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Fractional flow reserve (FFR) or non-hyperaemic pressure ratios are recommended to assess functional relevance of intermediate coronary stenosis. Both diagnostic methods require the placement of a pressure wire in the coronary artery during invasive coronary angiography. Quantitative flow ratio (QFR) is an angiography-based computational method for the estimation of FFR that does not require the use of pressure wires. We aimed to investigate whether a QFR-based diagnostic strategy yields a non-inferior 12-month clinical outcome compared with an FFR-based strategy. FAVOR III Europe was a multicentre, randomised, open-label, non-inferiority trial comparing a QFR-based with an FFR-based diagnostic strategy for patients with intermediate coronary stenosis. Enrolment was performed in 34 centres across 11 European countries. Patients aged 18 years or older with either chronic coronary syndrome or stabilised acute coronary syndrome, and with at least one intermediate non-culprit stenosis (40–90% diameter stenosis by visual estimate; referred to here as a study lesion), were randomly assigned (1:1) to the QFR-guided or the FFR-guided group. Randomisation was done using a concealed web-based system and was stratified by diabetes and presence of a left anterior descending coronary artery study lesion. The primary endpoint was a composite of death, myocardial infarction, and unplanned revascularisation at 12 months. The predefined non-inferiority margin was 3·4% and the primary analysis was performed in the intention-to-treat population. The trial was registered with ClinicalTrials.gov (NCT03729739) and long-term follow-up is ongoing. Between Nov 6, 2018, and July 21, 2023, 2000 patients were enrolled and randomly assigned to the QFR-guided strategy (1008 patients) or the FFR-guided strategy (992 patients). The median age was 67·3 years (IQR 59·9–74·7); 1538 (76·9%) patients were male and 462 (23·1%) were female. Median follow-up time was 365 days (IQR 365–365). At 12 months, a primary endpoint event had occurred in 67 (6·7%) patients in the QFR group, and in 41 (4·2%) patients in the FFR group (hazard ratio 1·63 [95% CI 1·11–2·41]). The event proportion difference was 2·5% (90% two-sided CI 0·9–4·2). The upper limit of the 90% CI exceeded the prespecified non-inferiority margin of 3·4%. Therefore, QFR did not meet non-inferiority to FFR. A total of 18 (1·8%) patients in each group experienced an adverse procedural event, the most frequent being procedure-related myocardial infarction, which occurred in ten (1·0%) patients in the QFR group and seven (0·7%) in the FFR group. One patient in the QFR group died in relation to the index procedure. The results of the FAVOR III Europe trial do not support the use of QFR if FFR is available to guide revascularisation decisions in patients with intermediate coronary stenosis. This finding could have implications for current clinical guidelines recommending QFR for this purpose. Medis Medical Imaging Systems and Aarhus University.

In this trial involving 2492 patients, coronary revascularization guided by iFR, as compared with fractional flow reserve-guided revascularization, was within the prespecified margin for noninferiority with respect to major adverse cardiac events. For the past 20 years, physiological measurements obtained during invasive procedures have been used to guide coronary revascularization. Pioneering work supported the use of flow measurements to make safe decisions about revascularization, 1 , 2 but this approach was soon superseded by the use of fractional flow reserve (FFR), which measures pressure as a surrogate of flow to estimate the severity of stenosis. 3 – 5 FFR was successful largely because of its technical simplicity and because clinical trials showed that it was associated with improved clinical outcomes after percutaneous coronary intervention (PCI). 6 , 7 Consequently, FFR is now included in the appropriate-use criteria for . . .

In a randomized trial, patients with coronary artery disease underwent PCI guided by either the instantaneous wave-free ratio or fractional flow reserve. At 1 year, iFR-guided PCI was noninferior to FFR-guided PCI with respect to the rate of major adverse cardiac events. Coronary revascularization is warranted only if a patient has one or more coronary-artery stenoses that are hemodynamically important. Large randomized studies have shown that fractional flow reserve (FFR) is superior to angiographic assessment for the detection of hemodynamically important coronary-artery stenoses and that use of FFR to guide coronary revascularization improves clinical outcomes. 1 – 3 FFR is measured by advancing a coronary-pressure guidewire distal to a stenotic lesion and then administering adenosine to assess the pressure gradient across the lesion during hyperemia. Studies have shown that resting indexes (derived from the pressure measurement at rest, without the administration of adenosine) have . . .

Patients with stable coronary artery disease were randomly assigned to fractional flow reserve–guided PCI or medical therapy. At 5 years, the composite of death, myocardial infarction, or urgent revascularization was significantly less frequent in the PCI group.

