FFR-guided Revascularization Research Articles

Role of fractional flow reserve for invasive functional evaluation in surgical myocardial revascularization: available evidence and state of the art

Fractional flow reserve (FFR) is the ratio of distal to proximal pressure during maximal hyperemia and indirectly estimates the blood flow across a stenotic coronary artery and the related degree of myocardial ischemia. Several studies have investigated the role of FFR in the setting of percutaneous myocardial revascularization and further research is ongoing. However, current evidence on FFR-guided surgical myocardial revascularization is controversial and limited. The main scientific interest is to clarify whether FFR-guided coronary artery bypass surgery is associated with clinical benefits in terms of mortality, myocardial infarction, major adverse cardiovascular events, minimally invasive surgical access compared with sternotomy and off-pump surgery. Furthermore some data suggest that conduit selection for coronary artery bypass grafting and surgical technique might be affected by FFR value. The aim of this article is to review the most recent available evidence about FFR-guided coronary artery bypass grafting and to discuss clinical implications and future perspectives.

Long-Term Clinical Outcomes of Fractional Flow Reserve-Guided Coronary Artery Revascularization in Chronic Kidney Disease.

Fractional flow reserve (FFR)-guided percutaneous coronary intervention has shown favorable long-term clinical outcomes. However, limited data exist evaluating the FFR assessment among the chronic kidney disease (CKD) population. The aim of this study was to evaluate the long-term clinical outcomes of FFR-guided coronary revascularization in patients with CKD. A total of 242 CKD patients who underwent FFR assessment were retrospectively analyzed. Patients were divided into two groups: revascularization (FFR ≤ 0.80) and non-revascularization (FFR > 0.80). The primary endpoint was the composite of cardiac death, non-fatal myocardial infarction, and target vessel failure (TVF). The key secondary endpoint was TVF. The Cox regression model was used for risk evaluation. With 91% of the ischemic vessels revascularized, the revascularization group had higher risks for both the primary endpoint (adjusted hazard ratio [aHR]: 2.06; 95% confidence interval [CI], 1.07–3.97; p = 0.030) and key secondary endpoint (aHR: 2.19, 95% CI: 1.10–4.37; p = 0.026), during a median follow-up of 2.9 years. This result was consistent among different CKD severities. In patients with CKD, functional ischemia in coronary artery stenosis was associated with poor clinical outcomes despite coronary revascularization.

Instantaneous wave-free ratio compared with fractional flow reserve in PCI: A cost-minimization analysis

BackgroundCoronary physiology is a routine diagnostic tool when assessing whether coronary revascularization is indicated. The iFR-SWEDEHEART trial demonstrated similar clinical outcomes when using instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) to guide revascularization. The objective of this analysis was to assess a cost-minimization analysis of iFR-guided compared with FFR-guided revascularization. MethodsIn this cost-minimization analysis we used a decision-tree model from a healthcare perspective with a time-horizon of one year to estimate the cost difference between iFR and FFR in a Nordic setting and a United States (US) setting. Treatment pathways and health care utilizations were constructed from the iFR-SWEDEHEART trial. Unit cost for revascularization and myocardial infarction in the Nordic setting and US setting were derived from the Nordic diagnosis-related group versus Medicare cost data. Unit cost of intravenous adenosine administration and cost per stent placed were based on the average costs from the enrolled centers in the iFR-SWEDEHEART trial. Deterministic and probabilistic sensitivity analyses were carried out to test the robustness of the result. ResultsThe cost-minimization analysis demonstrated a cost saving per patient of $681 (95% CI: $641 - $723) in the Nordic setting and $1024 (95% CI: $934 - $1114) in the US setting, when using iFR-guided compared with FFR-guided revascularization. The results were not sensitive to changes in uncertain parameters or assumptions. ConclusionsIFR-guided revascularization is associated with significant savings in cost compared with FFR-guided revascularization.

