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Background: Segmental postpercutaneous coronary intervention (PCI) pressure gradients may detect residual disease and potential targets for optimization. However, universal definitions of relevant segmental gradients are lacking., Objectives: This study sought to evaluate the diagnostic performance of post-PCI fractional flow reserve (FFR), distal coronary pressure-to-aortic pressure ratio (Pd/Pa), and diastolic pressure ratio (dPR) gradients to detect residual focal lesions and stent underexpansion as observed by intravascular ultrasound (IVUS)., Methods: Patients from the IVUS-guided optimization arm of the FFR REACT (FFR-guided PCI Optimization Directed by High-Definition IVUS Versus Standard of Care) trial with complete IVUS and FFR pullback data were included. Patients with angiographically successful PCI and post-PCI FFR <0.90 underwent FFR, Pd/Pa, and IVUS pullbacks. dPR was calculated offline using dedicated software. Segmental pressure gradients (distal, in stent, and proximal) in segments ≥5 mm were evaluated against IVUS-detected residual disease (distal or proximal focal lesions and stent underexpansion)., Results: A total of 139 vessels were included (mean post-PCI FFR: 0.83 ± 0.05, range 0.56-0.89). Focal distal and proximal lesions were detected by IVUS in 23 (17.4%) of 132 and 14 (12.6%) of 111 vessels, respectively, whereas stent underexpansion was present in 86 (61.9%) vessels. Diagnostic ability of segmental FFR gradients to predict IVUS-detected distal and proximal lesions was moderate-to-good (area under the curve [AUC]: 0.69 and 0.84, respectively) and poor to moderate for segmental Pd/Pa and dPR gradients (AUC ranging from 0.58 to 0.69). In-stent gradients had no discriminative ability to detect stent underexpansion (FFR AUC: 0.52; Pd/Pa AUC: 0.54; dPR AUC: 0.55)., Conclusions: In patients with post-PCI FFR <0.90, segmental post-PCI pressure gradients have moderate discriminative ability to identify IVUS-detected focal lesions but no discriminative ability to identify IVUS-detected stent underexpansion., Competing Interests: Funding Support and Author Disclosures The Erasmus Medical Center received institutional research support from ACIST Medical Systems, Inc. Ms Neleman and Dr Diletti have received institutional grant support from ACIST Medical Systems. Dr Van Mieghem has received institutional research grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Daiichi Sankyo, PulseCath BV, and Abiomed. Dr Daemen has received institutional grant/research support from Abbott Vascular, Boston Scientific, ACIST Medical Systems, Medtronic, Pie Medical, and ReCor medical; and received consulting and lecture fees from Abbott Vascular, Abiomed, ACIST Medical Systems, Boston Scientific, Cardialysis BV, CardiacBooster, Kaminari Medical, ReCor Medical, PulseCath, Pie Medical, Sanofi, Siemens Health Care and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023. Published by Elsevier Inc.)

Background: Severe coronary artery calcification is associated with stent underexpansion and subsequent stent failure., Aims: We aimed to identify optical coherence tomography (OCT)-derived predictors of absolute (minimal stent area [MSA]) and relative stent expansion in calcified lesions., Methods: This retrospective cohort study included patients who underwent percutaneous coronary intervention (PCI) with OCT assessment before and after stent implantation between May 2008 and April 2022. Pre-PCI OCT was used to assess calcium burden and post-PCI OCT was used to assess absolute and relative stent expansion., Results: A total of 361 lesions in 336 patients were analyzed. Target lesion calcification (defined as OCT-detected maximum calcium angle ≥ 30°) was present in 242 (67.0%) lesions. Following PCI, median MSA was 5.37 mm 2 in calcified lesions and 6.24 mm 2 in noncalcified lesions (p < 0.001). Median stent expansion was 78% in calcified lesions and 83% in noncalcified lesions (p = 0.325). In the subset of calcified lesions, average stent diameter, preprocedural minimal lumen area, and total calcium length were independent predictors of MSA in multivariable analysis (mean difference 2.69 mm 2 /mm 2 , 0.52 mm 2 /mm, and -0.28 mm 2 /5 mm, respectively, all p < 0.001). Total stent length was the only independent predictor of relative stent expansion (mean difference -0.465% per mm, p < 0.001). Calcium angle, thickness, and the presence of nodular calcification were not significantly associated with MSA or stent expansion in multivariable analyses., Conclusion: Calcium length appeared to be the most important OCT-derived predictor of MSA, whereas stent expansion was mainly determined by total stent length., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Objective: Thinner stent struts might lead to a higher risk of recoil and subsequently a smaller minimal stent area (MSA), which is known to be the strongest predictor of stent failure. We compared procedural performance between an ultrathin-strut biodegradable-polymer sirolimus-eluting stent (BP-SES) and a durable-polymer zotarolimus-eluting stent (DP-ZES) using intracoronary imaging., Methods: A consecutive cohort of patients underwent percutaneous coronary intervention (PCI) with either BP-SES or DP-ZES in a pseudorandomized fashion between July 2018 and October 2019. In the present subanalysis, we included cases in which post-PCI imaging with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was performed. The primary endpoint of the study was MSA. Secondary endpoints included percentage stent expansion and presence of residual edge disease, malapposition, tissue protrusion, submedial edge dissections, or edge hematoma., Results: A total of 141 treated lesions (78 BP-SES and 63 DP-ZES) in 127 patients were analyzed. Median age was 69.3 years (interquartile range [IQR], 57.3-75.6) and 74.0% of patients were male. All baseline and procedural characteristics were comparable between both groups. Median MSA was 5.80 mm² (IQR, 4.40-7.24) for BP-SES and 6.35 mm² (IQR, 4.76-8.31) for DP-ZES (P=.15). No significant differences in stent expansion, residual edge disease and presence of malapposition, tissue protrusion, submedial edge dissections, or edge hematomas were found. Stent diameter and stent length were found to be independent predictors of MSA., Conclusions: No significant differences in MSA were found between lesions treated with BP-SES vs DP-ZES. BP-SES and DP-ZES were comparable in terms of procedural performance.

