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Effects of Statin Plus Ezetimibe on Coronary Plaques in Acute Coronary Syndrome Patients with Diabetes Mellitus: Sub-Analysis of PRECISE-IVUS Trial.
Fujisue, K, Yamanaga, K, Nagamatsu, S, Shimomura, H, Yamashita, T, Nakao, K, Nakamura, S, Ishihara, M, Matsui, K, Sakaino, N, et al
Journal of atherosclerosis and thrombosis. 2021;(2):181-193
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Abstract
AIM: Coronary plaque regression is weak in acute coronary syndrome (ACS) patients with diabetes mellitus (DM). We evaluated whether dual lipid-lowering therapy (DLLT) with ezetimibe and atorvastatin attenuates coronary plaques in ACS patients with DM. METHODS The prospective, randomized controlled, multicenter PRECISE-IVUS (Plaque Regression with Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by Intravascular Ultrasound) trial assigned 246 patients undergoing percutaneous coronary intervention to DLLT or atorvastatin monotherapy and evaluated IVUS-derived changes in percent atheroma volume (ΔPAV), at baseline and 9-12-month follow-up, in 126 ACS cases, including 25 DM patients. The atorvastatin dose was up-titrated to achieve low-density lipoprotein cholesterol (LDL-C) <70 mg/dL. RESULTS In DM patients, the monotherapy group (n=13) and the DLLT group (n=12) showed a similar prevalence of coronary risks and baseline lipid profiles. During the study, the change in LDL-C level was similar between DM and non-DM patients. Compared with non-DM patients, DM patients showed weaker regression of ΔPAV by DLLT than those who underwent monotherapy (DM: -2.77±3.47% vs. -0.77±2.51%, P=0.11; non-DM: -2.01±3.36% vs. -0.08±2.66%, P=0.008). The change in LDL-C level was not correlated with ΔPAV in non-DM patients, but there was significant correlation between the change in LDL-C level and ΔPAV in DM patients (r=0.52, P=0.008). CONCLUSIONS ACS patients with DM showed weaker coronary plaque regression than their counterparts. A significant correlation between the change in LDL-C level and ΔPAV in DM patients suggested that more intensive lipid-lowering therapy is required in ACS patients with DM.
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Comparison of serial optical coherence tomography imaging following aggressive stent expansion technique: insight from the MECHANISM study.
Sasaki, W, Ishida, M, Itoh, T, Uchimura, Y, Oda, H, Taguchi, Y, Kaneko, K, Sakamoto, T, Goto, I, Sakuma, M, et al
The international journal of cardiovascular imaging. 2021;(2):419-428
Abstract
To compare early vascular healing following cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation between groups with or without aggressive stent expansion in patients treated by CoCr-EES for stable coronary artery disease (CAD). Seventy-one stable CAD lesions underwent CoCr-EES implantation and analysis of serial optical coherence tomography (OCT) images obtained post-procedure and at early-term (1- or 3-month) follow-up. The endpoints of this study were neointimal thickness at the time of 1- or 3-month OCT and presence and healing of stent edge dissection. Aggressive stent expansion was defined as a lesion complying with ILUMIEN III sizing protocol; that is, external elastic lamina (EEL) diameter minus maximum balloon diameter ≤ 0.25 mm. Comparing groups with and without aggressive stent expansion, median neointimal thickness at 1 and 3 months after CoCr-EES implantation was similar (1 month: 0.031 mm vs. 0.041 mm, respectively, p = 0.27; 3 months: 0.036 mm vs. 0.040 mm, respectively, p = 0.84). Regarding stent edge findings, the presence of any stent edge dissection immediately after percutaneous coronary intervention was also similar between the groups (25% vs. 15%, respectively; p = 0.30) and most stent edge dissections resolved completely within 3 months, regardless of location or dissection severity. After 1 year, no clinically driven target lesion revascularization or stent thrombosis was observed in either cohort. Even after aggressive stent expansion, early neointimal proliferation appeared modest with CoCr-EES implantation, and most stent edge dissections had resolved by 3 months. These findings may support the feasibility of EEL-based sizing by pre-stenting OCT.
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Nonculprit Lesion Plaque Morphology in Patients With ST-Segment-Elevation Myocardial Infarction: Results From the COMPLETE Trial Optical Coherence Tomography Substudys.
