p.52 抽出テキスト

Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD), and COMPLETE (Complete vs. Culprit-only Revascularization to Treat Multivessel Disease After Early PCI for STEMI) (further details on these trials is provided in the Supplementary data online evidence tables).508–511 In a systematic review of 10 randomized trials that included 7030 patients with STEMI and MVD, complete revascularization was associated with reduced CV mortality compared with IRA-only PCI.512 All-cause mortality was comparable in both groups. Complete revascularization was also associated with a reduced composite of CV death or new MI, supporting complete revascularization in patients with STEMI and MVD.512

10.3 Timing of non-infarct-related artery

revascularization in acute coronary syndrome 10.3.1. Patients presenting with ST-elevation myocardial infarction and multivessel coronary artery disease The previous ESC STEMI Guidelines recommended non-IRA PCI during the index procedure. The primary rationale for this recommendation was that all trials available until then had performed MVD PCI in that time frame. However, in the COMPLETE trial, non-IRA PCI in patients allocated to complete revascularization was performed either during hospitalization (67% of cases) or after discharge (33% of cases), at a mean time of 23 days after discharge but always within 45 days.511 No treatment effect by timing of PCI interaction was observed. Given that the optimal timing of revascularization (immediate vs. staged) has still not been investigated in adequately sized randomized trials with a superiority design, no recommendation in favour of an immediate vs. a staged (i.e. either during index hospitalization or within 45 days of discharge) non-IRA PCI strategy can be formulated. No surgical studies have specifically investigated non-IRA revascularization.

10.3.2 Patients presenting with non-ST-elevation

acute coronary syndrome and multivessel coronary artery disease While there are a large number of studies providing evidence for patients presenting with STEMI and MVD, there are fewer data guiding the management of patients presenting with NSTE-ACS and MVD.513 Currently, there is no dedicated trial comparing complete revascularization against IRA-only PCI for these patients. Observational studies and meta-analyses of non-randomized studies suggest that complete revascularization is associated with fewer deaths and MACE during follow-up in comparison to IRA-only PCI.514,515 However, given that these are analyses of treatment effects based on non-randomized studies, the results should be considered as hypothesis-generating at best and this remains a gap in evidence.

10.4 Evaluation of non-infarct-related

artery stenosis severity (angiography vs. physiology) Overestimation of the severity of non-IRA lesions during the PPCI procedure when assessed by quantitative coronary angiography as compared with a repeated angiogram performed within 9 months has been reported.516 Microvascular constriction may also occur in the non-IRAs, leading to some variation in functional measurements between baseline and follow-up, although the impact on decision-making may be modest.517–520 A sub-analysis of the FAME (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) trial reported that 65% of lesions in the angiographic severity range of 50–70% diameter stenosis, and 20% of lesions in the range 71–90%, have an FFR value above 0.80.521

The PRIME-FFR registry included 533 ACS patients and reported that systematic FFR measurement led to a change in the management strategy in 38% of cases (e.g. from CABG to PCI or to medical treatment), without an impact on MACE, death/MI, or angina symptoms at 1 year.522 A subgroup analysis of the FAME trial in 328 patients with ACS (UA or NSTEMI) and MVD reported that the adoption of FFR to guide PCI resulted in similar risk reductions of MACE compared with patients with stable angina, with a lower number of stents implanted and less contrast media use.523 The FAMOUS-NSTEMI (Fractional Flow Reserve Versus Angiographically Guided Management to Optimise Outcomes in Unstable Coronary Syndromes) trial randomized 350 patients with NSTE-ACS and at least one coronary stenosis (with diameter stenosis >30%) to either angiography-guided or FFR-guided management (medical therapy, PCI, or CABG), and demonstrated that a higher proportion of patients in the FFR-guided management group were initially treated with medical therapy. The FLOWER-MI (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) study randomized 1171 patients undergoing PPCI with MVD to complete revascularization guided by FFR or angiography. Compared with an angiography-guided approach, an FFR-guided strategy did not reduce the risk of death, MI, or urgent revascularization at 1 year.524 PCI was performed in 66.2% of patients in the FFR-guided group and in 97.1% of the angiography-guided group. In FLOWER-MI, complete revascularization during the index procedure was only performed in 4% of patients in both groups, and functional evaluation was mainly undertaken at the time of the second procedure.524 However, based on the study design, complete revascularization could also be performed during a separate staged procedure as early as possible before hospital discharge and within 5 days of the initial procedure. A meta-analysis of 10 RCTs (including 3031 patients undergoing PPCI) assessed outcomes in patients with complete revascularization vs. IRA-only PCI according to whether the decision to carry out non-IRA preventive PCI was based on angiography alone or on angiography plus FFR.525 Preventive PCI of the non-IRA was associated with a significant reduction in cardiac death and non-fatal MI only when the decision to proceed with non-IRA PCI was based solely on angiography. Similar findings were reported in another meta-analysis of seven RCTs including a total of 6597 patients undergoing PPCI.526 In patients randomised to the complete revascularization arm, an angiography-guided strategy (≥70% diameter stenosis) for non-IRA lesions was associated with lower rates of recurrent MI, whereas an FFR-guided (≤0.80 for lesions with ≤90% diameter stenosis) guided approach was not. In another meta-analysis, which pre-dated the FLOWER-MI trial, there was no heterogeneity in the primary outcome when complete revascularization was performed using an FFR-guided strategy (OR 0.78, 95% CI, 0.43–1.44) or an angiography-guided strategy (OR 0.61, 95% CI, 0.38–0.97; P = 0.52 for interaction).512 A pooled post-hoc patient-level analysis of three RCTs (FAME, DANAMI-3–PRIMULTI, and FAMOUS-NSTEMI) in ACS patients treated with a functionally complete revascularization strategy (i.e. PCI of the stenosis with FFR ≤0.80, deferral to medical therapy stenosis with FFR >0.80) reported that the residual SYNTAX score (a proxy of the residual coronary stenosis deferred to medical therapy) was not associated with MACE at 2 years, suggesting that it may be safe to defer the management of functionally non-significant stenoses in the non-IRA.527 The FRAME AMI (FFR Versus Angiography-Guided Strategy for Management of AMI With Multivessel Disease) trial compared selective PCI guided by FFR (PCI if FFR ≤0.80) to routine PCI

ESC Guidelines                                                                                                                                                                                          3771

Downloaded from academic.oup.com/eurheartj/article/44/38/3720/7243210 by guest on 07 October 2026