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1.
J Cardiol ; 2019 Sep 16.
Artigo em Inglês | MEDLINE | ID: mdl-31537439

RESUMO

BACKGROUND: Stent thrombosis (ST) is a rare but serious complication after deployment of a drug-eluting stent. The features of ST after implantation of an everolimus-eluting stent (EES) have not been fully elucidated. METHODS: A comprehensive survey of real-world adverse event reporting with conditions for approval under the Pharmaceuticals and Medical Devices Act identified 490 cases of ST with EES. A total of 370 patients with definite ST after EES implantation [287 with early (E)ST (within 30 days), 54 with late (L)ST (31-365 days), and 29 with very late (VL)ST (over 1 year)] were divided into an EST group and an LST/VLST group to compare the patients and lesions characteristics. RESULTS: The frequency of patients with hemodialysis and in-stent restenosis (ISR) lesions were significantly higher in the LST/VLST group than in the EST group (hemodialysis, 22.9% vs 2.7%, p = 0.0001; ISR lesions, 25.9% vs 9.4%, p = 0.0001). Characteristic demographic factors for LST/VLST versus EST identified by multivariable model were hemodialysis and ISR lesions (hemodialysis: odds ratio 7.348, 95% confidence interval 2.458-21.968, p = 0.0001; ISR lesions: odds ratio, 2.490, 95% confidence interval 1.100-5.638, p = 0.027). The in-hospital death rates from ST were not significantly different between the EST group and the LST/VLST group (EST, 15% vs LST/VLST, 21.7%, p = 0.147). CONCLUSIONS: Patient-related and lesion-related characteristics were significantly different between EST and LST/VLST. Data collection from adverse event reporting could be a helpful strategy for evaluation of this serious but rare complication.

2.
Circulation ; 140(3): 240-261, 2019 Jul 16.
Artigo em Inglês | MEDLINE | ID: mdl-31116032

RESUMO

Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.

3.
Eur Heart J ; 40(31): 2632-2653, 2019 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-31116395

RESUMO

Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.

4.
J Cardiol ; 74(1): 13-18, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31005388

RESUMO

The indication for MitraClip (Abbott Vascular, Santa Clara, CA, USA) in the USA is degenerative mitral regurgitation (DMR), but the Japanese indication includes both DMR and functional mitral regurgitation (FMR), in patients without severe left ventricular dysfunction. One of the reasons for this difference is that the Japanese Circulation Society submitted a formal request to the Japanese government for early approval of MitraClip for both DMR and FMR on the basis of unmet medical need for MR patients resistant to medical therapy, but at prohibitive risk for mitral valve surgery. Here, we describe the regulatory approval review process of MitraClip in Japan. Clinical data from outside Japan indicated that MitraClip provides significant improvements from baseline in New York Heart Association Class and hospitalizations for heart failure due to the reduction of MR grade without adversely affecting long-term prognosis in FMR patients as well as DMR patients. Also, a Japanese domestic trial showed a favorable acute procedural success rate without serious adverse events with MitraClip in both DMR and FMR patients. Further, it is considered in Japan that improvement of MR mechanically is clinically important in both DMR and FMR, in patients without severe left ventricular dysfunction. On the basis of these considerations, the MitraClip was approved in Japan for indications of both DMR and FMR with preserved cardiac function in patients at prohibitive risk for mitral valve surgery.

5.
Heart Vessels ; 34(6): 883-887, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30542918

RESUMO

Platelet reactivity in the presence of clopidogrel is deteriorated in patients undergoing hemodialysis (HD). However, the impact of residual platelet reactivity with prasugrel use in Japanese patients on HD remains unclear. This was a prospective, multi-center, single-arm study conducted to compare platelet reactivity of prasugrel 3.75 mg per day vs. clopidogrel 75 mg per day in patients on chronic HD. We assessed P2Y12 reaction units (PRU) using the VerifyNow® P2Y12 test for all enrolled patients at baseline (clopidogrel treatment) and at 14 days (prasugrel treatment) pre- and post-HD. Clinical outcomes data were obtained on day 14. A total of 38 patients on HD were included in this study. The PRU were significantly higher in patients on clopidogrel than in patients on prasugrel in both phases (pre-HD: clopidogrel 226 ± 80 vs. prasugrel 175 ± 82, p < 0.001) (post-HD: clopidogrel 256 ± 67 vs. prasugrel 210 ± 63, p < 0.001). There were no patients with bleeding or adverse events during the two weeks of prasugrel treatment. Prasugrel 3.75 mg per day, adjusted for Japanese patients, inhibited platelet aggregation better than clopidogrel, even after hemodialysis, which might contribute to the reduced incidence of major adverse event in patients undergoing HD.