The Full Revasc (Ffr-gUidance for compLete non-cuLprit REVASCularization) Registry-based randomized clinical trial

BackgroundComplete revascularization in ST elevation myocardial infarction (STEMI) patients with multivessel disease has resulted in reduction in composite clinical endpoints in medium sized trials. Only one trial showed an effect on hard clinical endpoints, but the revascularization procedure was guided by angiographic evaluation of stenosis severity. Consequently, it is not clear how Fractional Flow Reserve (FFR)-guided percutaneous coronary intervention (PCI) affects hard clinical endpoints in STEMI. Methods and ResultsThe Ffr-gUidance for compLete non-cuLprit REVASCularization (FULL REVASC) – is a pragmatic, multicenter, international, registry-based randomized clinical trial designed to evaluate whether a strategy of FFR-guided complete revascularization of non-culprit lesions, reduces the combined primary endpoint of total mortality, non-fatal MI and unplanned revascularization. 1,545 patients were randomized to receive FFR-guided PCI during the index hospitalization or initial conservative management of non-culprit lesions. We found that in angiographically severe non-culprit lesions of 90-99% severity, 1 in 5 of these lesions were re-classified as non-flow limiting by FFR. Considering lesions of intermediate severity (70%-89%), half were re-classified as non-flow limiting by FFR. The study is event driven for an estimated follow-up of at least 2.75 years to detect a 9.9%/year>7.425%/year difference (HR = 0.74 at 80% power (α = .05)) for the combined primary endpoint. ConclusionThis large randomized clinical trial is designed and powered to evaluate the effect of complete revascularization with FFR-guided PCI during index hospitalization on total mortality, non-fatal MI and unplanned revascularization following primary PCI in STEMI patients with multivessel disease. Enrollment completed in September 2019 and follow-up is ongoing.

Outcomes of Instantaneous Wave-Free Ratio versus Fractional Flow Reserve Guided Strategies for Coronary Revascularization in Patients with Acute Myocardial Infarction

Background: The instantaneous wave-free ratio (iFR) is non-hyperemic pressure-derived indices of the severity of stenosis. The index has been tested against fractional flow reserve (FFR) in small trials, and the two measures have been found to have similar diagnostic accuracy. However, studies of clinical outcomes associated with the use of iFR are lacking. Objectives: To improve the outcomes of percutaneous coronary intervention (PCI) in patients presenting with ST segment elevation myocardial infarction (STEMI) and have multivessel coronary artery disease (CAD) through using a new technology of iFR in STEMI patients. Subjects and methods: The present prospective cohort study was conducted by cooperation between Zagazig University Hospitals, Egypt and Chest Disease Hospital, Kuwait. During the period from April 2019 to April 2020. It included 188 patients presented with acute myocardial infarction (STEMI). Patients were divided into 2 groups each one enrolled 94 patients. Group I (iFR technique) and Group II (FFR technique), both were used to guide the decision as to whether percutaneous revascularization was appropriate. Results: There was no statistically significant difference regarding lesion characteristics assessed among studied patients. 90.4% of IFR group were not suffering from chest discomfort during the procedure versus 29.8% of FFR group with a high statistically significant difference among both groups. Four patients (4.3%) out of total number of the first group had sustained non-fatal MI, however only three cases (3.2%) had non-fatal MI, the calculated p value was 0.71. Conclusion: iFR-guided revascularization strategy was non-inferior to an FFR-guided revascularization strategy with respect to the rate of major adverse cardiac outcomes and was associated with less chest discomfort.

Safety and Long-Term Clinical Outcomes of Fractional Flow Reserve Guided Coronary Revascularisation

Increasingly, fractional flow reserve (FFR) is employed to assess coronary artery stenoses although there is limited real world long-term outcome data with a recent report questioning its safety. This study aimed to assess the in-hospital complications and clinical outcomes up to 10 years after FFR-guided revascularisation at a tertiary Australian hospital. The cohort comprised 274 consecutive patients undergoing FFR from 2010 to 2015 with follow-up to 2020. In-hospital complications and long-term outcomes were compared between patients with FFR≤0.80 and FFR>0.80. Major adverse cardiac events (MACE) comprised cardiac death, myocardial infarction (MI) and target vessel revascularisation (TVR). The FFR was ≤0.80 in 166 and >0.80 in 108 patients. Stable coronary disease was present in 95%. Revascularisation was undertaken in 86.7% of the FFR≤0.80 group and in 2.8% of the group with an FFR>0.80. In-hospital adverse events were 3.3% with no pressure wire-related coronary dissection, stroke or death. At median follow-up of 5 years, patients with FFR≤0.80 and FFR>0.80 had a similar rate of cardiac death (2.6% versus 5.0%, p=0.335) and MI (2.6% versus 6.9%, p=0.154). In the FFR>0.80 group, MACE (17.8% v 7.9%; p=0.018) and TVR (12.9% v 5.3%; p=0.033) were significantly higher. This observational study highlights the safety and long-term effectiveness of FFR-guided coronary revascularisation in patients with predominantly stable disease.