Background: Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) <0.90 is common and has been related to impaired patient outcome., Objectives: The authors sought to evaluate if PCI optimization directed by intravascular ultrasound (IVUS) in patients with post-PCI FFR <0.90 could improve 1-year target vessel failure (TVF) rates., Methods: In this single-center, randomized, double-blind trial, patients with a post-PCI FFR <0.90 at the time of angiographically successful PCI were randomized to IVUS-guided optimization or the standard of care (control arm). The primary endpoint was TVF (a composite of cardiac death, spontaneous target vessel myocardial infarction, and clinically driven target vessel revascularization) at 1 year., Results: A total of 291 patients with post-PCI FFR <0.90 were randomized (IVUS-guided optimization arm: n = 145/152 vessels, control arm: n = 146/157 vessels). The mean post-PCI FFR was 0.84 ± 0.05. A total of 104 (68.4%) vessels in the IVUS-guided optimization arm underwent additional optimization including additional stenting (34.9%) or postdilatation only (33.6%), resulting in a mean increase in post-PCI FFR in these vessels from 0.82 ± 0.06 to 0.85 ± 0.05 (P < 0.001) and a post-PCI FFR ≥0.90 in 20% of the vessels. The 1-year TVF rate was comparable between the 2 study arms (IVUS-guided optimization arm: 4.2%, control arm: 4.8%; P = 0.79). There was a trend toward a lower incidence of clinically driven target vessel revascularization in the IVUS-guided optimization arm (0.7% vs. 4.2%, P = 0.06)., Conclusions: IVUS-guided post-PCI FFR optimization significantly improved post-PCI FFR. Because of lower-than-expected event rates, post-PCI FFR optimization did not significantly lower TVF at the 1-year follow-up., Competing Interests: Funding Support and Author Disclosures The Erasmus Medical Center received institutional research support from ACIST Medical Systems, Inc. Dr Diletti has received institutional research grant support from ACIST Medical Systems, Inc. Dr Van Mieghem has received institutional research grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Daiichi-Sankyo, PulseCath BV, and Abiomed. Dr Daemen has received institutional grant/research support from AstraZeneca, Abbott Vascular, Boston Scientific, ACIST Medical Systems, Inc, Medtronic, Pie Medical, and ReCor medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Vessel Fractional Flow Reserve (vFFR) as assessed by three-dimensional quantitative coronary angiography has high correlation with pressure wire-based fractional flow reserve in both a pre- and post-PCI setting. The present study aims to assess the prognostic value of post-PCI vFFR on the incidence of target vessel failure (TVF), a composite endpoint of cardiac death, target vessel myocardial infarction and target vessel revascularization (TVR) at 5-year follow up., Methods: Post-PCI vFFR was calculated after routine PCI in a total of 748 patients (832 vessels) with available orthogonal angiographic projections of the stented segment., Results: Median age was 65 (IQR 55-74) years, 18.2% were diabetic, and 29.1% presented with stable angina. Median post-PCI vFFR was 0.91 (IQR 0.86-0.95). Vessels were categorized into tertiles based on post-PCI vFFR: low (vFFR <0.88), middle (vFFR 0.88-0.93), and upper (vFFR ≥0.94). Vessels in the lower and middle tertile were more often LADs and had smaller stent diameters (p<0.001). Vessels in the lower and middle tertile had a higher risk of TVF as compared to vessels in the upper tertile (24.6% and 21.5% vs. 17.1%; adjusted HR 1.84 (95%CI 1.15-2.95), p = 0.011, and 1.58 (95%CI 1.02-2.45), p = 0.040) at 5-years follow-up. Additionally, vessels in the lower tertile had higher rates of TVR as compared to vessels in the higher tertile (12.6% vs. 6.5%, adjusted HR 1.93 (95%CI 1.06-3.53), p = 0.033)., Conclusion: Lower post-PCI vFFR values are associated with a significantly increased risk of TVF and TVR at 5-years follow-up., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Coronary calcification has been linked to cardiovascular events. We developed and validated an algorithm to automatically quantify coronary calcifications on intravascular ultrasound (IVUS). We aimed to assess the prognostic value of an IVUS-calcium score (ICS) on patient-oriented composite endpoint (POCE)., Methods: We included patients that underwent coronary angiography plus pre-procedural IVUS imaging. The ICS was calculated per patient. The primary endpoint was a composite of all-cause mortality, stroke, myocardial infarction, and revascularization (POCE)., Results: In a cohort of 408 patients, median ICS was 85. Both an ICS ≥ 85 and a 100 unit increase in ICS increased the risk of POCE at 6-year follow-up (adjusted hazard ratio (aHR) 1.51, 95%CI 1.05-2.17, p value = 0.026, and aHR 1.21, 95%CI 1.04-1.41, p value = 0.014, respectively)., Conclusions: The ICS, calculated by a validated automated algorithm derived from routine IVUS pullbacks, was strongly associated with the long-term risk of POCE., (© 2021. The Author(s).)