Pinilla-Echeverri, N, Mehta, SR, Wang, J, Lavi, S, Schampaert, E, Cantor, WJ, Bainey, KR, Welsh, RC, Kassam, S, Mehran, R, et al
Circulation. Cardiovascular interventions. 2020;(7):e008768
Abstract
BACKGROUND Complete revascularization with routine percutaneous coronary intervention of nonculprit lesions after primary percutaneous coronary intervention improves outcomes in ST-segment-elevation myocardial infarction. Whether this benefit is associated with nonculprit lesion vulnerability is unknown. METHODS In a prospective substudy of the COMPLETEs trial (Complete vs Culprit-Only Revascularization to Treat Multi-Vessel Disease After Early PCI for STEMI), we performed optical coherence tomography of at least 2 coronary arteries before nonculprit lesion percutaneous coronary intervention in 93 patients with ST-segment-elevation myocardial infarction and multivessel disease; and the ST-segment-elevation myocardial infarction culprit vessel if there was unstented segment amenable to imaging. Nonculprit lesions were categorized as obstructive (≥70% stenosis by visual angiographic assessment) or nonobstructive, and as thin-cap fibroatheroma (TCFA) or non-TCFA by optical coherence tomography criteria. TCFA was defined as a lesion with mean fibrous cap thickness <65 μm overlying a lipid arc >90°. RESULTS On a patient level, at least one obstructive TCFA was observed in 44/93 (47%) of patients. On a lesion level, there were 58 TCFAs among 150 obstructive nonculprit lesions compared with 74 TCFAs among 275 nonculprit lesions (adjusted TCFA prevalence: 35.4% versus 23.2%, P=0.022). Compared with obstructive non-TCFAs, obstructive TCFAs had similar lesion length (23.1 versus 20.8 mm, P=0.16) but higher lipid quadrants (55.2 versus 19.2, P<0.001), greater mean lipid arc (203.8° versus 84.5°, P<0.001), and more macrophages (97.1% versus 54.4%, P<0.001) and cholesterol crystals (85.8% versus 44.3%, P<0.001). For nonobstructive lesions, TCFA lesions had similar lesion length (16.7 versus 14.6 mm, P=0.11), but more lipid quadrants (36.4 versus 13.5, P<0.001), and greater mean lipid arc (191.8° versus 84.2°, P<0.001) compared with non-TCFA. CONCLUSIONS Among patients who underwent optical coherence tomography imaging in the COMPLETE trial, nearly 50% had at least one obstructive nonculprit lesion containing complex vulnerable plaque. Obstructive lesions more commonly harbored vulnerable plaque morphology than nonobstructive lesions. This may help explain the benefit of routine percutaneous coronary intervention of obstructive nonculprit lesions in patients with ST-segment-elevation myocardial infarction and multivessel disease. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01740479s.
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Deep Learning-Based Quantification of Epicardial Adipose Tissue Volume and Attenuation Predicts Major Adverse Cardiovascular Events in Asymptomatic Subjects.
Eisenberg, E, McElhinney, PA, Commandeur, F, Chen, X, Cadet, S, Goeller, M, Razipour, A, Gransar, H, Cantu, S, Miller, RJH, et al
Circulation. Cardiovascular imaging. 2020;(2):e009829
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Abstract
BACKGROUND Epicardial adipose tissue (EAT) volume (cm3) and attenuation (Hounsfield units) may predict major adverse cardiovascular events (MACE). We aimed to evaluate the prognostic value of fully automated deep learning-based EAT volume and attenuation measurements quantified from noncontrast cardiac computed tomography. METHODS Our study included 2068 asymptomatic subjects (56±9 years, 59% male) from the EISNER trial (Early Identification of Subclinical Atherosclerosis by Noninvasive Imaging Research) with long-term follow-up after coronary artery calcium measurement. EAT volume and mean attenuation were quantified using automated deep learning software from noncontrast cardiac computed tomography. MACE was defined as myocardial infarction, late (>180 days) revascularization, and cardiac death. EAT measures were compared to coronary artery calcium score and atherosclerotic cardiovascular disease risk score for MACE prediction. RESULTS At 14±3 years, 223 subjects suffered MACE. Increased EAT volume and decreased EAT attenuation were both independently associated with MACE. Atherosclerotic cardiovascular disease risk score, coronary artery calcium, and EAT volume were associated with increased risk of MACE (hazard ratio [95%CI]: 1.03 [1.01-1.04]; 1.25 [1.19-1.30]; and 1.35 [1.07-1.68], P<0.01 for all) and EAT attenuation was inversely associated with MACE (hazard ratio, 0.83 [95% CI, 0.72-0.96]; P=0.01), with corresponding Harrell C statistic of 0.76. MACE risk progressively increased with EAT volume ≥113 cm3 and coronary artery calcium ≥100 AU and was highest in subjects with both (P<0.02 for all). In 1317 subjects, EAT volume was correlated with inflammatory biomarkers C-reactive protein, myeloperoxidase, and adiponectin reduction; EAT attenuation was inversely related to these biomarkers. CONCLUSIONS Fully automated EAT volume and attenuation quantification by deep learning from noncontrast cardiac computed tomography can provide prognostic value for the asymptomatic patient, without additional imaging or physician interaction.