Alternative methods for functional assessment of intermediate coronary lesions.

Wire-based fractional flow reserve (FFR) is a diagnostic tool used to evaluate the ischemic burden of coronary lesions. Large-scale studies have shown that FFR-guided revascularization is associated with better clinical outcomes. However, wide adoption of this technology is limited due to the considerable cost, additional time needed for set-up and performance of the measurement as well as the invasiveness of the procedure which requires pressure wire placement across the lesion into the distal segment of the coronary artery. To overcome these limitations new, promising, and less-/non-invasive methods were developed. These methods are based on computational fluid dynamics analysis and three-dimensional lumen reconstruction. The aim of this paper is to review scientific evidence supporting the clinical safety and efficacy of these techniques, such as instantaneous wave-free ratio, quantitative flow ratio and FFR calculated from computed tomographic angiography.

Fractional flow reserve-guided PCI in patients with and without left ventricular hypertrophy: a DANAMI-3-PRIMULTI substudy.

The aim of this substudy was to investigate the correlation between fractional flow reserve (FFR) and diameter stenosis in patients with STEMI with and without left ventricular hypertrophy (LVH), and the influence of LVH on complete FFR-guided revascularisation versus culprit only, in terms of risk of clinical outcome. In this DANAMI-3-PRIMULTI substudy, 279 patients with STEMI had cardiac magnetic resonance (CMR) imaging for assessment of left ventricular mass index. Ninety-six patients had FFR evaluation of a non-culprit lesion. Diameter stenosis of the non-culprit lesion was determined with two-dimensional quantitative coronary analysis. The diameter stenosis (56.9% vs 54.3%, p=0.38) and FFR value (0.83 vs 0.85, p=0.34) were significantly correlated in both groups (Spearman's ρ=-0.40 and -0.41 without LVH and with LVH, respectively; p<0.001) but were not different between patients without and with LVH (p for interaction=0.87). FFR-guided complete revascularisation was associated with reduced risk of death, myocardial infarction or ischaemia-driven revascularisation both for patients without LVH (HR 0.42, 95% CI: 0.20-0.85) and for patients with LVH (HR 0.50, 95% CI: 0.17-1.47), with no interaction between the FFR-guided complete revascularisation and LVH (p for interaction=0.82). LVH did not interact with the correlation between diameter stenosis and FFR and did not modify the impact of complete revascularisation on the occurrence of subsequent clinical events.

The benefit of complete revascularization after primary PCI for STEMI is attenuated by increasing age: Results from the DANAMI-3-PRIMULTI randomized study.

To ascertain the effect of age on outcomes after culprit-only and complete revascularization after Primary PCI (PPCI) for ST-elevation myocardial infarction (STEMI). The numbers of older patients being treated with PPCI are increasing. The optimal management of nonculprit stenoses in such patients is unclear. We conducted an analysis of patients aged ≥75 years randomized in the DANAMI-3-PRIMULTI study to either culprit-only or complete FFR-guided revascularization. The primary endpoint was a composite of all-cause mortality, nonfatal reinfarction, and ischaemia-driven revascularization of lesions in noninfarct-related arteries after a median of 27 months of follow-up. One hundred and ten of six hundred and twenty seven patients in the DANAMI-3-PRIMULTI trial were aged ≥75 years. These patients were more likely female (p < .001), hypertensive (p < .001), had lower hemoglobin levels (p < .001), and higher serum creatinine levels (p < .001) than the younger patients in the trial. Other than less use of drug-eluting stents (96.6 versus 88.0%: p = .02), there were no significant differences in procedural technique and success between patients aged <75 years and those ≥75 years of age. There was no significant difference in the incidence of the primary endpoint in patients ≥75 years randomized to culprit-only or FFR-guided complete revascularization (HR 1.49 [95% CI 0.57-4.65]; log-rank p = .19; p for interaction versus patients <75 years <.001). There was a significant interaction between age as a continuous variable, treatment assignment, and the primary outcome (p < .001); beyond the age of about 75 years, there may be no prognostic advantage to complete revascularization. In patients ≥75 years, after treatment of the culprit lesion in STEMI, there is no significant prognostic benefit to prophylactic complete revascularization of nonculprit stenoses. Pending further study, data would support a symptom-guided approach to further invasive treatment.