Assuntos
Plaquetas/efeitos dos fármacos , Clopidogrel/uso terapêutico , Inibidores da Agregação de Plaquetas/uso terapêutico , Cloridrato de Prasugrel/uso terapêutico , Diálise Renal , Idoso , Relação Dose-Resposta a Droga , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
6.
Kobe J Med Sci ; 64(2): E56-E63, 2018 Sep 18.
Artigo em Inglês | MEDLINE | ID: mdl-30381727

RESUMO

We previously reported that the cytochrome P450 (CYP) 2C19 reduced-function polymorphism was associated with decreased responsiveness to clopidogrel and intra-stent thrombus formation, as well as subsequent ischemic events after drug-eluting stent (DES) implantation. However, the relationship between the polymorphism and bleeding events remains unclear. Among 1427 consecutive patients who underwent DES implantation at Kobe University Hospital, 247 patients (341 lesions) were enrolled for this prospective observational study. All patients underwent follow-up optical coherence tomography (OCT) at 8 months and CYP2C19 genotyping. The patients were divided into three groups according to the phenotypic effect of the CYP2C19 polymorphism: extensive metabolizers (EM), intermediate metabolizers (IM), and poor metabolizers (PM). OCT findings, and ischemic and bleeding events were compared among the three groups. The frequency of intra-stent thrombi showed an increasing pattern among the patients with EM, IM, and PM (13.3%, 22.6%, and 33.3%, respectively; p = 0.04). The incidence of major adverse cardiovascular events (MACE) also showed an increase across the three groups from extensive to poor metabolizers (7.8%, 10.5%, and 33.3%, respectively; p < 0.01), whereas the frequency of bleeding showed no significant difference among the groups (15.6%, 19.4%, and 21.2%, respectively; p = 0.69). The CYP2C19 polymorphism is associated with the frequency of MACE, but is not related to the incidence of bleeding after percutaneous coronary intervention in Japanese patients receiving clopidogrel.


Assuntos
Citocromo P-450 CYP2C19/genética , Stents Farmacológicos/efeitos adversos , Idoso , Grupo com Ancestrais do Continente Asiático/genética , Doenças Cardiovasculares/enzimologia , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/genética , Clopidogrel/farmacocinética , Citocromo P-450 CYP2C19/metabolismo , Feminino , Estudos de Associação Genética , Hemorragia/etiologia , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação de Plaquetas/farmacocinética , Polimorfismo Genético , Estudos Prospectivos , Resultado do Tratamento
7.
J Cardiol ; 72(3): 193-199, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29980334

RESUMO

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.


Assuntos
Vasos Coronários/efeitos dos fármacos , Stents Farmacológicos , Everolimo/administração & dosagem , Tomografia de Coerência Óptica/métodos , Cicatrização/efeitos dos fármacos , Idoso , Vasos Coronários/patologia , Feminino , Seguimentos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Hiperplasia/diagnóstico por imagem , Hiperplasia/etiologia , Masculino , Pessoa de Meia-Idade , Neointima/diagnóstico por imagem , Neointima/etiologia , Neointima/patologia , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/etiologia , Período Pós-Operatório , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
8.
Heart Vessels ; 33(12): 1423-1433, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29967954

RESUMO

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.


