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1.
Pan Afr Med J ; 33: 188, 2019.
Artigo em Francês | MEDLINE | ID: mdl-31692728

RESUMO

Brain radionecrosis is a rare but life-threatening complication of external-beam radiotherapy for ENT cancers, in particular of the nasopharynx, and for brain tumors. Very few studies were conducted on this complication in the African population as well as in the Maghreb population. Therefore our study aims to describe the demographic, clinical, paraclinical, therapeutic and evolutionary features of cerebral radionecrosis in the Department of Neurology at the Mohammed V Military Teaching Hospital in Rabat over a period of 18 years (2000-2017). The study involved 4 women and 13 men, with an average age of 50 years. The mean time between the end of the radiotherapy and the onset of neurological signs was 28 months. Systematic Brain MRI, sometimes complemented by spectro-MRI, allowed the diagnosis in 100% of cases. Etiologically, this complication occurred after radiotherapy for nasopharyngeal carcinoma and cancer of the larynx in all cases. Fifteen patients were treated with a combination of: bolus application of corticosteroids, platelet aggregation inhibitors associated with hyperbaric oxygen therapy with good evolution of two patients in whom oxygen therapy was contraindicated due to a lung problem and ENT cancer, received a combination of bolus application of corticosteroids and platelet aggregation inhibitors with unchanged evolution. These results demonstrate the importance of early diagnosis in patients with potentially serious conditions, in particular neuropsychiatric conditions, as well as of treatment combining bolus application of corticosteroids and hyperbaric oxygen therapy because this is the best guarantee of a favorable outcome, without omitting the crucial role of preventive measures.


Assuntos
Encéfalo/patologia , Oxigenação Hiperbárica/métodos , Lesões por Radiação/diagnóstico por imagem , Corticosteroides/administração & dosagem , Adulto , Idoso , Feminino , Hospitais Militares , Humanos , Neoplasias Laríngeas/radioterapia , Imagem por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Marrocos , Neoplasias Nasofaríngeas/radioterapia , Necrose , Inibidores da Agregação de Plaquetas/administração & dosagem , Lesões por Radiação/terapia , Estudos Retrospectivos
2.
Am Surg ; 85(8): 871-876, 2019 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-31560306

RESUMO

The aim of this study was to evaluate the impact of prehospital antiplatelet and/or anticoagulant (APAC) use on treatment and outcomes in patients with severe blunt chest injury. Patients with three or more rib fractures and a hospital length of stay (LOS) > three days admitted from 2014 to 2015 were included. Demographics, mortality, complications, injuries, hospital and ICU LOS, use of blood products, and thoracostomy were studied. Of 383 patients, 27.4 per cent were on APAC medication. Patients on APAC were older (P < 0.0001), had higher Glasgow Coma Score (P < 0.0001), and had lower Injury Severity Score (P < 0.0001) and total number of fractures (P = 0.0013) than the non-APAC group. APAC was not a predictor of mortality with or without age adjustment. In multiple linear regressions, APAC did not predict an increased LOS. APAC patients did not demonstrate an increase in admission diagnosis or complication of hemothorax, blood transfusions, tube thoracostomy, tracheostomy, LOS, or mortality rates. Similar findings are present in the subgroup of patients studied with high kinetic energy mechanism of injury. Our study does not support the perceived morbidity of APAC therapy in patients with severe blunt chest injury.


Assuntos
Anticoagulantes/administração & dosagem , Hemorragia/etiologia , Inibidores da Agregação de Plaquetas/administração & dosagem , Fraturas das Costelas/complicações , Ferimentos não Penetrantes/complicações , Fatores Etários , Idoso , Transfusão de Componentes Sanguíneos/estatística & dados numéricos , Feminino , Escala de Coma de Glasgow , Humanos , Escala de Gravidade do Ferimento , Unidades de Terapia Intensiva/estatística & dados numéricos , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Estudos Retrospectivos , Fraturas das Costelas/sangue , Fraturas das Costelas/terapia , Ferimentos não Penetrantes/sangue , Ferimentos não Penetrantes/terapia
3.
Medicina (B Aires) ; 79(4): 315-321, 2019.
Artigo em Espanhol | MEDLINE | ID: mdl-31487255

RESUMO

One of the main pillars of acute ischemic stroke management is antiplatelet therapy. Different treatment schemes have been compared, suggesting that the combination of multiple antiplatelet drugs is associated with a reduced risk of stroke recurrence. However, it has also been associated with an increased risk of bleeding complications which, in the long term, surpass the mentioned benefits. However, considering that most stroke recurrences occur i n the short term, a time limited double antiplatelet scheme could result in significant benefits to patients with acute ischemic stroke. On this basis, we conducted a rapid systematic review of the literature in order to evaluate the effects of a short-term double antiplatelet therapy both on stroke recurrence and complications. All trials comparing double versus single antiplatelet therapy in patients with acute ischemic stroke were included. Results showed that double therapy reduces recurrence risk but probably marginally increases major bleeding complications. We suggest double antiplatelet therapy for the initial management of patients with minor (Score NIH < or equal to 3 or transient isquemic attack -TIA) acute ischemic stroke.