Fractional flow reserve-guided multivessel angioplasty in myocardial infarction: three-year follow-up with cost benefit analysis of the Compare-Acute trial.

The Compare-Acute trial showed superiority of fractional flow reserve (FFR)-guided acute complete revascularisation compared to culprit-only treatment in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) at one year. The aim of this study was to investigate the outcome at three years, together with cost analysis of this strategy. After primary percutaneous coronary intervention (PCI), 885 patients with STEMI and MVD were randomised (1:2 ratio) to FFR-guided complete revascularisation (295 patients) or infarct-related artery (IRA)-only treatment (590 patients). After 36 months, the primary endpoint (composite of death, myocardial infarction, revascularisation, stroke) occurred significantly less frequently in the FFR-guided complete revascularisation group: 46/295 patients (15.6%) versus 178/590 patients (30.2%) (HR 0.46, 95% CI: 0.33-0.64; p<0.001). This benefit was driven mainly by the reduction of revascularisations in the follow-up (12.5% vs 25.2%; HR 0.45, 95% CI: 0.31-0.64; p<0.001). Cost analysis shows benefit of the FFR-guided complete revascularisation strategy, which can reduce the cost per patient by up to 21% at one year (8,150€ vs 10,319€) and by 22% at three years (8,653€ vs 11,100€). In patients with STEMI and MVD, FFR-guided complete revascularisation is more beneficial in terms of outcome and healthcare costs compared to IRA-only revascularisation at 36 months.

Computerised Methodologies for Non-Invasive Angiography-Derived Fractional Flow Reserve Assessment: A Critical Review.

Fractional flow reserve is the gold standard for assessing the haemodynamic significance of intermediate coronary artery stenoses. Cumulative evidence has shown that FFR-guided revascularisation reduces stent implantations and improves patient outcomes. However, despite the wealth of evidence and guideline recommendations, its use in clinical practice remains minimal. Patient and technical limitations of FFR as well as the need for intracoronary instrumentation, use of adenosine, and increased costs have limited FFR's applicability in clinical practice. Over the last decade, several angiography-derived FFR software packages have been developed which do not require intracoronary pressure assessment with a guidewire or need for administration of hyperaemic agents. At present, there are 3 commercially available software packages and several other non-commercial technologies that have been described in the literature. These technologies have been validated against invasive FFR showing good accuracy and correlation. However, the methodology behind these solutions is different—some algorithms are based on solving the governing equations of fluid dynamics such as the Navier–Stokes equation while others have opted for a more simplified mathematical formula approach. The aim of this review is to critically appraise the methodology behind all the known angiography-derived FFR technologies highlighting the key differences and limitations.

Utilization and Outcomes of Measuring Fractional Flow Reserve in Patients With Stable Ischemic Heart Disease

