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1.
Yonsei Med J ; 61(9): 741-749, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32882758

RESUMO

PURPOSE: Non-vitamin K antagonist oral anticoagulants (NOACs) are widely used in patients with atrial fibrillation (AF) because of their effectiveness in preventing stroke and their better safety, compared with warfarin. However, there are concerns for an increased risk of bleeding associated with concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) or selective serotonin reuptake inhibitors (SSRIs) with NOACs. In this study, we aimed to evaluate the risk of bleeding events in individuals taking concomitant NSAIDs or SSRIs with NOACs after being diagnosed with AF. MATERIALS AND METHODS: A nested case-control analysis to assess the safety of NSAIDs and SSRIs among NOAC users with AF was performed using data from Korean National Health Insurance Service from January 2012 to December 2017. Among patients who were newly prescribed NOACs, 1233 cases hospitalized for bleeding events were selected, and 24660 controls were determined. RESULTS: The risk of bleeding events was higher in patients receiving concomitant NSAIDs [adjusted odds ratio (aOR) 1.41; 95% confidence interval (CI) 1.24-1.61] or SSRIs (aOR 1.92; 95% CI 1.52-2.42) with NOACs, compared to no use of either drug, respectively. The risk of upper gastrointestinal bleeding was higher in patients receiving concomitant NSAIDs or SSRIs without proton pump inhibitors (PPIs) (NSAIDs: aOR 2.47; 95% CI 1.26-4.83, SSRI: aOR 10.8; 95% CI 2.41-2.48) compared to no use. CONCLUSION: When NSAIDs or SSRIs are required for NOAC users with AF, physicians need to monitor bleeding events and consider the use of PPIs, especially for combined use of both drugs or when initiating NOACs treatment.


Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Hemorragia Gastrointestinal/prevenção & controle , Hemorragia/prevenção & controle , Inibidores de Captação de Serotonina/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Varfarina/uso terapêutico , Administração Oral , Idoso , Anti-Inflamatórios não Esteroides/efeitos adversos , Fibrilação Atrial/complicações , Estudos de Casos e Controles , Feminino , Hemorragia Gastrointestinal/complicações , Hemorragia/epidemiologia , Humanos , Pessoa de Meia-Idade , Inibidores de Captação de Serotonina/efeitos adversos , Acidente Vascular Cerebral/etiologia
2.
Medicine (Baltimore) ; 99(38): e22243, 2020 Sep 18.
Artigo em Inglês | MEDLINE | ID: mdl-32957370

RESUMO

Although obesity is an established risk factor of primary stroke, the association between obesity and post-stroke mortality remains unclear. The aim of this study was to investigate the association between dynamic obesity status and mortality in survivors of their first stroke in China.Of 775 patients with first-ever ischemic stroke included in a longitudinal study, 754 patients were included in this study and categorized into 4 categories of body mass index (BMI) (underweight, normal weight, overweight, and obese) and 2 categories of waist circumference (WC) (normal WC and abdominal obesity) according to standard Chinese criteria. The mortality information and obesity status were obtained via telephone follow-up every 3 months, beginning in 2010 through 2016. Time-dependent Cox proportional hazards models were used to estimate the unadjusted and adjusted hazard ratios (HRs) for the relationship between all-cause mortality and dynamic obesity status.Of 754 patients, 60.87% were male, and the overall mean age was 61.45 years. After adjusting for possible confounders, significant inverse associations were identified between BMI and WC and all-cause mortality. Compared with those with normal BMI or WC, those with abdominal obesity or overweight had a significantly lower risk of all-cause mortality (HR and 95% confidence intervals [CIs]: .521 [.303-.897] and 0.545 [.352-.845], respectively), whereas patients with underweight had the highest risk and those with obesity had lower risk of mortality, though it was not statistically significant (1.241 [.691-2.226] and .486 [.192-1.231], respectively).Overweight and abdominal obesity were paradoxically associated with reduced risk of mortality in patients who survived their first-ever ischemic stroke in China. Future prospective studies must look at evaluating the role of obesity in different stroke subtypes and devise appropriate weight-management strategies for optimal prognoses in secondary prevention in these survivors.


