Nikola Jagic

Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease

BACKGROUND The preferred initial treatment for patients with stable coronary artery disease is the best available medical therapy. We hypothesized that in patients with functionally significant stenoses, as determined by measurement of fractional flow reserve (FFR), percutaneous coronary intervention (PCI) plus the best available medical therapy would be superior to the best available medical therapy alone. METHODS In patients with stable coronary artery disease for whom PCI was being considered, we assessed all stenoses by measuring FFR. Patients in whom at least one stenosis was functionally significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus the best available medical therapy (PCI group) or the best available medical therapy alone (medical-therapy group). Patients in whom all stenoses had an FFR of more than 0.80 were entered into a registry and received the best available medical therapy. The primary end point was a composite of death, myocardial infarction, or urgent revascularization. RESULTS Recruitment was halted prematurely after enrollment of 1220 patients (888 who underwent randomization and 332 enrolled in the registry) because of a significant between-group difference in the percentage of patients who had a primary end-point event: 4.3% in the PCI group and 12.7% in the medical-therapy group (hazard ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P<0.001). The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group (1.6% vs. 11.1%; hazard ratio, 0.13; 95% CI, 0.06 to 0.30; P<0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered by a myocardial infarction or evidence of ischemia on electrocardiography (hazard ratio, 0.13; 95% CI, 0.04 to 0.43; P<0.001). Among patients in the registry, 3.0% had a primary end-point event. CONCLUSIONS In patients with stable coronary artery disease and functionally significant stenoses, FFR-guided PCI plus the best available medical therapy, as compared with the best available medical therapy alone, decreased the need for urgent revascularization. In patients without ischemia, the outcome appeared to be favorable with the best available medical therapy alone. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT01132495.).

Fractional Flow Reserve–Guided PCI for Stable Coronary Artery Disease

BACKGROUND We hypothesized that in patients with stable coronary artery disease and stenosis, percutaneous coronary intervention (PCI) performed on the basis of the fractional flow reserve (FFR) would be superior to medical therapy. METHODS In 1220 patients with stable coronary artery disease, we assessed the FFR in all stenoses that were visible on angiography. Patients who had at least one stenosis with an FFR of 0.80 or less were randomly assigned to undergo FFR-guided PCI plus medical therapy or to receive medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy alone and were included in a registry. The primary end point was a composite of death from any cause, nonfatal myocardial infarction, or urgent revascularization within 2 years. RESULTS The rate of the primary end point was significantly lower in the PCI group than in the medical-therapy group (8.1% vs. 19.5%; hazard ratio, 0.39; 95% confidence interval [CI], 0.26 to 0.57; P<0.001). This reduction was driven by a lower rate of urgent revascularization in the PCI group (4.0% vs. 16.3%; hazard ratio, 0.23; 95% CI, 0.14 to 0.38; P<0.001), with no significant between-group differences in the rates of death and myocardial infarction. Urgent revascularizations that were triggered by myocardial infarction or ischemic changes on electrocardiography were less frequent in the PCI group (3.4% vs. 7.0%, P=0.01). In a landmark analysis, the rate of death or myocardial infarction from 8 days to 2 years was lower in the PCI group than in the medical-therapy group (4.6% vs. 8.0%, P=0.04). Among registry patients, the rate of the primary end point was 9.0% at 2 years. CONCLUSIONS In patients with stable coronary artery disease, FFR-guided PCI, as compared with medical therapy alone, improved the outcome. Patients without ischemia had a favorable outcome with medical therapy alone. (Funded by St. Jude Medical; FAME 2 ClinicalTrials.gov number, NCT01132495.).

A first-in-man clinical evaluation of Ultimaster, a new drug-eluting coronary stent system: CENTURY study.

AIMS To report the six-month angiographic and two-year clinical outcome data from the first-in-man study with the Ultimaster DES, a thin-strut cobalt-chromium sirolimus-eluting stent (SES) with an innovative abluminal-gradient-coated bioresorbable polymer. METHODS AND RESULTS CENTURY is a multicentre, single-arm, prospective study that enrolled 105 patients (113 lesions) with coronary artery disease. All patients were scheduled to have an angiographic follow-up at six months, while 45 and 20 patients respectively had IVUS and OCT assessments. The primary endpoint was six-month in-stent late lumen loss. Secondary endpoints included clinical, IVUS and OCT outcomes. Clinical follow-up is available up to two years and will continue up to five years. Procedural success was 97.1% and device success was 100%. Angiographic late loss at six months was 0.04±0.35 mm, also reflected in a low binary restenosis rate of 0.9% and confirmed by IVUS-assessed neointimal volume obstruction of 1.02±1.62%. The mean strut coverage assessed by OCT was 96.2% with 1.66±4.02 malapposed stent struts. There were no deaths in the study, three (2.9%) periprocedural and one (0.9%) spontaneous myocardial infarction, not related to the target vessel. At one and two years, the target lesion failure rate was 3.8% and 5.7%, while the TLR rate was 1.9% and 2.8%, respectively. There was one acute definite stent thrombosis. CONCLUSIONS The Ultimaster™ novel bioresorbable polymer sirolimus-eluting stent demonstrated good performance, including high procedural success and strong suppression of neointimal proliferation at six months. Good safety and effectiveness were shown up to two years in the studied population.

Coronary spasm that caused non-ST elevation myocardial infarction appeared in cath lab due to vasovagal reaction.