BackgroundThe use and clinical outcomes of fractional flow reserve (FFR) measurement in patients with stable ischemic heart disease (SIHD) are uncertain, as prior studies have been based on selected populations. ObjectivesThis study sought to evaluate contemporary, real-world patterns of FFR use and its effect on outcomes among unselected patients with SIHD and angiographically intermediate stenoses. MethodsThe authors used data from the Veterans Affairs Clinical Assessment, Reporting, and Tracking (CART) Program to analyze patients who underwent coronary angiography between January 1, 2009, and September 30, 2017, and had SIHD with angiographically intermediate disease (40% to 69% diameter stenosis on visual inspection). The authors documented trends in FFR utilization and evaluated predictors using generalized mixed models. They applied Cox proportional hazards models to determine the association between an FFR-guided revascularization strategy and all-cause mortality at 1 year. ResultsA total of 17,989 patients at 66 sites were included. The rate of FFR use gradually increased from 14.8% to 18.5% among all patients with intermediate lesions, and from 44% to 75% among patients who underwent percutaneous coronary intervention. One-year mortality was 2.8% in the FFR group and 5.9% in the angiography-only group (p < 0.0001). After adjustment for patient, site-level, and procedural factors, FFR-guided revascularization was associated with a 43% lower risk of mortality at 1 year compared with angiography-only revascularization (hazard ratio: 0.57; 95% confidence interval: 0.45 to 0.71; p < 0.0001). ConclusionsIn patients with SIHD and angiographically intermediate stenoses, use of FFR has slowly risen, and was associated with significantly lower 1-year mortality.

Rationale and design of the Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction (FLOWER-MI) trial

BackgroundIn ST-elevation myocardial infarction (STEMI) patients presenting with multivessel disease (MVD), recent studies have demonstrated the superiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) for non-culprit lesions compared to culprit lesion treatment-only therapy. FFR- and angio-guided PCI have however never been compared in STEMI patients. Trial designFLOWER-MI is an open-label multicenter national randomized clinical trial. The aim is to investigate FFR-guided complete revascularization in comparison to angio-guided complete revascularization in STEMI patients with successful PCI of the culprit lesion and ≥50% stenosis in at least one additional non-culprit lesion requiring PCI. Eligible patients will be randomized after successful primary PCI in a 1:1 fashion to either FFR-guided or angio-guided complete revascularization during the index procedure or a staged procedure before discharge (≤5 days). Patients assigned to FFR guidance first have FFR measured in each non-culprit vessel and only undergo PCI if FFR is ≤0.80. The primary end point of the study is a composite of major adverse cardiac events, including all-cause death, non-fatal MI, and unplanned hospitalization leading to urgent revascularization at 1 year. Secondary end points will include the individual adverse events, cost-effectiveness, quality of life, and 30-day, 6-month, and 3-year outcomes. Based on estimated event rates, a sample size of 1170 patients is needed to show superiority of the FFR-guided revascularization with 80% power. ConclusionThe aim of FLOWER-MI trial is to assess whether FFR-guided complete revascularization in the acute setting is superior angio-guided complete revascularization.

Clinical usefulness of instantaneous wave-free ratio for the evaluation of coronary artery lesion with prior myocardial infarction: A multi-center study

BackgroundFractional flow reserve (FFR) is useful for assessing the functional significance of coronary artery stenosis, even in lesions with prior myocardial infarction (pMI). Instantaneous wave-free ratio (iFR) is a vasodilator-free alternative for the physiological assessment of coronary artery stenosis. In addition, iFR shows good diagnostic agreement with FFR and an iFR-guided revascularization strategy was non-inferior to an FFR-guided revascularization strategy. However, the clinical usefulness of iFR for the evaluation of a coronary artery lesions with pMI has not been evaluated. Methods and ResultsA total of 200 lesions from 200 patients (44 pMI territories lesions and 156 non-pMI coronary artery lesions) were analyzed retrospectively. Major adverse cardiac events (MACE) were defined as cardiovascular death, non-fatal MI, unstable angina pectoris, fatal arrhythmia and heart failure during 12 months follow-up after the physiological assessment of coronary artery stenosis. iFR was closely correlated with FFR in pMI and non-pMI lesions (r = 0.81 and 0.72; P < 0.001, respectively). In pMI lesions, an iFR cut-off of 0.89 was optimal against a clinical FFR cut-off of 0.80 according to receiver operating characteristics (ROC) curve analysis, whereas in non-pMI lesions, the iFR cut-off value was 0.92 without statistical significance. In addition, the event rate of MACE was similar between pMI and non-pMI patients during follow-up even in the presence or absence of an PCI procedure. ConclusionsiFR may be a useful alternative method compared with FFR for clinical decision-making even in pMI patients.

The Role of Fractional Flow Reserve and Instantaneous Wave-Free Ratio Measurements in Patients with Acute Coronary Syndrome.