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Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years.
Onuma, Y, Honda, Y, Asano, T, Shiomi, H, Kozuma, K, Ozaki, Y, Namiki, A, Yasuda, S, Ueno, T, Ando, K, et al
JACC. Cardiovascular interventions. 2020;(1):116-127
Abstract
OBJECTIVES The aim of this study was to investigate the vascular responses and fates of the scaffold after bioresorbable vascular scaffold (BVS) implantation using multimodality imaging. BACKGROUND Serial comprehensive image assessments after BVS implantation in the context of a randomized trial have not yet been reported. METHODS In the ABSORB Japan trial, 400 patients were randomized to a BVS (n = 266) or a cobalt-chromium everolimus-eluting stent (n = 134). Through 3 years, patients underwent serial angiography and intravascular ultrasound or optical coherence tomography (OCT). RESULTS Luminal dimension at 3 years was consistently smaller with the BVS than with the cobalt-chromium everolimus-eluting stent (mean angiographic minimal luminal diameter 2.04 ± 0.63 mm vs. 2.40 ± 0.56 mm, mean difference -0.37 mm [95% confidence interval: -0.50 to -0.24 mm]; p < 0.001), mainly because of smaller device area (6.13 ± 2.03 mm2 vs. 7.15 ± 2.16 mm2, mean difference -1.04 mm2 [95% confidence interval: -1.66 to -0.42 mm2]; p < 0.001), and larger neointimal area (2.10 ± 0.61 mm2 vs. 1.86 ± 0.64 mm2, mean difference 0.24 mm2 [95% confidence interval: 0.06 to 0.43 mm2]; p = 0.01) by OCT. BVS-treated vessels did not show previously reported favorable vessel responses, such as positive vessel remodeling, late luminal enlargement, and restoration of vasomotion, although the OCT-based healing score was on average zero (interquartile range: 0.00 to 0.00). At 3 years, intraluminal scaffold dismantling (ISD) was observed in 14% of BVS. On serial OCT, ISD was observed in 6 lesions at 2 years, where the struts had been fully apposed at post-procedure, while ISD was observed in 12 lesions at 3 years, where 8 lesions were free from ISD on 2-year OCT. In 5 cases of very late scaffold thrombosis, strut discontinuities were detected in all 4 cases with available OCT immediately before reintervention. CONCLUSIONS In this multimodality serial imaging study, luminal dimension at 3 years was smaller with the BVS than with the cobalt-chromium everolimus-eluting stent. ISD, suspected to be one of the mechanisms of very late BVS thrombosis, was observed in a substantial proportion of cases at 3 years, which developed between post-procedure and 2 years and even beyond 2 years. (AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284).
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Machine learning of clinical variables and coronary artery calcium scoring for the prediction of obstructive coronary artery disease on coronary computed tomography angiography: analysis from the CONFIRM registry.
Al'Aref, SJ, Maliakal, G, Singh, G, van Rosendael, AR, Ma, X, Xu, Z, Alawamlh, OAH, Lee, B, Pandey, M, Achenbach, S, et al
European heart journal. 2020;(3):359-367
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Abstract
AIMS: Symptom-based pretest probability scores that estimate the likelihood of obstructive coronary artery disease (CAD) in stable chest pain have moderate accuracy. We sought to develop a machine learning (ML) model, utilizing clinical factors and the coronary artery calcium score (CACS), to predict the presence of obstructive CAD on coronary computed tomography angiography (CCTA). METHODS AND RESULTS The study screened 35 281 participants enrolled in the CONFIRM registry, who underwent ≥64 detector row CCTA evaluation because of either suspected or previously established CAD. A boosted ensemble algorithm (XGBoost) was used, with data split into a training set (80%) on which 10-fold cross-validation was done and a test set (20%). Performance was assessed of the (1) ML model (using 25 clinical and demographic features), (2) ML + CACS, (3) CAD consortium clinical score, (4) CAD consortium clinical score + CACS, and (5) updated Diamond-Forrester (UDF) score. The study population comprised of 13 054 patients, of whom 2380 (18.2%) had obstructive CAD (≥50% stenosis). Machine learning with CACS produced the best performance [area under the curve (AUC) of 0.881] compared with ML alone (AUC of 0.773), CAD consortium clinical score (AUC of 0.734), and with CACS (AUC of 0.866) and UDF (AUC of 0.682), P < 0.05 for all comparisons. CACS, age, and gender were the highest ranking features. CONCLUSION A ML model incorporating clinical features in addition to CACS can accurately estimate the pretest likelihood of obstructive CAD on CCTA. In clinical practice, the utilization of such an approach could improve risk stratification and help guide downstream management.
