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Background: Biolimus-eluting stents (BESs) with a biodegradable polymer in abluminal coating achieve more complete coverage at 9 months compared with sirolimus-eluting stents (SESs) with a durable polymer, as assessed by optical coherence tomography (OCT). Whether this advantage persists or augments after complete resorption of the polymer (>12 months) is unknown.Methods: The LEADERS trial compared the performance of BES with that of SES. Patients were randomly allocated to a sequential angiographic follow-up, including OCT in selected sites, at 9 and 24 months. Struts coverage was compared using Bayesian hierarchical models as the primary outcome for the OCT substudy.Results: Fifty-six patients (26 BES, 30 SES) were enrolled in the OCT substudy. Twenty-one patients (10 BES, 11 SES) agreed to perform a second OCT follow-up at 24 months. Eleven lesions and 12 stents were analyzed sequentially in the BES group (2,455 struts at 9 months, 2,131 struts at 24 months) and 11 lesions and 18 stents in the SES group (3,421 struts at 9 months, 4,170 struts at 24 months). The previously reported advantage of BES over SES in terms of better strut coverage at 9 months was followed by improvement in coverage of the SES, resulting in identical coverage in both BES and SES at 24 months: 1.5% versus 1.8% uncovered struts, difference -0.2%, 95% credibility interval, -3.2% to 2.6%, P = .84.Conclusions: More complete strut coverage of BES as compared with SES at 9 months was followed by improvement of coverage in SES between 9 and 24 months and a similar long-term coverage in both stent types at 24 months. [ABSTRACT FROM AUTHOR]

Yaojun Zhang,1,2 Christos V Bourantas,1 Vasim Farooq,1 Takashi Muramatsu,1 Roberto Diletti,1 Yoshinobu Onuma,1 Hector M Garcia-Garcia,1 Patrick W Serruys11Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands; 2Division of Cardiovascular Diseases, Nanjing First Hospital, Nanjing Medical University, Nanjing, People's Republic of ChinaAbstract: Drug-eluting stents have reduced the risk of in-stent restenosis and have broadened the application in percutaneous coronary intervention in coronary artery disease. However, the concept of using a permanent metallic endovascular device to restore the patency of a stenotic artery has inherited pitfalls, namely the presence of a foreign body within the artery causing vascular inflammation, late complications such as restenosis and stent thrombosis, and impeding the restoration of the physiologic function of the stented segment. Bioresorbable scaffolds (BRS) were introduced to potentially overcome these limitations, as they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage. Currently, several BRSs are available, undergoing evaluation either in clinical trials or in preclinical settings. The aim of this review is to present the new developments in BRS technology, describe the mechanisms involved in the resorption process, and discuss the potential future prospects of this innovative therapy.Keywords: bioresorbable scaffold, drug-eluting stent, biodegradable, design, mechanism, coronary artery disease

In current clinical practice, qualitative or semi-quantitative measures are primarily used to report coronary artery disease on cardiac CT. With advancements in cardiac CT technology and automated post-processing tools, quantitative measures of coronary disease severity have become more broadly available. Quantitative coronary CT angiography has great potential value for clinical management of patients, but also for research. This document aims to provide definitions and standards for the performance and reporting of quantitative measures of coronary artery disease by cardiac CT., Competing Interests: Declaration of competing interest Héctor M. García-García reports the following Institutional grant support: Biotronik, Boston Scientific, Medtronic, Abbott, Neovasc, Shockwave, Phillips and Corflow; Consultancy fee from Boston Scientific, Abbott and Amgen. Koen Nieman acknowledges support from the NIH (NIH R01- HL141712; NIH R01 - HL146754), and reports unrestricted institutional research support from Siemens Healthineers, Bayer, HeartFlow Inc, Novartis unrelated to this work, consulting for Novartis and Siemens Medical Solutions USA, Artrya, Cleerly, Elucid, and equity in Lumen Therapeutics. Maksymilian P. Opolski reports institutional grant support from B. Braun; consulting for Boston Scientific and proctorship for Boston Scientific, Terumo and Biotronik. Michelle Williams has given talks for Canon Medical Systems, Siemens Healthineers and Novartis. Damini Dey has received software royalties from Cedars-Sinai Medical Center and is supported by grants from the NIH/NHLBI (1R01HL148787-01A1 and 1R01HL151266). Jonathon Leipsic is a consultant and holds stock options in HeartFlow Inc., is a consultant to Circle CVI and has received modest corelab personal fees from Arineta and has received modest speaking fees from GE Healthcare and Philips HealthCare. Michael T Lu reports institutional research support from the American Heart Association (18UNPG34030172; 810,966), AstraZeneca, Ionis, Johnson & Johnson Innovation, Kowa, the National Academy of Medicine, and the NIH (U01HL123339; U24HL164284; R33HL141047; R01HL164629). Maros Ferencik received grant support from the American Heart Association and National Institutes of Health. Maros Ferencik received consulting fees HeartFlow, Elucid, Siemens Healthineers., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: patients with atrial fibrillation (AF) under treatment with chronic oral anticoagulation (OAC) often require coronary angiography with or without percutaneous coronary intervention (PCI). Deciding the management of OAC during this periprocedural period requires balancing the risks of hemorrhage and thrombotic complications. Guidelines recommend an uninterrupted strategy in patients receiving Vitamin-K Antagonists (VKA). However, for patients undergoing coronary angiography or PCI while on direct oral anticoagulants (DOACs), withdrawal 12-24 h prior to the procedure is still recommended. This is based on expert opinions given the lack of evidence. Therefore, whether DOAC discontinuation prior to trans-radial coronary procedures should be the strategy of choice is a matter of debate and solid evidence is needed to guide clinical decision making., Methods: The DOAC-NOSTOP study is a prospective, single-arm, open-label study evaluating the safety of DOACs continuation in 200 patients undergoing transradial percutaneous coronary procedures. DOAC treatment will not be interrupted throughout the periprocedural period. Primary outcome will be Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 events, assessed at a 30-day follow-up., Conclusions: The DOAC-NOSTOP is the first study prospectively assessing the risk of bleeding with uninterrupted DOAC in patients undergoing trans-radial percutaneous coronary procedures., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: The impact on age on the short-term and long-term prognosis in patients with Takotsubo syndrome (TTS) is unclear. We aimed to evaluate whether age has prognostic implications during hospital stay and long-term follow-up of TTS patients., Methods: 688 consecutive patients were admitted for TTS in 7 tertiary centers from January-2008 to June-2021. We divided our cohort into two groups (patients <75 years and ≥75 years). Clinical, analytical, and hemodynamic variables as well as in-hospital management were registered and compared between groups. Mortality rates during hospital stay and follow-up were assessed. Adverse cardiovascular events (ACE) were defined as the composite of cardiovascular death, heart failure event, acute myocardial infarction, stroke and symptomatic arrhythmia., Results: Median age was 74.7 years and 49.4 % were ≥75 years. 86.9 % were women and 22.3 % were secondary forms of TTS. In-hospital mortality was 3.6 % (1.5 % cardiovascular). Median clinical follow-up was 4.3 years. Mortality during the follow-up period was 23 % (5.0 % cardiovascular) while ACE were 22.5 %, mainly due to heart failure events. Kaplan-Meier curves showed both higher rates of mortality and ACE in ≥75 years group (30.2 % vs 15.8 %; p < 0.001 and 28.3 % vs 16.7 %; p < 0.001). Age was independently associated with higher rates of overall mortality and ACE in patients with TTS. Hypertension, absence of sinus rhythm, Killip class > I and a more impaired coronary microvascular resistance were also associated to ACE in TTS patients., Conclusions: Advanced age was associated with higher rate of overall mortality and ACE during long-term follow-up in TTS patients., Competing Interests: Declaration of competing interest Dr. Hector M. Garcia-Garcia reports the following institutional grant support: Biotronik, Boston Scientific, Medtronic, Abbott, Neovasc, Shockwave, Phillips and Corflow. The following is the supplementary data related to this article. Supplementary data to this article can be found online at https://doi.org/10.1016/j.carrev.2023.10.018., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Coronary artery disease is defined by the existence of atherosclerotic plaque on the arterial wall, which can cause blood flow impairment, or plaque rupture, and ultimately lead to myocardial ischemia. Intravascular ultrasound (IVUS) imaging can provide a detailed characterization of lumen and vessel features, and so plaque burden, in coronary vessels. Prediction of the regions in a vascular segment where plaque burden can either increase (progression) or decrease (regression) following a certain therapy, has remained an elusive major milestone in cardiology. Studies like IBIS-4 showed an association between plaque burden regression and high-intensity rosuvastatin therapy over 13 months. Nevertheless, it has not been possible to predict if a patient would respond in a favorable/adverse fashion to such a treatment. This work aims to (i) Develop a framework that processes lumen and vessel cross-sectional contours and extracts geometric descriptors from baseline and follow-up IVUS pullbacks; and to (ii) Develop, train, and validate a machine learning model based on baseline/follow-up IVUS datasets that predicts future percent of atheroma volume changes in coronary vascular segments using only baseline information, i.e. geometric features and clinical data. This is a post hoc analysis, revisiting the IBIS-4 study. We employed 140 arteries, from 81 patients, for which expert delineation of lumen and vessel contours were available at baseline and 13-month follow-up. Contour data from baseline and follow-up pullbacks were co-registered and then processed to extract several frame-wise features, e.g. areas, plaque burden, eccentricity, etc. Each pullback was divided into regions of interest (ROIs), following different criteria. Frame-wise features were condensed into region-wise markers using tools from statistics, signal processing, and information theory. Finally, a stratified 5-fold cross-validation strategy (20 repetitions) was used to train/validate an XGBoost regression models. A feature selection method before the model training was also applied. When the models were trained/validated on ROI defined by the difference between follow-up and baseline plaque burden, the average accuracy and Mathews correlation coefficient were 0.70 and 0.41 respectively. Using a ROI partition criterion based only on the baseline's plaque burden resulted in averages of 0.60 accuracy and 0.23 Mathews correlation coefficient. An XGBoost model was capable of predicting plaque progression/regression changes in coronary vascular segments of patients treated with rosuvastatin therapy in 13 months. The proposed method, first of its kind, successfully managed to address the problem of stratification of patients at risk of coronary plaque progression, using IVUS images and standard patient clinical data., (© 2024. The Author(s).)