The role of fractional flow reserve to guide revascularization in patients with stable angina is well established. The instantaneous wave-free ratio (iFR) is an emerging adenosine-free resting index that is non-inferior to FFR and has potential to streamline the functional evaluation of coronary artery disease. The feasibility and utility of intracoronary physiology in patients with acute coronary syndrome (ACS) is unclear. This review will discuss the physiological principles and validity of using FFR and iFR in patients presenting with ACS. We will also provide an overview of the available evidence for their role in guiding revascularization in this patient group. The use of intracoronary physiology in culprit lesions of patients presenting with STEMI is not recommended and its accuracy is uncertain in patients with NSTEMI. In contrast, the physiological assessment of non-culprit vessels with FFR and IFR is a reliable measure of lesion-specific ischemia. Recent studies have demonstrated that FFR-guided revascularization of non-culprit lesions improves clinical outcomes although the role of iFR in this patient cohort is unknown. Physiology-guided revascularization of non-culprit ACS lesions improves clinical outcomes. Future studies investigating the complementary role of plaque morphology, biomechanics, and systemic inflammation may provide clinicians with a more comprehensive framework to guide treatment decisions.

Prognostic impact of diabetes mellitus and index of microcirculatory resistance in patients undergoing fractional flow reserve-guided revascularization

BackgroundThe prognostic impact of diabetes mellitus (DM) with or without coronary microvascular dysfunction (CMD) in patients undergoing fractional flow reserve (FFR)-guided revascularization has not been clarified. We sought to investigate the clinical outcomes of patients undergoing FFR-guided revascularization according to the existence of DM and CMD. MethodsA total of 283 patients with available FFR data as well as index of microcirculatory resistance (IMR) were selected from the 3 V FFR-FRIENDS study. CMD was defined as an IMR ≥25U. Patients were grouped according to the presence of DM and CMD into group A (DM-, CMD-), group B (DM-, CMD+), group C (DM+, CMD-), and group D (DM+, CMD+). The primary outcome was a major adverse cardiac event (MACE, a composite of myocardial infarction, ischemia-driven revascularization, and cardiac death) at 2 years. ResultsDM patients displayed a notably higher risk of MACEs in comparison with non-DM patients (HR 4.88, 95% CI 1.54–15.48, p = 0.003). MACEs at 2 years among the four groups were 2.2%, 2.0%, 7.0%, and 18.5%, respectively. Group D exhibited a significantly higher risk of MACEs as compared to group A (HR 8.98, 95% CI 2.15–37.41, p = 0.003). Multivariable regression analysis showed that the presence of DM and CMD was an independent predictor of a 2-year MACE (HR 11.24, 95% CI 2.53–49.88, p = 0.002), and integrating CMD into a model with DM increased discriminant ability (C-index 0.683 vs. 0.710, p = 0.010, integrated discrimination improvement 0.015, p = 0.040). ConclusionAmong the patients undergoing FFR-guided revascularization, those with DM and CMD were correlated with an augmented risk of MACEs. Integration of CMD improved risk stratification in predicting the occurrence of a MACE.

467FFR guided acute complete revascularization versus culprit lesion only treatment in patients presenting with STEMI; 3-year cost-analysis data from COMPARE-ACUTE trial

