Results from iMODERN Announced at TCT 2025 and Published Simultaneously in NEJM
SAN FRANCISCO – OCTOBER 28, 2025 – Three-year findings from the iMODERN trial show that instantaneous wave-free ratio (iFR)-guided revascularization performed during the initial procedure is not superior to deferred cardiac magnetic resonance (CMR)-guided management of non-culprit lesions for patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease.
Findings were reported today at TCT® 2025, the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®). TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.
Current guidelines recommend revascularization of non-culprit lesions in patients with STEMI and multivessel disease with percutaneous coronary intervention (PCI). Guidance also suggests non-culprit PCI in selected hemodynamically stable patients with low-complexity multivessel disease. However, it remains unclear whether performing revascularization during the initial procedure improves outcomes compared to a deferred strategy.
In this investigator-initiated, prospective, open-label, superiority, randomized controlled trial, patients treated with successful primary PCI and one or more non-culprit lesions were randomly assigned to either complete revascularization during the index event of every noninfarct coronary lesion greater than 50% with iFR less than or equal to 0.89, or deferred revascularization based on stress perfusion CMR performed within six weeks after the index procedure.
At 41 international sites, a total of 1,146 patients were randomized to immediate iFR-guided revascularization of non-culprit lesions (N=558) and deferred revascularization guided by CMR (N=588). A total of 237 of 556 patients (42.6%) in the iFR group and 110 of 587 patients (18.7%) in the CMR group underwent non-culprit-lesion coronary-artery PCI in the intention-to-treat analysis. The primary end point, consisting of a composite of all-cause death, recurrent myocardial infarction, and hospitalization for heart failure at three-year follow-up, occurred in 9.3% of the iFR group compared to 9.8% in the CMR group [HR 0.95 (95% CI 0.65-1.40, p=0.81)]. While hospitalizations for heart failure were lower with iFR compared with deferred CMR group [0.6% vs 2.3% HR 0.24 (95% CI 0.07-0.84)], the other components of the composite endpoint did not differ significantly between groups.
Secondary outcomes including cardiac death (1.9% iFR versus 2.0% CMR), target lesion failure (10.2% iFR vs. 10.5% CMR), unplanned coronary angiography (12.2% iFR vs. 14.2% CMR), unstable angina (3.3% iFR vs. 3.9% CMR), and major bleeding (1.9% iFR versus 1.1% CMR) were similar among both groups at three years. Stroke or transient ischemic attack occurred in 1.3% of the iFR group compared with 3.7% in the CMR group (hazard ratio, 0.36; 95% CI, 0.15 to 0.86) and stent thrombosis occurred in 1.7% of patients assigned to iFR and 0.6% in the CMR group (hazard ratio, 3.11; 95% CI, 0.84 to 11.49).
“Both immediate iFR-guided PCI and deferred CMR-guided PCI were safe and effective for STEMI patients with multivessel disease,” said Robin Nijveldt, PhD, MD, Professor of Cardiovascular Imaging and Medical Director, Center for Cardiovascular Care, Radboud University Medical Center. “However, the three-year data show that immediate iFR of non-culprit lesions was not superior to a delayed approach in regards to death from any cause, recurrent myocardial infarction or heart failure hospitalization.”
The study was funded by an unrestricted research grant from Philips and Biotronik, along with a Public-Private Partnership allowance from the Dutch Ministry of Economic Affairs (grant number LSHM 16036).
Dr. Nijveldt reported receiving grant/research support from Philips, Volcano and Biotronik as well as consultant fees/honoraria from Pfizer, BMS, Sanofi and Daiichi Sankyo.