Coronary calcification represents a challenge in the treatment of coronary artery disease by stent placement. It negatively affects stent expansion and has been related to future adverse cardiac events. Intravascular ultrasound (IVUS) is known for its high sensitivity in detecting coronary calcification. At present, automated quantification of calcium as detected by IVUS is not available. For this reason, we developed and validated an optimized framework for accurate automated detection and quantification of calcified plaque in coronary atherosclerosis as seen by IVUS. Calcified lesions were detected by training a supported vector classifier per IVUS A-line on manually annotated IVUS images, followed by post-processing using regional information. We applied our framework to 35 IVUS pullbacks from each of the three commonly used IVUS systems. Cross-validation accuracy for each system was >0.9, and the testing accuracy was 0.87, 0.89 and 0.89 for the three systems. Using the detection result, we propose an IVUS calcium score, based on the fraction of calcium-positive A-lines in a pullback segment, to quantify the extent of calcified plaque. The high accuracy of the proposed classifier suggests that it may provide a robust and accurate tool to assess the presence and amount of coronary calcification and, thus, may play a role in image-guided coronary interventions., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the very long-term clinical outcome after radioactive stent (RS) implantation and intracoronary β radiation brachytherapy (IRBT)., Background: Radioactive stents (RS) and intracoronary β radiation brachytherapy (IRBT) were introduced to prevent restenosis after percutaneous coronary intervention (PCI). Both techniques were associated with a higher incidence of major adverse cardiac events (MACE) in the short and intermediate-term follow up as compared to conventional PCI., Methods: One hundred and thirty-three patients received radioactive stents ( 32 P) and 301 patients were treated with IRBT adjunctive to PCI. These groups were propensity matched to respectively 266 and 602 control patients who were treated with routine PCI during the same inclusion period. Endpoints were all-cause mortality and MACE, defined as all-cause death, any myocardial infarction or any revascularization., Results: Median follow-up duration was 17 years. All-cause mortality rates were similar in all groups. Adjusted hazard ratios for MACE and mortality in the RS cohort were 1.55 (95% CI 1.20-2.00) and 0.92 (95% CI 0.63-1.34), respectively. Adjusted hazard ratios for MACE and all-cause mortality in the IRBT cohort were 1.41 (95% CI 1.18-1.67) and 0.95 (95% CI 0.74-1.21), respectively. The difference in MACE rates was predominantly driven by coronary revascularizations in both groups, with a higher MI rate in the IRBT group as well., Conclusions: Coronary radiation therapy was associated with early increased MACE rates, but the difference in MACE rates decreased beyond 2 years, resulting in a comparable long-term clinical outcome. Importantly, no excess in mortality was observed., (© 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.)

To quantify the impact of cardiac motion on stent length measurements with Optical Coherence Tomography (OCT) and to demonstrate in vivo OCT imaging of implanted stents, without motion artefacts. The study consists of: clinical data evaluation, simulations and in vivo tests. A comparison between OCT-measured and nominal stent lengths in 101 clinically acquired pullbacks was carried out, followed by a simulation of the effect of cardiac motion on stent length measurements, experimentally and computationally. Both a commercial system and a custom OCT, capable of completing a pullback between two consecutive ventricular contractions, were employed. A 13 mm long stent was implanted in the left anterior descending branch of two atherosclerotic swine and imaged with both OCT systems. The analysis of the clinical OCT images yielded an average difference of 1.1 ± 1.6 mm, with a maximum difference of 7.8 mm and the simulations replicated the statistics observed in clinical data. Imaging with the custom OCT, yielded an RMS error of 0.14 mm at 60 BPM with the start of the acquisition synchronized to the cardiac cycle. In vivo imaging with conventional OCT yielded a deviation of 1.2 mm, relative to the length measured on ex-vivo micro-CT, while the length measured in the pullback acquired by the custom OCT differed by 0.20 mm. We demonstrated motion artefact-free OCT-imaging of implanted stents, using ECG triggering and a rapid pullback.

Objective: In an adult porcine model of familial hypercholesterolemia (FH), coronary plaque development was characterized. To elucidate the underlying mechanisms of the observed inter-individual variation in disease severity, detailed lipoprotein profiles were determined. Approach and Results: FH pigs (3 years old, homozygous LDLR R84C mutation) received an atherogenic diet for 12 months. Coronary atherosclerosis development was monitored using serial invasive imaging and histology. A pronounced difference was observed between mildly diseased pigs which exclusively developed early lesions (maximal plaque burden, 25% [23%-34%]; n=5) and advanced-diseased pigs (n=5) which developed human-like, lumen intruding plaques (maximal plaque burden, 69% [57%-77%]) with large necrotic cores, intraplaque hemorrhage, and calcifications. Advanced-diseased pigs and mildly diseased pigs displayed no differences in conventional risk factors. Additional plasma lipoprotein profiling by size-exclusion chromatography revealed 2 different LDL (low-density lipoprotein) subtypes: regular and larger LDL. Cholesterol, sphingosine-1-phosphate, ceramide, and sphingomyelin levels were determined in these LDL-subfractions using standard laboratory techniques and high-pressure liquid chromatography mass-spectrometry analyses, respectively. At 3 months of diet, regular LDL of advanced-diseased pigs contained relatively more cholesterol (LDL-C; regular/larger LDL-C ratio 1.7 [1.3-1.9] versus 0.8 [0.6-0.9]; P =0.008) than mildly diseased pigs, while larger LDL contained more sphingosine-1-phosphate, ceramides, and sphingomyelins. Larger and regular LDL was also found in plasma of 3 patients with homozygous FH with varying LDL-C ratios., Conclusions: In our adult FH pig model, inter-individual differences in atherosclerotic disease severity were directly related to the distribution of cholesterol and sphingolipids over a distinct LDL profile with regular and larger LDL shortly after the diet start. A similar LDL profile was detected in patients with homozygous FH.

