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1.
BMC Cardiovasc Disord ; 21(1): 92, 2021 02 15.
Article in English | MEDLINE | ID: mdl-33588758

ABSTRACT

BACKGROUND: The impact of reduction in glycemic excursion on coronary plaques remains unknown. This study aimed to elucidate whether a dipeptidyl peptidase 4 inhibitor could reduce the glycemic excursion and stabilize the coronary plaques compared with conventional management in coronary artery disease (CAD) patients with impaired glucose tolerance (IGT). METHODS: This was a multicenter, randomized controlled trial including CAD patients with IGT under lipid-lowering therapy receiving either vildagliptin (50 mg once a day) or no medication (control group) regarding glycemic treatment. The primary endpoint was changes in the minimum fibrous cap thickness and lipid arc in non-significant native coronary plaques detected by optical coherence tomography at 6 months after intervention. Glycemic variability expressed as the mean amplitude of glycemic excursion (MAGE) measured with a continuous glucose monitoring system was evaluated before and 6 months after intervention. RESULTS: A total of 20 participants with 47 lesions were allocated to either the vildagliptin group (10 participants, 22 lesions) or the control group (10 participants, 25 lesions). The adjusted difference of mean changes between the groups was - 18.8 mg/dl (95% confidence interval, - 30.8 to - 6.8) (p = 0.0064) for the MAGE (vildagliptin, - 20.1 ± 18.0 mg/dl vs. control, 2.6 ± 12.7 mg/dl), - 22.8° (- 40.6° to - 5.1°) (p = 0.0012) for the mean lipid arc (vildagliptin, - 9.0° ± 25.5° vs. control, 15.8° ± 16.8°), and 42.7 µm (15.3 to 70.1 µm) (p = 0.0022) for the minimum fibrous cap thickness (vildagliptin, 35.7 ± 50.8 µm vs. control, - 15.1 ± 25.2 µm). CONCLUSIONS: Vildagliptin could reduce the MAGE at 6 months and may be associated with the decreased lipid arc and increased minimum FCT of the coronary plaques in CAD patients with IGT as compared with the control group. These findings may represent its potential stabilization effect on coronary plaques, which are characteristic in this patient subset. Trial registration Registered in the UMIN clinical trial registry (UMIN000008620), Name of the registry: VOGUE trial, Date of registration: Aug 6, 2012, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000010058.


Subject(s)
Blood Glucose/drug effects , Coronary Artery Disease/drug therapy , Dipeptidyl-Peptidase IV Inhibitors/therapeutic use , Glucose Intolerance/drug therapy , Plaque, Atherosclerotic , Vildagliptin/therapeutic use , Aged , Biomarkers/blood , Blood Glucose/metabolism , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/pathology , Dipeptidyl-Peptidase IV Inhibitors/adverse effects , Female , Glucose Intolerance/blood , Glucose Intolerance/diagnosis , Humans , Japan , Lipids/blood , Male , Middle Aged , Rupture, Spontaneous , Time Factors , Tomography, Optical Coherence , Treatment Outcome , Vildagliptin/adverse effects
2.
Circ Rep ; 3(1): 55-65, 2020 Dec 23.
Article in English | MEDLINE | ID: mdl-33693290

ABSTRACT

Background: In this study we investigated the efficacy and safety of very short duration (1-month) dual antiplatelet therapy (DAPT) followed by prasugrel monotherapy. In particular, we compared intrastent conditions using optical coherence tomography (OCT) after second-generation drug-eluting stent implantation between standard-duration and 1-month DAPT followed by prasugrel monotherapy. Methods and Results: Between May 2015 and February 2018, 120 consecutive patients who underwent elective Resolute zotarolimus-eluting stent implantation were enrolled and divided into those receiving standard-duration or 1-month (1M) DAPT followed by prasugrel monotherapy; 47 patients (n=55 stents) and 46 patients (n=54 stents) in the standard and 1M groups, respectively, completed the protocol. The primary endpoint was the prevalence of abnormal intrastent tissue at the 9-month examination, as observed by OCT. The secondary endpoint was the presence of composite adverse events, including all-cause death, myocardial infarction, stent thrombosis, target lesion and vessel revascularization, and major and minor bleeding. The prevalence of abnormal intrastent tissue was similar between the standard and 1M groups (1.6% vs. 1.5%, respectively; non-inferiority P<0.01). There was a tendency for fewer composite events in the 1M than standard group at the 30-month follow-up examination (28.3% vs. 44.7%, respectively; P=0.41). Conclusions: In conclusion, 1M DAPT followed by prasugrel monotherapy after second-generation drug-eluting stent implantation was not inferior to standard-duration DAPT in terms of intrastent thrombus formation and composite adverse events.

3.
J Cardiol ; 72(3): 193-199, 2018 09.
Article in English | MEDLINE | ID: mdl-29980334

ABSTRACT

BACKGROUND: Although a prospective randomized control study revealed that 3-month dual anti-platelet therapy (DAPT) is safe and does not compromise the efficacy of everolimus-eluting stent (EES) in selected patients, detailed vessel healing at early phase after EES implantation has yet to be investigated in Japanese patients. METHODS AND RESULTS: A total of 27 lesions in 19 patients treated with EES were serially evaluated by using optical coherence tomography (OCT) at 3, 6, and 12 months after stent implantation. In addition to standard quantitative OCT parameters, the percentage of stents with peri-strut low-intensity area (PLIA, a region around stent struts homogenously showing lesser intensity than the surrounding tissue, suggesting fibrin deposition or impaired neointima maturation) and that with in-stent thrombi were evaluated. There was a significant, but small increase in neointimal thickness (63±17µm; 83±30µm; and 111±44µm, respectively; p=0.006) and small decrease in average lumen area (6.80±2.57mm2, 6.62±2.58mm2, 6.33±2.58mm2, p=0.038) from the 3- to the 12-month follow-up. The incidences of uncovered and malapposed struts were low at 3 months and did not significantly change at 6 months and 12 months (3.01±4.43; 2.45±3.75; and 1.47±3.16, p=0.143, and 0.75±0.65; 0.63±0.73; and 0.58±1.42, p=0.162, respectively). Also, frequency of struts with PLIA was already low at three months and significantly decreased during the follow-up (6.4±6.5; 4.6±5.4; and 2.3±3.3, respectively; p=0.001). CONCLUSION: Favorable vessel healing was achieved at 3 months after EES implantation without neointimal hyperplasia which was persistently suppressed up to 12 months.