Assuntos
Aspirina/administração & dosagem , Benzodiazepinas/administração & dosagem , Clopidogrel/administração & dosagem , Ataque Isquêmico Transitório/tratamento farmacológico , Ataque Isquêmico Transitório/prevenção & controle , Inibidores da Agregação de Plaquetas/administração & dosagem , Poliaminas/administração & dosagem , Quimioterapia Combinada , Humanos , Recidiva , Prevenção Secundária
5.
Georgian Med News ; (291): 64-66, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31418733

RESUMO

A serious long-term complication of drug-eluting stent (DES) implantation is the occurrence of very late stent thrombosis (VLST) beyond 1 year after implantation. While VLST has been observed as late as 1 year following the initial procedure, it remains unknown whether DES thrombosis is a finite phenomenon that abates over time or is a risk that persists indefinitely. Very late stent thrombosis is an infrequent yet potentially fatal complication associated with drug-eluting stents. We report the case of a 40-year-old man who sustained an ST-segment-elevation myocardial infarction 2 years after initial paclitaxel-eluting stent implantation. Focal incomplete endothelialization of the stent struts is the likely cause of VLST; neointimal formation, neoatherosclerosis, and late stent malapposition might also have contributed. According to the current guidelines 12 months of dual antiplatelet therapy (DAPT) is recommended following DES implantation. However, there are uncertainties surrounding the optimal duration of dual antiplatelet therapy in patients who suffer from drug-eluting very late stent thrombosis. Clinicians face challenges in treating these patients, particularly when competing medical demands necessitate the discontinuation of dual antiplatelet therapy.


Assuntos
Stents Farmacológicos/efeitos adversos , Trombose/etiologia , Adulto , Humanos , Masculino , Paclitaxel/administração & dosagem , Inibidores da Agregação de Plaquetas/administração & dosagem , Fatores de Tempo , Resultado do Tratamento
6.
Lancet ; 394(10199): 672-683, 2019 08 24.
Artigo em Inglês | MEDLINE | ID: mdl-31448738

RESUMO

BACKGROUND: A fixed-dose combination therapy (polypill strategy) has been proposed as an approach to reduce the burden of cardiovascular disease, especially in low-income and middle-income countries (LMICs). The PolyIran study aimed to assess the effectiveness and safety of a four-component polypill including aspirin, atorvastatin, hydrochlorothiazide, and either enalapril or valsartan for primary and secondary prevention of cardiovascular disease. METHODS: The PolyIran study was a two-group, pragmatic, cluster-randomised trial nested within the Golestan Cohort Study (GCS), a cohort study with 50 045 participants aged 40-75 years from the Golestan province in Iran. Clusters (villages) were randomly allocated (1:1) to either a package of non-pharmacological preventive interventions alone (minimal care group) or together with a once-daily polypill tablet (polypill group). Randomisation was stratified by three districts (Gonbad, Aq-Qala, and Kalaleh), with the village as the unit of randomisation. We used a balanced randomisation algorithm, considering block sizes of 20 and balancing for cluster size or natural log of the cluster size (depending on the skewness within strata). Randomisation was done at a fixed point in time (Jan 18, 2011) by statisticians at the University of Birmingham (Birmingham, UK), independent of the local study team. The non-pharmacological preventive interventions (including educational training about healthy lifestyle-eg, healthy diet with low salt, sugar, and fat content, exercise, weight control, and abstinence from smoking and opium) were delivered by the PolyIran field visit team at months 3 and 6, and then every 6 months thereafter. Two formulations of polypill tablet were used in this study. Participants were first prescribed polypill one (hydrochlorothiazide 12·5 mg, aspirin 81 mg, atorvastatin 20 mg, and enalapril 5 mg). Participants who developed cough during follow-up were switched by a trained study physician to polypill two, which included valsartan 40 mg instead of enalapril 5 mg. Participants were followed up for 60 months. The primary outcome-occurrence of major cardiovascular events (including hospitalisation for acute coronary syndrome, fatal myocardial infarction, sudden death, heart failure, coronary artery revascularisation procedures, and non-fatal and fatal stroke)-was centrally assessed by the GCS follow-up team, who were masked to allocation status. We did intention-to-treat analyses by including all participants who met eligibility criteria in the two study groups. The trial was registered with ClinicalTrials.gov, number NCT01271985. FINDINGS: Between Feb 22, 2011, and April 15, 2013, we enrolled 6838 individuals into the study-3417 (in 116 clusters) in the minimal care group and 3421 (in 120 clusters) in the polypill group. 1761 (51·5%) of 3421 participants in the polypill group were women, as were 1679 (49·1%) of 3417 participants in the minimal care group. Median adherence to polypill tablets was 80·5% (IQR 48·5-92·2). During follow-up, 301 (8·8%) of 3417 participants in the minimal care group had major cardiovascular events compared with 202 (5·9%) of 3421 participants in the polypill group (adjusted hazard ratio [HR] 0·66, 95% CI 0·55-0·80). We found no statistically significant interaction with the presence (HR 0·61, 95% CI 0·49-0·75) or absence of pre-existing cardiovascular disease (0·80; 0·51-1·12; pinteraction=0·19). When restricted to participants in the polypill group with high adherence, the reduction in the risk of major cardiovascular events was even greater compared with the minimal care group (adjusted HR 0·43, 95% CI 0·33-0·55). The frequency of adverse events was similar between the two study groups. 21 intracranial haemorrhages were reported during the 5 years of follow-up-ten participants in the polypill group and 11 participants in the minimal care group. There were 13 physician-confirmed diagnoses of upper gastrointestinal bleeding in the polypill group and nine in the minimal care group. INTERPRETATION: Use of polypill was effective in preventing major cardiovascular events. Medication adherence was high and adverse event numbers were low. The polypill strategy could be considered as an additional effective component in controlling cardiovascular diseases, especially in LMICs. FUNDING: Tehran University of Medical Sciences, Barakat Foundation, and Alborz Darou.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doenças Cardiovasculares/prevenção & controle , Combinação de Medicamentos , Prevenção Secundária/métodos , Adulto , Idoso , Anticolesterolemiantes/administração & dosagem , Anti-Hipertensivos/administração & dosagem , Aspirina/administração & dosagem , Atorvastatina/administração & dosagem , Pressão Sanguínea/efeitos dos fármacos , Fármacos Cardiovasculares/uso terapêutico , Doenças Cardiovasculares/epidemiologia , LDL-Colesterol/efeitos dos fármacos , Diabetes Mellitus/epidemiologia , Enalapril/administração & dosagem , Feminino , Humanos , Hidroclorotiazida/administração & dosagem , Masculino , Adesão à Medicação/estatística & dados numéricos , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/administração & dosagem , Valsartana/administração & dosagem
7.
Medicine (Baltimore) ; 98(30): e16586, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31348297