Bivalirudin, with selective use of glycoprotein (GP) IIb/IIIa inhibitor agents, is an accepted standard of care in primary percutaneous coronary intervention (PPCI). We aimed to compare antithrombotic therapy with bivalirudin or unfractionated heparin during this procedure. In our open-label, randomised controlled trial, we enrolled consecutive adults scheduled for angiography in the context of a PPCI presentation at Liverpool Heart and Chest Hospital (Liverpool, UK) with a strategy of delayed consent. Before angiography, we randomly allocated patients (1:1; stratified by age [<75 years vs ≥75 years] and presence of cardiogenic shock [yes vs no]) to heparin (70 U/kg) or bivalirudin (bolus 0·75 mg/kg; infusion 1·75 mg/kg per h). Patients were followed up for 28 days. The primary efficacy outcome was a composite of all-cause mortality, cerebrovascular accident, reinfarction, or unplanned target lesion revascularisation. The primary safety outcome was incidence of major bleeding (type 3–5 as per Bleeding Academic Research Consortium definitions). This study is registered with ClinicalTrials.gov, number NCT01519518. Between Feb 7, 2012, and Nov 20, 2013, 1829 of 1917 patients undergoing emergency angiography at our centre (representing 97% of trial-naive presentations) were randomly allocated treatment, with 1812 included in the final analyses. 751 (83%) of 905 patients in the bivalirudin group and 740 (82%) of 907 patients in the heparin group had a percutaneous coronary intervention. The rate of GP IIb/IIIa inhibitor use was much the same between groups (122 patients [13%] in the bivalirudin group and 140 patients [15%] in the heparin group). The primary efficacy outcome occurred in 79 (8·7%) of 905 patients in the bivalirudin group and 52 (5·7%) of 907 patients in the heparin group (absolute risk difference 3·0%; relative risk [RR] 1·52, 95% CI 1·09–2·13, p=0·01). The primary safety outcome occurred in 32 (3·5%) of 905 patients in the bivalirudin group and 28 (3·1%) of 907 patients in the heparin group (0·4%; 1·15, 0·70–1·89, p=0·59). Compared with bivalirudin, heparin reduces the incidence of major adverse ischaemic events in the setting of PPCI, with no increase in bleeding complications. Systematic use of heparin rather than bivalirudin would reduce drug costs substantially. Liverpool Heart and Chest Hospital, UK National Institute of Health Research, The Medicines Company, AstraZeneca, The Bentley Drivers Club (UK).

Symptomatic relief is the primary goal of percutaneous coronary intervention (PCI) in stable angina and is commonly observed clinically. However, there is no evidence from blinded, placebo-controlled randomised trials to show its efficacy. ORBITA is a blinded, multicentre randomised trial of PCI versus a placebo procedure for angina relief that was done at five study sites in the UK. We enrolled patients with severe (≥70%) single-vessel stenoses. After enrolment, patients received 6 weeks of medication optimisation. Patients then had pre-randomisation assessments with cardiopulmonary exercise testing, symptom questionnaires, and dobutamine stress echocardiography. Patients were randomised 1:1 to undergo PCI or a placebo procedure by use of an automated online randomisation tool. After 6 weeks of follow-up, the assessments done before randomisation were repeated at the final assessment. The primary endpoint was difference in exercise time increment between groups. All analyses were based on the intention-to-treat principle and the study population contained all participants who underwent randomisation. This study is registered with ClinicalTrials.gov, number NCT02062593. ORBITA enrolled 230 patients with ischaemic symptoms. After the medication optimisation phase and between Jan 6, 2014, and Aug 11, 2017, 200 patients underwent randomisation, with 105 patients assigned PCI and 95 assigned the placebo procedure. Lesions had mean area stenosis of 84·4% (SD 10·2), fractional flow reserve of 0·69 (0·16), and instantaneous wave-free ratio of 0·76 (0·22). There was no significant difference in the primary endpoint of exercise time increment between groups (PCI minus placebo 16·6 s, 95% CI −8·9 to 42·0, p=0·200). There were no deaths. Serious adverse events included four pressure-wire related complications in the placebo group, which required PCI, and five major bleeding events, including two in the PCI group and three in the placebo group. In patients with medically treated angina and severe coronary stenosis, PCI did not increase exercise time by more than the effect of a placebo procedure. The efficacy of invasive procedures can be assessed with a placebo control, as is standard for pharmacotherapy. NIHR Imperial Biomedical Research Centre, Foundation for Circulatory Health, Imperial College Healthcare Charity, Philips Volcano, NIHR Barts Biomedical Research Centre.