Subject(s)
Coronary Vessels/drug effects , Drug-Eluting Stents , Everolimus/administration & dosage , Tomography, Optical Coherence/methods , Wound Healing/drug effects , Aged , Coronary Vessels/pathology , Female , Follow-Up Studies , Heart Valve Prosthesis Implantation/methods , Humans , Hyperplasia/diagnostic imaging , Hyperplasia/etiology , Male , Middle Aged , Neointima/diagnostic imaging , Neointima/etiology , Neointima/pathology , Postoperative Complications/diagnostic imaging , Postoperative Complications/etiology , Postoperative Period , Prospective Studies , Randomized Controlled Trials as Topic , Treatment Outcome
4.
Heart Vessels ; 33(12): 1423-1433, 2018 Dec.
Article in English | MEDLINE | ID: mdl-29967954

ABSTRACT

Intra-stent thrombus (IS-Th) formed immediately after percutaneous coronary intervention (PCI) is associated with subsequent adverse coronary events. However, the impact of on-treatment platelet reactivity on IS-Th is unknown. PRASFIT-Elective is a multicenter study of PCI patients receiving prasugrel (20/3.75 mg, loading/maintenance dose) or clopidogrel (300/75 mg), with aspirin (100 mg). Among the 742 study patients, 111 were pre-specified for the OCT sub-study. Of these, 82 underwent OCT immediately after PCI to assess IS-Th and at an 8-month follow-up to evaluate the fate of the IS-Th. Lesions were considered resolved when IS-Th were detected after PCI but not on the follow-up or persistent when IS-Th were observed on both scans. The P2Y12 Reactive Unit (PRU) value was determined at the initial PCI and 4 and 48 weeks post-PCI. In 76 patients (86 lesions), we detected 230 IS-Th initially, and 196 IS-Th (85.2%) were resolved at the 8-month OCT. At PCI, but not 4 or 48 weeks after, the resolved IS-Th group had a lower PRU than the persistent IS-Th group (199 ± 101 vs. 266 ± 102, p = 0.008). Multivariate logistic regression analyses revealed that lower PRU at PCI and less calcified lesions were independent predictive factors for the resolution of IS-Th. Local lesion-related factors and lower on-treatment platelet reactivity at the time of PCI may contribute to the resolution of IS-Th after EES implantation, potentially improving clinical outcome.


Subject(s)
Blood Platelets/metabolism , Clopidogrel/administration & dosage , Drug-Eluting Stents/adverse effects , Everolimus , Percutaneous Coronary Intervention/adverse effects , Prasugrel Hydrochloride/administration & dosage , Tomography, Optical Coherence/methods , Aged , Blood Platelets/drug effects , Coronary Artery Disease/surgery , Coronary Vessels/diagnostic imaging , Dose-Response Relationship, Drug , Double-Blind Method , Female , Follow-Up Studies , Graft Occlusion, Vascular/diagnosis , Graft Occlusion, Vascular/drug therapy , Humans , Male , Platelet Aggregation Inhibitors/therapeutic use , Treatment Outcome
5.
J Cardiol ; 72(1): 66-73, 2018 07.
Article in English | MEDLINE | ID: mdl-29456058

ABSTRACT

BACKGROUND: The use of short-duration dual antiplatelet therapy (DAPT) remains controversial. To investigate efficacy and safety of short-duration DAPT, we performed a detailed comparison of intra-stent conditions by optical coherence tomography (OCT) after second-generation drug-eluting stent implantation with short-term and standard DAPT. METHODS AND RESULTS: Eighty-two consecutive patients with stable angina pectoris who received Resolute zotarolimus-eluting stents (R-ZESs; Medtronic Cardiovascular, Santa Rosa, CA, USA) were enrolled. Patients were assigned to 3-month (3M group: 41 patients) and standard (standard group: 41 patients) DAPT. In the 3M group, clopidogrel was discontinued 3 months after stent implantation. In the standard group, DAPT was maintained until follow-up OCT. At 9 months, neointimal proliferation was significantly larger in the 3M group, but there were no significant between-group differences in the proportion of uncovered and malapposed strut. The prevalence of abnormal intra-stent tissue (AIT) at 9 months was equivalent between groups. A multiple regression analysis revealed malapposition at 9 months as the strongest independent predictor of AIT at 9 months, and the prevalence of AIT was not associated with DAPT duration. Over 2 years, cardiac events were equal between groups; however, major bleeding was higher tendency in the standard group than in the 3M group. CONCLUSION: This OCT study indicated that reducing DAPT's duration may provide acceptable arterial healing in patients with implanted R-ZESs.