RESUMO

RATIONALE: Acute myeloid leukemia (AML), in patients with coronary heart disease (CHD) and treated percutaneous coronary intervention (PCI), is rarely seen in clinic. There are few similar cases reported, and there are no evidence-based medicine guidelines for the treatment. PATIENT CONCERNS: A 52-year-old man was diagnosed with coronary atherosclerotic heart disease in November 2011, and received a stent placement in the left anterior descending coronary artery 1 year later. One day after the surgery, his laboratory tests showed pancytopenia. DIAGNOSES: Based on precise diagnosis of leukemia, namely cell morphology, immunology, cytogenetics, and molecular biological typing, the patient was diagnosed with AML-M2. INTERVENTIONS: The patient received idarubicin with cytarabine in 1st cycles, and single cytarabine regimen was used in 2nd and 3rd cycles for the accumulative toxicity of idarubicin in postinduction chemotherapy. Meanwhile, staged-treatment strategy was implemented by using antiplatelet drugs during different chemotherapy phases, and personalized pharmaceutical care on the basis of the recognition of potential adverse effects of chemotherapy regimen. OUTCOMES: Until now, the disease-free survival in the patient has been over 6 years, and he is still followed up in clinic. LESSONS: Although leukemia accompanied with coronary heart disease, even after receiving the coronary stenting therapy is rarely seen in clinic, the treatment with antiplatelet drugs for post chemotherapy patients with coronary disease is necessary. Clinical pharmacists are supposed to be more proficient in developing personalized drug treatment strategies, especially maintaining the balance between the effect and the risk in difficult and complex cases.


Assuntos
Doença das Coronárias/complicações , Doença das Coronárias/cirurgia , Leucemia Mieloide Aguda/complicações , Intervenção Coronária Percutânea/métodos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Humanos , Leucemia Mieloide Aguda/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/administração & dosagem , Tromboembolia/prevenção & controle
8.
Arch Cardiovasc Dis ; 112(8-9): 469-484, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31262635

RESUMO

BACKGROUND: Current drug-eluting stents (c-DESs) reduce the occurrence of ischaemic events, but expose recipients to stent thrombosis and bleeding secondary to preventive antiplatelet therapy. To date, comparative data on the relative effectiveness and safety of the various c-DESs in real life are limited. AIM: To compare ischaemic and bleeding risks across the major c-DESs used in France. METHODS: French national health insurance reimbursement and hospitalization databases were used. Patients implanted with a c-DES in 2014 were followed for 1 year. The risks of ischaemic events (revascularization, myocardial infarction and/or stroke), major bleeding events and death were compared across six c-DESs (XIENCE®, PROMUS®, RESOLUTE®, BIOMATRIX®, NOBORI® and ORSIRO®), using multilevel Cox models adjusted for baseline individual and hospital characteristics. RESULTS: A total of 52,891 subjects were included: 34.4% with XIENCE®; 27.6% with PROMUS®; 24.0% with RESOLUTE®; 8.0% with BIOMATRIX®; 5.0% with NOBORI®; and 1.0% with ORSIRO®. Among them, 9378 had at least one event (ischaemic, 6064; major bleeding, 1968; death, 2411), resulting in an overall incidence rate of 19 per 100 person-years. In the multivariable analysis, the risk of ischaemic events, major bleeding events or death did not differ between the c-DESs overall (adjusted hazard ratios between 0.85 [95% confidence interval 0.68-1.07] and 1.04 [95% confidence interval 0.98-1.10] compared with XIENCE® used as the reference) and when each outcome was considered separately. CONCLUSIONS: In real life, major ischaemic and bleeding risks do not differ across the various c-DESs over the first year following implantation. Future studies are needed to assess comparative c-DES effectiveness and safety longer term.


