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ESC: FRAME-AMI Trial Finds Best Strategy to Select Non Infarct Related Artery Lesions for Intervention
Barcelona, Spain – August 29, 2022: Selection of non-infarct related artery (IRA) lesions for intervention using fractional flow reserve (FFR) is superior to routine angiography-based selection in patients with acute myocardial infarction and multivessel disease. That’s the finding of late breaking research presented in a Hot Line session at ESC Congress 2022.1
Principal investigator Professor Joo-Yong Hahn of Samsung Medical Center, Seoul, Republic of Korea said: “In patients with acute myocardial infarction and multivessel coronary artery disease, using FFR to select non-IRA lesions for percutaneous coronary intervention (PCI) was superior to selection of non-IRA lesions based on angiographic diameter stenosis regarding the risk of death, myocardial infarction, or repeat revascularisation.”
Randomised trials have consistently found that PCI of non-IRA lesions for complete revascularisation in patients with ST-segment elevation myocardial infarction (STEMI) improves clinical outcomes compared with IRA-only PCI.2-6 ESC guidelines recommend that revascularisation of non-IRA lesions should be considered in STEMI patients with multivessel disease during the index procedure or before hospital discharge.7-9 However, the optimal strategy to select targets for non-IRA PCI has not been clarified. Therefore, the FRAME-AMI trial compared FFR-guided PCI with angiography-guided PCI for non-IRA lesions among patients with acute myocardial infarction and multivessel disease.
FRAME-AMI was an investigator-initiated, open-label trial conducted at 14 sites in Korea. The trial randomly assigned patients with acute myocardial infarction 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 ≤0.80 or (2) angiography-guided PCI of non-IRA with >50% diameter stenosis. In both groups, complete revascularisation during the index procedure was recommended. However, staged procedures during the index hospitalisation were permitted at operators’ discretion. The primary endpoint was a composite of all-cause death, myocardial infarction, or repeat revascularisation.
Between August 2016 and December 2020, a total of 562 patients underwent randomisation. The average age was 63 years and 16% were women. Non-IRA lesions were treated by immediate PCI after successful treatment of IRA in 337 patients (60.0%) and by staged procedure during the same hospitalisation in 225 patients (40.0%). During a median follow up of 3.5 years (interquartile range 2.7–4.1 years), 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% confidence interval [CI] 0.25–0.75; p=0.003).
The incidence of death was significantly lower in the FFR group compared with the angiography group, occurring in 5 patients versus 16 patients, respectively (Kaplan–Meier event rates at 4 years, 2.1% versus 8.5%; HR 0.30; 95% CI 0.11–0.83; p=0.020). The incidence of myocardial infarction was also significantly lower in the FFR group compared with the angiography group, occurring in 7 patients versus 21 patients, respectively (Kaplan–Meier event rates at 4 years, 2.5% versus 8.9%; HR 0.32; 95% CI 0.13–0.75; p=0.009). Ten patients in the FFR group had an unplanned revascularisation 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% versus 9.0%; HR 0.61; 95% CI 0.28–1.34; p=0.216).
Professor Hahn said: “The benefit of FFR-guided PCI on the primary endpoint was consistent regardless of the type of myocardial infarction (STEMI or non-STEMI). 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 myocardial infarction and multivessel disease.”
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This press release accompanies both a presentation and an ESC press conference at ESC Congress 2022. It does not necessarily reflect the opinion of the European Society of Cardiology.
Funding: The trial was funded by an unrestricted research grant from Medtronic, BIOTRONIK, Chong Kun Dang Pharmaceutical, and JW Pharmaceutical. None of the funders were involved with the protocol development or the study process, including site selection, management, data collection, and analysis of the results. The executive committee and all the authors vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol.
Disclosures: Prof. Joo-Yong Hahn received an Institutional Research Grant from National Evidence-based Healthcare Collaborating Agency, Ministry of Health & Welfare, Republic of Korea, Abbott Vascular, Biosensors, Boston Scientific, Daiichi Sankyo, Donga-ST, and Medtronic Inc.
References and notes
1FRAME-AMI will be discussed during:
- Hot Line Session 7 on Sunday 28 August at 16:30 to 17:30 CEST in the Barcelona auditorium.
- Meet the Trialist – FRAME-AMI on Monday 29 August at 12:00 to 12:20 CEST on the ESC TV Stage.
2Wald DS, Morris JK, Wald NJ, et al. Randomized trial of preventive angioplasty in myocardial infarction. N Engl J Med. 2013;369:1115–1123.
3Gershlick AH, Khan JN, Kelly DJ, et al. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015;65:963–972.
4Engstrom T, Kelbaek H, Helqvist S, et al. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015;386:665–671.
5Smits PC, Abdel-Wahab M, Neumann FJ, et al. Fractional flow reserve-guided multivessel angioplasty in myocardial infarction. N Engl J Med. 2017;376:1234–1244.
6Mehta SR, Wood DA, Storey RF, et al. Complete revascularization with multivessel PCI for myocardial infarction. N Engl J Med. 2019;381:1411–1421.
7Ibanez B, James S, Agewall S, et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2018;39:119–177.
8Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019;40:87–165.
9Collet JP, Thiele H, Barbato E, et al. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021;42:1289–1367.
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