Background: Certain immunoglobulins (Ig) are proposed to have protective functions in atherosclerosis., Objectives: We tested whether serum levels of IgG and IgM autoantibodies against malondialdehyde low density lipoprotein (MDA-LDL) are associated with clinical coronary heart disease (CHD) and unfavorable plaque characteristics., Methods: NORDIL was a prospective study investigating adverse cardiovascular outcomes in hypertensive patients. IBIS-3 analyzed lesions in a non-culprit coronary artery with <50% stenosis using radiofrequency intravascular ultrasound (RF-IVUS) and near-infrared spectroscopy (NIRS). Imaging was repeated after a median of 386?days on rosuvastatin. Associations of antibodies with incident CHD and imaging parameters were assessed in the two sub-studies respectively., Findings: From 10,881 NORDIL patients, 87 had serum sampled at baseline and developed CHD over 4.5 years, matched to 227 controls. Higher titers of IgM anti-MDA-LDL had a protective effect on adverse outcomes, with odds ratio 0.29 (0.11, 0.76; p=0.012; p=0.016 for trend). Therefore, the effect was explored at the lesional level in IBIS-3. 143 patients had blood samples and RF-IVUS measurements available, and NIRS was performed in 90 of these. At baseline, IgM anti-MDA-LDL levels had a strong independent inverse relationship with lesional necrotic core volume (p=0.027) and percentage of plaque occupied by necrotic core (p=0.011), as well as lipid core burden index (p=0.024) in the worst 4 mm segment., Interpretation: Our study supports the hypothesis that lower circulating levels of IgM anti-MDA-LDL are associated with clinical CHD development, and for the first time relates these findings to atherosclerotic plaque characteristics that are linked to vulnerability., (© 2018 The Authors. Published by Elsevier B.V.)

Aims: The European Collaborative Project on Inflammation and Vascular Wall Remodeling in Atherosclerosis - Intravascular Ultrasound (ATHEROREMO-IVUS) study was designed as an exploratory clinical study in order to investigate the associations between genetic variation, coronary atherosclerosis phenotypes, and plaque vulnerability as determined by IVUS., Methods and Results: The ATHEROREMO-IVUS study was a prospective, observational study of 581 patients with stable angina pectoris or acute coronary syndrome (ACS) who were referred for coronary angiography to the Thoraxcenter, Rotterdam, enriched with 265 IBIS-2 participants (total population, n=846). Prior to catheterisation, blood samples were drawn for genetic analyses. During the catheterisation procedure, IVUS was performed in a non-culprit coronary artery. The primary endpoint was the presence of vulnerable plaque as determined by IVUS virtual histology (VH). In addition, we performed a genome-wide association study of plaque morphology. We observed strong signals associated with plaque morphology in several chromosomal regions: twelve SNPs (rs17300022, rs6904106, rs17177818, rs2248165, rs2477539, rs16865681, rs2396058, rs4753663, rs4082252, rs6932, rs12862206, rs6780676) in or near eight different genes (GNA12, NMBR, SFMBT2, CUL3, SESN3, SLC22A25, EFBN2, SEC62) were most significant., Conclusions: In conclusion, we found twelve SNPs in or in the proximity of eight genes, which were possibly associated with markers of vulnerable plaque. ClinicalTrials.gov Identifier: NCT01789411.

Aims: Previous studies have reported the safety and feasibility of both time-domain optical coherence tomography (TD-OCT) and Fourier-domain OCT (FD-OCT) in highly selected patients and clinical settings. However, the generalizability of these data is limited, and data in unselected patient populations reflecting a routine cathlab practice are lacking. We compared safety of intracoronary FD-OCT imaging to intravascular ultrasound (IVUS) imaging in a large real-world series of consecutive patients who underwent invasive imaging during coronary catheterization in our centre., Methods and Results: This is a prospective, single-centre registry of patients scheduled for coronary angiography or intervention undergoing intracoronary imaging with FD-OCT or IVUS between April 2008 and December 2013. Intra-procedural and major in-hospital adverse events that could be possibly related to invasive imaging were registered routinely by the operator as part of our clinical report and prospectively recorded in our database. These events were retrospectively individually adjudicated by an independent safety committee. Between April 2008 and December 2013, 13 418 diagnostic or interventional coronary catheterization procedures were performed. Of these, 1142 procedures used OCT and 2476 procedures used IVUS. Invasive imaging-related complications were rare, did not differ between the two imaging methods (OCT: n = 7, 0.6%; IVUS: n = 12, 0.5%; P = 0.6), and were self-limiting after retrieval of the imaging catheter or easily treatable in the catheterization laboratory. No major adverse events, prolongation of hospital stay, or permanent patient harm was observed., Conclusion: FD-OCT is safe in an unselected and heterogeneous group of patients with varying clinical settings., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Background: Limited data are available on bioresorbable vascular scaffolds (BVS) performance in bifurcations lesions and on the impact of BVS wider struts on side-branch impairment., Methods: Patients with at least one coronary bifurcation lesion involving a side-branch ≥2mm in diameter and treated with at least one BVS were examined. Procedural and angiographic data were collected and a dedicated methodology for off-line quantitative coronary angiography (QCA) in bifurcation was applied (eleven-segment model), to assess side-branch impairment occurring any time during the procedure. Two- and three-dimensional QCA were used. Optical coherence tomography (OCT) analysis was performed in a subgroup of patients and long-term clinical outcomes reported., Results: A total of 102 patients with 107 lesions, were evaluated. Device- and procedural-successes were 99.1% and 94.3%, respectively. Side-branch impairment occurring any time during the procedure was reported in 13 bifurcations (12.1%) and at the end of the procedure in 6.5%. Side-branch minimal lumen diameter (Pre: 1.45±0.41mm vs Final: 1.48±0.42mm, p=0.587) %diameter-stenosis (Pre: 26.93±16.89% vs Final: 27.80±15.57%, p=0.904) and minimal lumen area (Pre: 1.97±0.89mm(2) vs Final: 2.17±1.09mm(2), p=0.334), were not significantly affected by BVS implantation. Mean malapposed struts at the bifurcation polygon-of-confluence were 0.63±1.11., Conclusions: The results of the present investigation suggest feasibility and relative safety of BVS implantation in coronary bifurcations. BVS wide struts have a low impact on side-branch impairment when considering bifurcations with side-branch diameter≥2mm., (Copyright © 2016. Published by Elsevier Ireland Ltd.)

