This study compared fractional flow reserve (FFR) vs. angiography to guide the angioplasty of non-culprit vessels in patients with acute coronary syndrome (ACS) and multivessel disease.
Landmark studies such as COMPLETE, COMPARE-ACUTE and DANAMI-3-PRIMULTI have demonstrated the prognostic value of revascularization (after treatment of the artery responsible for the ACS) of non-culprit arteries with respect to cardiovascular events.
Such revascularization can be decided or deferred through the estimation of stenosis, whether angiographically or through a functional measurement (FFR).
The FLOWER-MI study was published in 2021 and its data suggested that the assessment of non-culprit lesions with FFR with respect to conventional angiography did not evidence a benefit regarding death, acute myocardial infarction (AMI), or revascularization at 1 year. However, it should be noted that this study had a short follow-up and that a significant percentage of revascularizations had a TIMI flow <2. Therefore, the strategy of choice for these non-culprit vessels remains controversial.
JM Lee et al. conducted the FRAME-AMI study, with the aim of comparing percutaneous transluminal coronary angioplasty (PTCA) of non-culprit lesions guided by FFR vs. angiography, in patients with ACS and multivessel disease.
This was a randomized, open-label, multicenter study conducted in Korea. Researchers assessed consecutive patients with ST-elevation ACS (STEACS) or non-ST-elevation ACS (NSTEACS) who underwent PTCA of the culprit vessel. Vessels with stenosis ≥50% in a major epicardial artery or lesions in a secondary branch with a diameter >2mm were considered non-culprit vessels. Patients with single-vessel disease, flow-limiting stenosis with TIMI <2, left main coronary artery lesions, shock, or the presence of chronic total occlusions were excluded.
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A 1:1 randomization was performed; recommendations included complete revascularization in the same procedure or stepwise, according to operator discretion. Resolute Onyx and Orsiro stents were used.
The primary endpoint (PEP) was a composite of death, AMI, stroke, or repeat revascularization. Secondary endpoints included individual primary outcomes, cardiac death, culprit or non-culprit vessel revascularization, etc.
From August 2016 to December 2020, 562 patients were randomized, 284 to FFR- and 278 to angiography-guided PTCA. Out of all patients enrolled, 47.2% had STEACS; 60% of revascularizations were in the index procedure (40% were performed in a stepwise fashion) and intravascular imaging was performed in 29.6%.
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Fewer stents per patient (2.2 vs. 2.5, p < 0.001) and less contrast (p = 0.042) were used in the FFR arm. At a 3.5-year follow-up, there was a 7.4% vs. 19.7% decrease in events in terms of the PEP, with a hazard ratio [HR]: 0.43; (95% confidence interval [CI]: 0.25-0.75; p = 0.003). Furthermore, fewer events were observed with FFR, such as mortality at four years (HR: 0.30; 95% CI: 0.11-0.83; p = 0.020) or AMI (HR: 0.32; 95% CI: 0.13–0.75; p = 0.009), with non-significant differences in revascularization or contrast-induced nephropathy.
Conclusions
According to the data observed in this study, which differ from those observed in FLOWER-MI, using a functional test such as FFR to guide percutaneous treatment is better than the angiographic strategy with respect to cardiovascular events at a mean follow-up of 3.5 years.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Original Title: Fractional flow reserve versus angiography-guided strategy in acute myocardial infarction with multivessel disease: a randomized trial.
Reference: Lee JM, Kim HK, Park KH, Choo EH, Kim CJ, Lee SH, Kim MC, Hong YJ, Ahn SG, Doh JH, Lee SY, Park SD, Lee HJ, Kang MG, Koh JS, Cho YK, Nam CW, Koo BK, Lee BK, Yun KH, Hong D, Joh HS, Choi KH, Park TK, Yang JH, Song YB, Choi SH, Gwon HC, Hahn JY; FRAME-AMI Investigators. Fractional flow reserve versus angiography-guided strategy in acute myocardial infarction with multivessel disease: a randomized trial. Eur Heart J. 2022 Dec 20:ehac763. doi: 10.1093/eurheartj/ehac763. Epub ahead of print. PMID: 36540034.
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