FRAME-AMI Trial Compares FFR and Angiography to Select Non–Infarct-Related Artery Lesions for PCI in Patients With AMI and Multivessel Disease

August 28, 2022—Findings from the FRAME-AMI study found that selection of non–infarct-related artery (non-IRA) lesions for percutaneous coronary intervention (PCI) using fractional flow reserve (FFR) is superior to routine angiography-based selection in patients with acute myocardial infarction (AMI) and multivessel disease, announced the European Society of Cardiology.

FRAME-AMI is an investigator-initiated, open-label trial conducted at 14 sites in Korea. Professor Joo-Yong Hahn, MD, of Samsung Medical Center in Seoul, Republic of Korea, serves as Principal Investigator for the trial.

“In patients with AMI and multivessel coronary artery disease, 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, myocardial infarction [MI], or repeat revascularization,” concluded Professor Hahn in the ESC press release.

The late-breaking research was presented in a Hot Line session at the 2022 ESC Congress held August 26-29 in Barcelona, Spain.

As noted in the ESC press release, the background of the study is that randomized trials have consistently found that PCI of non-IRA lesions for complete revascularization in patients with ST-segment elevation myocardial infarction (STEMI) improves clinical outcomes compared with IRA-only PCI.

ESC guidelines recommend that revascularization of non-IRA lesions should be considered in STEMI patients with multivessel disease during the index procedure or before hospital discharge. However, the optimal strategy to select targets for non-IRA PCI has not been clarified.

According to the ESC press release, the FRAME-AMI trial randomly assigned patients with AMI and multivessel coronary artery disease who had undergone successful PCI of the IRA to undergo either (1) FFR-guided PCI of non-IRA with FFR ≤ 0.8 or (2) angiography-guided PCI of non-IRA with > 50% diameter stenosis.

In both groups, complete revascularization during the index procedure was recommended. However, staged procedures during the index hospitalization were permitted at the operators’ discretion.

The primary endpoint was a composite of all-cause death, MI, or repeat revascularization.

In FRAME-AMI, the investigator enrolled a total of 562 patients who underwent randomization between August 2016 and December 2020. The average age was 63 years, and 16% were women.

As summarized in the ESC press release, non-IRA lesions were treated by immediate PCI after successful treatment of IRA in 337 patients (60%) and by staged procedure during the same hospitalization in 225 patients (40%).

During a median follow-up of 3.5 years (IQR, 2.7-4.1 years), the FRAME-AMI investigators found the following:

• The primary endpoint occurred in 18 of 284 patients in the FFR group and 40 of 278 patients in the angiography group (Kaplan-Meier event rates at 4 years, 7.4% versus 19.7%; hazard ratio [HR], 0.43; 95% CI, 0.25-0.75; P = .003).
• The incidence of death was significantly lower in the FFR group compared with the angiography group, occurring in five and 16 patients, respectively (Kaplan-Meier event rates at 4 years, 2.1% vs 8.5%; HR, 0.30; 95% CI, 0.11-0.83; P = .02).
• The incidence of MI was significantly lower in the FFR group compared with the angiography group, occurring in seven versus 21 patients, respectively (Kaplan-Meier event rates at 4 years, 2.5% vs 8.9%; HR, 0.32; 95% CI, 0.13-0.75; P = .009).
• 10 patients in the FFR group had an unplanned revascularization compared with 16 patients in the angiography group, with no significant difference between the two groups (Kaplan-Meier event rates at 4 years, 4.3% vs 9%; HR, 0.61; 95% CI, 0.28-1.34; P = .216).

“The benefit of FFR-guided PCI on the primary endpoint was consistent regardless of the type of MI (STEMI or non-STEMI),” commented Dr. Hahn in the ESC press release. “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 AMI and multivessel disease.”