Purpose: Recently developed handheld ultrasound devices (HHUD) represent a promising method to evaluate the cardiovascular abnormalities at the point of care. However, this technology has not been rigorously evaluated. The aim of this study was to explore the correlation and the agreement between the LVEF (Left Ventricular Ejection Fraction) visually assessed by a moderately experienced sonographer using an HHUD compared to the routine LVEF assessment performed at the Echocardiography Laboratory., Methods: This was a prospective single center study which enrolled 120 adult inpatients and outpatients referred for a comprehensive Echocardiography (EC)., Results: The mean age of the patients was 69.9 ± 12.5 years. There were 47 females (39.2%). The R-squared was r 0.94 (p < 0.0001) and the ICC was 0.93 (IC 95% 0.91-0.95, p ≤ 0.0001). The Bland-Altman plot showed limits of agreement (LOA): Upper LOA 10.61 and Lower LOA - 8.95. The overall agreement on the LVEF assessment when it was stratified as "normal" or "reduced" was 89.1%, with a kappa of 0.77 (p < 0.0001). When the LVEF was classified as "normal", "mildly reduced", "moderately reduced", or "severely reduced," the kappa was 0.77 (p < 0.0001). The kappa between the HHUD EC and the comprehensive EC for the detection of RWMAs in the territories supplied by the LAD, LCX and RCA was 0.85, 0.73 and 0.85, respectively., Conclusion: With current HHUD, an averagely experienced operator can accurately bedside visual estimate the LVEF. This may facilitate the incorporation of this technology in daily clinical practice improving the management of patients., (© 2023. The Author(s), under exclusive licence to Springer Nature B.V.)

Aims: Standard manual analysis of IVUS to study the impact of anti-atherosclerotic therapies on the coronary vessel wall is done by a core laboratory (CL), the ground truth (GT). Automatic segmentation of IVUS with a machine learning (ML) algorithm has the potential to replace manual readings with an unbiased and reproducible method. The aim is to determine if results from a CL can be replicated with ML methods., Methods: This is a post-hoc, comparative analysis of the IBIS-4 (Integrated Biomarkers and Imaging Study-4) study (NCT00962416). The GT baseline and 13-month follow-up measurements of lumen and vessel area and percent atheroma volume (PAV) after statin induction were repeated by the ML algorithm., Results: The primary endpoint was change in PAV. PAV as measured by GT was 43.95 % at baseline and 43.02 % at follow-up with a change of -0.90 % (p = 0.007) while the ML algorithm measured 43.69 % and 42.41 % for baseline and follow-up, respectively, with a change of -1.28 % (p < 0.001). Along the most diseased 10 mm segments, GT-PAV was 52.31 % at baseline and 49.42 % at follow-up, with a change of -2.94 % (p < 0.001). The same segments measured by the ML algorithm resulted in PAV of 51.55 % at baseline and 47.81 % at follow-up with a change of -3.74 % (p < 0.001)., Conclusions: PAV, the most used endpoint in clinical trials, analyzed by the CL is closely replicated by the ML algorithm. ML automatic segmentation of lumen, vessel and plaque effectively reproduces GT and may be used in future clinical trials as the standard., Competing Interests: Declaration of competing interest Héctor M. García-García reports the following Institutional grant support: Biotronik, Boston Scientific, Medtronic, Abbott, Neovasc, Shockwave, Phillips and Corflow; Speaker's fee from Boston Scientific and Amgen. Lorenz Räber reports institutional grant support: Abbott, Biotronik, Boston Scientific, Sanofi, Regeneron, Infraredx and consultation fees by Abbott, Amgen, AstraZeneca, Occlutec, Medtronic, Sanofi, Vifor. Marco Roffi reports institutional research grants from Terumo, Biotronik, Medtronic and Cordis/Cardinal Health., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Despite major advances in pharmacotherapy and interventional procedures, coronary artery disease (CAD) remains a principal cause of morbidity and mortality worldwide. Invasive coronary imaging along with the computation of hemodynamic forces, primarily endothelial shear stress and plaque structural stress, have enabled a comprehensive identification of atherosclerotic plaque components, providing a unique insight into the understanding of plaque vulnerability and progression, which may help guide patient treatment. However, the invasive-only approach to CAD has failed to show high predictive value. Meanwhile, it is becoming increasingly evident that along with the "vulnerable plaque", the presence of a "vulnerable patient" state is also necessary to precipitate an acute coronary thrombotic event. Non-invasive imaging techniques have also evolved, providing new opportunities for the identification of high-risk plaques, the study of atherosclerosis in asymptomatic individuals, and general population screening. Additionally, risk stratification scores, circulating biomarkers, immunology, and genetics also complete the armamentarium of a broader "vulnerable plaque and patient" concept approach. In the current review article, the invasive and non-invasive modalities used for the detection of high-risk plaques in patients with CAD are summarized and critically appraised. The challenges of the vulnerable plaque concept are also discussed, highlighting the need to shift towards a more interdisciplinary approach that can identify the "vulnerable plaque" in a "vulnerable patient".