Aims: Statins are highly effective in reducing major adverse clinical events, but the direct effects on coronary plaque composition remain debatable. Our aim was to mechanistically evaluate the treatment effect of high-intensity statin therapy on compositional coronary plaque changes., Methods and Results: The third Integrated Biomarker and Imaging Study (IBIS-3) was a prospective, investigator-initiated, single-centre study. Serial radiofrequency intravascular ultrasound (RF-IVUS) measurements of a predefined non-stenotic segment in a non-culprit coronary artery were performed to evaluate the effect of rosuvastatin (intended dose: 40 mg daily) on necrotic core (NC) volume in patients with stable angina or acute coronary syndrome. Changes in lipid core burden index (LCBI) were evaluated through serial near-infrared spectroscopy (NIRS) imaging in a subset. Serial RF-IVUS (and NIRS) data of a median segment of 41 mm (interquartile range: 32 to 49 mm) were complete in 164 (103) patients. Follow-up measurements were performed at six and 12 months in 30 (26) and 134 (77) patients, respectively. Mean levels of low-density lipoprotein cholesterol decreased by 30%, from 2.49 mmol/l to 1.73 mmol/l at the end of follow-up. High-dose rosuvastatin therapy resulted in a non-significant change of -1.4 mm3 (95% CI: -3.0, 0.1) in NC volume during follow-up (p=0.074). The change in NC percentage of total plaque volume was -1.4% (95% CI: -2.4 to -0.4; p=0.006). A neutral effect was also observed on LCBI. Indications of significant regression of NC volume and LCBI in the highest baseline quartiles were observed, which should cautiously be regarded as hypothesis-generating., Conclusions: High-intensity rosuvastatin therapy during one year resulted in a neutral effect on NC and LCBI within non-stenotic, non-culprit coronary segments with a relatively low atheroma burden. This study has been registered in The Netherlands Trial Register (NTR) nr. 2872.

Aims: In coronary bifurcations assessment, evaluation of side-branch (SB) ostia by an optical coherence tomography (OCT) pullback performed in the main branch (MB) could speed up lesion evaluation and minimize contrast volume. Dedicated software that reconstructs the cross-sections perpendicular to the SB centreline could improve this assessment. We aimed to validate a new method for assessing the SB ostium from an OCT pullback performed in the MB., Methods and Results: Thirty-one sets of frequency-domain OCT pullbacks from 28 patients, both from the MB and the SB of a coronary artery bifurcation were analysed. Measurements of the SB ostium from the SB pullback were used as a reference. Measurements of the SB ostium from the MB pullback were then performed in a laboratory setting by (i) conventional analysis and (ii) cut-plane analysis, and the measurement error for each analysis was estimated. Correlations of SB ostium measurements acquired from the MB pullback in comparison with reference measurements acquired from the SB pullback were higher with cut-plane analysis compared with conventional analysis, albeit not reaching statistical significance (area: rcut-plane = 0.927 vs. rconventional = 0.870, P = 0.256; mean diameter: rcut-plane = 0.918 vs. rconventional = 0.788, P = 0.056; minimum diameter: rcut-plane = 0.841 vs. rconventional = 0.812, P = 0.734; maximum diameter: rcut-plane = 0.770 vs. rconventional = 0.635, P = 0.316). Cut-plane analysis was associated with lower absolute error than conventional analysis (area: 0.56 ± 0.45, vs. 1.50 ± 1.31 mm(2), P < 0.001; mean diameter: 0.18 ± 0.14 vs. 0.44 ± 0.30 mm, P < 0.001)., Conclusion: Measurements of SB ostium performed in a laboratory setting by cut-plane analysis of an OCT pullback of the main branch have high correlation with reference measurements performed in a SB OCT pullback and lower error compared with conventional analysis., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

Background: iMAP is a new intravascular ultrasound (IVUS) derived technique for tissue characterization using spectral analysis. Since there is a need for reproducibility data to design longitudinal studies, we sought to assess the in vivo reproducibility of this imaging technique., Methods: iMAP (40 MHz, Boston Scientific Corporation) was performed in patients referred for elective percutaneous intervention and in whom a nonintervened vessel was judged suitable for a safe IVUS analysis. Overall 20 patients with 20 non-angiographically significant lesions were assessed by two independent observers. Five of these 20 patients received an additional iMAP analysis using a new IVUS catheter and using the same catheter after its engagement and reengagement., Results: The interobserver relative difference in plaque area was 2.5%. Limits of agreement for lumen, vessel, and plaque area measurements were 1.62, -2.47 mm(2) ; 2.09, -3.71 mm(2) ; 2.80, -3.72 mm(2) ; respectively. Limits of agreement for fibrotic, lipidic, necrotic, and calcified measurements were 1.32, -1.44 mm(2) ; 0.24, -0.36 mm(2) ; 1.50, -2.26 mm(2) ; 0.09, -0.11 mm(2) ; respectively. The intercatheter and intracatheter relative difference in plaque area were 0.9% and 4.1%, respectively. Although the variability for compositional measurements increased using two different catheters or using the same catheter twice, the variability for compositional measurements keeps always below 10%., Conclusions: Our analysis demonstrates that the geometrical and compositional iMAP analysis is acceptably reproducible., (Copyright © 2011 Wiley Periodicals, Inc., a Wiley company.)