Assuntos
Isquemia Encefálica/mortalidade , Obesidade/epidemiologia , Acidente Vascular Cerebral/mortalidade , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Índice de Massa Corporal , Isquemia Encefálica/epidemiologia , Isquemia Encefálica/prevenção & controle , China/epidemiologia , Comorbidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Obesidade/terapia , Prevalência , Estudos Prospectivos , Fatores de Risco , Prevenção Secundária , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/prevenção & controle , Sobreviventes , Circunferência da Cintura , Adulto Jovem
3.
Medicine (Baltimore) ; 99(36): e22054, 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32899067

RESUMO

BACKGROUND: Anticoagulant therapy is used for stroke prevention and proved to be effective and safe in the long term. The study aims to analyse the cost-effectiveness relationship of using of direct-acting oral anticoagulants vs vitamin K antagonists to prevent ischaemic stroke in patients with nonvalvular atrial fibrillation, including all the active ingredients marketed in Spain, prescribed for 2 years in the Primary Care service of the Institut Català de la Salut. METHODS: Population-based cohort study, in which the cost of the 2 treatment groups will be evaluated. Direct costs (pharmacy, primary care, emergency and hospitalization) and indirect costs (lost productivity) will be included from a social perspective. Effectiveness (assessed as the occurrence of a health event, the 1 of primary interest being stroke) will be determined, with a 2-year time horizon and a 3% discount rate. The average cost of the 2 groups of drugs will be compared using a regression model to determine the factors with the greatest influence on determining costs. We will carry out a univariate ('one-way') deterministic sensitivity analysis. DISCUSSION: We hope to provide relevant information about direct and indirect costs of oral anticoagulants, which, together with aspects of effectiveness and safety, could help shape the consensual decision-making of evaluating bodies.


Assuntos
Acenocumarol/economia , Anticoagulantes/economia , Fibrilação Atrial/tratamento farmacológico , Isquemia Encefálica/patologia , Ensaios Clínicos Pragmáticos como Assunto/métodos , Varfarina/economia , Acenocumarol/administração & dosagem , Acenocumarol/uso terapêutico , Administração Oral , Anticoagulantes/administração & dosagem , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/epidemiologia , Isquemia Encefálica/prevenção & controle , Análise Custo-Benefício , Inibidores do Fator Xa , Humanos , Atenção Primária à Saúde/organização & administração , Segurança , Espanha/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Resultado do Tratamento , Vitamina K/antagonistas & inibidores , Varfarina/administração & dosagem , Varfarina/uso terapêutico
4.
Arch Cardiovasc Dis ; 113(8-9): 525-533, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32873521

RESUMO

BACKGROUND: Transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE) can be used to detect the presence of left atrial thrombus and left atrial spontaneous echocardiographic contrast (LASEC). AIM: To evaluate the prognostic value of TTE and TOE in predicting stroke and all-cause death at 5-year follow-up in patients with non-valvular atrial fibrillation (NVAF). METHODS: This study included patients hospitalised with electrocardiography-diagnosed NVAF in Saint-Antoine University Hospital, Paris, between July 1998 and December 2011, who underwent TTE and TOE evaluation within 24hours of admission. Cox proportional-hazards models were used to identify predictors of the composite outcome (stroke or all-cause death). RESULTS: During 5 years of follow-up, stroke/death occurred in 185/903 patients (20.5%). By multivariable analysis, independent predictors of stroke/death were CHA2DS2-VASc score (hazard ratio [HR] 1.35, 95% confidence interval [CI] 1.25-1.47; P<0.001), left atrial area>20 cm2 (HR 1.59, 95% CI 1.08-2.35; P=0.018), moderate LASEC (HR 1.72, 95% CI 1.13-2.62; P=0.012) and severe LASEC (HR 2.04, 95% CI 1.16-3.58; P=0.013). Independent protective predictors were dyslipidaemia (HR 0.60, 95% CI 0.43-0.83; P=0.002) and discharge prescription of anti-arrhythmics (HR 0.59, 95% CI 0.40-0.87; P=0.008). Adding LASEC to the CHA2DS2-VASc score modestly improved predictive accuracy and risk classification, with a C index of 0.71 vs. 0.69 (P=0.004). CONCLUSIONS: In this retrospective monocentric study, the presence of moderate/severe LASEC was an independent predictor of stroke/death at 5-year follow-up in patients with NVAF. The inclusion of LASEC in stroke risk scores could modestly improve risk stratification.