Assuntos
Doença da Artéria Coronariana/terapia , Trombose Coronária/epidemiologia , Stents Farmacológicos , Hemorragia/induzido quimicamente , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Inibidores da Agregação de Plaquetas/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/mortalidade , Trombose Coronária/mortalidade , Bases de Dados Factuais , Feminino , França/epidemiologia , Hemorragia/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/administração & dosagem , Desenho de Prótese , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
9.
Vasc Endovascular Surg ; 53(7): 602-605, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31272299

RESUMO

INTRODUCTION: Carotid angioplasty and stenting (CAS) represents an effective procedure for treating carotid artery disease. The acute in-stent thrombosis is an extremely rare complication of CAS especially when it occurs postprocedurally during the first 24 hours. Improper antiplatelet therapy or poor response to antiplatelet medications is known to be associated with a higher risk of in-stent thrombosis during early postprocedural period following a successful intervention. MATERIAL AND METHODS: A patient who experienced acute carotid in-stent thrombosis in early postprocedural period is described. He had been taking dual antiplatelet therapy for 2 weeks before undergoing a successful CAS. Moreover, pharmacogenetics studies showed the patient to be a clopidogrel ultrarapid metabolizer, which theoretically confers hyperresponsivity to medication. Alongside the report itself, a brief literature review of relevant sources pertinent to the case has been conducted. RESULTS: According to the available literature, this is the first case report describing an ultrarapid clopidogrel metabolizer who underwent an uneventful CAS but experienced acute carotid in-stent thrombosis in early postprocedural period. A rescue procedure included an endovascular intervention consisting of thrombectomy and local alteplase application, followed by postprocedural administration of intravenous eptifibatide. At discharge, patient's dual antiplatelet therapy included ticagrelor instead of clopidogrel. CONCLUSION: Acute carotid in-stent thrombosis is a highly unexpected complication of CAS and can occur despite ultrarapid clopidogrel metabolism trait.


Assuntos
Angioplastia com Balão/instrumentação , Estenose das Carótidas/terapia , Clopidogrel/metabolismo , Citocromo P-450 CYP2C19/metabolismo , Inibidores da Agregação de Plaquetas/metabolismo , Stents , Trombose/etiologia , Doença Aguda , Administração Intravenosa , Angiografia Digital , Angioplastia com Balão/efeitos adversos , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/fisiopatologia , Clopidogrel/administração & dosagem , Angiografia por Tomografia Computadorizada , Citocromo P-450 CYP2C19/genética , Substituição de Medicamentos , Eptifibatida/administração & dosagem , Genótipo , Humanos , Masculino , Pessoa de Meia-Idade , Variantes Farmacogenômicos , Fenótipo , Inibidores da Agregação de Plaquetas/administração & dosagem , Fatores de Risco , Trombectomia , Trombose/diagnóstico por imagem , Trombose/terapia , Ticagrelor/administração & dosagem , Resultado do Tratamento
10.
Int J Evid Based Healthc ; 17 Suppl 1: S53-S56, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31283583

RESUMO

Stroke is one of the leading causes of mortality and the leading cause of functional impairment and cognitive deficits worldwide. It is important that clinical practice guidelines development is based on robust statistical and epidemiological data and their analysis throughout the whole process of guidelines development and implementation. The aim of this short communication is to analyse epidemiology of prevalence and incidence of ischaemic stroke, its main causes, brain imaging using MRI, recanalization therapies, secondary prevention with antiplatelet and anticoagulants, mortality data and to inform development of stroke clinical practice guidelines in the Czech Republic. The main analysed diagnosis was I63 (cerebral infarction) and secondary diagnoses were: I48 (atrial fibrillation and flutter), I35.9 (nonspecified aortic valve disease), Q21.1 (atrial septal defect) or I33.0 (acute and subacute endocarditis). We have also analysed use of brain imaging with MRI, recanalization treatment using intravenous thrombolysis and mechanical thrombectomy, stroke secondary prevention with antiplatelet drugs and anticoagulation as well as hospital admissions and mortality. In total, 159 344 patients were diagnosed with an ischaemic stroke from 2015 to 2017. Average prevalence of ischaemic stroke in the Czech Republic is 54.9 patients per 100 000. 22.2% of patients with stroke received intravenous thrombolysis or mechanical thrombectomy in 2017.


Assuntos
Isquemia Encefálica/epidemiologia , Isquemia Encefálica/terapia , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/terapia , Anticoagulantes/administração & dosagem , Encéfalo/diagnóstico por imagem , Isquemia Encefálica/diagnóstico por imagem , Isquemia Encefálica/etiologia , República Tcheca/epidemiologia , Feminino , Humanos , Incidência , Imagem por Ressonância Magnética , Masculino , Inibidores da Agregação de Plaquetas/administração & dosagem , Prevalência , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/etiologia , Trombectomia/estatística & dados numéricos , Terapia Trombolítica/estatística & dados numéricos
11.
J Clin Neurosci ; 66: 33-37, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31160199