Background: A 63-year-old man presented with class II anginal symptoms., Investigations: Cardiac catheterization, intravascular ultrasound (IVUS) virtual histology, optical coherence tomography and off-line palpography., Diagnosis: The patient was diagnosed as having a culprit lesion in the left circumflex artery and a vulnerable plaque in the left anterior descending artery., Management: The culprit lesion was treated with two overlapping drug-eluting stents. The vulnerable plaque was then treated with a self-expanding stent tailored to shield vulnerable plaques (vProtect Luminal Shield). After dilatation of the stent with a low-pressure balloon, IVUS and optical coherence tomography showed excellent apposition of the stent to the vessel wall, with no signs of tissue prolapse or edge dissections. At the 6-month follow-up appointment, the stent showed complete tissue coverage without signs of in-stent restenosis., Conclusions: Six months of follow-up has demonstrated that a patient with an IVUS-derived, thin capped fibroatheroma was successfully treated with a stent tailored to shield vulnerable plaques.

Objectives: This study sought to evaluate late recoil of a novel bioabsorbable everolimus-eluting coronary stent (BVS), which is composed of a poly-L-lactic acid backbone, coated with a bioabsorbable polymer containing everolimus., Background: Little is known about the mechanical behavior of bioabsorbable polymer stents after deployment in diseased human coronary arteries., Methods: The study population consisted of 16 patients, who were treated with elective BVS implantation for single de novo native coronary artery lesions and were followed at 6 months. All patients underwent an intravascular ultrasound examination at post-procedure and follow-up. A total of 484 paired cross-sectional areas (CSAs) were acquired and analyzed. Late absolute stent recoil was defined as stent area at post-procedure (X) - stent area at follow-up (Y). Late percent stent recoil was defined as (X - Y)/X x 100. In each CSA, plaque morphology was assessed qualitatively and classified as calcific, fibronecrotic, or fibrocellular plaque., Results: Late absolute and percent recoil of the BVS was 0.65 +/- 1.71 mm(2) (95% confidence interval [CI]: 0.49 to 0.80 mm(2)) and 7.60 +/- 23.3% (95% CI: 5.52% to 9.68%). Calcified plaques resulted in significantly less late recoil (0.20 +/- 1.54 mm(2) and 1.97 +/- 22.2%) than fibronecrotic plaques (1.03 +/- 2.12 mm(2) and 12.4 +/- 28.0%, p = 0.001 and p = 0.001, respectively) or fibrocellular plaque (0.74 +/- 1.48 mm(2) and 8.90 +/- 19.8%, p = 0.001 and p = 0.001, respectively)., Conclusions: The BVS shrank in size during the follow-up period. The lesion morphology of stented segments might affect the degree of late recoil of the BVS. (ABSORB Everolimus Eluting Coronary Stent System First in Man Clinical Investigation; NCT00300131).

Background: Noninvasive assessment of coronary atherosclerotic plaque may be useful for risk stratification and treatment of atherosclerosis., Materials and Methods: We studied 47 patients to investigate the accuracy of coronary plaque volume measurement acquired with 64-slice multislice computed tomography (MSCT), using newly developed quantification software, when compared with quantitative intracoronary ultrasound (QCU). Quantitative MSCT coronary angiography (QMSCT-CA) was performed to determine plaque volume for a matched region of interest (regional plaque burden) and in significant plaque defined as a plaque with > or =50% area obstruction in QCU, and compared with QCU. Dataset with image blurring and heavy calcification were excluded from analysis., Results: In 100 comparable regions of interest, regional plaque burden was highly correlated (coefficient r = 0.96; P < 0.001) between QCU and QMSCT-CA, but QMSCT-CA overestimated the plaque burden by a mean difference of 7 +/- 33 mm3 (P = 0.03). In 76 significant plaques detected within the regions of interest, plaque volume determined by QMSCT-CA was highly correlated (r = 0.98; P < 0.001) with a slight underestimation of 2 +/- 17 mm3 (P = not significant) when compared with QCU. Calcified and mixed plaque volume was slightly overestimated by 4 +/- 19 mm3 (P = ns) and noncalcified plaque volume was significantly underestimated by 9 +/- 11 mm3 (P < 0.001) with QMSCT-CA. Overall, the limits of agreement for plaque burden/volume measurement between QCU and QMSCT-CA were relatively large. Reproducibility for the measurements of regional plaque burden with QMSCT-CA was good, with a mean intraobserver and interobserver variability of 0% +/- 16% and 4% +/- 24%, respectively., Conclusions: Quantification of coronary plaque within selected proximal or middle coronary segments without image blurring and heavy calcification with 64-slice CT was moderately accurate with respect to intravascular ultrasound and demonstrated good reproducibility. Further improvement in CT resolution is required for more reliable measurement of coronary plaques using quantification software.