Background: The long-term cardiovascular (CV) outcomes of COVID-19 have not been fully explored., Methods: This was an international, multicenter, retrospective cohort study conducted between February and December 2020. Consecutive patients ≥18 years who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 were included. Patients were classified into two cohorts depending on the nasopharyngeal swab result and clinical status: confirmed COVID-19 (positive RT-PCR) and control (without suggestive symptoms and negative RT-PCR). Data were obtained from electronic records, and clinical follow-up was performed at 1-year. The primary outcome was CV death at 1-year. Secondary outcomes included arterial thrombotic events (ATE), venous thromboembolism (VTE), and serious cardiac arrhythmias. An independent clinical event committee adjudicated events. A Cox proportional hazards model adjusted for all baseline characteristics was used for comparing outcomes between groups. A prespecified landmark analysis was performed to assess events during the post-acute phase (31-365 days)., Results: A total of 4,427 patients were included: 3,578 (80.8%) in the COVID-19 and 849 (19.2%) control cohorts. At one year, there were no significant differences in the primary endpoint of CV death between the COVID-19 and control cohorts (1.4% vs. 0.8%; HRadj 1.28 [0.56-2.91]; p = 0.555), but there was a higher risk of all-cause death (17.8% vs. 4.0%; HRadj 2.82 [1.99-4.0]; p = 0.001). COVID-19 cohort had higher rates of ATE (2.5% vs. 0.8%, HRadj 2.26 [1.02-4.99]; p = 0.044), VTE (3.7% vs. 0.4%, HRadj 9.33 [2.93-29.70]; p = 0.001), and serious cardiac arrhythmias (2.5% vs. 0.6%, HRadj 3.37 [1.35-8.46]; p = 0.010). During the post-acute phase, there were no significant differences in CV death (0.6% vs. 0.7%; HRadj 0.67 [0.25-1.80]; p = 0.425), but there was a higher risk of deep vein thrombosis (0.6% vs. 0.0%; p = 0.028). Re-hospitalization rate was lower in the COVID-19 cohort compared to the control cohort (13.9% vs. 20.6%; p = 0.001)., Conclusions: At 1-year, patients with COVID-19 experienced an increased risk of all-cause death and adverse CV events, including ATE, VTE, and serious cardiac arrhythmias, but not CV death., Study Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT04359927., Competing Interests: GC received research grants from Boston Scientific, Medis, SMT, Siemens, Insight Lifetech. BB reports that he is a consulting expert, on behalf of the plaintiff, for litigation related to two specific brand models of IVC filters. HGG reports a relationship with Biotronik, Boston Scientific, Medtronic, Abbott, Neovasc, Shockwave, Philips, and CorFlow that includes: funding grants. DJA declares that he has received consulting fees or honoraria from Abbott, Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, and Sanofi. DJA also declares that his institution has received research grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Idorsia, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, Renal Guard Solutions, and the Scott R. MacKenzie Foundation. JRC is consultant for and has received institutional research grants from Edwards Lifesciences, Medtronic and Boston Scientific. MS declares that he is a consultant for Abbott Vascular and iVascular. SB declares that he is a consultant from Boston Scientific, iVascular and Teleflex, and he received speaker’s fee from Abbott Vascular, outside the present work. Other authors have nothing to disclose. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2022 Ortega-Paz et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Microvascular resistance (MR) is increased in takotsubo syndrome (TTS) and can be assessed by a validated pressure-wire-free tool called nonhyperemic angiography-derived index of microcirculatory resistance (NH-IMRangio)., Objectives: The authors aimed to study whether the degree and extent of an altered MR in TTS patients were associated with 1-year prognosis., Methods: The authors recruited 181 consecutive patients with TTS who underwent cardiac angiography. Impaired MR was defined as an NH-IMRangio ≥25. The degree and extent of impaired MR were assessed by the value of maximum NH-IMRangio in each major coronary artery and by the number of coronary arteries with an NH-IMRangio ≥25, respectively. Major adverse cardiac events (MACE) were a composite of cardiovascular death, heart failure event, acute myocardial infarction, and hospitalization for symptomatic arrhythmias., Results: A total of 166 patients had NH-IMRangio available. The mean age was 74.8 years, and 83% were women. The rate of MACE at 1 year was 21.1%, mainly due to heart failure events that were generally mild. Kaplan-Meier curves showed higher rates of MACE in patients with higher NH-IMRangio (28.9% vs 13.3%; P = 0.019) and in those with 3 coronary arteries with increased MR compared to those with 2 or 1 affected arteries (33.3% vs 15.9% vs 9.5%; P = 0.040 and P = 0.040, respectively). After a multivariable Cox regression analysis, higher values of NH-IMRangio (HR: 3.41 [95% CI: 1.54-7.52]; P = 0.002) and the presence of 3 coronary arteries with increased MR (HR: 6.39 [95% CI: 1.46-27.87]; P = 0.014) were independent predictors of MACE in TTS patients., Conclusions: The degree and extent of an impaired MR assessed by a validated pressure-wire-free tool were independent predictors of MACE at 1-year follow-up in TTS patients., Competing Interests: Funding Support and Author Disclosures Dr García-García has received grants from Biotronik, Boston Scientific, Medtronic, Abbott, Neovasc, Shockwave, Phillips, and Corflow. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Quantitative flow ratio (QFR) is a recently proposed angiographic index that allows to assess the pressure loss in coronary arteries in a similar fashion as the fractional flow reserve (FFR). The purpose of this study was to evaluate the diagnostic performance of QFR as compared to FFR, in a Latin-American population of patients with suspected ischaemic heart disease. QFR was retrospectively derived from coronary angiograms. The association, diagnostic performance, and continuous agreement of fixed-flow QFR (fQFR) and contrast-flow QFR (cQFR) with FFR was assessed by continuous and dichotomous methods. 90 vessels form 66 patients were finally included. The study comprised coronary stenoses of intermediate severity, both angiographically (diameter stenosis: 46.6 ± 12.8%) and physiologically [median FFR = 0.83 (quartile 1-3, 0.76-0.89)]. The correlation of FFR with both fQFR [ρ = 0.841, (95% CI 0.767 to 0.893), p < 0.001] and cQFR [ρ = 0.833, (95% CI 0.755 to 0.887), p < 0.001] was strong. The diagnostic performance of cQFR was good [area under the ROC curve of 0.92 (95% CI 0.86 to 0.97, p < 0.001)], with 0.80 as the optimal cQFR cut-off against FFR ≤ 0.80. This 0.80 cQFR cut-off classified correctly 83.3% of total stenoses, with a sensitivity of 85.2% and specificity of 80.6%. QFR was strongly associated with FFR and exhibited a high diagnostic performance in this Latin-American population., (© 2022. The Author(s), under exclusive licence to Springer Nature B.V.)

Intravascular ultrasound (IVUS) provides grayscale images of the entire vessel wall, and its technology has recently been improved, resulting in more accurate tissue characterization. Compared with conventional IVUS, high-definition (HD) IVUS provides better resolution, better image quality, faster acquisition and integration of processing tools for more efficient cath lab workflow. HD-IVUS includes transducers with higher frequencies (≥ 45 MHz), allowing a higher near field resolution combined with enough tissue penetration for a more precise assessment of the entire vessel wall. HD-IVUS preserves the potential advantages of conventional (40 MHz) IVUS over optical coherence tomography by adding a substantially higher spatial resolution. For this reason, this technology has generated increasing interest among interventional cardiologists and researchers to provide better detailed morphological evaluation on complicated plaques in acute coronary syndrome patients and better stent optimization. In this review, we provide the state-of-the-art on this technology and its current clinical applications., (© 2022. The Author(s), under exclusive licence to Springer Nature B.V.)