Assuntos
Fibrilação Atrial/diagnóstico por imagem , Ecocardiografia Transesofagiana , Átrios do Coração/diagnóstico por imagem , Acidente Vascular Cerebral/etiologia , Idoso , Idoso de 80 Anos ou mais , Antiarrítmicos/uso terapêutico , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/mortalidade , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/uso terapêutico , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/prevenção & controle , Fatores de Tempo
5.
Rev Med Suisse ; 16(706): 1718-1720, 2020 Sep 16.
Artigo em Francês | MEDLINE | ID: mdl-32936558

RESUMO

Atrial fibrillation is a common cardiac disease of aging. The risk of stroke and bad prognosis increase with age and atrial fibrillation. Compared with younger people, elderly people have higher risks for both thrombosis and bleeding. Stroke prevention with oral anticoagulants is the cornerstone of the management of atrial fibrillation but is often questioned because of the risk of bleeding, furthermore comorbidities, comedications, fall risks, poor compliance. These factors frequently found in frail elderly patients complicate the management of antithrombotic therapy. This article reviews the evidence for the risks and benefits of anticoagulation in the elderly with atrial fibrillation, by comparing the new oral anticoagulants to vitamin K antagonists.


Assuntos
Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Fibrilação Atrial , Acidente Vascular Cerebral/prevenção & controle , Administração Oral , Idoso , Fibrinolíticos , Humanos , Medição de Risco , Fatores de Risco , Vitamina K/antagonistas & inibidores
6.
Cochrane Database Syst Rev ; 9: CD001081, 2020 09 12.
Artigo em Inglês | MEDLINE | ID: mdl-32918282

RESUMO

BACKGROUND: Stroke is the third leading cause of death and the most common cause of long-term disability. Severe narrowing (stenosis) of the carotid artery is an important cause of stroke. Surgical treatment (carotid endarterectomy) may reduce the risk of stroke, but carries a risk of operative complications. This is an update of a Cochrane Review, originally published in 1999, and most recently updated in 2017. OBJECTIVES: To determine the balance of benefit versus risk of endarterectomy plus best medical management compared with best medical management alone, in people with a recent symptomatic carotid stenosis (i.e. transient ischaemic attack (TIA) or non-disabling stroke). SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, Web of Science Core Collection, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) portal to October 2019. We also reviewed the reference lists of all relevant studies and abstract books from research proceedings. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing carotid artery surgery plus best medical treatment with best medical treatment alone.  DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias, and extracted the data. We assessed the results and the quality of the evidence of the primary and secondary outcomes by the GRADE method, which classifies the quality of evidence as high, moderate, low, or very low. MAIN RESULTS: We included three trials involving 6343 participants. The trials differed in the methods of measuring carotid stenosis and in the definition of stroke. Using the primary electronic data files, we pooled and analysed individual patient data on 6092 participants (35,000 patient-years of follow-up), after reassessing the carotid angiograms and outcomes from all three trials, and redefining outcome events where necessary, to achieve comparability. Surgery increased the five-year risk of any stroke or operative death in participants with less than 30% stenosis (risk ratio (RR) 1.25, 95% confidence interval (CI) 0.99 to 1.56; 2 studies, 1746 participants; high-quality evidence). Surgery decreased the five-year risk of any stroke or operative death in participants with 30% to 49% stenosis (RR 0.97, 95% CI 0.79 to 1.19; 2 studies, 1429 participants; high-quality evidence), was of benefit in participants with 50% to 69% stenosis (RR 0.77, 95% CI 0.63 to 0.94; 3 studies, 1549 participants; moderate-quality evidence), and was highly beneficial in participants with 70% to 99% stenosis without near-occlusion (RR 0.53, 95% CI 0.42 to 0.67; 3 studies, 1095 participants; moderate-quality evidence). However, surgery decreased the five-year risk of any stroke or operative death in participants with near-occlusions (RR 0.95, 95% CI 0.59 to 1.53; 2 studies, 271 participants; moderate-quality evidence). AUTHORS' CONCLUSIONS: Carotid endarterectomy reduced the risk of recurrent stroke for people with significant stenosis. Endarterectomy might be of some benefit for participants with 50% to 69% symptomatic stenosis (moderate-quality evidence) and highly beneficial for those with 70% to 99% stenosis (moderate-quality evidence).