Aims: This study sought to evaluate the effect of perindopril in coronary remodelling., Methods and Results: In this sub-study of a double-blind, multicentre trial, patients without clinical evidence of heart failure were randomized to perindopril 8 mg/day or placebo for at least 3 years and IVUS investigation was performed at both time-points. Positive and negative remodelling were defined as a relative increase (positive remodelling) or decrease (negative remodelling) of the mean vessel cross-sectional area (CSA)>2 SD of the mean intra-observer difference. A total of 118 matched evaluable IVUS (711 matched 5 mm segments) were available at follow-up. After a median follow-up of 3.0 (inter-quartile range 1.9, 4.1) years, there was no significant difference in the change of plaque CSA between perindopril (360 segments) and placebo (351 segments) groups, P=0.27. Conversely, the change in vessel CSA was significantly different between groups (perindopril -0.18+/-2.4 mm2 vs. placebo 0.19+/-2.4, P = 0.04). Negative remodelling occurred more frequently in the perindopril than in the placebo group (34 vs. 25%, P=0.01). In addition, the placebo group showed a larger, although not significant, mean remodelling index (RI) than the perindopril group (1.03+/-0.2 vs. 1.00+/-0.2, P=0.06). The temporal change in vessel dimensions assessed by the RI was significantly correlated with the change in plaque dimensions (r=0.48, P<0.0001)., Conclusion: In this sub-analysis of a multicentre, controlled study, long-term administration of perindopril was associated with a constrictive remodelling pattern without affecting the lumen.

The multicenter EUROPA trial of 12,218 patients showed that perindopril decreased adverse clinical events in patients with established coronary heart disease. The PERSPECTIVE study, a substudy of the EUROPA trial, evaluated the effect of perindopril on coronary plaque progression as assessed by quantitative coronary angiography and intravascular ultrasound (IVUS). In total 244 patients (mean age 57 years, 81% men) were included. Evaluable paired quantitative coronary angiograms were obtained from 96 patients randomized to perindopril and from 98 patients to placebo. Concomitant treatment at baseline consisted of aspirin (90%), lipid-lowering agents (70%), and beta blockers (60%). The primary and secondary end point was the difference of minimum and mean lumen diameters (quantitative coronary angiography) or mean plaque cross-sectional area (IVUS) measured at baseline and 3-year follow-up between the perindopril and placebo groups. After a median follow-up of 3.0 years (range 1.9 to 4.1), no differences in change in quantitative coronary angiographic or IVUS measurements were detected between the perindopril and placebo groups (minimum and mean luminal diameters -0.07 +/- 0.4 vs -0.02 +/- 0.4 mm, p = 0.34; mean luminal diameter -0.05 +/- 0.2 vs -0.05 +/- 0.3 mm, p = 0.89; mean plaque cross-sectional area -0.18 +/- 1.2 vs -0.02 +/- 1.2 mm(2), p = 0.48). In conclusion, we found no progression in coronary artery disease by quantitative coronary angiography and IVUS with long-term administration of perindopril or placebo, possibly because most patients were on concomitant treatment with a statin.

Objectives: The purpose of this study was to investigate the long-term clinical and angiographic profile of sirolimus-eluting stent (SES) versus paclitaxel-eluting stent (PES) in patients undergoing percutaneous intervention for left main (LM) coronary disease., Background: The long-term clinical and angiographic impact of SES as opposed to PES implantation in this subset of patients is unknown., Methods: From April 2002 to March 2004, 110 patients underwent percutaneous intervention for LM stenosis at our institution; 55 patients were treated with SES and 55 with PES. The two groups were well balanced for all baseline characteristics., Results: At a median follow-up of 660 days (range 428 to 885), the cumulative incidence of major adverse cardiovascular events was similar (25% in the SES group vs. 29%, in the PES group; hazard ratio 0.88 [95% confidence interval 0.43 to 1.82]; p = 0.74), reflecting similarities in both the composite death/myocardial infarction (16% in the SES group and 18% in the PES group) and target vessel revascularization (9% in the SES group and 11% in the PES group). Angiographic in-stent late loss (mm), evaluated in 73% of the SES group and in 77% of the PES group, was 0.32 +/- 74 in the main and 0.36 +/- 0.59 in the side branch in the SES group vs. 0.46 +/- 0.57 (p = 0.36) and 0.52 +/- 0.42 (p = 0.41) in the PES group, respectively., Conclusions: In consecutive patients undergoing percutaneous LM intervention, PES may perform closely to SES both in terms of angiographic and long-term clinical outcome.

Recently, the plaque characterization field was explored with the use of the substrate (frequency domain analysis) rather than the envelope (amplitude or gray-scale imaging) of the intravascular ultrasound (IVUS) radiofrequency data. However, there is no data about the agreement of quantitative outcome between the two methods. The aim of this study was to assess the correlation and agreement between quantitative coronary ultrasound and the geometrical measurements provided by the spectral analysis of ultrasound radiofrequency data [IVUS-Virtual Histology (IVUS-VH), Volcano Therapeutics). Twenty-five patients were included in this study. The IVUS catheter used was a commercially available mechanical sector scanner (Ultracross 2.9 Fr 30 MHz catheter, Boston Scientific) covered with an outer sheath. IVUS-VH significantly underestimated lumen [relative difference (RD)=14.8+/-5.6; P<0.001], vessel (RD=14.1+/-4.8; P<0.001), and plaque (RD=11.5+/-10.8; P<0.001) cross-sectional areas (CSAs). Nevertheless, when adjusted for the ultrasound propagation delay caused by the sheath, relative differences of measurements were remarkably low (0.49%+/-6.3%, P=0.64 for lumen; 2.33%+/-4.6%, P=0.007 for vessel; and 4.2%+/-10.4%, P=0.005 for plaque CSA). These data suggest that the volumetric output of the IVUS-VH software underestimates measurements when acquired with a 30 MHz catheter. However, after applying a mathematical adjustment method for the ultrasound propagation delay caused by the outer sheath of the 30 MHz catheter, relative differences of direct measurements were negligible. These results suggest that ultrasound radiofrequency data analysis could provide, aside from precise compositional data, an accurate geometrical output., (Copyright (c) 2005 Wiley-Liss, Inc.)