Background: There is little information on the performance of the new generation of stents with bioabsorbable polymers in the Latin American population. This registry aimed to further validate the safety and efficacy of the Orsiro bioresorbable-polymer sirolimus-eluting stent (BPSES) in unselected patients undergoing percutaneous coronary intervention (PCI) in Chilean centers., Methods: We prospectively enrolled patients undergoing PCI with BPSES in 6 Chilean centers. The primary endpoint was defined as the composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization at 1-year follow-up., Results: From April 2017 to February 2019, 520 patients were enrolled in the registry, more frequently male (74.6%), with a mean age of 62.7 ± 10.8 years and a high prevalence of diabetes (40.2%). The clinical presentation was stable angina in 41.1% (n = 214), acute MI in 52.5% (n = 167 [32.1%] ST-elevation MI and n = 106 [20.4%] non-ST-elevation MI), and unstable angina in 6.3% (n = 33). Of 610 treated lesions, 425 (69.7%) were American College of Cardiology/American Heart Association type B or C lesions. Device and procedural success were achieved in 99.4% and 98.7% of the patients, respectively. The primary endpoint of the study occurred in 4%, primarily driven by cardiac death., Conclusions: The results of the ROSES multicenter registry indicated good clinical outcomes of BPSES Orsiro in all-comers Latin Americann patients undergoing PCI, despite the high-risk patients and treated lesions., Competing Interests: Declaration of competing interest HMG & GM's institutions receive grants from Biotronik to conduct research projects, (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: To assess the diagnostic performance of computed tomography angiography (CTA) and intravascular ultrasound (IVUS) derived minimum lumen areas (MLA) from the same lesions that correspond to an FFR ≤0.80., Methods and Results: A total of 24 patients (33 arteries) were collected retrospectively according to the following inclusion criteria: presence of a CTA diagnostic followed by an IVUS and FFR percutaneous coronary procedures. CTA and IVUS lumen contours were automatically performed using previously validated methods.The correlation between CTA and IVUS for the MLA was r = 0.45. In terms of MLA, the mean difference between CTA and IVUS was 0.81 mm2. Of note, a much smaller CTA-derived MLA (2.10 mm2) was found to be related to significant FFR lesions compared to that of the MLA derived from IVUS (3.19 mm2). The area under the curve, accuracy, sensitivity and specificity for this CTA-derived MLA were 0.80, 0.76, 0.50 and 0.87, respectively, while these values for IVUS-derived MLA were 0.87, 0.85, 0.80 and 0.87., Conclusions: Computed tomography angiography and intravascular ultrasound-derived minimum lumen areas have moderate diagnostic efficiency, albeit slightly better for IVUS, in identifying hemodynamically severe coronary stenoses. The utility of MLA, automatically derived from either CTA or IVUS as an alternative to FFR to guide the decision to revascularize, should be tested clinically., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Segmentation of lumen and vessel contours in intravascular ultrasound (IVUS) pullbacks is an arduous and time-consuming task, which demands adequately trained human resources. In the present study, we propose a machine learning approach to automatically extract lumen and vessel boundaries from IVUS datasets. The proposed approach relies on the concatenation of a deep neural network to deliver a preliminary segmentation, followed by a Gaussian process (GP) regressor to construct the final lumen and vessel contours. A multi-frame convolutional neural network (MFCNN) exploits adjacency information present in longitudinally neighboring IVUS frames, while the GP regression method filters high-dimensional noise, delivering a consistent representation of the contours. Overall, 160 IVUS pullbacks (63 patients) from the IBIS-4 study (Integrated Biomarkers and Imaging Study-4, Trial NCT00962416), were used in the present work. The MFCNN algorithm was trained with 100 IVUS pullbacks (8427 manually segmented frames), was validated with 30 IVUS pullbacks (2583 manually segmented frames) and was blindly tested with 30 IVUS pullbacks (2425 manually segmented frames). Image and contour metrics were used to characterize model performance by comparing ground truth (GT) and machine learning (ML) contours. Median values (interquartile range, IQR) of the Jaccard index for lumen and vessel were 0.913, [0.882,0.935] and 0.940, [0.917,0.957], respectively. Median values (IQR) of the Hausdorff distance for lumen and vessel were 0.196mm, [0.146,0.275]mm and 0.163mm, [0.122,0.234]mm, respectively. Also, the mean value of lumen area predictions, and limits of agreement were -0.19mm 2 , [1.1,-1.5]mm 2 , while the mean value and limits of agreement of plaque burden were 0.0022, [0.082,-0.078]. The results obtained with the model developed in this work allow us to conclude that the proposed machine learning approach delivers accurate segmentations in terms of image metrics, contour metrics and clinically relevant variables, enabling its use in clinical routine by mitigating the costs involved in the manual management of IVUS datasets., Competing Interests: Declaration of Competing Interest The authors declare that there is no conflict of interest with regards to the present work., (Copyright © 2021. Published by Elsevier B.V.)

The characterization of vascular geometry is a fundamental step towards the correct interpretation of coronary artery disease. In this work, we report a comprehensive comparison of the geometry featured by coronary vessels as obtained from coronary computed tomography angiography (CCTA) and the combination of intravascular ultrasound (IVUS) with bi-plane angiography (AX) modalities. We analyzed 34 vessels from 28 patients with coronary disease, which were deferred to CCTA and IVUS procedures. We discuss agreement and discrepancies between several geometric indexes extracted from vascular geometries. Such an analysis allows us to understand to which extent the coronary vascular geometry can be reliable in the interpretation of geometric risk factors, and as a surrogate to characterize coronary artery disease., (© 2021 John Wiley & Sons, Ltd.)

Aims: Assessment of minimum lumen areas in intravascular ultrasound (IVUS) pullbacks is time-consuming and demands adequately trained personnel. In this work, we introduce a novel and fully automated pipeline to segment the lumen boundary in IVUS datasets., Methods and Results: First, an automated gating is applied to select end-diastolic frames and bypass saw-tooth artefacts. Second, within a machine learning (ML) environment, we automatically segment the lumen boundary using a multi-frame (MF) convolutional neural network (MFCNN). Finally, we use the theory of Gaussian processes (GPs) to regress the final lumen boundary. The dataset consisted of 85 IVUS pullbacks (52 patients). The dataset was partitioned at the pullback-level using 73 pullbacks for training (20 586 frames), 6 pullbacks for validation (1692 frames), and 6 for testing (1692 frames). The degree of overlapping, between the ground truth and ML contours, median (interquartile range, IQR) systematically increased from 0.896 (0.874-0.933) for MF1 to 0.925 (0.911-0.948) for MF11. The median (IQR) of the distance error was also reduced from 3.83 (2.94-4.98)% for MF1 to 3.02 (2.25-3.95)% for MF11-GP. The corresponding median (IQR) in the lumen area error remained between 5.49 (2.50-10.50)% for MF1 and 5.12 (2.15-9.00)% for MF11-GP. The dispersion in the relative distance and area errors consistently decreased as we increased the number of frames, and also when the GP regressor was coupled to the MFCNN output., Conclusion: These results demonstrate that the proposed ML approach is suitable to effectively segment the lumen boundary in IVUS scans, reducing the burden of costly and time-consuming manual delineation., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.)