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Decrease in oxidized high-density lipoprotein is associated with slowed progression of coronary artery calcification: Subanalysis of a prospective multicenter study.
Miki, T, Miyoshi, T, Kotani, K, Kohno, K, Asonuma, H, Sakuragi, S, Koyama, Y, Nakamura, K, Ito, H
Atherosclerosis. 2019;:1-6
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BACKGROUND AND AIMS Oxidized high-density lipoprotein (oxHDL) is characterized by reduced anti-inflammatory properties compared with HDL. However, the role of oxHDL in the pathogenesis of coronary artery calcification (CAC), a marker of subclinical atherosclerosis, remains unclear. We prospectively investigated the association between the change in oxHDL and progression of CAC in a substudy of a multicenter study. METHODS In the principal study, patients with a CAC score of 1-999 were treated with pitavastatin with/without eicosapentaenoic acid. Measurement of CAC with multidetector-row computed tomography and a blood test were performed at baseline and at the 1-year follow-up. In the principal study, the increase in CAC did not differ among treatment groups. In this substudy, patients were divided into two groups: CAC progression (change in Agatston score of >0) and no CAC progression. RESULTS In total, 140 patients were analyzed. The oxHDL level significantly decreased from 167 (132-246) at baseline to 122 (103-149) after treatment (median [25th-75th percentile], U/ml) (p < 0.001). The annual change in CAC was significantly positively associated with changes in oxHDL (r = 0.17, p = 0.04), triglycerides (r = 0.17, p = 0.04), and high-sensitivity C-reactive protein (r = 0.22, p = 0.01) but was not associated with changes in low-density lipoprotein cholesterol or HDL-cholesterol. Multiple logistic analysis demonstrated that the decrease in oxHDL per 10 U/ml was independently associated with CAC progression (odds ratio, 0.95; 95% confidence interval, 0.90-0.99; p = 0.04). CONCLUSIONS The decrease in oxHDL is associated with the attenuation of CAC progression, suggesting that oxHDL is a potential target for atherosclerosis prevention.
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Risk Reclassification With Coronary Computed Tomography Angiography-Visualized Nonobstructive Coronary Artery Disease According to 2018 American College of Cardiology/American Heart Association Cholesterol Guidelines (from the Coronary Computed Tomography Angiography Evaluation for Clinical Outcomes : An International Multicenter Registry [CONFIRM]).
Han, D, Beecy, A, Anchouche, K, Gransar, H, Dunham, PC, Lee, JH, Achenbach, S, Al-Mallah, MH, Andreini, D, Berman, DS, et al
The American journal of cardiology. 2019;(9):1397-1405
Abstract
The 2018 American College of Cardiology (ACC)/American Heart Association (AHA) cholesterol management guideline recommends risk enhancers in the borderline-risk and statin recommended/intermediate-risk groups. We determined the risk reclassification by the presence and severity of coronary computed tomography angiography (CCTA)-visualized coronary artery disease (CAD) according to statin eligibility groups. Of 35,281 individuals who underwent CCTA, 1,303 asymptomatic patients (age 59, 65% male) were identified. Patients were categorized as low risk, borderline risk, statin recommended/intermediate risk or statin recommended/high risk according to the guideline. CCTA-visualized CAD was categorized as no CAD, nonobstructive, or obstructive. Major adverse cardiovascular events (MACE) were defined as a composite outcome of all-cause mortality, nonfatal myocardial infarction, and late coronary revascularization (>90 days). We tested a reclassification wherein no CAD reclassifies downward, and the presence of any CAD reclassifies upward. During a median follow-up of 2.9 years, 93 MACE events (7.1%) were observed. Among the borderline-risk and statin-recommended/intermediate-risk groups eligible for risk enhancers, the presence or absence of any CCTA-visualized CAD led to a net increase of 2.3% of cases and 22.4% of controls correctly classified (net reclassification index [NRI] 0.27, 95% CI 0.13 to 0.41, p = 0.0002). The NRI was not significant among low- or statin-recommended/high-risk patients (all p >0.05). The presence or absence of CCTA-visualized CAD, including both obstructive and nonobstructive CAD, significantly improves reclassification in patients eligible for risk enhancers in 2018 ACC/AHA guidelines. Patients in low- and high-risk groups derive no significant improvement in risk reclassification from CCTA.