Subject(s)
Aspirin/administration & dosage , Clopidogrel/administration & dosage , Coronary Vessels/diagnostic imaging , Drug-Eluting Stents , Platelet Aggregation Inhibitors/administration & dosage , Tomography, Optical Coherence , Aged , Angina Pectoris/therapy , Coronary Stenosis/therapy , Drug Administration Schedule , Drug Therapy, Combination , Female , Follow-Up Studies , Hemorrhage/epidemiology , Humans , Japan/epidemiology , Male , Percutaneous Coronary Intervention , Sirolimus/administration & dosage , Sirolimus/analogs & derivatives , Thrombosis/prevention & control
6.
J Cardiol ; 70(6): 545-552, 2017 Dec.
Article in English | MEDLINE | ID: mdl-28619235

ABSTRACT

BACKGROUND: Previous studies have suggested that peri-procedural myocardial infarction (PMI) following percutaneous coronary intervention (PCI) is associated with adverse short- and long-term outcomes, and several morphological predictors of PMI have been studied. However, the determinants of PMI under novel anti-platelet therapy are not fully elucidated. METHODS AND RESULTS: PRASFIT-Elective is a multicenter, parallel-group study of PCI patients in non-acute settings receiving either prasugrel or clopidogrel in addition to aspirin. Among 742 study patients, 94 (116 lesions) underwent optical coherence tomography (OCT) to evaluate the area of intra-stent tissue (IST, which comprises tissue protrusion and thrombus) after stenting in addition to standard parameters. We investigated the relationship between the peak creatine kinase (CK)-MB fraction levels after PCI and post-stent OCT findings, as well as on-treatment platelet reactivity determined by the P2Y12 reaction units (PRU) at PCI, in a post hoc manner. The multivariate linear analysis revealed that a larger total IST area (standardized coefficient: 0.370, p<0.001) and smaller minimal stent diameter (standardized coefficient: -0.242, p<0.014), but not the PRU value (p=0.988), were independently associated with CK-MB leakage. The IST area after stenting was mainly determined by the target lesion lipid index (averaged lipid arc×lipid length) (r=0.583, p<0.001). CONCLUSION: Following elective PCI, a large IST area originating from a lipid-rich plaque and a smaller minimal stent diameter were associated with PMI.


Subject(s)
Myocardial Infarction/etiology , Percutaneous Coronary Intervention , Stents , Aged , Aspirin/therapeutic use , Clopidogrel , Creatine Kinase, MB Form/blood , Double-Blind Method , Elective Surgical Procedures , Female , Humans , Male , Middle Aged , Myocardial Infarction/diagnostic imaging , Platelet Aggregation Inhibitors/therapeutic use , Prasugrel Hydrochloride/therapeutic use , Thrombosis/prevention & control , Ticlopidine/analogs & derivatives , Ticlopidine/therapeutic use , Tomography, Optical Coherence
7.
Cardiovasc Diabetol ; 15(1): 121, 2016 08 26.
Article in English | MEDLINE | ID: mdl-27565734

ABSTRACT

BACKGROUND: Recent experimental studies have revealed that n-3 fatty acids, such as eicosapentaenoic acid (EPA) regulate postprandial insulin secretion, and correct postprandial glucose and lipid abnormalities. However, the effects of 6-month EPA treatment on postprandial hyperglycemia and hyperlipidemia, insulin secretion, and concomitant endothelial dysfunction remain unknown in patients with impaired glucose metabolism (IGM) and coronary artery disease (CAD). METHODS AND RESULTS: We randomized 107 newly diagnosed IGM patients with CAD to receive either 1800 mg/day of EPA (EPA group, n = 53) or no EPA (n = 54). Cookie meal testing (carbohydrates: 75 g, fat: 28.5 g) and endothelial function testing using fasting-state flow-mediated dilatation (FMD) were performed before and after 6 months of treatment. The primary outcome of this study was changes in postprandial glycemic and triglyceridemic control and secondary outcomes were improvement of insulin secretion and endothelial dysfunction. After 6 months, the EPA group exhibited significant improvements in EPA/arachidonic acid, fasting triglyceride (TG), and high-density lipoprotein cholesterol (HDL-C). The EPA group also exhibited significant decreases in the incremental TG peak, area under the curve (AUC) for postprandial TG, incremental glucose peak, AUC for postprandial glucose, and improvements in glycometabolism categorization. No significant changes were observed for hemoglobin A1c and fasting plasma glucose levels. The EPA group exhibited a significant increase in AUC-immune reactive insulin/AUC-plasma glucose ratio (which indicates postprandial insulin secretory ability) and significant improvements in FMD. Multiple regression analysis revealed that decreases in the TG/HDL-C ratio and incremental TG peak were independent predictors of FMD improvement in the EPA group. CONCLUSIONS: EPA corrected postprandial hypertriglyceridemia, hyperglycemia and insulin secretion ability. This amelioration of several metabolic abnormalities was accompanied by recovery of concomitant endothelial dysfunction in newly diagnosed IGM patients with CAD. Clinical Trial Registration UMIN Registry number: UMIN000011265 ( https://www.upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000013200&language=E ).


Subject(s)
Coronary Artery Disease/drug therapy , Eicosapentaenoic Acid/administration & dosage , Endothelium, Vascular/drug effects , Hyperglycemia/drug therapy , Hypertriglyceridemia/drug therapy , Hypoglycemic Agents/administration & dosage , Hypolipidemic Agents/administration & dosage , Insulin/metabolism , Postprandial Period , Aged , Biomarkers/blood , Blood Glucose/drug effects , Blood Glucose/metabolism , Coronary Artery Disease/blood , Coronary Artery Disease/diagnosis , Coronary Artery Disease/physiopathology , Drug Administration Schedule , Eicosapentaenoic Acid/adverse effects , Endothelium, Vascular/physiopathology , Female , Humans , Hyperglycemia/blood , Hyperglycemia/diagnosis , Hyperglycemia/physiopathology , Hypertriglyceridemia/blood , Hypertriglyceridemia/diagnosis , Hypertriglyceridemia/physiopathology , Hypoglycemic Agents/adverse effects , Hypolipidemic Agents/adverse effects , Inflammation Mediators/blood , Insulin/blood , Insulin Secretion , Japan , Male , Middle Aged , Prospective Studies , Recovery of Function , Single-Blind Method , Time Factors , Treatment Outcome , Triglycerides/blood , Vasodilation/drug effects
8.
J Cardiol ; 67(6): 531-7, 2016 06.
Article in English | MEDLINE | ID: mdl-26299610