In this trial involving patients with three-vessel coronary artery disease, PCI guided by assessment of fractional flow reserve was not noninferior to CABG with respect to the composite end point of death, myocardial infarction, stroke, or repeat revascularization at 1 year. The incidence of this composite end point was higher among those assigned to FFR-guided PCI than among those assigned to CABG.

Current international clinical practice guidelines recommend complete revascularization for patients with ST-segment elevation myocardial infarction (STEMI) with multivessel coronary artery disease 1 on the basis of evidence from randomized, controlled trials. 2 The COMPLETE trial (Complete versus Culprit-Only Revascularization Strategies to Treat Multivessel Disease after Early PCI for STEMI), which included 4041 patients with STEMI, showed a 26% lower risk of death from cardiovascular causes or myocardial infarction and a greater improvement in angina scores after 3 years of follow-up among patients who had been assigned to undergo complete revascularization of angiographically significant nonculprit lesions than among patients who had had no . . .

IntroductionAn evidence-based selection between fractional flow reserve (FFR) and optical coherence tomography (OCT) to drive percutaneous coronary intervention is still lacking.MethodsPatients enrolled in the Fractional Flow Reserve vs. Optical Coherence Tomography to Guide Revascularization of Intermediate Coronary Stenoses (FORZA) trial and in the OCT-Features Of moRphology, coMposItion anD instABility of culprit and not culprit coronary pLaquE in ACS patient (OCT-FORMIDABLE) registry were included. Target vessel revascularisation (TVR) and major adverse cardiac events (MACE), a composite endpoint of cardiac death, myocardial infarction (MI) and TVR were considered as coprimary endpoints. Phenomapping with clustering was performed: incidence of outcomes according to FFR and OCT was explored.Results405 patients were treated according to OCT and 405 to FFR. Three different clusters were identified. 48% of the patients were included in the first cluster, presenting mainly with stable angina and a relevant burden of risk factors (cardiovascular risk factors, CVRFs). 21% of the patients were included in the second cluster, presenting with ST segment elevation MI (STEMI) and with low rates of CVRFs. 31% of the patients, being admitted mostly for non-STEMI (NSTEMI) and with high rates of CVRFs, were included in the third cluster. FFR and OCT performed similarly in terms of MACE and TVR in the first cluster. In the second cluster, rates of MACE were lower in the OCT arm (3% vs 12%, p 0.04), mainly driven by TVR (2% vs 6%, p 0.18). In the third cluster, rates of TVR were significantly reduced in the OCT arm (6% vs 14%, p 0.037) with a neutral impact on MACE (12% vs 15%, p 0.71).ConclusionsCompared with a functional assessment, an OCT-based approach reduces revascularisation in patients with STEMI/NSTEMI, while FFR proved non-inferior for patients with stable angina.

ObjectiveThe study evaluates the relationship of coronary stenosis, atherosclerotic plaque characteristics (APCs) and age using artificial intelligence enabled quantitative coronary computed tomographic angiography (AI-QCT).MethodsThis is a post-hoc analysis of data from 303 subjects enrolled in the CREDENCE (Computed TomogRaphic Evaluation of Atherosclerotic Determinants of Myocardial IsChEmia) trial who were referred for invasive coronary angiography and subsequently underwent coronary computed tomographic angiography (CCTA). In this study, a blinded core laboratory analysing quantitative coronary angiography images classified lesions as obstructive (≥50%) or non-obstructive (<50%) while AI software quantified APCs including plaque volume (PV), low-density non-calcified plaque (LD-NCP), non-calcified plaque (NCP), calcified plaque (CP), lesion length on a per-patient and per-lesion basis based on CCTA imaging. Plaque measurements were normalised for vessel volume and reported as % percent atheroma volume (%PAV) for all relevant plaque components. Data were subsequently stratified by age <65 and ≥65 years.ResultsThe cohort was 64.4±10.2 years and 29% women. Overall, patients >65 had more PV and CP than patients <65. On a lesion level, patients >65 had more CP than younger patients in both obstructive (29.2 mm3 vs 48.2 mm3; p<0.04) and non-obstructive lesions (22.1 mm3 vs 49.4 mm3; p<0.004) while younger patients had more %PAV (LD-NCP) (1.5% vs 0.7%; p<0.038). Younger patients had more PV, LD-NCP, NCP and lesion lengths in obstructive compared with non-obstructive lesions. There were no differences observed between lesion types in older patients.ConclusionAI-QCT identifies a unique APC signature that differs by age and degree of stenosis and provides a foundation for AI-guided age-based approaches to atherosclerosis identification, prevention and treatment.