RESUMO

Antiplatelet therapy at the time of spontaneous intracerebral hemorrhage (sICH) may increase risk for hemorrhage expansion and mortality. Current guidelines recommend considering a single dose of desmopressin in sICH associated with cyclooxygenase-1 inhibitors or adenosine diphosphate receptor inhibitors. Adult subjects with sICH and concomitant antiplatelet therapy admitted to a large, tertiary care center were included. We sought to compare the risk of hematoma expansion in patients that received desmopressin for antiplatelet reversal in the setting of sICH to similar patients that did not receive desmopressin. The primary outcomes were the incidence of relative and absolute hematoma expansion. In total, 71 patients (29 received desmopressin, 42 did not receive desmopressin) were analyzed. All patients in the desmopressin group received a 0.3 mcg/kg intravenous dose prior to hematoma expansion assessment. Relative hematoma expansion occurred in 5/29 (17%) with desmopressin compared to 11/42 (26%) without desmopressin (OR 0.59 [95% CI 0.18-1.92]). Absolute hematoma expansion occurred in 9/29 (30%) with desmopressin compared to 12/42 (28%) without desmopressin (OR 1.13 [95% CI 0.40-3.16]). Multiple logistic regression controlling for significant covariates did not reveal a significant effect of desmopressin on relative or absolute hematoma expansion (OR 0.65 [95% CI 0.18-2.43] and OR 1.55 [0.48-4.99], respectively). We failed to find evidence that desmopressin administration for antiplatelet reversal in sICH reduces the incidence of hematoma expansion. Larger studies, focusing on the early phase of sICH, are needed to characterize the clinical efficacy and safety of desmopressin for antiplatelet reversal before widespread implementation.


Assuntos
Hemorragia Cerebral/tratamento farmacológico , Hemorragia Cerebral/epidemiologia , Desamino Arginina Vasopressina/administração & dosagem , Hematoma/tratamento farmacológico , Hematoma/epidemiologia , Hemostáticos/administração & dosagem , Inibidores da Agregação de Plaquetas/administração & dosagem , Administração Intravenosa , Adulto , Idoso , Idoso de 80 Anos ou mais , Hemorragia Cerebral/induzido quimicamente , Estudos de Coortes , Feminino , Hematoma/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/efeitos adversos , Estudos Retrospectivos , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/epidemiologia , Fatores de Tempo , Resultado do Tratamento
12.
Int J Cardiovasc Imaging ; 35(10): 1777-1784, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31201589

RESUMO

The aim of this study was to elucidate the vascular responses to paclitaxel-eluting stent (Zilver PTX stent) in superficial femoral artery lesion at different elapsed times using angioscopy. Patients who received Zilver PTX stent implantation from five centers were enrolled. We performed angioscopic examinations at 2, 6, and 12 months after implantation and evaluated neointimal coverage (NIC) grade, intra-stent thrombus (IS-Th) grade, and presence of yellow plaque. NIC grade 0 was defined as stent struts exposed; grade 1, struts transparently visible although covered; grade 2, struts embedded in the neointima, but translucent; and grade 3, struts fully embedded and invisible. IS-Th was graded as follows: grade 0 (none), 1 (focal), and 2 (diffusely spread). Angioscopic follow-up evaluation was performed at 2 months (25 patients, 42 lesions), 6 months (18 patients, 23 stents), and 12 months (14 patients, 24 stents) after stent implantation. Dominant NIC grade significantly increased over time; however, 16.3% of the cases had NIC grade 1 or 2 at 12 months. IS-Th grade decreased; however IS-Th and yellow plaque were persistently observed in 62.5% and 83.3% cases, respectively, at 12 months. An ongoing healing response was observed at 12 months after implantation; however, thrombogenic findings were noted. Prolonged dual antiplatelet therapy could potentially enhance the clinical utility of Zilver PTX.


Assuntos
Ligas , Angioscopia , Fármacos Cardiovasculares/administração & dosagem , Stents Farmacológicos , Procedimentos Endovasculares/instrumentação , Artéria Femoral/diagnóstico por imagem , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Stents Metálicos Autoexpansíveis , Cicatrização , Idoso , Idoso de 80 Anos ou mais , Fármacos Cardiovasculares/efeitos adversos , Proliferação de Células , Procedimentos Endovasculares/efeitos adversos , Feminino , Artéria Femoral/fisiopatologia , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Neointima , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Inibidores da Agregação de Plaquetas/administração & dosagem , Valor Preditivo dos Testes , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
13.
Gastroenterology ; 157(3): 682-691.e2, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31152740

RESUMO

BACKGROUND & AIMS: Proton pump inhibitors (PPIs) are effective at treating acid-related disorders. These drugs are well tolerated in the short term, but long-term treatment was associated with adverse events in observational studies. We aimed to confirm these findings in an adequately powered randomized trial. METHODS: We performed a 3 × 2 partial factorial double-blind trial of 17,598 participants with stable cardiovascular disease and peripheral artery disease randomly assigned to groups given pantoprazole (40 mg daily, n = 8791) or placebo (n = 8807). Participants were also randomly assigned to groups that received rivaroxaban (2.5 mg twice daily) with aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg) alone. We collected data on development of pneumonia, Clostridium difficile infection, other enteric infections, fractures, gastric atrophy, chronic kidney disease, diabetes, chronic obstructive lung disease, dementia, cardiovascular disease, cancer, hospitalizations, and all-cause mortality every 6 months. Patients were followed up for a median of 3.01 years, with 53,152 patient-years of follow-up. RESULTS: There was no statistically significant difference between the pantoprazole and placebo groups in safety events except for enteric infections (1.4% vs 1.0% in the placebo group; odds ratio, 1.33; 95% confidence interval, 1.01-1.75). For all other safety outcomes, proportions were similar between groups except for C difficile infection, which was approximately twice as common in the pantoprazole vs the placebo group, although there were only 13 events, so this difference was not statistically significant. CONCLUSIONS: In a large placebo-controlled randomized trial, we found that pantoprazole is not associated with any adverse event when used for 3 years, with the possible exception of an increased risk of enteric infections. ClinicalTrials.gov Number: NCT01776424.