ABSTRACT

BACKGROUND: Hemodialysis (HD) patients are at high risk for adverse clinical outcomes after drug-eluting stent (DES) implantation. However, the impact of residual platelet reactivity under dual anti-platelet therapy in this subset of patients remains unclear. METHODS: We enrolled 142 stable angina patients (194 lesions) treated with DES, who were taking aspirin and 75mg clopidogrel and had undergone 8-month angiography with optical coherence tomography (OCT). OCT findings and major adverse cardiac events (MACEs) at 1 year (cardiac death, acute coronary syndrome, target lesion and vessel revascularization, and stent thrombosis) were compared between 28 HD patients and 114 non-HD patients. Responsiveness to clopidogrel was assessed by measuring P2Y12 reaction unit (PRU) at 8 months. RESULTS: PRU was significantly higher in HD patients than in non-HD patients (p=0.006), even though proportion of cytochrome P450 2C19 genotype was equivalent. HD patients had a significantly higher rate of thrombi formation (assessed using OCT) and MACEs than non-HD patients (thrombi: p=0.001; MACEs: p=0.0001). The PRU value was independently associated with MACEs in both groups. The optimal cutoff values of PRU for predicting MACEs were 235 for HD patients and 259 for non-HD patients. CONCLUSIONS: HD was associated with a high residual platelet reactivity, which may contribute to the higher incidence of MACEs after DES implantation in HD patients. HD may be a patient profile that merits a more potent anti-platelet regimen.


Subject(s)
Angina, Stable/therapy , Drug-Eluting Stents/adverse effects , Platelet Aggregation Inhibitors/administration & dosage , Renal Dialysis/adverse effects , Ticlopidine/analogs & derivatives , Aged , Aspirin/administration & dosage , Blood Platelets/drug effects , Case-Control Studies , Clopidogrel , Drug Therapy, Combination , Female , Humans , Male , Middle Aged , Thrombosis/etiology , Ticlopidine/administration & dosage , Tomography, Optical Coherence
9.
EuroIntervention ; 12(11): e1366-e1374, 2016 Dec 10.
Article in English | MEDLINE | ID: mdl-26690315

ABSTRACT

AIMS: Although pathological studies have indicated the development of neoatherosclerosis (NA) after stenting, its risk factors and impact on future clinical events remain unclear. We aimed to clarify the possible risk factors for NA development and to evaluate the impact of NA in a large Japanese observational OCT database of patients with coronary heart disease. METHODS AND RESULTS: One hundred and seventy-five consecutive patients (314 lesions) who underwent OCT examination >1 year after bare metal or drug-eluting stent implantation were enrolled. We assessed the presence of NA by follow-up OCT and compared adverse clinical events between NA+ and NA- patients. Forty-six patients had NA at the follow-up OCT. These patients had higher low-density lipoprotein (LDL) cholesterol and C-reactive protein (CRP) levels at follow-up. In multivariate logistic analysis, LDL cholesterol and CRP levels at follow-up were independently associated with the presence of NA (odds ratio [OR]: 1.022, p=0.008, OR 1.022, p=0.001, respectively). Moreover, patients with NA had a higher incidence of major adverse cardiac events (MACE) at follow-up. Multivariate Cox hazard analysis showed that the presence of NA was an independent risk factor for MACE (hazard ratio: 2.909, p=0.012). CONCLUSIONS: High LDL cholesterol and CRP levels may be risk factors for NA development in patients treated with coronary stents. Moreover, the presence of NA was independently associated with MACE, suggesting the need for careful clinical follow-up of these patients.


Subject(s)
Atherosclerosis/therapy , Coronary Artery Disease/therapy , Drug-Eluting Stents , Adult , Aged , Coronary Restenosis/etiology , Coronary Restenosis/therapy , Drug-Eluting Stents/adverse effects , Female , Hospitals, University , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/methods , Registries , Risk Factors , Time , Tomography, Optical Coherence/methods
10.
Int J Cardiol Heart Vasc ; 11: 1-6, 2016 Jun.
Article in English | MEDLINE | ID: mdl-28616517

ABSTRACT

BACKGROUND: Clinical efficacy of balloon pulmonary angioplasty (BPA) to the patients with non-operable chronic thromboembolic pulmonary hypertension (CTEPH) for improving pulmonary hemodynamics and exercise tolerance has been reported in these several years. However, reperfusion pulmonary injury (RPI) remains to be a major complication of BPA to overcome. This study elucidated the local predictor of RPI. METHODS: Twenty-eight consecutive patients with non-operable CTEPH underwent BPA for lesions in the segmental or sub-segmental vessels. Pre- and post-BPA pulmonary arterial pressures at proximal (Pp) and distal (Pd) to the stenosis were measured by a 0.014-in. pressure wire. Positive or negative RPI was evaluated by chest computed tomography in each re-perfused segment separately 4 h after BPA. RESULTS: Pressure measurements pre- and post-BPA were obtained from 110 lesions, where Pd and pressure ratio (Pd/Pp) increased after BPA in all lesions. Among them, RPI was observed in 49 lesions (44.5%). In the RPI-positive lesions, post-BPA Pd and post-BPA Pd/Pp were higher compared with the RPI-negative lesions. Multivariate logistic analysis revealed that the post-BPA Pd was independently associated with RPI incidence. Receiver operating characteristic curve analysis demonstrated the best cut-off value of 19.5 mm Hg for post-BPA Pd to predict RPI. CONCLUSIONS: High reperfusion pressure after BPA could be a predictor of RPI. Monitoring local pressure during BPA procedure may have a potential to reduce the incidence of RPI.