Assuntos
Plaquetas/metabolismo , Clopidogrel/administração & dosagem , Stents Farmacológicos/efeitos adversos , Everolimo , Intervenção Coronária Percutânea/efeitos adversos , Cloridrato de Prasugrel/administração & dosagem , Tomografia de Coerência Óptica/métodos , Idoso , Plaquetas/efeitos dos fármacos , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Seguimentos , Oclusão de Enxerto Vascular/diagnóstico , Oclusão de Enxerto Vascular/tratamento farmacológico , Humanos , Masculino , Inibidores da Agregação de Plaquetas/uso terapêutico , Resultado do Tratamento
9.
J Vasc Interv Radiol ; 29(5): 657-660, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29548874

RESUMO

In Japan, a recent issue that required an urgent response was the streamlining of regulations concerning clinical trials of medical devices. On July 31, 2017, the Ministry of Health, Labour and Welfare enacted a new regulatory framework called the fast-break scheme for innovative medical devices aiming to expedite patient access while reducing the premarket regulatory burden of clinical trials and enhancing postmarketing commitments. The new framework is expected to provide greater benefits to patients who require access to new medical devices and to companies via improved transparency and predictability, as well as to reduce the social and medical cost incurred for medical innovation.


Assuntos
Ensaios Clínicos como Assunto/legislação & jurisprudência , Aprovação de Equipamentos/legislação & jurisprudência , Regulamentação Governamental , Humanos , Japão , Vigilância de Produtos Comercializados
10.
Circ J ; 82(6): 1487-1490, 2018 05 25.
Artigo em Inglês | MEDLINE | ID: mdl-29563353

RESUMO

A prospective randomized clinical trial showed that the BioFreedom stent (Biosensors International), which is a polymer-free and carrier-free drug-coated stent, was significantly superior to a bare-metal stent (BMS) in patients at high bleeding risk who were receiving a 1-month course of dual antiplatelet therapy (DAPT). However, the stent thrombosis rate (2.01% for BioFreedom vs. 2.20% for BMS) was 4-6-fold higher than that of approved drug-eluting stents based on real-world data in Japan. Furthermore, the frequency of stent thrombosis at more than 1 month with the BioFreedom stent was slightly higher than that at less than 1 month. This result suggested that it would not be acceptable to stop DAPT universally at 1 month. Thus, the target patients for the BioFreedom stent are unspecified patients at high bleeding risk needing to continue DAPT for as long as necessary in Japan. Therefore, based on the pre- and post-marketing balance of medical devices regulations, regulatory approval was given for unspecified patients conditionally upon real-world data collection of 2,000 patients with a Use-Results Survey, instead of conducting additional pre-marketing clinical trial(s). The Use-Results Survey System is part of a strategy to expedite patients' access to innovative medical devices and to accelerate the development of medical devices.


Assuntos
Stents Farmacológicos/normas , Aprovação de Equipamentos , Stents Farmacológicos/efeitos adversos , Hemorragia/etiologia , Humanos , Japão , Inquéritos e Questionários , Resultado do Tratamento
11.
J Cardiol ; 70(6): 545-552, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28619235

RESUMO

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.


Assuntos
Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea , Stents , Idoso , Aspirina/uso terapêutico , Clopidogrel , Creatina Quinase Forma MB/sangue , Método Duplo-Cego , Procedimentos Cirúrgicos Eletivos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico por imagem , Inibidores da Agregação de Plaquetas/uso terapêutico , Cloridrato de Prasugrel/uso terapêutico , Trombose/prevenção & controle , Ticlopidina/análogos & derivados , Ticlopidina/uso terapêutico , Tomografia de Coerência Óptica
13.
Int J Cardiol Heart Vasc ; 11: 1-6, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28616517

RESUMO

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.

14.
EuroIntervention ; 12(11): e1366-e1374, 2016 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-26690315

RESUMO

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.


Assuntos
Aterosclerose/terapia , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Adulto , Idoso , Reestenose Coronária/etiologia , Reestenose Coronária/terapia , Stents Farmacológicos/efeitos adversos , Feminino , Hospitais Universitários , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Sistema de Registros , Fatores de Risco , Tempo , Tomografia de Coerência Óptica/métodos
15.
J Cardiol ; 67(6): 531-7, 2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-26299610

RESUMO

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.