Assuntos
Aspirina/administração & dosagem , Doenças Cardiovasculares/tratamento farmacológico , Inibidores do Fator Xa/administração & dosagem , Hemorragia Gastrointestinal/prevenção & controle , Pantoprazol/administração & dosagem , Doença Arterial Periférica/tratamento farmacológico , Inibidores da Agregação de Plaquetas/administração & dosagem , Inibidores da Bomba de Prótons/administração & dosagem , Rivaroxabana/administração & dosagem , Idoso , Aspirina/efeitos adversos , Doenças Cardiovasculares/diagnóstico , Método Duplo-Cego , Esquema de Medicação , Enterocolite Pseudomembranosa/induzido quimicamente , Enterocolite Pseudomembranosa/microbiologia , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Pantoprazol/efeitos adversos , Doença Arterial Periférica/diagnóstico , Inibidores da Agregação de Plaquetas/efeitos adversos , Estudos Prospectivos , Inibidores da Bomba de Prótons/efeitos adversos , Medição de Risco , Fatores de Risco , Rivaroxabana/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
14.
EuroIntervention ; 15(6): e551-e557, 2019 08 09.
Artigo em Inglês | MEDLINE | ID: mdl-31186218

RESUMO

AIMS: Early mortality after percutaneous coronary intervention (PCI) is relatively rare. Current risk prediction models for this event are outdated. We sought to derive a 30-day mortality risk score after PCI. METHODS AND RESULTS: The score was derived from a pooled database of 21 randomised clinical trials using a logistic regression model incorporating clinical and angiographic variables. The score was validated in a separate unrestricted study population, the Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents (ADAPT-DES) registry. Of 32,882 eligible patients, 75% had data for all 19 variables used for score derivation. The independent predictors of 30-day mortality were age, presentation with ACS, diabetes mellitus, use of first-generation drug-eluting stents, left main or left anterior descending artery lesion, prior myocardial infarction (MI), and suboptimal flow in the artery before or after PCI. The median [interquartile range] score in the derivation cohort was 5 [3, 6] and overall mortality was 0.49%, ranging from 0.08% to 1.64% with scores of 0-16. The 30-day mortality rate was approximately tenfold higher in patients with a score at or above versus below the median of 5 (0.86% versus 0.08%, p<0.0001). Discrimination in both cohorts was very good (C statistic=0.848 and 0.828, respectively), and calibration was satisfactory. CONCLUSIONS: A novel risk score incorporating eight readily available clinical and angiographic variables had high discrimination for 30-day death after PCI across a wide range of clinical scenarios.


Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação de Plaquetas/administração & dosagem , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco/métodos , Humanos , Inibidores da Agregação de Plaquetas/efeitos adversos , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
15.
Ann Vasc Surg ; 59: 307.e7-307.e12, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31075448

RESUMO

Thoracic aortic thrombus is a rare condition that can be a significant source of distal embolic events. This study details experience on the use of an endovascular technique for the management of thoracic aortic thrombus with a stent graft in 5 cases. Four of the cases were diagnosed with aortic arch thrombus, and 1 was diagnosed with distal descending aortic thrombus. All patients were females with age ranging from 44 to 71 years. Arterial embolism was the main clinical finding in most cases, which involved the upper extremities (n = 1) and cerebral embolism (n = 3), while 1 patient was asymptomatic. All 5 surgeries were considered technically successful with 0 perioperative all-cause mortality. Patients were discharged in a stable condition and were prescribed anticoagulant and antiplatelet medications. During follow-up visits, there were no instances of stent-graft failure or collapse, leak, or distal migration. Furthermore, there was complete resolution of the intraluminal thrombus, and all patients were asymptomatic.


Assuntos
Aorta Torácica/cirurgia , Doenças da Aorta/cirurgia , Arteriopatias Oclusivas/cirurgia , Implante de Prótese Vascular/métodos , Procedimentos Endovasculares/métodos , Trombose/cirurgia , Adulto , Idoso , Anticoagulantes/administração & dosagem , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/fisiopatologia , Doenças da Aorta/diagnóstico por imagem , Doenças da Aorta/fisiopatologia , Aortografia/métodos , Arteriopatias Oclusivas/diagnóstico por imagem , Arteriopatias Oclusivas/fisiopatologia , Prótese Vascular , Implante de Prótese Vascular/instrumentação , Angiografia por Tomografia Computadorizada , Procedimentos Endovasculares/instrumentação , Feminino , Humanos , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/administração & dosagem , Estudos Retrospectivos , Stents , Trombose/diagnóstico por imagem , Trombose/fisiopatologia , Resultado do Tratamento
16.
Herz ; 44(4): 365-378, 2019 Jun.
Artigo em Alemão | MEDLINE | ID: mdl-31087108