11.
Can J Cardiol ; 31(8): 980-8, 2015 Aug.
Article in English | MEDLINE | ID: mdl-26117623

ABSTRACT

BACKGROUND: The Nobori (Terumo Corporation, Tokyo, Japan) is a biolimus A9-eluting stent (BES) featured with a biodegradable polymer coated on the abluminal side only. We previously reported that favourable vessel healing was achieved at 6-12 months after BES implantation. However, detailed long-term vessel reaction after BES deployment is unclear. METHODS: Twenty-two BESs were serially evaluated using optical coherence tomography (OCT) at 6, 12, and 24 months after stenting. Average neointimal thickness, uncovered struts, and neointimal unevenness score (each cross-section as maximum neointimal thickness in 1 cross section divided by the average neointimal thickness of the same cross-section) were manually measured. In addition, we evaluated the percentage of struts with peri-strut low-intensity area (a region around stent struts that homogenously showed less intensity than the surrounding tissue, which suggests fibrin deposition or impaired neointima maturation), thrombi, and atherogenic neointimas (neointimas containing a diffuse border and poor-signal region with invisible struts due to marked signal attenuation). RESULTS: Serial OCT observation revealed a small gradual increase in neointimal thickness from 6 to 24 months (73 ± 24 µm; 81 ± 26 µm; and 108 ± 35 µm, respectively, P = 0.001) with a nonsignificant decrease in the lumen area (6.36 ± 1.98 mm(2); 6.18 ± 2.04 mm(2); and 5.87 ± 2.06 mm(2); P = 0.72). Frequency of uncovered struts (3.89 ± 3.91%; 1.55 ± 1.63%; and 0.23 ± 0.67%; P = 0.001), neointimal unevenness score (1.95 ± 0.18% to 1.86 ± 0.19% to 1.78 ± 0.17; P = 0.012), percentage of thrombi (5%, 0%, and 0%; P = 0.37) and peri-strut low-intensity area (6.8%, 5.1%, and 1.6%; P = 0.017) decreased from 6 to 12 and 24 months. Atherogenic neointima was not observed in the event-free OCT cohort. CONCLUSIONS: The Nobori stent achieved acceptable long-term vessel healing, mostly without adverse vessel reactions.


Subject(s)
Coated Materials, Biocompatible , Coronary Artery Disease/surgery , Coronary Vessels/pathology , Drug-Eluting Stents , Polymers , Sirolimus/analogs & derivatives , Tomography, Optical Coherence/methods , Aged , Coronary Angiography , Coronary Artery Disease/diagnosis , Coronary Vessels/surgery , Female , Follow-Up Studies , Humans , Male , Neointima , Prospective Studies , Prosthesis Design , Reproducibility of Results , Sirolimus/pharmacology , Time Factors , Treatment Outcome
12.
Cardiovasc Diabetol ; 14: 78, 2015 Jun 11.
Article in English | MEDLINE | ID: mdl-26062762

ABSTRACT

BACKGROUND: Glucose fluctuation has been recognized as a residual risk apart from dyslipidemia for the development of coronary artery disease (CAD). This study aimed to investigate the association between glucose fluctuation and coronary plaque morphology in CAD patients. METHODS: This prospective study enrolled 72 consecutive CAD patients receiving adequate lipid-lowering therapy. They were divided into 3 tertiles according to the mean amplitude of glycemic excursions (MAGE), which represents glucose fluctuation, measured by continuous glucose monitoring (tertile 1; < 49.1, tertile 2; 49.1 ~ 85.3, tertile 3; >85.3). Morphological feature of plaques were evaluated by optical coherence tomography. Lipid index (LI) (mean lipid arc × length), fibrous cap thickness (FCT), and the prevalence of thin-cap fibroatheroma (TCFA) were assessed in both culprit and non-culprit lesions. RESULTS: In total, 166 lesions were evaluated. LI was stepwisely increased according to the tertile of MAGE (1958 ± 974 [tertile 1] vs. 2653 ± 1400 [tertile 2] vs. 4362 ± 1858 [tertile 3], p < 0.001), whereas FCT was the thinnest in the tertile 3 (157.3 ± 73.0 µm vs. 104.0 ± 64.1 µm vs. 83.1 ± 34.7 µm, p < 0.001, respectively). The tertile 3 had the highest prevalence of TCFA. Multiple linear regression analysis showed that MAGE had the strongest effect on LI and FCT (standardized coefficient ß = 0.527 and -0.392, respectively, both P < 0.001). Multiple logistic analysis identified MAGE as the only independent predictor of the presence of TCFA (odds ratio 1.034; P < 0.001). CONCLUSIONS: Glucose fluctuation and hypoglycemia may impact the formation of lipid-rich plaques and thinning of fibrous cap in CAD patients with lipid-lowering therapy.


Subject(s)
Blood Glucose/metabolism , Coronary Artery Disease/pathology , Dyslipidemias/drug therapy , Hyperglycemia/metabolism , Hypoglycemia/metabolism , Hypolipidemic Agents/therapeutic use , Plaque, Atherosclerotic/pathology , Tomography, Optical Coherence , Aged , Aged, 80 and over , Cohort Studies , Coronary Artery Disease/epidemiology , Coronary Artery Disease/metabolism , Coronary Artery Disease/surgery , Dyslipidemias/complications , Dyslipidemias/metabolism , Female , Humans , Hyperglycemia/complications , Hyperglycemia/epidemiology , Hypoglycemia/complications , Hypoglycemia/epidemiology , Linear Models , Logistic Models , Male , Middle Aged , Monitoring, Ambulatory , Multivariate Analysis , Percutaneous Coronary Intervention , Plaque, Atherosclerotic/epidemiology , Plaque, Atherosclerotic/metabolism , Plaque, Atherosclerotic/surgery , Prospective Studies , Risk Factors
13.
JACC Cardiovasc Interv ; 8(6): 800-811, 2015 May.
Article in English | MEDLINE | ID: mdl-25999102