Assuntos
Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas , Complicações Pós-Operatórias/prevenção & controle , Acidente Vascular Cerebral/prevenção & controle , Adulto , Fatores Etários , Idoso , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/patologia , Endarterectomia das Carótidas/efeitos adversos , Endarterectomia das Carótidas/mortalidade , Endarterectomia das Carótidas/normas , Feminino , Humanos , Ataque Isquêmico Transitório/etiologia , Masculino , Complicações Pós-Operatórias/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Risco , Fatores Sexuais , Acidente Vascular Cerebral/etiologia , Fatores de Tempo
7.
Khirurgiia (Mosk) ; (7): 31-38, 2020.
Artigo em Russo | MEDLINE | ID: mdl-32736461

RESUMO

OBJECTIVE: To identify predictors of progression of precerebral atherosclerosis in long-term period after coronary artery bypass surgery. MATERIAL AND METHODS: There were 97 procedures of carotid endarterectomy in patients after previous coronary artery bypass grafting for the period from 2006 to 2017. Inclusion criteria were previous CABG, no significant (over 60%) stenosis of internal carotid arteries at discharge after CABG. The control group included 447 patients without progression of precerebral atherosclerosis in long-term period after CABG. RESULTS: Careful monitoring of progression of precerebral atherosclerosis and therapeutic prevention of ischemic stroke are required in patients with mild-to-moderate ICA stenosis after CABG. The most significant predictors of progression of precerebral atherosclerosis after CABG were AF (OR=1.97, 95% CI 1.04-3.73), previous occlusion of stent (OR=7.89, 95% CI=2.3-27.0), chronic brain ischemia grade II or III (OR=22.45, 95% CI=11.9-42.3), chronic kidney disease (OR=15.8, 95% CI=5.04-49.5). CONCLUSION: It was revealed that the majority of predictors of adverse ischemic cerebral and myocardial events are indirectly associated with atrial fibrillation.


Assuntos
Estenose das Carótidas/cirurgia , Ponte de Artéria Coronária , Doença da Artéria Coronariana/cirurgia , Fibrilação Atrial/complicações , Estenose das Carótidas/complicações , Estenose das Carótidas/diagnóstico , Doença da Artéria Coronariana/complicações , Progressão da Doença , Endarterectomia das Carótidas , Humanos , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Resultado do Tratamento
8.
Vasc Health Risk Manag ; 16: 285-297, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32764949

RESUMO

Purpose: To ascertain the most appropriate treatment for chronic, stable, coronary artery disease (CAD) in patients submitted to elective coronary angiography. Patients and Methods: A total of 814 patients included in the prospective cohort study were referred for elective coronary angiography and were followed up on average for 6±1.9 years. Main outcomes were all-cause death, cardiovascular death, non-fatal myocardial infarction (MI) and stroke and late revascularization and their combinations as major adverse cardiac and cerebral events (MACCE): MACCE-1 included cardiovascular death, nonfatal MI, and stroke; MACCE-2 was MACCE-1 plus late revascularization. Survival curves and adjusted Cox proportional hazard models were used to explore the association between the type of treatment and outcomes. Results: All-cause death was lower in participants submitted to percutaneous coronary intervention (PCI) (0.41, 0.16-1.03, P=0.057) compared to medical treatment (MT). Coronary-artery bypass grafting (CABG) had an overall trend for poorer outcomes: cardiovascular death 2.53 (0.42-15.10), combined cardiovascular death, nonfatal MI, and stroke 2.15 (0.73-6.31) and these events plus late revascularization (2.17, 0.86-5.49). The corresponding numbers for PCI were 0.27 (0.05-1.43) for cardiovascular death, 0.77 (0.32-1.84) for combined cardiovascular death, nonfatal MI, and stroke and 2.35 (1.16-4.77) with the addition of late revascularization. These trends were not influenced by baseline blood pressure, left ventricular ejection fraction and previous MI. Patients with diabetes mellitus had a significantly higher risk of recurrent revascularization when submitted to PCI than CABG. Conclusion: Patients with confirmed CAD in elective coronary angiography do not have a better prognosis when submitted to CABG comparatively to medical treatment. Patients treated with PCI had a trend for the lower incidence of combined cardiovascular events, at the expense of additional revascularization procedures. Patients without significant CAD had a similar prognosis than CAD patients treated with medical therapy.