Abstract Background Compare-Acute trial showed a 1-year superior outcome of FFR-guided acute complete revascularization (FFR-CR) compared to culprit-lesion-only revascularization (CLO) in patients presenting with ST-segment elevation myocardial infarction (STEMI) and multi-vessel disease (MVD). Long-term results and financial impact of this strategy are unknown. Purpose To evaluate if FFR-CR strategy is superior to CLO strategy in terms of health care costs at 3 year follow-up. Methods Compare-Acute is a multicenter, investigator-initiated prospective randomized controlled trial that involved 24 sites. Patients with STEMI and MVD were randomized 1:2 after successful primary PCI, towards FFR-CR or CLO treatment strategies (295 vs 590 pts). All stenosis ≥50% by angiography in the non-infarct artery were investigated by FFR in both arms. In the FFR-CR arm, all non-culprit (NC) lesions with a FFR ≤0.80 were treated by PCI. In the CLO arm pts underwent blinded FFR procedure of the NC lesions. Further treatment of these lesions was based on symptoms and/or ischemia testing during follow-up with an allowed treatment window of 45 days. The primary endpoint was defined as a composite of all-cause mortality, non-fatal myocardial infarction, any revascularization and cerebrovascular events (MACCE) at 12 months. The major secondary endpoints are MACCE and health care costs from both strategies up to 3-year follow-up. Cost-analysis is done from an insurance/governmental perspective in countries that use Diagnosis Related Group (DRG) costs: the Netherlands, Germany, Sweden and Poland. Results 1-year results have already been published and showed superior outcome of patients in the FFR-CR arm. According to the Dutch system, at 1 year of follow-up the average cost per patient was 8.150€ in the FFR-CR arm, and 10.319€ in the CLO arm (−21%). The better cost-effectiveness of FFR-CR strategy remained at 3 years of follow-up: average cost per patient was 8.653€ in the FFR-CR arm and 11.100€ in the CLO arm (−22%). Same 3-year data was confirmed using DRG analysis according to the German system (FFR-CR 4.887€ vs CLO 5.200€; −6.0%) and the Swedish system (FFR-CR 6.205€ vs CLO 8.133€; −23.7%). FFR-CR strategy was not more costly according to the Polish system (FFR-CR 3.704€ vs CLO 3.685€; +0.5%). Moreover, the better outcome of the FFR-CR group was mantained at 3 year follow-up (data not shown). Figure 1 Conclusion Our cost-analysis of the Compare Acute Trial shows that the strategy of FFR-guided complete revascularization in patients with STEMI and MVD is not only superior in terms of outcome, but also in terms of health care costs at 1 year. This benefit is maintained at 3 years follow-up.

1154FFR guided acute complete revascularization versus culprit lesion only treatment in patients presenting with STEMI and multi vessel disease; final 3-year outcome data from Compare-Acute trial

Abstract Background Compare-Acute trial showed a 1-year superior outcome of FFR-guided acute complete revascularization (FFR-CR) compared to culprit-lesion-only revascularization (CLO) in patients presenting with ST-segment elevation myocardial infarction (STEMI) and multi-vessel disease (MVD). Long-term outcome results are unknown. Purpose To evaluate if FFR-CR strategy is superior to CLO strategy in terms of outcome at 3 year follow-up. Methods Compare-Acute is a multicenter, investigator-initiated prospective randomized controlled trial that involved 24 sites. Patients with STEMI and MVD were randomized, after successful primary PCI towards FFR-CR or CLO treatment strategies with a 1:2 ratio (295 pts vs 590 pts). All stenosis ≥50% in the non-infarct artery were investigated by FFR in both arms. In the FFR-CR arm, all non-culprit (NC) lesions with a FFR ≤0.80 were treated by PCI. In the CLO arm pts underwent blinded FFR procedure of the NC lesions. Further treatment of these lesions was based on symptoms and/or ischemia testing during follow-up with an allowed treatment window of 45 days. The primary endpoint was defined as a composite of all-cause mortality, non-fatal myocardial infarction, any revascularization and cerebrovascular events (MACCE) at 12 months. The major secondary endpoint is MACCE from both strategies up to 3-year follow-up. Results 1-year clinical outcomes have already been presented and published. At 36 months the composite end-point of MACCE occurred in 46 patients in the FFR-CR group vs 178 patients in the CLO group (15.6% vs 30.2%; HR 0.46, 95% CI 0.29–0.59; p&lt;0.01), as shown in Fig. 1. The incidence of death (4 pts vs 10 pts; 1.4% vs 1.7%; HR 0.86, 95% CI 0.39–1.8; p=0.71), MI (20 pts vs 53 pts; 7.1% vs 9.3%; HR 0.74, 95% CI 0.44–1.24; p=0.25) and stroke (1 pt vs 7 pts; 0.3% vs 1.2%; HR 0.29, 95% CI 0.03–2.3; p=0.24) was not significantly different in the two groups, but revascularizations were significantly higher in the CLO group: 37 patients in the FFR-CR group vs 149 patients in the CLO group (13.0% vs 26.0%; HR 0.45; 95% CI 0.31–0.64; p&lt;0.01). Furthermore, in a subgroup analysis, when we considered only patients with FFR positive non-culprit lesions in both arms, we found a higher incidence of MI at follow-up in the CLO arm compared to the FFR-CR arm: 30/224 vs 13/194 (13.4% vs 6.7%; p 0.03). MACCE-free survival at 3 years Conclusion With this analysis of the Compare-Acute trial we confirm that the benefit of a FFR-guided complete revascularization strategy in patients with STEMI and MVD is maintained at 3 years of follow-up. This difference is mainly driven by increased revascularizations in the CLO arm, but also by increased incidence of MI in the CLO subgroup with FFR+ lesions that were left untreated.