`To analyze the impact of additional coronary artery disease, quantified by the SYNTAX (SYNergy between PCI with TAXus and cardiac surgery) score, on left ventricular ejection fraction (LVEF) and long-term outcomes in a cohort of ST-elevated myocardial infarction (STEMI) patients with a concomitant chronic total coronary occlusion (CTO). A total of 302 STEMI patients were randomized to percutaneous coronary intervention of a CTO (CTO PCI) (n = 148) or conservative CTO treatment (n = 154). SYNTAX scores were calculated by an independent corelab (Cardialysis BV, Rotterdam) at two time-points: (1) at baseline, and (2) after primary PCI in the conservative CTO arm and after CTO PCI in the invasive arm (named 'discharge SYNTAX score'). The population was divided in two groups (below or equal to the median SYNTAX score preprimary PCI, or above the median). At 4-month follow-up, the LVEF was significantly lower in patients in the group with a SYNTAX score above the group median (42.8% vs 48.5%, p = 0.001), and the SYNTAX score was an independent predictor for LVEF at 4 months (β-0.151 (SE 0.068), p = 0.028). In the group with a SYNTAX score above the group median the mortality rate was higher (10.1% vs 3.9%, p = 0.025), and there was a trend towards a higher MACE rate (15.4% vs 8.5%, p = 0.063). In conclusion, in this sub-analysis of the EXPLORE trial we observed a worse LVEF and a higher mortality rate for patients with a SYNTAX score above the median. We found that the SYNTAX score is an independent negative predictor for LVEF and an independent positive predictor for LVEDV at 4-month follow-up., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: The minimum fibrous cap thickness (FCT) is considered a major criterion of coronary plaque vulnerability according to autopsy studies. We aimed to assess the reproducibility in the measurement of the optical coherence tomography (OCT)-detected minimum FCT and the agreement in the classification of thin-cap fibroatheroma (TCFA), by a software-based semi-automatic method compared with the manual method., Methods and Results: A total of 50 frames with fibroatheromas (FA) were randomly selected from the Integrated Biomarker Imaging Study-4 (IBIS-4). Two experienced OCT analysts independently measured the minimum FCT at two different time points, manually and by three different semi-automatic software-based algorithms, based on the assessment of light intensity along the axial scan line. A TCFA was defined as an FA with minimum FCT <65 μm. The inter- and intra-observer reproducibility of the manual measurement of the minimum FCT was moderate with an intra-class correlation coefficient (ICC) of 0.71 and 0.79, respectively. The corresponding ICCs by either one of the three semi-automatic algorithms were 0.99. When categorising FA according to the minimum FCT based on the manual assessment, the inter- and intra-observer agreement was poor (κ=0.23) and moderate (κ=0.50), respectively. In contrast, the semi-automatic assessment showed perfect agreement for both inter- and intra-observer assessments (κ=0.90-1.00 and 1.00, respectively)., Conclusions: While semi-automatic assessment of FCT and TCFA classification was associated with excellent reproducibility and agreement, manual measurements were associated with a moderate reproducibility and agreement in the quantification of FCT and classification of TCFA.

Aims: Our aim was to assess vascular response after polymer-free sirolimus-eluting stent (SES) implantation by using an optical coherence tomography (OCT)-derived vascular healing score (HS), quantifying the deficiency of healing., Methods and Results: In a prospective, multicentre, single-arm, open-label study, OCT examinations were performed at three months in 45 patients (47 lesions). Per protocol, 24 lesions which had not reached adequate vascular healing according to study criteria were scheduled for OCT examination at six months. The HS was calculated at two time points. Serial OCT imaging demonstrated that the proportion of covered stent struts increased from a median of 87.1% at three months to 98.6% at six months (p<0.001). The neointimal thickness increased from a median of 82.8 µm to 112.2 µm (p<0.001), whereas the median percentages of malapposed struts were 0.2% and 0.0% at the two respective time points. Neointimal volume obstruction increased from 6.3% to 12.8%, and the HS decreased from a median of 28.1 at three months to 2.4 at six months., Conclusions: In patients who had inadequate vascular healing three months after polymer-free SES implantation, serial OCT showed almost complete vascular healing at six months.

Aims: Several studies have suggested good procedural and similar clinical outcomes between everolimus-eluting Absorb bioresorbable stents (BRS) versus conventional drug-eluting stents (DES), but the evidence is not definitive. Our aim was to perform a systematic review and meta-analysis to investigate the effects of BRS versus conventional drug-eluting and bare metallic stents on the cardiovascular endpoints and all-cause mortality., Methods and Results: The follow-up in the included studies was up to 13 months. The following endpoints were evaluated: all-cause mortality, cardiac death, patient-oriented major adverse cardiac events (POCE), device-oriented major adverse cardiac events (DOCE), any-cause myocardial infarction (MI), target vessel MI (TVMI), target vessel revascularisation (TVR) and target lesion revascularisation (TLR). The results of 10 studies with 5,773 subjects showed a statistically significant increase in the risk of TVMI between BRS and conventional stents (odds ratio [OR]: 1.45, 95% confidence interval [CI]: 1.03-2.05, p=0.032). None of the other differences reached statistical significance: all-cause mortality (OR: 0.67, 95% CI: 0.30-1.49, p=0.333), cardiac death (OR: 1.00, 95% CI: 0.47-2.12, p=0.996), POCE (OR: 0.91, 95% CI: 0.68-1.22, p=0.546), DOCE (OR: 1.12, 95% CI: 0.86-1.46, p=0.387), any-cause MI (OR: 1.34, 95% CI: 0.98-1.82, p=0.064), TVR (OR: 0.99, 95% CI: 0.73-1.33, p=0.934) and TLR (OR: 0.92, 95% CI: 0.66-1.29, p=0.641). Similar results were observed after restricting the meta-analysis to the comparison of BRS vs. EES., Conclusions: Our meta-analysis suggests a significantly higher risk of TVMI with BRS compared with conventional stents and no significant differences in the rates of occurrence of the other outcomes during one-year follow-up. Further studies with larger samples sizes, longer follow-up, different clinical scenarios and more complex lesions are required to confirm or refute our findings.