ABSTRACT

OBJECTIVES: This study sought to investigate the effect of daily glucose fluctuation on coronary plaque properties in patients with coronary artery disease (CAD) pre-treated with lipid-lowering therapy. BACKGROUND: There is growing evidence that glucose fluctuation, as a residual risk apart from dyslipidemia, is an important factor contributing to the development of CAD. METHODS: This prospective study enrolled 70 consecutive CAD patients who were referred for percutaneous coronary intervention and whose low-density lipoprotein cholesterol level was <120 mg/dl under statin treatment or <100 mg/dl without statins. Daily glucose fluctuation was analyzed by measuring the mean amplitude of glycemic excursion (MAGE). The plaque properties in the culprit and nonculprit lesions were assessed by virtual histology intravascular ultrasound, and the volume percentage of necrotic core within the plaque (%NC) and the presence of thin-cap fibroatheroma were evaluated. RESULTS: In total, 165 lesions were evaluated in 70 patients (40 diabetic and 30 nondiabetic patients). %NC was well correlated with MAGE (r = 0.490, p <0.001). A linear mixed effect model showed that MAGE had the strongest effect on %NC (coefficient ß = 0.080 ± 0.020 [standard error], p < 0.001). The generalized linear mixed effect model revealed that MAGE was the only independent predictor of the presence of thin-cap fibroatheroma (odds ratio: 1.037; 95% confidence interval: 1.010 to 1.065; p = 0.007). CONCLUSIONS: Daily glucose fluctuation may have an effect on coronary plaque vulnerability in patients with CAD pre-treated with lipid-lowering therapy. Further investigations should address the rationale for the early detection and control of glucose fluctuation in the era of universal statin use for CAD patients.


Subject(s)
Blood Glucose/metabolism , Coronary Artery Disease/etiology , Coronary Vessels/pathology , Dyslipidemias/drug therapy , Glucose Metabolism Disorders/complications , Hypolipidemic Agents/therapeutic use , Plaque, Atherosclerotic , Aged , Aged, 80 and over , Biomarkers/blood , Cholesterol, LDL/blood , Coronary Angiography , Coronary Artery Disease/blood , Coronary Artery Disease/diagnosis , Coronary Artery Disease/therapy , Coronary Vessels/diagnostic imaging , Dyslipidemias/blood , Dyslipidemias/complications , Dyslipidemias/diagnosis , Early Diagnosis , Female , Fibrosis , Glucose Metabolism Disorders/blood , Glucose Metabolism Disorders/diagnosis , Glucose Tolerance Test , Humans , Japan , Male , Monitoring, Ambulatory/methods , Necrosis , Odds Ratio , Percutaneous Coronary Intervention , Predictive Value of Tests , Prospective Studies , Registries , Risk Factors , Rupture, Spontaneous , Time Factors , Treatment Outcome , Ultrasonography, Interventional
14.
J Cardiol ; 65(4): 298-304, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25082295

ABSTRACT

BACKGROUND: Previous reports have suggested the importance of delayed arterial healing and the development of neoatherosclerosis as major contributors to stent thrombosis and delayed restenosis. The difference of in vivo assessment of long-term vessel healing between first-generation drug-eluting stents and current generation everolimus-eluting stents (EESs) is limited. The aim of this study was to evaluate long-term arterial healing in EES in comparison with the first generation sirolimus-eluting stents (SES). METHODS: We evaluated 31 EES (23 patients) and 8 SES (7 patients) by serial optical coherence tomography at 12 months (mid-phase) and 24 months (late-phase) after stenting and evaluated the change in neointimal thickness (NIT), the percentages of uncovered struts, peri-strut low intensity area (PLIA; region around stent struts homogenously lower-intensity appearance than surrounding tissue), and thrombus. RESULTS: Although the average NIT showed no significant changes from the mid- to the late-phase follow-up in both EES and SES groups, the change in NIT and minimum lumen area was significantly larger in SES than EES (5.2±29.4 vs. 37.2±48.9; p=0.02, -0.06±0.36 vs. -0.45±0.74; p=0.04, respectively). The incidence of uncovered struts and struts with PLIA of EES was lower than those of SES, at both phases. Stents with in-stent thrombus of EES tended to be lower than that of SES at both phase follow-ups. CONCLUSION: Although both SES and EES showed progressive luminal narrowing from the mid- to the late-phase follow-up, the extent of delayed lumen narrowing and delayed neointimal proliferation was significantly less in the second generation EES than the first generation SES. EESs seem to offer sustained stability in efficacy, without sacrificing safety, up to 2 years after implantation.


Subject(s)
Coronary Vessels/pathology , Drug-Eluting Stents , Immunosuppressive Agents/administration & dosage , Sirolimus/analogs & derivatives , Sirolimus/administration & dosage , Aged , Everolimus , Female , Humans , Male , Middle Aged , Neointima/pathology , Time Factors , Tomography, Optical Coherence
15.
Int J Cardiol ; 179: 476-83, 2015 Jan 20.
Article in English | MEDLINE | ID: mdl-25465810

ABSTRACT

BACKGROUND: The contribution of clopidogrel response due to cytochrome P450 (CYP) 2C19 loss-of-function polymorphism after drug-eluting stent (DES) implantation is unclear. METHODS: A total of 196 patients who had undergone optical coherence tomography (OCT) at 8 months following first-generation DES (120 lesions) and current-generation everolimus-eluting stent (EES) implantation (127 lesions) were enrolled. Patients were divided into 3 groups by CYP2C19 polymorphism: extensive metabolizers (EMs), intermediate metabolizers (IMs), and poor metabolizers (PMs). OCT findings were compared among the 3 groups. Responsiveness to clopidogrel was assessed by VerifyNow platelet reactivity unit (PRU). RESULTS: The incidence of intra-stent thrombi was significantly higher after first-generation DES implantation compared with EES implantation (35% vs 13%, respectively; p=0.0001). In the first-generation DES group, the incidence of intra-stent thrombi significantly increased among EMs, IMs, and PMs (21% vs 36% vs 63%, respectively; p=0.007), while there was no significant difference among the 3 groups after EES implantation (10% vs 13% vs 20%, respectively; p=0.55). The PRU significantly increased among EMs, IMs, and PMs in each stent group. In multivariate analyses, although PMs had a 3-fold higher risk of thrombi formation compared with non-PMs after first-generation DES implantation, there were no significant differences in thrombi formation between the 2 groups after EES implantation. The optimal PRU cutoff values for the prediction of intra-stent thrombi with first-generation DES and EES were 234 and 256, respectively. CONCLUSION: CYP2C19 loss-of-function polymorphism is associated with a higher incidence of intra-stent thrombi after first-generation DES implantation, while the impact is attenuated following EES implantation.


