the composite of all-cause mortality, non-culprit vessel unplanned revascularization, non-fatal myocardial infarction (defined according to the Fourth Universal Definition of Myocardial Infarction, including procedural MI and spontaneous MI)
Inappropriate revascularization
Inappropriate revascularization according to μFR value
Change in clinical decision making
Change in clinical decision making about revascularization strategy from intended PCI to medical therapy
μFR reproducibility
Test-re-test repeatability of μFR
Length of stay
Duration of hospitalization
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