Objectives: Levels of inflammatory biomarkers associate with changes of coronary atheroma burden in statin-treated patients with stable coronary artery disease. This study sought to determine changes of plaque composition in vivo in relation to high-sensitivity C-reactive protein (hs-CRP) levels in patients with ST-elevation myocardial infarction (STEMI) receiving high-intensity statin therapy., Methods: The IBIS-4 study performed serial (baseline and 13-month), 2-vessel intravascular ultrasound (IVUS) and radiofrequency-IVUS of the non-infarct-related arteries in patients with STEMI treated with high-intensity statin therapy. The present analysis included 44 patients (80 arteries) with serial measurements of hs-CRP., Results: At follow-up, median low-density lipoprotein cholesterol (LDL-C) levels decreased from 126 to 77 mg/dl, HDL-C increased from 44 to 47 mg/dl, and hs-CRP decreased from 1.6 to 0.7 mg/L. Regression of percent atheroma volume (-0.99%, 95% CI -1.84 to -0.14, p = 0.024) was accompanied by reduction of percent fibro-fatty (p = 0.04) and fibrous tissue (p < 0.001), and increase in percent necrotic core (p = 0.006) and dense calcium (p < 0.001). Follow-up levels of hs-CRP, but not LDL-C, correlated with changes in percent necrotic core (p = 0.001) and inversely with percent fibrous tissue volume (p = 0.008). Similarly, baseline-to-follow-up change of hs-CRP correlated with the change in percent necrotic core volume (p = 0.02)., Conclusions: In STEMI patients receiving high-intensity statin therapy, stabilization of VH-IVUS-defined necrotic core was confined to patients with lowest on-treatment levels and greatest reduction of hs-CRP. Elevated CRP levels at follow-up may identify progression of high-risk coronary plaque composition despite intensive statin therapy and overall regression of atheroma volume., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background and Aims: To assess the relationship between the extent and phenotype of coronary atherosclerosis, as assessed by in-vivo grayscale and radiofrequency intravascular ultrasound (IVUS), and circulating Troponin levels in patients with established stable coronary artery disease (CAD)., Methods: In this single-center, cross-sectional analysis, high-sensitivity Troponin T (hsTnT) was measured and IVUS was performed in a predefined non-stenotic segment of a non-culprit coronary artery in 231 patients with stable CAD undergoing elective angiography., Results: HsTnT was detectable (>3 pg/mL) in 212 patients (92%) and a concentration above 14 pg/mL was observed in 19.5%. Normalised segmental plaque volumes were positively associated with hsTnT levels (25.0 mm(3) increase in segmental plaque volume per SD increase in ln-transformed hsTnT, 95% CI: 6.0-44.0, p = 0.010). Higher hsTnT levels were measured in patients with a virtual histology derived thin-cap fibroatheroma (VH-TCFA, adj. odds ratio for presence of VH-TCFA = 1.52 per SD increase in ln-transformed hsTnT, 95% CI: 1.10-2.11, p = 0.011). Patients with a VH-TCFA had a 2-fold increased prevalence of hsTnT concentration ≥14 pg/mL (adj. OR 2.35, 95% CI: 1.12-4.91, p = 0.024). In addition, a 3-fold increased prevalence of hsTnT concentration ≥14 pg/mL was observed in patients with a VH-TCFA with a lesional plaque volume higher than the median (adj. OR 3.36, 95% CI: 1.44-7.84, p = 0.005)., Conclusions: Segmental plaque volume and presence of VH-TCFA lesions are associated with higher circulating hsTnT concentrations in stable CAD patients. Subclinical plaque rupture or erosion and distal embolisation may be hypothesized as a potential pathophysiological mechanism with respect to Troponin elevation and its relation with adverse outcome in this patient population., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Aims: Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES) in patients with STEMI., Methods and Results: ABSORB-STEMI TROFI II was a multicentre, single-blind, non-inferiority, randomized controlled trial. Patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES. The primary endpoint was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition. Between 06 January 2014 and 21 September 2014, 191 patients (Absorb [n = 95] or EES [n = 96]; mean age 58.6 years old; 17.8% females) were enrolled at eight centres. At 6 months, HS was lower in the Absorb arm when compared with EES arm [1.74 (2.39) vs. 2.80 (4.44); difference (90% CI) -1.06 (-1.96, -0.16); Pnon-inferiority < 0.001]. Device-oriented composite endpoint was also comparably low between groups (1.1% Absorb vs. 0% EES). One case of definite subacute stent thrombosis occurred in the Absorb arm (1.1% vs. 0% EES; P = ns)., Conclusion: Stenting of culprit lesions with Absorb in the setting of STEMI resulted in a nearly complete arterial healing which was comparable with that of metallic EES at 6 months. These findings provide the basis for further exploration in clinically oriented outcome trials., (© The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Virtual histology intravascular ultrasound (VH-IVUS) imaging is an innovative tool for the morphological evaluation of coronary atherosclerosis. Evidence for the effects of statin therapy on VH-IVUS parameters have been inconclusive. Consequently, we performed a systematic review and meta-analysis to investigate the impact of statin therapy on plaque volume and its composition using VH-IVUS., Methods: The search included PubMed, Cochrane Library, Scopus and Embase (through 30 November 2014) to identify prospective studies investigating the effects of statin therapy on plaque volume and its composition using VH-IVUS., Results: We identified nine studies with 16 statin treatment arms and 830 participants. There was a significant effect of statin therapy in reducing plaque volume (standardized mean difference (SMD): -0.137, 95 % confidence interval (CI): -0.255, -0.019; P = 0.023), external elastic membrane volume (SMD: -0.097, 95 % CI: -0.183, -0.011; P = 0.027) but not lumen volume (SMD: -0.025, 95 % CI: -0.110, +0.061; P = 0.574). There was a significant reduction in fibrous plaque volume (SMD: -0.129, 95 % CI: -0.255, -0.003; P = 0.045) and an increase of dense calcium volume (SMD: +0.229, 95 % CI: +0.008, +0.450; P = 0.043), while changes in fibro-fatty (SMD: -0.247, 95 % CI: -0.592, +0.098; P = 0.16) and necrotic core (SMD: +0.011, 95 % CI: -0.144, +0.165; P = 0.892) tissue volumes were not statistically significant., Conclusions: This meta-analysis indicates a significant effect of statin therapy on plaque and external elastic membrane volumes and fibrous and dense calcium volumes. There was no effect on lumen volume, fibro-fatty and necrotic tissue volumes.

Background: Three-dimensional (3D) quantitative coronary angiography (QCA) provides more accurate measurements by minimizing inherent limitations of two-dimensional (2D) QCA. The aim of this study was to compare the measurements between 2D and 3D QCA analyses in bifurcation lesions., Methods and Results: A total of 114 cases with non-left main bifurcation lesions in the TRYTON pivotal IDE Coronary Bifurcation Trial (ClinicalTrials.gov: NCT01258972) were analyzed using a validated bifurcation QCA software (CAAS 5.10, Pie Medical Imaging, Maastricht, the Netherlands). All cases were analyzed in matched projections between pre- and post-procedure. The 2D analysis was performed using one of two angiographic images used for 3D reconstruction showing a larger distal bifurcation angle. In the treated segments (stent and balloon), there were no differences in minimal luminal diameter (MLD) between 2D and 3D, while diameter stenosis (DS) was significantly higher in 2D compared to 3D both pre-procedure and post-procedure (53.9% for 2D vs. 52.1% for 3D pre-procedure, P < 0.01; 23.2% for 2D vs. 20.9% for 3D post-procedure, P = 0.01). In the sub-segment level analysis, lengths of proximal main branch, distal main branch, and side branch were consistently shorter in 2D compared to 3D both pre-procedure and post-procedure. Using 3D QCA, the anatomic location of the smallest MLD or the highest DS was relocated to a different bifurcation sub-segment in a considerable proportion of the patients compared to when 2D-QCA was used (kappa values: 0.50 for MLD, 0.55 for DS)., Conclusions: Our data showed differences in addressing anatomical severity and location of coronary bifurcation lesions between in vivo 2D and 3D QCA analyses. More studies are needed to investigate potential clinical benefits in using 3D approach over 2D QCA for the assessment of bifurcation lesions., (© 2015 Wiley Periodicals, Inc.)