Assuntos
Angina Estável/terapia , Stents Farmacológicos/efeitos adversos , Inibidores da Agregação de Plaquetas/administração & dosagem , Diálise Renal/efeitos adversos , Ticlopidina/análogos & derivados , Idoso , Aspirina/administração & dosagem , Plaquetas/efeitos dos fármacos , Estudos de Casos e Controles , Clopidogrel , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Trombose/etiologia , Ticlopidina/administração & dosagem , Tomografia de Coerência Óptica
16.
Cardiovasc Diabetol ; 14: 78, 2015 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-26062762

RESUMO

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.


Assuntos
Glicemia/metabolismo , Doença da Artéria Coronariana/patologia , Dislipidemias/tratamento farmacológico , Hiperglicemia/metabolismo , Hipoglicemia/metabolismo , Hipolipemiantes/uso terapêutico , Placa Aterosclerótica/patologia , Tomografia de Coerência Óptica , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/metabolismo , Doença da Artéria Coronariana/cirurgia , Dislipidemias/complicações , Dislipidemias/metabolismo , Feminino , Humanos , Hiperglicemia/complicações , Hiperglicemia/epidemiologia , Hipoglicemia/complicações , Hipoglicemia/epidemiologia , Modelos Lineares , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Monitorização Ambulatorial , Análise Multivariada , Intervenção Coronária Percutânea , Placa Aterosclerótica/epidemiologia , Placa Aterosclerótica/metabolismo , Placa Aterosclerótica/cirurgia , Estudos Prospectivos , Fatores de Risco
17.
Can J Cardiol ; 31(8): 980-8, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26117623

RESUMO

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.


Assuntos
Materiais Revestidos Biocompatíveis , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/patologia , Stents Farmacológicos , Polímeros , Sirolimo/análogos & derivados , Tomografia de Coerência Óptica/métodos , Idoso , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Vasos Coronários/cirurgia , Feminino , Seguimentos , Humanos , Masculino , Neointima , Estudos Prospectivos , Desenho de Prótese , Reprodutibilidade dos Testes , Sirolimo/farmacologia , Fatores de Tempo , Resultado do Tratamento
18.
JACC Cardiovasc Interv ; 8(6): 800-811, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25999102

RESUMO

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.


Assuntos
Glicemia/metabolismo , Doença da Artéria Coronariana/etiologia , Vasos Coronários/patologia , Dislipidemias/tratamento farmacológico , Transtornos do Metabolismo de Glucose/complicações , Hipolipemiantes/uso terapêutico , Placa Aterosclerótica , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , LDL-Colesterol/sangue , Angiografia Coronária , Doença da Artéria Coronariana/sangue , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/terapia , Vasos Coronários/diagnóstico por imagem , Dislipidemias/sangue , Dislipidemias/complicações , Dislipidemias/diagnóstico , Diagnóstico Precoce , Feminino , Fibrose , Transtornos do Metabolismo de Glucose/sangue , Transtornos do Metabolismo de Glucose/diagnóstico , Teste de Tolerância a Glucose , Humanos , Japão , Masculino , Monitorização Ambulatorial/métodos , Necrose , Razão de Chances , Intervenção Coronária Percutânea , Valor Preditivo dos Testes , Estudos Prospectivos , Sistema de Registros , Fatores de Risco , Ruptura Espontânea , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia de Intervenção
19.
J Cardiol ; 65(4): 298-304, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25082295

RESUMO

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.


Assuntos
Vasos Coronários/patologia , Stents Farmacológicos , Imunossupressores/administração & dosagem , Sirolimo/análogos & derivados , Sirolimo/administração & dosagem , Idoso , Everolimo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neointima/patologia , Fatores de Tempo , Tomografia de Coerência Óptica
20.
Int J Cardiol ; 179: 476-83, 2015 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-25465810

RESUMO

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.


Assuntos
Sistema Enzimático do Citocromo P-450/genética , Stents Farmacológicos , Imunossupressores/administração & dosagem , Sirolimo/análogos & derivados , Trombose/genética , Idoso , Clopidogrel , Angiografia Coronária , Everolimo , Feminino , Genótipo , Humanos , Masculino , Inibidores da Agregação de Plaquetas/metabolismo , Polimorfismo Genético , Fatores de Risco , Sirolimo/administração & dosagem , Trombose/tratamento farmacológico , Ticlopidina/análogos & derivados , Ticlopidina/metabolismo , Tomografia de Coerência Óptica
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