Subject(s)
Cytochrome P-450 Enzyme System/genetics , Drug-Eluting Stents , Immunosuppressive Agents/administration & dosage , Sirolimus/analogs & derivatives , Thrombosis/genetics , Aged , Clopidogrel , Coronary Angiography , Everolimus , Female , Genotype , Humans , Male , Platelet Aggregation Inhibitors/metabolism , Polymorphism, Genetic , Risk Factors , Sirolimus/administration & dosage , Thrombosis/drug therapy , Ticlopidine/analogs & derivatives , Ticlopidine/metabolism , Tomography, Optical Coherence
16.
Circ J ; 78(11): 2665-73, 2014.
Article in English | MEDLINE | ID: mdl-25262962

ABSTRACT

BACKGROUND: This study directly compared optical coherence tomography (OCT) and histopathology for the assessment of vascular response to first- and second-generation drug-eluting stents. METHODS AND RESULTS: Sirolimus-, everolimus-, and biolimus-eluting stents (SES, EES, and BES, respectively) were randomly implanted into the coronary arteries of 12 porcine. OCT was conducted after implantation: at 1, 3, and 6 months; histopathology was assessed at 3 and 6 months. At 1-month OCT, EES had the highest neointimal area (NA) and lowest neointimal unevenness score (NUS). At 6 months, NA and NUS were equivalent among the stent types. ∆NA from 1 to 6 months was lowest for EES, and ∆NA correlated with the histopathological inflammation score at 6 months, which was highest for SES (P<0.001). The mean signal intensity (MSI) and the attenuation were different for the stent types at 3 months, and were associated with inflammation score. Moderate diagnostic efficiency for measuring MSI was found, with an optimal cut-off of 6.88 predicting a high (≥grade 3) inflammation score. CONCLUSIONS: EES had the greatest uniformity and the least neointimal proliferation and were associated with less persistent inflammation. OCT provides accurate morphometric data; furthermore, quantitative measurement of the optical properties may help assess histological inflammation, which was more predominantly associated with SES than with EES and BES.


Subject(s)
Coronary Artery Disease , Coronary Vessels/pathology , Disease Models, Animal , Drug-Eluting Stents/adverse effects , Neointima/pathology , Tomography, Optical Coherence , Animals , Coronary Artery Disease/pathology , Coronary Artery Disease/surgery , Inflammation/etiology , Inflammation/pathology , Swine , Swine, Miniature , Time Factors
17.
Circ J ; 78(9): 2188-96, 2014.
Article in English | MEDLINE | ID: mdl-25017738

ABSTRACT

BACKGROUND: Previous reports have shown potential disadvantages of limus-derivative drugs for the stenting treatment of patients with diabetes mellitus (DM). METHODS AND RESULTS: We studied 159 coronary artery lesions (DM: n=72, non-DM: n=87) in 123 patients treated with everolimus-eluting stent (EES) and who underwent scheduled 9-month follow-up angiography with optical coherence tomography (OCT) regardless of symptoms. In addition to standard OCT variables, neointimal unevenness score (maximum/average neointimal thickness) and stent eccentricity index (minimum/maximum stent diameter) were calculated for each cross-section. To investigate a potential baseline difference between DM and non-DM lesions, pre- and post-interventional intravascular ultrasound (IVUS) images were also evaluated as an IVUS subgroup analysis. The average neointimal thickness and neointimal coverage did not differ between DM and non-DM patients. DM patients had, however, greater asymmetric stent expansion and variability of neointimal thickness than non-DM patients. There was a weak, but significant association between average stent eccentricity index and neointimal unevenness score. The IVUS substudy showed that the culprit plaque volume and plaque eccentricity in DM patients were significantly greater than in non-DM patients. CONCLUSIONS: Although EES provided a similar level of average neointimal thickness and coverage both in the presence and absence of DM, uneven neointimal suppression occurred in DM patients. A larger plaque volume of the culprit lesion may hamper symmetric stent expansion, possibly explaining the non-uniform neointimal suppression in DM patients.


Subject(s)
Coronary Artery Disease/surgery , Drug-Eluting Stents , Graft Occlusion, Vascular/pathology , Immunosuppressive Agents , Neointima/pathology , Sirolimus/analogs & derivatives , Tomography, Optical Coherence , Aged , Coronary Artery Disease/pathology , Diabetes Mellitus , Everolimus , Female , Follow-Up Studies , Graft Occlusion, Vascular/etiology , Humans , Male , Middle Aged , Neointima/etiology
18.
Circ J ; 78(8): 1882-90, 2014.
Article in English | MEDLINE | ID: mdl-24909891