Assuntos
Fármacos Cardiovasculares/uso terapêutico , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Procedimentos Endovasculares , Intervenção Coronária Percutânea , Idoso , Fármacos Cardiovasculares/efeitos adversos , Causas de Morte , Doença Crônica , Doença da Artéria Coronariana/mortalidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/prevenção & controle , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Valor Preditivo dos Testes , Estudos Prospectivos , Encaminhamento e Consulta , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/prevenção & controle , Fatores de Tempo , Resultado do Tratamento
9.
N Z Med J ; 133(1519): 41-54, 2020 07 31.
Artigo em Inglês | MEDLINE | ID: mdl-32777794

RESUMO

BACKGROUND: Concomitant atrial fibrillation (AF) and acute coronary syndrome (ACS) present the difficult therapeutic dilemma of balancing bleeding, cardio-embolic and coronary thrombotic risks with appropriate combinations of antithrombotic medications. We aim to evaluate current New Zealand practice by identifying the incidence of AF in ACS; describe the population characteristics; and assess our antithrombotic management. METHODS: Consecutive patients ≥18y presenting with ACS who had coronary angiography (2017-2018) were identified from the All New Zealand ACS Quality Improvement (ANZACS-QI) registry. The cohort was divided into three groups: 1) patients with pre-existing AF; 2) new-onset AF; and 3) no AF. Antithrombotic regimens included dual antiplatelet therapy (DAPT), dual antithrombotic therapy (DAT-single antiplatelet plus an oral anticoagulant (OAC)) and triple antithrombotic therapy (TAT). RESULTS: There were 9,489 patients, 9.6% with pre-existing AF, 4.4% new AF and 86% without AF. Both AF groups were older (median 74 vs 71 vs 65y, p=0.001), had poorer renal function, were more likely to present with heart failure (16% vs 19% vs 8%, p=0.001) and have left ventricular ejection fraction <40% (22% vs 28% vs 13%, p<0.001). They received less percutaneous coronary intervention (PCI) (53% vs 59% vs 70%, p=0.001). In the cohort, 25 different combinations of antithrombotic agents were utilised. Ninety-six percent of patients with any AF had a CHA2DS2VASC stroke risk score of ≥2, of whom 48% did not receive OAC. Twenty-four percent received TAT and 19% DAT. OAC use increased slightly with increasing stroke risk but were independent of CRUSADE bleeding risk. Of patients with AF treated with PCI, 53% received DAPT, 11% DAT and 35% TAT. 51% of those at high stroke risk were discharged on DAPT only. In contrast, 19% at low stroke risk received TAT. CONCLUSION: In New Zealand, one in seven patients presenting with ACS have AF, a third being new-onset AF. Antithrombotic management is inconsistent, with underutilisation of anticoagulants, particularly the DAT regimen, and is inadequately informed by stroke and bleeding risk scores.


Assuntos
Síndrome Coronariana Aguda , Fibrilação Atrial , Síndrome Coronariana Aguda/complicações , Síndrome Coronariana Aguda/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/complicações , Fibrilação Atrial/epidemiologia , Feminino , Fibrinolíticos/uso terapêutico , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Nova Zelândia/epidemiologia , Estudos Retrospectivos , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle
10.
Curr Opin Anaesthesiol ; 33(5): 661-667, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32769748

RESUMO

PURPOSE OF REVIEW: Few outcomes in surgery are as important to patients as that of their neurologic status. The purpose of this review is to discuss and categorize the most common perioperative neurologic complications. We will also discuss strategies to help prevent and mitigate these complications for our patients. RECENT FINDINGS: There are several strategies the anesthesiologist can undertake to prevent or treat conditions, such as perioperative neurocognitive disorders, spinal cord ischemia, perioperative stroke, and postoperative visual loss. SUMMARY: A thorough understanding of threats to patients' neurologic well-being is essential to excellent clinical practice.