RESUMO

Dual antiplatelet therapy (DAPT) is the cornerstone of maintenance medication following elective percutaneous coronary intervention and also after acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, unstable angina pectoris); however, DAPT is not sufficient for stroke prevention in atrial fibrillation (SPAF). For SPAF, oral anticoagulation (OAC) with vitamin K antagonists (VKA) or non-vitamin K-dependent anticoagulants (NOAC) is required. If a patient who is receiving anticoagulants for SPAF, requires a coronary intervention, triple therapy consisting of OAC plus DAPT is given, at least for a limited time following the procedure. This article reviews the current data from studies testing strategies with NOACs plus one or two antiplatelet substances in comparison to triple therapy with VKA.


Assuntos
Anticoagulantes , Fibrilação Atrial , Intervenção Coronária Percutânea , Inibidores da Agregação de Plaquetas , Síndrome Coronariana Aguda/terapia , Administração Oral , Anticoagulantes/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Quimioterapia Combinada , Humanos , Inibidores da Agregação de Plaquetas/administração & dosagem
17.
Lancet ; 393(10191): 2613-2623, 2019 06 29.
Artigo em Inglês | MEDLINE | ID: mdl-31128924

RESUMO

BACKGROUND: Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear. We aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events. METHODS: The REstart or STop Antithrombotics Randomised Trial (RESTART) was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. We followed participants for the primary outcome (recurrent symptomatic intracerebral haemorrhage) for up to 5 years. We analysed data from all randomised participants using Cox proportional hazards regression, adjusted for minimisation covariates. This trial is registered with ISRCTN (number ISRCTN71907627). FINDINGS: Between May 22, 2013, and May 31, 2018, 537 participants were recruited a median of 76 days (IQR 29-146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to avoid antiplatelet therapy. Participants were followed for a median of 2·0 years (IQR [1·0- 3·0]; completeness 99·3%). 12 (4%) of 268 participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage compared with 23 (9%) of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI 0·25-1·03]; p=0·060). 18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39-1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02 [0·65-1·60]; p=0·92). INTERPRETATION: These results exclude all but a very modest increase in the risk of recurrent intracerebral haemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage. The risk of recurrent intracerebral haemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention. FUNDING: British Heart Foundation.


Assuntos
Hemorragia Cerebral/epidemiologia , Inibidores da Agregação de Plaquetas/administração & dosagem , Acidente Vascular Cerebral/complicações , Doenças Vasculares/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Hemorragia Cerebral/induzido quimicamente , Feminino , Humanos , Masculino , Cooperação do Paciente , Inibidores da Agregação de Plaquetas/efeitos adversos , Estudos Prospectivos , Resultado do Tratamento , Reino Unido
18.
Clin Drug Investig ; 39(8): 765-773, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31140114

RESUMO

BACKGROUND AND OBJECTIVE: Ticagrelor is a P2Y12 receptor inhibitor approved as an antiplatelet drug for patients with acute coronary syndrome or a history of myocardial infarction. Ticagrelor is also being investigated for the reduction of vaso-occlusive crises in pediatric patients with sickle cell disease. A pediatric formulation suitable for this age range was developed; the development strategy is described. Primary objectives were determining the relative bioavailability of ticagrelor pediatric tablets and granules for oral suspension to the adult immediate-release tablet, and the pediatric tablets taken whole and dispersed/suspended in water to the granules for oral suspension. Bioequivalence between the pediatric tablet taken whole or suspended in water was also assessed. Secondary objectives were comparing the formulations' safety and tolerability. METHODS: We conducted a randomized, four-period, cross-over, single-dose study. Pharmacokinetic parameters were assessed for ticagrelor and its active metabolite AR-C124910XX. Bioequivalence was concluded if the 90% confidence intervals of the maximum plasma concentration and area under the plasma concentration-time curve ratios were contained completely within the 80.00-125.00% limits for ticagrelor/AR-C124910XX. RESULTS: Forty-four healthy adults (95% white; 57% male) were included. Similar bioavailability of ticagrelor (and AR-C124910XX) was demonstrated for all comparisons tested. Ticagrelor pediatric tablets taken whole were bioequivalent to pediatric tablets suspended in water. The plasma concentration-time profiles for ticagrelor and AR-C124910XX were similar, showing rapid ticagrelor absorption and AR-C124910XX formation. All formulations were well tolerated. CONCLUSION: Similar bioavailability of a new pediatric dispersible tablet formulation of ticagrelor for use across a wide age range of pediatric patients was demonstrated compared with other oral ticagrelor formulations. CLINICALTRIALS. GOV IDENTIFIER: NCT03126695. EUDRACT: 2017-000371-93.