Death or myocardial infarction, the most serious clinical consequences of atherosclerosis, often result from plaque rupture at non-flow limiting lesions. Current diagnostic imaging with coronary angiography only detects large plaques that already impinge on the lumen and cannot accurately identify those that have a propensity to cause unheralded events. Accurate evaluation of the composition or of the biomechanical characteristics of plaques with invasive or non-invasive methods, alone or in conjunction with assessment of circulating biomarkers, could help identify high-risk patients, thus providing the rationale for aggressive treatments in order to reduce future clinical events. The IBIS (Integrated Biomarker and Imaging Study) study is a prospective, single-center, non-randomized, observational study conducted in Rotterdam. The aim of the IBIS study is to evaluate both invasive (quantitative coronary angiography, intravascular ultrasound (IVUS) and palpography) and non-invasive (multislice spiral computed tomography) imaging techniques to characterize non-flow limiting coronary lesions. In addition, multiple classical and novel biomarkers will be measured and their levels correlated with the results of the different imaging techniques. A minimum of 85 patients up to a maximum of 120 patients will be included. This paper describes the study protocol and methodological solutions that have been devised for the purpose of comparisons among several imaging modalities. It outlines the analyses that will be performed to compare invasive and non-invasive imaging techniques in conjunction with multiple biomarkers to characterize non-flow limiting subclinical coronary lesions.

Purpose: Mechanical injury from balloon angioplasty and stenting is known to cause prolonged endothelial dysfunction, even distal to the injured segment. Intravascular irradiation therapy is associated with delayed healing response and may therefore also impede endothelial functional recovery. This study was conducted to assess endothelial function late after the irradiation of atherosclerotic coronary arteries., Methods and Materials: In 15 patients (8 with additional radiation and 7 with stenting only), directly after the intervention and at 6-month follow-up, endothelial function of the distal segment was studied by assessment of coronary diameter after intracoronary acetylcholine (Ach). Coronary flow reserve (CFR) and intravascular ultrasound (IVUS) investigation were performed for unequivocal interpretation of angiographic data., Results: No significant different response to Ach could be detected at baseline nor at follow-up (-17 +/- 14% vs. -17 +/- 15% for radiation vs. nonradiation at baseline, P=1.0; -8 +/- 11% vs. -9 +/- 13% at follow-up, P=.8). IVUS data revealed more constrictive remodeling in the nonradiation patients, but a minimal increase in mean plaque area in the radiation patients compared with a significant decrease in nonradiation patients (+4% vs. -25%, P=.02)., Conclusions: Irradiation of atherosclerotic coronary arteries does not affect endothelium-dependent vasodilatation acutely or at 6 months. Irradiated segments demonstrated less negative remodeling but higher plaque burden than the controls did.

Background: Incomplete stent apposition (ISA) has been previously documented after sirolimus-eluting stent (SES) implantation. The aim of this study was to investigate the long-term intravascular ultrasound (IVUS) findings of ISA in patients who received SES., Methods and Results: A total of 13 patients who received SES and showed ISA at follow-up IVUS (follow-up I) were investigated. IVUS was performed on all of these patients 12 months later (follow-up II). Quantitative ISA area measurement was also performed at follow-up I and II. No vascular remodeling was observed in the vessel segment with ISA; external elastic membrane area was 19.4+/-6.6 versus 19.5+/-6.4 mm2 at follow-up I and II, respectively. There was also no significant change in external elastic membrane area between vessel segment with ISA and without ISA (+1.5% versus -3.0%, respectively; P=0.27) at late follow-up. The ISA area, either including (2.5+/-1.7 versus 3.8+/-6.3 mm2; P=NS) or excluding (2.5+/-1.8 versus 2.4+/-1.7 mm2; P=NS) a single patient with aneurysm formation, was not significantly different between follow-up I and II. One patient manifested a coronary aneurysm in the stented segment at late follow-up that was probably present at the initial follow-up but masked by thrombus. It was successfully treated with a covered stent. All patients were asymptomatic, and no patient experienced late thrombotic occlusion., Conclusions: Vessel dimensions and area of ISA did not change over time, except for 1 coronary aneurysm that became apparent. ISA after implantation of a SES was not associated with adverse events at late follow-up.

The latest generation of multislice spiral computed tomography (MSCT) scanners is capable of noninvasive coronary angiography. We evaluated its diagnostic accuracy to detect stenotic coronary artery disease (CAD). In 53 patients with suspected CAD, contrast-enhanced MSCT and conventional angiography were performed. The CT data were acquired within a single breathhold, and isocardiophasic slices were reconstructed by means of retrospective electrocardiographic gating. Coronary segments of > or = 2 mm in diameter, measured by quantitative angiography, were evaluated. In 70% of the 358 available segments, image quality was regarded as adequate for assessment. The overall sensitivity, specificity, and positive and negative predictive values to detect > or = 50% stenotic lesions in the assessable segments were 82% (42 of 51 lesions), 93% (285 of 307 nonstenotic segments), and 66% and 97%, respectively, regarding conventional quantitative angiography as the gold standard. Proximal segments were assessable in 92%, and distal segments and side branches in 71% and 50%, respectively. Including the undetected lesions in non-assessable segments, overall sensitivity decreased to 61% but remained 82% for lesions in proximal coronary segments. MSCT correctly predicted absent, single, or multiple lesions in 55% of patients. Thus, despite potentially high image quality, current MSCT protocols offer only reasonable diagnostic accuracy in an unselected patient group with a high prevalence of CAD.