ABSTRACT

BACKGROUND: Nobori is a novel biolimus A9-eluting stent (BES) coated with a biodegradable polymer only on the abluminal side, which degrades over 6-9 months post-stent deployment. The course of vessel reaction after deployment at these time points remains unclear. METHODS AND RESULTS: We serially evaluated 28 BES implanted in de novo coronary lesions of 23 patients using optical coherence tomography (OCT) at 6 and 12 months post-stenting. Standard OCT variables, the percentage of stent with peri-strut low-intensity area (PLIA, a region around stent struts homogenously showing lesser intensity than the surrounding tissue, suggesting fibrin deposition or impaired neointima maturation) and that with in-stent thrombi were evaluated. There was a significant, but small increase in neointimal thickness (72 ± 23 to 82 ± 25 µm, P=0.006) from the 6- to the 12-month follow-up, without a significant decrease in minimum lumen area (P=0.30). The incidences of uncovered and malapposed struts were low at 6 months and reduced further at 12 months (3.96 ± 3.97% to 1.51 ± 1.63%, P=0.001, and 0.50 ± 1.84% to 0.06 ± 0.24%, P=0.20, respectively). The frequency of stent with PLIA decreased during the follow-up (57% to 32%, P=0.05) and that with in-stent thrombi also numerically decreased (7% to 0%, P=0.24). CONCLUSIONS: Neointimal hyperplasia was persistently suppressed following BES implantation up to 12 months. Simultaneously, favorable vessel healing was achieved at 6 months without a delaying adverse reaction for up to 12 months.


Subject(s)
Biodegradable Plastics , Drug-Eluting Stents , Regeneration , Sirolimus/analogs & derivatives , Tomography, Optical Coherence , Aged , Female , Follow-Up Studies , Humans , Hyperplasia/pathology , Hyperplasia/physiopathology , Male , Middle Aged , Neointima/pathology , Neointima/physiopathology
19.
Can J Cardiol ; 30(8): 904-11, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24882511

ABSTRACT

BACKGROUND: Although drug-eluting stents have significantly reduced the midterm incidence of target lesion revascularization (TLR), in vivo studies on long-term vessel healing of sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) are limited. The aim of this study was to compare long-term arterial healing with SESs and PESs. METHODS: We evaluated 27 SESs (23 patients) and 21 PESs (20 patients) by serial optical coherence tomography at 6 months (midphase) and ≥ 3 years (late phase) after stenting and evaluated the change of neointimal thickness (NIT), the percentages of uncovered and malapposed struts, peristrut low-intensity area (region around stent struts with a homogeneously lower intensity appearance than surrounding tissue), thrombus, and atherogenic neointima. RESULTS: At follow-up, most SESs showed a progressive increase in the average NIT, whereas PESs showed variable changes. Between midphase and late phase, NIT increased significantly in SESs (midphase, 94.1 ± 49.3; late phase, 130.2 ± 78.7; P = 0.001) but decreased significantly in PESs (midphase, 167.4 ± 122.9; late phase, 136.0 ± 77.7; P = 0.04). The percentages of uncovered struts decreased significantly in SESs; conversely, variable changes were observed in PESs. Peristrut low-intensity area and thrombus formation decreased in SESs but remained largely unchanged in PESs. The prevalence of atherogenic neointima was greater in the late phase than in the midphase in both groups but was similar for both stents. CONCLUSIONS: Long-term vessel healing was different for SESs and PESs. Progressive vessel healing was consistently observed in SESs, whereas a heterogeneous process of delayed vessel healing was noted for PESs.


Subject(s)
Cardiovascular Agents/administration & dosage , Coronary Vessels/drug effects , Drug-Eluting Stents , Neointima/drug therapy , Paclitaxel/administration & dosage , Sirolimus/administration & dosage , Aged , Coronary Thrombosis/pathology , Coronary Vessels/pathology , Female , Follow-Up Studies , Humans , Male , Neointima/pathology , Percutaneous Coronary Intervention , Tomography, Optical Coherence
20.
Int J Cardiovasc Imaging ; 30(5): 857-65, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24748583

ABSTRACT

The consequences of acute strut malapposition in everolimus-eluting stents (EES) are unknown. This study investigated the impact of strut-vessel (S-V) distance and plaque type underneath acute strut malapposition on the mid-term vessel response in EES. Twenty-nine patients (35 EES) underwent optical coherence tomography (OCT) immediately after percutaneous coronary intervention and at 8-month follow-up. S-V distance and plaque type (lipid, calcified, or fibrous) underneath acute strut malapposition were evaluated. Follow-up OCT classified acute strut malapposition as persistent or resolved. The S-V cutoff value for predicting resolved strut malapposition and the incidence of intra-stent thrombi were determined. Among 569 cases of acute strut malapposition, involving 29,168 struts, 139 (24.4 %) were persistent. Mean S-V distance was significantly longer in persistent than in resolved strut malapposition (600 ± 294 vs. 231 ± 95 µm; P < 0.0001). S-V distance ≤380 µm was the best cutoff value for predicting resolved strut malapposition (sensitivity 93.5 %, specificity 69.8 %, area under curve 0.878). Acute strut malapposition with S-V distance ≤380 µm remained persistent more frequently over lipid/calcified than over fibrous plaques (lipid: 13.4 %, calcified: 18.2 %, fibrous: 4.2 %; lipid vs. fibrous, P = 0.001; calcified vs. fibrous, P = 0.02). Intra-stent thrombi were more frequent in stents with ≥1 persistent strut malapposition than in those without [4/11 stents (36.3 %) vs. 0/24 (0 %); P = 0.006]. Lipid and calcified plaque, together with S-V distance, affect the resolution of acute strut malapposition in EES. Persistent strut malapposition is associated with the presence of thrombi at follow-up, which could be the substrate for late stent thrombosis.


Subject(s)
Coronary Disease/drug therapy , Drug-Eluting Stents/adverse effects , Immunosuppressive Agents/administration & dosage , Percutaneous Coronary Intervention , Plaque, Atherosclerotic/drug therapy , Postoperative Complications/diagnosis , Prosthesis Failure/adverse effects , Sirolimus/analogs & derivatives , Tomography, Optical Coherence , Aged , Coronary Disease/surgery , Everolimus , Female , Humans , Male , Plaque, Atherosclerotic/pathology , Sensitivity and Specificity , Sirolimus/administration & dosage
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