6113Gender differences in long-term outcomes in patients with deferred revascularization following fractional flow reserve assessment: international collaboration registry of physiologic evaluation

Abstract Background Studies of sex differences in fractional flow reserve (FFR) measurements have shown that in comparison with men, angiographic lesions of similar visual severity are less likely to be ischemia producing in women. Gender specific differences may influence revascularization decision making and prognosis after deferred revascularization following FFR measurement. Purpose This study sought to investigate the gender difference in long-term prognosis of patients of deferred revascularization following FFR assessment. Methods A total of 879 patients (879 vessels) with deferred revascularization with FFR &gt;0.75 who underwent FFR and CFR measurements were enrolled from 3 countries (Korea, Japan, and Spain). Long-term outcomes were assessed in 649 men and 230 women by the patient-oriented composite outcome (POCO, a composite of any death, any myocardial infarction [MI], and any revascularization). We applied inverse-probability weighting (IPW) based on propensity scores to account for differences at baseline between women and men (age, hypertension, hyperlipidemia, diabetes mellitus, lesion location, clinical status, FFR, Reference diameter, Diameter stenosis, lesion length). The median follow-up duration was 1855 days (745–1855 days). Results Median FFR values were 0.88 (0.83–0.93) in men and 0.89 (0.85–0.94) in women, respectively. The occurrences of POCO were significantly high in men compared with that in women (10.5% vs 4.2%, P=0.007). Kaplan–Meier analysis revealed that women had a significantly lower risk of POCO (χ2=7.2, P=0.007). Multivariate COX regression analysis revealed that age, male, diabetes mellitus, diameter stenosis, lesion length, and coronary flow reserve were independent predictors of POCO. After applying IPW, the hazard ratio of male for POCO was 2.20 (95% confidence interval: 1.12 to 4.33, P=0.023). Conclusion This large multinational study reveals that long-term outcome differs between women and men in favour of women after FFR-guided revascularization deferral. Acknowledgement/Funding None

Design and rationale of ischaemia-driven complete revascularisation versus usual care in patients with non-ST-elevation myocardial infarction and multivessel coronary disease: the South Limburg Myocardial Infarction (SLIM) trial.

AimsTo compare ischaemia-driven complete coronary revascularisation by percutaneous coronary intervention (PCI) with usual care in patients with non-ST-elevation myocardial infarction (non-STEMI) and multivessel disease (MVD).MethodsThe South Limburg Myocardial Infarction (SLIM) trial (NCT03562572) is an investigator-initiated, prospective, multicentre, randomised controlled trial that compares fractional flow reserve (FFR)-guided complete revascularisation during the index procedure with usual care in non-STEMI patients with MVD. A total of 414 patients will be randomised in a 1:1 fashion. The primary endpoint is the composite of all-cause mortality, non-fatal myocardial infarction, and any revascularisation and stroke (MACCE) at 12 months. The secondary endpoints are: MACCE at 24 and 36 months, and the composite of cardiac death, myocardial infarction, any revascularisation, stroke, major bleeding and left ventricular ejection fraction below 45% at 12, 24 and 36 months. Furthermore, quality of life will be assessed by the Patient Health Questionnaire (PHQ-9) and the Short Form (36) Health Survey (SF-36) at 1 and 12 months of follow-up.ConclusionThe SLIM trial aims to provide evidence whether FFR-guided complete revascularisation by PCI is superior to usual care with respect to clinical outcomes (major adverse cardiovascular events) in non-STEMI patients with MVD.