Background: Despite the frequent use of spectral analysis of intravascular ultrasound radiofrequency data (VH(®) IVUS) in clinical studies, the assessment for reproducibility using this with high frequency IVUS remains unexplored., Purpose: The aim of this study was to examine the reproducibility of VH IVUS using 45-MHz rotational IVUS in ex vivo human coronary arteries., Methods: Data were collected using 45-MHz VH IVUS (Revolution(®), Volcano Corporation, San Diego, CA, USA) via a series of pullbacks from eight human coronary artery specimens. Imaging data were analyzed by two independent observers. Intraobserver and interobserver reproducibility were assessed using five pullbacks from five vessels. The intercatheter reproducibility was assessed using three different catheters in each of the five vessels. The intracatheter reproducibility was assessed between the two sequential pullbacks from each of the 15 catheters used in the intercatheter assessment., Results: Geometrical measurements consistently showed low variability (relative difference <10%) and excellent intraclass correlation coefficients (ICCs), ranging from 0.88 to 1.00. With respect to the compositional measurements, the relative differences were predominantly higher than those of geometrical measurements. In particular, fibrous-fatty area showed a higher relative difference (17.5% in intercatheter assessment) compared to fibrous, necrotic core, and dense calcium areas (6.5%, 8.4%, and 6.4%, respectively). However, each compositional measurement also showed acceptable reproducibility (ICCs ranging from 0.82 to 1.00)., Conclusions: The 45-MHz rotational VH IVUS technology had acceptable reproducibility with respect to geometrical and compositional assessments in ex vivo human coronary arteries. These data are crucial when designing future longitudinal studies addressing geometrical measurements and plaque characterization by 45-MHz VH IVUS., (Copyright © 2014 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Background: Near-infrared spectroscopy (NIRS) is capable of identifying lipid core-containing plaques, which can subsequently be quantified as a lipid core burden index (LCBI). Currently, no data are available on the long-term prognostic value of NIRS in patients with coronary artery disease (CAD)., Objectives: This study sought to determine the long-term prognostic value of intracoronary NIRS as assessed in a nonculprit vessel in patients with CAD., Methods: In this prospective, observational study, NIRS imaging was performed in a nonculprit coronary artery in 203 patients referred for angiography due to stable angina pectoris (SAP) or acute coronary syndrome (ACS). The primary endpoint was the composite of all-cause mortality, nonfatal ACS, stroke, and unplanned coronary revascularization., Results: The 1-year cumulative incidence of the primary endpoint was 10.4%. Cumulative 1-year rates in patients with an LCBI equal to and above the median (43.0) versus those with LCBI values below the median were 16.7% versus 4.0% (adjusted hazard ratio: 4.04; 95% confidence interval: 1.33 to 12.29; p = 0.01). The relation between LCBI and the primary endpoint was similar in SAP and ACS patients (p value for heterogeneity = 0.14). Similar differences between high and low LCBI were observed in pre-specified secondary endpoints., Conclusion: CAD patients with an LCBI equal to or above the median of 43.0, as assessed by NIRS in a nonculprit coronary artery, had a 4-fold risk of adverse cardiovascular events during 1-year follow-up. This observation warrants confirmation by larger studies with extended follow-up. (The European Collaborative Project on Inflammation and Vascular Wall Remodeling in Atherosclerosis - Intravascular Ultrasound Study [AtheroRemoIVUS]; NCT01789411)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: To investigate the incidence of incomplete stent apposition and to explore the impact of the presence of thrombus and protruding plaque after stent implantation on neointima formation at follow-up in ST-segment elevation myocardial infarction (STEMI) patients with serial optical frequency domain imaging (OFDI) investigations., Methods and Results: In a multi-centre study, 141 patients with ST elevation myocardial infarction <12 h from onset were randomized to either PPCI with thrombectomy (TB) using an Eliminate catheter (TB: n = 71) or without TB (non-TB: n = 70). OFDI after drug-eluting stenting was performed using TERUMO OFDI system. Per protocol, at follow-up 49 patients segments were reimaged. At post-procedure and follow-up, there were no differences in stent and lumen areas between the two groups. At follow-up, per strut-level analysis, percentage of incompletely apposed struts was 0.42 ± 0.94 vs. 0.38 ± 0.77% (P = 0.76), and percentage of covered struts was 92.7 ± 7.2 vs. 94.4 ± 9.2% (P = 0.47) in the TB and non-TB groups, respectively. There was a positive correlation between intra-stent structure (ISS) volume at post-procedure and the neointima volume at 6-month follow-up (Pearson's r = 0.409, P = 0.04). Up to 12 months, there have been two and four patients having target vessel failure in the TB and in the non-TB groups, respectively., Conclusions: In patients with STEMI, there were no significant differences in OFDI parameters between TB and non-TB groups at both post-procedure and 6-month follow-up. However, ISS volume at post-procedure was positively associated with neointimal volume at 6-month follow-up., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

Background: Coronary plaque size modification, by either local (device) or systemic treatments, has been the target for many years., Methods: From ABSORB Cohort A (Absorb BVS 1.0), ABSORB Cohort B (Absorb BVS 1.1), SPIRIT FIRST (Multi-Link Vision vs. Xience V) & SPIRIT II (Xience V vs. Taxus), we calculated the total plaque area (vessel minus lumen area - thus it comprises both compartments - the plaque behind struts and the neointima.) changes by IVUS., Results: A total of 313 patients were included. Comparison-at-6-month follow-up: All devices induced an increase in the total plaque area. The largest increase occurred with Vision and Taxus stents as compared to other devices [Absorb BVS (1.0 and 1.1) and Xience V], (p=0.0002). Comparison-at-2-year follow-up: Absorb BVS 1.1 had a larger increase from post procedure in total plaque compared to Absorb BVS 1.0, Xience V and Taxus (p=0.0499). However, in Absorb BVS 1.1 total plaque showed a reduction of 2.2% from 1 to 3 years. Specifically, the total plaque in the sequential cohorts of Absorb BVS 1.1 increased 16.2% from baseline to 2 years (Cohort B1) while at 3 years this increase is only 5% compared to baseline (Cohort B2)., Conclusions: Local devices affect coronary plaque size differently and it depends on the platform (metallic vs. polymeric) and on whether it is a bare - or drug eluting stent. Coronary scaffolds appear to be a promising alternative to metallic stents since they allow plaque regression at long-term follow-up., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Objectives: The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS)., Background: Clinical outcomes of diabetic patients after BVS implantation have been unreported., Methods: This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up., Results: The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group)., Conclusions: In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and diabetic patients treated with EES at 1-year follow-up. (ABSORB Clinical Investigation, Cohort B; NCT00856856; ABSORB EXTEND Clinical Investigation; NCT01023789; Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT FIRST]; NCT00180453; A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT II]; NCT00180310; Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System [EECSS] [SPIRIT III]; NCT00180479; Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT IV Clinical Trial]; NCT00307047)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aimed to update the Logistic Clinical SYNTAX score to predict 3-year survival after percutaneous coronary intervention (PCI) and compare the performance with the SYNTAX score alone., Background: The SYNTAX score is a well-established angiographic tool to predict long-term outcomes after PCI. The Logistic Clinical SYNTAX score, developed by combining clinical variables with the anatomic SYNTAX score, has been shown to perform better than the SYNTAX score alone in predicting 1-year outcomes after PCI. However, the ability of this score to predict long-term survival is unknown., Methods: Patient-level data (N = 6,304, 399 deaths within 3 years) from 7 contemporary PCI trials were analyzed. We revised the overall risk and the predictor effects in the core model (SYNTAX score, age, creatinine clearance, and left ventricular ejection fraction) using Cox regression analysis to predict mortality at 3 years. We also updated the extended model by combining the core model with additional independent predictors of 3-year mortality (i.e., diabetes mellitus, peripheral vascular disease, and body mass index)., Results: The revised Logistic Clinical SYNTAX models showed better discriminative ability than the anatomic SYNTAX score for the prediction of 3-year mortality after PCI (c-index: SYNTAX score, 0.61; core model, 0.71; and extended model, 0.73 in a cross-validation procedure). The extended model in particular performed better in differentiating low- and intermediate-risk groups., Conclusions: Risk scores combining clinical characteristics with the anatomic SYNTAX score substantially better predict 3-year mortality than the SYNTAX score alone and should be used for long-term risk stratification of patients undergoing PCI., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The prevalence and clinical sequelae of optical frequency domain imaging (OFDI)-detected intimal flaps caused by vessel trauma or plaque rupture in the proximal native coronary arteries have not been described. Methods and Results: OFDI investigation was performed following stent implantation in patients with ST-segment elevation myocardial infarction (STEMI). We defined a flap-like structure (FS) as a disruption or discontinuation of the endoluminal vessel surface, and classified as actual flap or artifact. FS in the left main stem, or maximally 20mm distal to the guiding catheter in the proximal right coronary artery were assessed. A total of 8,931 frames in 97 patients were analyzed in a frame-by-frame fashion (0.125-mm interval). OFDI identified 8 FS in 7 patients, none of which was evident angiographically. All FS were left untreated because the operators per protocol were blinded to the OFDI images. A total of 5 FS in 5 patients (5.1%) appeared to be actual flaps in which only the intima was involved (mean distance from guiding catheter: 4.8±2.7mm). The remaining 3 FS in 3 patients were artifacts; namely, residual blood and interface light reflectivity. There were no adverse cardiac events during 6-months follow-up. Conclusions: In 5.1% of STEMI patients, post-procedural OFDI identified flaps with minimal involvement of the intima in the proximal coronary arteries. A precise interpretation of FS may help decision making to avoid unnecessary procedures. (Clinical Trial Registration Information: ClinicalTrials.gov identifier: NCT01271361.).