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Impact of iodine concentration and iodine delivery rate on contrast enhancement in coronary CT angiography: a randomized multicenter trial (CT-CON).
Rengo, M, Dharampal, A, Lubbers, M, Kock, M, Wildberger, JE, Das, M, Niezen, A, van Tilborg, F, Kofflard, M, Laghi, A, et al
European radiology. 2019;(11):6109-6118
Abstract
OBJECTIVE To compare the effect of contrast medium iodine concentration on contrast enhancement, heart rate, and injection pressure when injected at a constant iodine delivery rate in coronary CT angiography (CTA). METHODS One thousand twenty-four patients scheduled for coronary CTA were prospectively randomized to receive one of four contrast media: iopromide 300 mg I/ml, iohexol 350 mg I/ml, iopromide 370 mg I/ml, or iomeprol 400 mg I/ml. Contrast media were delivered at an equivalent iodine delivery rate of 2.0 g I/s. Intracoronary attenuation was measured and compared (per vessel and per segment). Heart rate before and after contrast media injection was documented. Injection pressure was recorded (n = 403) during contrast medium injection and compared between groups. RESULTS Intracoronary attenuation values were similar for the different contrast groups. The mean attenuation over all segments ranged between 384 HU for 350 mg I/ml and 395 HU for 400 mg I/ml (p = 0.079). Dose-length product (p = 0.8424), signal-to-noise ratio (all p > 0.05), time to peak (p = 0.324), and changes in heart rate (p = 0.974) were comparable between groups. The peak pressures differed: 197.4 psi for 300 mg I/ml (viscosity 4.6 mPa s), 229.8 psi for 350 mg I/ml (10.4 mPa s), 216.1 psi for 370 mg I/ml (9.5 mPa s), and 243.7 psi for 400 mg I/ml (12.6 mPa s) (p < 0.0001). CONCLUSION Intravascular attenuation and changes in heart rate are independent of iodine concentration when contrast media are injected at the same iodine delivery rate. Differences in injection pressures are associated with the viscosity of the contrast media. KEY POINTS • The contrast enhancement in coronary CT angiography is independent of the iodine concentration when contrast media are injected at body temperature (37 °C) with the same iodine delivery rate. • Iodine concentration does not influence the change in heart rate when contrast media are injected at identical iodine delivery rates. • For a fixed iodine delivery rate and contrast temperature, the viscosity of the contrast medium affects the injection pressure.
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Cut-off value of mal-apposition volume and depth for resolution at early phase of acute incomplete stent apposition after CoCr-EES implantation.
Uchimura, Y, Itoh, T, Oda, H, Taguchi, Y, Sasaki, W, Kaneko, K, Sakamoto, T, Goto, I, Sakuma, M, Ishida, M, et al
The international journal of cardiovascular imaging. 2019;(11):1979-1987
Abstract
The purpose of this study was to clarify a cut-off value for acute incomplete stent apposition (ISA) volume and maximum-depth to predict ISA resolution at 1- and 3-month follow-up in patients treated with cobalt-chromium everolimus-eluting stents. In total, 95 cases and 103 stents were registered in the MECHANISM-Elective sub-study. Acute ISA-volume was measured by the trapezoid rule. ISA resolution of cut-off value at 1- and 3-month was estimated by ISA-volume and maximum-depth using receiver operatorating characteristic curve analysis. The total number of analysed acute ISAs was 202 in the 1-month group and 225 in the 3-month group. A total of 123 ISAs at 1-month and a total of 169 ISAs at 3-month had been resolved. The cut-off value of ISA resolution by ISA-volume was 0.169 mm3 at 1-month (AUC: 0.725, sensitivity: 72.2%, specificity: 61.0%) and 0.295 mm3 at 3-month (AUC: 0.757, sensitivity: 75.0%, specificity: 60.4%). The cut-off value of ISA resolution by ISA maximum-depth demonstrated was 0.285 mm at 1-month (area under curve (AUC): 0.789, sensitivity: 70.9%, specificity: 69.9%) and 0.305 mm at 3-month (AUC: 0.663, sensitivity: 60.7%, specificity: 66.9%). Incidence of ISA resolution was significantly lower in combination with cut-off values of ISA-volume and maximum-depth (33%, p < 0.001, at 1-month; 56%, p = 0.003, at 3-month). Combining the cut-off value of ISA-volume with the maximum-depth might be helpful to consider the endpoint of the PCI procedure.