Percutaneous coronary intervention (PCI) of non-infarct-related artery (IRA) lesions for complete revascularisation improves clinical outcomes compared with IRA-only PCI in patients with STEMI and multivessel coronary artery disease (CAD).1,2 However, the most effective strategy for identifying appropriate targets to enable complete revascularisation has not been determined.
In a Hot Line session yesterday, Professor Joo-Yong Hahn (Samsung Medical Center - Seoul, Republic of Korea) presented findings from the FRAME-AMI trial, which compared the use of fractional flow reserve (FFR) with angiography to guide PCI in non-IRA lesions in this setting.
FRAME-AMI was an open-label investigator-led study conducted at 14 centres in Korea and enrolling patients with acute myocardial infarction (MI) and multivessel CAD (>50% diameter stenosis in a major epicardial coronary artery or major side branch with vessel diameter ≥2.0 mm by visual estimation). Following successful IRA PCI, patients were randomised 1:1 to receive FFR-guided PCI of non-IRA stenosis with FFR ≤0.80 or angiography-guided PCI of non-IRA stenosis (diameter >50%). Although complete revascularisation during the index procedure was recommended for all patients, staged procedures during the index hospitalisation were at the operators’ discretion. The primary endpoint was a composite of all-cause death, MI or unplanned revascularisation.
Between August 2016 and December 2020, 562 patients were randomised. The average age of patients was 63 years and 16% were women. Non-IRA lesions were treated by immediate PCI in 60% of patients and by staged procedure during the same hospitalisation in 40% of patients.
At a median follow up of 3.5 years, FFR was associated with a lower risk of the primary endpoint, which occurred in 18/284 patients in the FFR group and 40/278 patients in the angiography group (event rates at 4 years: 7.4% versus 19.7%; hazard ratio [HR] 0.43; 95% CI 0.25 to 0.75; p=0.003).
FFR was also associated with significantly fewer deaths than angiography (5 versus 16, respectively; event rates at 4 years: 2.1% versus 8.5%; HR 0.30; 95% CI 0.11 to 0.83; p=0.020) and a lower incidence of MI (7 versus 21, respectively; event rates at 4 years: 2.5% versus 8.9%; HR 0.32; 95% CI 0.13 to 0.75; p=0.009). Unplanned revascularisations were seen in 10 patients receiving FFR and in 16 undergoing angiography (KM event rates at 4 years, 4.3% versus 9.0%; HR 0.61; 95% CI 0.28 to 1.34; p=0.216).
“In patients with acute MI and multivessel CAD, using FFR to select non-IRA lesions for PCI was superior to selection of non-IRA lesions based on angiographic diameter stenosis regarding the risk of death, MI or repeat revascularisation,” says Prof. Hahn. “The benefit of FFR-guided PCI on the primary endpoint was consistent regardless of the type of MI (STEMI or non-STEMI).” He concludes: “Guidelines are unlikely to change solely based on the results of our trial, but in clinical practice, interventional cardiologists may choose to adopt FFR-guided decision making in patients with acute MI and multivessel disease.”