Coronary artery spasm is sometimes an unrecognized cause of myocardial ischemia. Myocardial ischemia is not always a product of fixed stenosis; it can also be induced by dynamic, transient stenosis. The angiogram represents the current state of vasculature at the time of examination and absence of stenosis does not mean disease absence. We present a case of right coronary artery spasm that caused non-ST elevation myocardial infarction and arrhythmias and was induced again in the cath lab due to vasovagal reaction.

Knuckle technique guided by intravascular ultrasound for in-stent restenosis occlusion treatment

One of the rarest lesions is in-stent restenosis chronic total occlusion (CTO). Limited data suggest that the treatment success rate is dependent on the possibility to cross into the lumen of an occluded stent, and the decision about what technique to use varies by operator preference. The knuckle technique is used to create a deliberate dissection plane in various CTO techniques. A guide wire is pushed until a complex loop is formed and advanced through the lesion. In this report we present a case where a knuckle wire guided by intravascular ultrasound control is used to penetrate the distal cap in an in-stent restenosis CTO lesion.

Serbia: coronary and structural heart interventions from 2010 to 2015

Serbias interventional community has been facing the multifaceted challenge of an ageing population with cardiovascular diseases as the primary cause of death nationwide, coronary artery disease (CAD) being the most prevalent subset. The following two fields of activity have marked the trajectory of progress in the field of interventional cardiology in Serbia: first, the expansion of the infrastructure, mainly through the opening of new catheterisation laboratories across all of the countrys administrative regions, which has resulted in better accessibility to coronary interventions for the general population; second, the creation of national platforms for continuous education, training and the promotion of clinical research in interventional cardiology, with close programmatic links to European Association of Percutaneous Cardiovascular Interventions (EAPCI)-based educational initiatives, including the curriculum for interventional cardiology. As growth seems to be inherent to the concept of progress, we report here on the expanding numbers of coronary interventions in the period between January 2010 and December 2015, and the early experiences with structural heart interventions in Serbia.

Numerical simulation of the flow field and mass transport pattern within the coronary artery

In this study, the steady and pulsatile flow field with mass transport analysis in an anatomically correct model of coronary artery is simulated numerically using a specific patient data from a 64-multislice computed tomography scanner. It is assumed that the blood flow is laminar and that the Navier–Stokes equations of motion are applied. Downstream of the bifurcation, a strong skewing occurs towards the flow divider walls as a result of branching. For the low-density lipoprotein (LDL) transport analysis where a specific boundary condition at the arterial walls is applied, LDL is generally elevated at locations where shear stress distribution is low, but it does not co-locate at whole domain. This numerical simulation gives an insight, as well as detailed quantitative data, of haemodynamic conditions in the left coronary artery as well as mass transfer patterns for a specific patient.

Three-dimensional reconstruction and NURBS-based structured meshing of coronary arteries from the conventional X-ray angiography projection images

Despite its two-dimensional nature, X-ray angiography (XRA) has served as the gold standard imaging technique in the interventional cardiology for over five decades. Accordingly, demands for tools that could increase efficiency of the XRA procedure for the quantitative analysis of coronary arteries (CA) are constantly increasing. The aim of this study was to propose a novel procedure for three-dimensional modeling of CA from uncalibrated XRA projections. A comprehensive mathematical model of the image formation was developed and used with a robust genetic algorithm optimizer to determine the calibration parameters across XRA views. The frames correspondences between XRA acquisitions were found using a partial-matching approach. Using the same matching method, an efficient procedure for vessel centerline reconstruction was developed. Finally, the problem of meshing complex CA trees was simplified to independent reconstruction and meshing of connected branches using the proposed nonuniform rational B-spline (NURBS)-based method. Because it enables structured quadrilateral and hexahedral meshing, our method is suitable for the subsequent computational modelling of CA physiology (i.e. coronary blood flow, fractional flow reverse, virtual stenting and plaque progression). Extensive validations using digital, physical, and clinical datasets showed competitive performances and potential for further application on a wider scale.

Association of coronary ischemia estimated by fractional flow reserve and psychological characteristics of patients

Introduction Psychological characteristics of patients, depression, stress and anxiety are recognized as important confounding risk factors for ischemic heart disease. However, the impact of psychological characteristics on coronary ischemia and vice versa remain poorly understood. Aim To demonstrate the interplay of psychological characteristics, depression, stress and anxiety with coronary ischemia estimated with fractional flow reserve (FFR). Material and methods From 2014 to 2016, 147 patients who were planned for FFR measurement were included in this study. Psychological characteristics of patients were evaluated using the Depression, Anxiety and Stress Scale 21 items (DASS 21) self-report questionnaire. Results Comparing the FFR ischemic vs. FFR non-ischemic groups, a significant difference was observed regarding results achieved for the depression, anxiety and stress scales. Multivariate logistic regression analysis was used to model the correlation between FFR and the DAS scale. It was clear, when controlling for previous myocardial infarction, that FFR was significant in all analyses. However, when the Canadian Cardiovascular Society grading of angina pectoris (CCS) class was entered in the model, FFR was not a significant predictor of anxiety, but was significant in other analysis. Conclusions Higher degrees of the psychological characteristics depression, stress and anxiety were observed in the group of patients with coronary ischemia, corresponding to lower fractional flow values.

Identifying culprit lesions in non-ST-elevation myocardial infarction: are new diagnostic tools always better?

Address for correspondence: Dr Miodrag J. Sreckovic, Clinical Centre Kragujevac, Interventional Cardiology, Faculty of Medical Sciences, Kragujevac, Serbia, tel: 381693371777, e-mail: sreckovic7@gmail.com Conflict of interest: none declared Kardiologia Polska Copyright