Assuntos
Inibidores da Agregação de Plaquetas/farmacocinética , Antagonistas do Receptor Purinérgico P2Y/farmacocinética , Comprimidos , Ticagrelor/farmacocinética , Adenosina/análogos & derivados , Adolescente , Disponibilidade Biológica , Criança , Estudos Cross-Over , Feminino , Humanos , Masculino , Inibidores da Agregação de Plaquetas/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Equivalência Terapêutica , Ticagrelor/administração & dosagem
19.
N Engl J Med ; 380(20): 1906-1917, 2019 05 16.
Artigo em Inglês | MEDLINE | ID: mdl-31091372

RESUMO

BACKGROUND: Cryptogenic strokes constitute 20 to 30% of ischemic strokes, and most cryptogenic strokes are considered to be embolic and of undetermined source. An earlier randomized trial showed that rivaroxaban is no more effective than aspirin in preventing recurrent stroke after a presumed embolic stroke from an undetermined source. Whether dabigatran would be effective in preventing recurrent strokes after this type of stroke was unclear. METHODS: We conducted a multicenter, randomized, double-blind trial of dabigatran at a dose of 150 mg or 110 mg twice daily as compared with aspirin at a dose of 100 mg once daily in patients who had had an embolic stroke of undetermined source. The primary outcome was recurrent stroke. The primary safety outcome was major bleeding. RESULTS: A total of 5390 patients were enrolled at 564 sites and were randomly assigned to receive dabigatran (2695 patients) or aspirin (2695 patients). During a median follow-up of 19 months, recurrent strokes occurred in 177 patients (6.6%) in the dabigatran group (4.1% per year) and in 207 patients (7.7%) in the aspirin group (4.8% per year) (hazard ratio, 0.85; 95% confidence interval [CI], 0.69 to 1.03; P = 0.10). Ischemic strokes occurred in 172 patients (4.0% per year) and 203 patients (4.7% per year), respectively (hazard ratio, 0.84; 95% CI, 0.68 to 1.03). Major bleeding occurred in 77 patients (1.7% per year) in the dabigatran group and in 64 patients (1.4% per year) in the aspirin group (hazard ratio, 1.19; 95% CI, 0.85 to 1.66). Clinically relevant nonmajor bleeding occurred in 70 patients (1.6% per year) and 41 patients (0.9% per year), respectively. CONCLUSIONS: In patients with a recent history of embolic stroke of undetermined source, dabigatran was not superior to aspirin in preventing recurrent stroke. The incidence of major bleeding was not greater in the dabigatran group than in the aspirin group, but there were more clinically relevant nonmajor bleeding events in the dabigatran group. (Funded by Boehringer Ingelheim; RE-SPECT ESUS ClinicalTrials.gov number, NCT02239120.).


Assuntos
Antitrombinas/administração & dosagem , Dabigatrana/administração & dosagem , Acidente Vascular Cerebral/prevenção & controle , Idoso , Antitrombinas/efeitos adversos , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Dabigatrana/efeitos adversos , Método Duplo-Cego , Feminino , Hemorragia/induzido quimicamente , Humanos , Incidência , Embolia Intracraniana/tratamento farmacológico , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/administração & dosagem , Inibidores da Agregação de Plaquetas/efeitos adversos , Recidiva , Prevenção Secundária , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidade
20.
J Neurosurg Sci ; 63(3): 265-269, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31096724

RESUMO

BACKGROUND: Acute ischemic stroke (AIS) is associated with significant morbidity and mortality and has a very narrow window of treatment with fibrinolytics. We investigated the safety and efficacy of combined chlorpromazine and promethazine (C+P) treatment in AIS. METHODS: A total of 64 consecutive patients diagnosed with AIS were selected and were randomly (double-blind) assigned into either the control group (standard of care [SOC] treatment) or the treatment group (SOC+C+P [12.5+12.5 mg BID or 25+25 mg BID]) which were treated for 2 weeks. The National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) were computed prior to and after treatment to evaluate neurological deficits and daily functional status. RESULTS: In our study, 64 patients (males=81.3%) were divided into either the control (34 patients, 83.3% males, mean age=58.8±11.7 years) or the study group (30 patients, 79.4% males, mean age=62.3±9.1 years). While the NIHSS scores were not different between the control and treatment group at admission (P>0.05), a greater proportion of the cohort in both the groups (control group low NIHSS=79.4%, high NIHSS=20.6%, P<0.01) had a lower NIHSS at admission and (treatment group low NIHSS=83.3%, high NIHSS=16.7%, P<0.01). Interestingly, while both the control and treatment group had lower NIHSS and mRS scores at 90d post treatment compared to those at baseline, there were no significant differences in those scores between the two group (P>0.05) suggesting no improved benefit with C+P. Moreover, using C+P did not lead to any serious adverse effects when compared to the treatment group. CONCLUSIONS: While the addition of low dose chlorpromazine and promethazine to standard of care for acute ischemic stroke did not have any significant improvement in functional outcomes, there were no serious adverse effects. Thus, the use of chlorpromazine and promethazine in the acute ischemic stroke setting and future studies using higher doses of C+P are justified.


Assuntos
Clorpromazina/administração & dosagem , Fármacos Neuroprotetores/administração & dosagem , Prometazina/administração & dosagem , Acidente Vascular Cerebral/tratamento farmacológico , Adulto , Idoso , Aspirina/administração & dosagem , Atorvastatina/administração & dosagem , Método Duplo-Cego , Quimioterapia Combinada , Edaravone/administração & dosagem , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/administração & dosagem , Alcaloides de Vinca/administração & dosagem
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