First generation drug-eluting stents have considerably reduced in-stent restenosis and broadened the applications of percutaneous coronary interventions for the treatment of coronary artery disease. The polymer is an integral part of drug-eluting stents in that, it controls the release of an antiproliferative drug. The main safety concern of first generation drug-eluting stents with permanent polymers--stent thrombosis--has been caused by local hypersensitivity, delayed vessel healing, and endothelial dysfunction. This has prompted the development of newer generation drug-eluting stents with biodegradable polymers or even polymer-free drug-eluting stents. Recent clinical trials have shown the safety and efficacy of drug-eluting stents with biodegradable polymer, with proven reductions in very late stent thrombosis as compared to first generation drug-eluting stents. However, the concept of using a permanent metallic prosthesis implies major drawbacks, such as the presence of a foreign material within the native coronary artery that causes vascular inflammation and neoatherosclerosis, and also impedes the restoration of the vasomotor function of the stented segment. Bioresorbable scaffolds have been introduced to overcome these limitations, since they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage. This update article presents the current status of these new technologies and highlights their future perspectives in interventional cardiology., (Copyright © 2012 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.)

Objectives: The aim of this study was to investigate the incidence and clinical sequelae of small side branch occlusion (SBO) after Absorb (Abbott Vascular, Santa Clara, California) bioresorbable vascular scaffold (BVS) implantation., Background: The thicker strut of metallic stents potentially contributes to a higher incidence of SBO., Methods: We performed a post-hoc angiographic assessment of 1,209 side branches in 435 patients enrolled in the ABSORB-EXTEND single-arm trial (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions), in comparison with 682 side branches in 237 patients treated with the everolimus-eluting metallic stent (EES) in the SPIRIT (A Clinical Evaluation of an Investigational Device. The Abbott XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) first and II trials. Any visible side branches originating within the device implantation site or the 5-mm proximal and distal margins were included in the angiographic assessment. The SBO was defined as a reduction in Thrombolysis In Myocardial Infarction flow grade 0 or 1., Results: Post-procedural SBO was observed in 73 side branches (6.0%) in BVS group and 28 side branches (4.1%) in EES group (p = 0.09). Patients with post-procedural SBO were significantly associated with an increased incidence of in-hospital myocardial infarction (6.5% in SBO group vs. 0.5% in non-SBO group, p < 0.01). Multivariable analysis revealed that BVS was an independent predictor of post-procedural SBO (odds ratio: 2.09; 95% confidence interval: 1.18 to 3.68). By stratified analysis, BVS demonstrated a higher incidence of post-procedural SBO compared with EES only in small side branches with a reference vessel diameter ≤0.5 mm (10.5% vs. 3.9%, p = 0.03 between the groups, p for interaction = 0.08)., Conclusions: Bioresorbable vascular scaffold was associated with a higher incidence of post-procedural SBO compared with EES. This effect was more pronounced with small side branches with a reference vessel diameter ≤0.5 mm. (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions: NCT01023789)., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We compared the incidence of late increase in hs-cTnI between ACS and non-ACS patients treated with standard of care with or without darapladib., Methods: A total of 323 (161 ACS and 162 non-ACS patients) were included. High sensitivity troponin I was measured at baseline and at 4, 13, 26 and 52 weeks., Results: ACS patients had statistically higher hs-cTnI values during longer term follow-up at which these patients were no longer in the acute setting of myocardial ischemia, but were regarded to have stable CAD (mean hsTnI value in ACS patients: 1.180 versus 0.886 ng/L in non-ACS patients, p = 0.02). Multivariate logistic regression revealed three predictors of any 2-fold increase in hs-cTnI levels compared to the previous visit when interactions were not considered. Treatment with darapladib (adjusted OR 0.53; 95% CI: 0.30-0.92) and initial presentation with ACS (adjusted OR 0.42; 95% CI: 0.23-0.77) were associated with less frequent occurrence of a 2-fold increase in hs-cTnI levels. In contrast, diabetes was associated with a higher incidence of 2-fold increases in hs-cTnI levels (adjusted OR 2.20; 95% CI: 1.04-4.64). Logistic regression to predict any 2-fold increase in hs-cTnI by ACS status showed that in the ACS group, treatment with darapladib decreased the risk of elevation of hs-cTnI (OR 0.219; 95% CI: 0.087, 0.553, p = 0.0013)., Conclusion: In patients with ACS, treatment with darapladib is associated with less increase in cardiac troponin I compared to standard of care alone. This beneficial effect may be associated with darapladib's capability of reducing necrotic core in coronary plaques., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Objective: To report the agreement between gray-scale intravascular ultrasound (GS-IVUS) and optical coherence tomography (OCT) in assessing the bioresorbable vascular scaffolds (BVS) structures and their respective reproducibility., Background: BVS are composed of an erodible polymer. Ultrasound and light signals backscattered from polymeric material differs from metallic stents using GS-IVUS and OCT., Methods: Forty-five patients included in the ABSORB trial were treated with a 3.0 × 18 mm BVS and imaged with GS-IVUS 20 MHz and OCT post-implantation. Qualitative (ISA, side-branch struts, protrusion, and dissections) and quantitative (number of struts, lumen, and scaffold area) measurements were assessed by two investigators. The agreement and the inter- and intraobserver reproducibility were investigated using the kappa (κ) and the interclass correlation coefficient (ICC)., Results: GS-IVUS and OCT agreement was predominantly poor at a lesion, frame, and strut level analysis (κ and ICC <0.4) for qualitative measurements. GS-IVUS demonstrated a reduced ability to detect cross-sections with ISA (4.5% vs. 20.6%), side-branch (SB) struts (6.3% vs. 7.8%), protrusions (3.2% vs. 9.6%), and dissections (0.2% vs. 9.0%) compared with OCT. GS-IVUS reproducibility was poor-moderate (κ and ICC <0.6) except for ISA and SB-struts (κ and ICC between 0.2 and 0.75). OCT showed an excellent reproducibility (κ and ICC > 0.75) except for the assessment of tissue protrusion (κ and ICC between 0.47 and 0.94). GS-IVUS reproducibility was poor-moderate (ICC ≤ 0.5) in assessing the number of struts but excellent with OCT (ICC > 0.85). The reproducibility to assess lumen and scaffold areas was excellent using both techniques (ICC > 0.85)., Conclusions: GS-IVUS has a poor capacity to detect qualitative findings post-BVS implantation and its reproducibility is low compared with OCT. The use of GS-IVUS should be limited when assessing lumen and scaffold areas., (Copyright © 2011 Wiley Periodicals, Inc.)

We explored the impact of patient demographics, anthropometric measurements, cardiovascular risk factors, and soluble biomarkers on necrotic core and atheroma size in patients with coronary disease. The IBIS-2 trial enrolled 330 patients. In the multivariate analysis, at baseline, creatinine had a positive, whereas baseline mean lumen diameter and myeloperoxidase had a negative, independent association with percentage of necrotic core (PNC); while age, glomerular filtration rate <60, HbA1c, previous PCI or CABG and baseline % diameter stenosis were positively, and acute coronary syndromes (ACS) were negatively associated with baseline percentage atheroma volume (PAV). The variables associated with a decrease in PNC from baseline were darapladib, ACS and a large content of NC at baseline, while variables associated with an increase in PNC were previous stroke and % diameter stenosis at baseline. Those variables associated with a decrease in PAV from baseline were waist circumference, statin use, CD40L and baseline PAV, while the only variable associated with an increase in PAV was baseline diastolic blood pressure. Treatment with darapladib was associated with a decrease in necrotic core, but was not associated with a decrease in percentage atheroma volume. On the contrary, statin use was only associated with a decrease in percentage atheroma volume.