Assuntos
Doenças do Sistema Nervoso/prevenção & controle , Complicações Pós-Operatórias/prevenção & controle , Isquemia do Cordão Espinal/prevenção & controle , Acidente Vascular Cerebral/prevenção & controle , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Humanos , Período Perioperatório
11.
Am Heart J ; 228: 1-7, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32739652

RESUMO

BACKGROUND: Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor is the cornerstone for prevention ischemic events in patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention. However, the optimal antiplatelet strategy for ACS patients with both high bleeding and high ischemic risks is unclear. STUDY DESIGN: The OPT-BIRISK trial is a multicenter, double-blinded, placebo-controlled randomized study designed to test the superiority of extended antiplatelet therapy with clopidogrel monotherapy compared with aspirin and clopidogrel for reduction of bleeding events in ACS patients with both high bleeding and high ischemic risks ("bi-risk"). A total of 7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS will be randomized to receive clopidogrel monotherapy or aspirin plus clopidogrel for 9 months followed by aspirin monotherapy for 3 months. The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization. The key secondary end point is major adverse cardiac and cerebral events at 9 months after randomization, defined as a composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization. CONCLUSIONS: OPT-BIRISK is the first large-scale randomized trial aimed to explore the optimal antiplatelet strategy for bi-risk ACS patients after percutaneous coronary intervention in current clinical practice. The results will add evidence regarding de-escalation antiplatelet therapy for patients at special risk.


Assuntos
Síndrome Coronariana Aguda , Aspirina , Clopidogrel , Hemorragia , Risco Ajustado/métodos , Acidente Vascular Cerebral , Síndrome Coronariana Aguda/complicações , Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/cirurgia , Adulto , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Clopidogrel/administração & dosagem , Clopidogrel/efeitos adversos , Método Duplo-Cego , Stents Farmacológicos/efeitos adversos , Terapia Antiplaquetária Dupla/efeitos adversos , Terapia Antiplaquetária Dupla/métodos , Feminino , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação de Plaquetas/administração & dosagem , Inibidores da Agregação de Plaquetas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/induzido quimicamente , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle
12.
Cochrane Database Syst Rev ; 8: CD009716, 2020 08 17.
Artigo em Inglês | MEDLINE | ID: mdl-32813275

RESUMO

BACKGROUND: Stroke is a leading cause of morbidity and mortality worldwide. Antiplatelet agents are considered to be the cornerstone for secondary prevention of stroke, but the role of using multiple antiplatelet agents early after stroke or transient ischaemic attack (TIA) to improve outcomes has not been established. OBJECTIVES: To determine the effectiveness and safety of initiating, within 72 hours after an ischaemic stroke or TIA, multiple antiplatelet agents versus fewer antiplatelet agents to prevent stroke recurrence. The analysis explores the evidence for different drug combinations. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (last searched 6 July 2020), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 7 of 12, 2020) (last searched 6 July 2020), MEDLINE Ovid (from 1946 to 6 July 2020), Embase (1980 to 6 July 2020), ClinicalTrials.gov, and the WHO ICTRP. We also searched the reference lists of identified studies and reviews and used the Science Citation Index Cited Reference search for forward tracking of included studies. SELECTION CRITERIA: We selected all randomised controlled trials (RCTs) that compared the use of multiple versus fewer antiplatelet agents initiated within 72 hours after stroke or TIA. DATA COLLECTION AND ANALYSIS: We extracted data from eligible studies for the primary outcomes of stroke recurrence and vascular death, and secondary outcomes of myocardial infarction; composite outcome of stroke, myocardial infarction, and vascular death; intracranial haemorrhage; extracranial haemorrhage; ischaemic stroke; death from all causes; and haemorrhagic stroke. We computed an estimate of treatment effect and performed a test for heterogeneity between trials. We analysed data on an intention-to-treat basis and assessed bias for all studies. We rated the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included 15 RCTs with a total of 17,091 participants. Compared with fewer antiplatelet agents, multiple antiplatelet agents were associated with a significantly lower risk of stroke recurrence (5.78% versus 7.84%, risk ratio (RR) 0.73, 95% confidence interval (CI) 0.66 to 0.82; P < 0.001; moderate-certainty evidence) with no significant difference in vascular death (0.60% versus 0.66%, RR 0.98, 95% CI 0.66 to 1.45; P = 0.94; moderate-certainty evidence). There was a higher risk of intracranial haemorrhage (0.42% versus 0.21%, RR 1.92, 95% CI 1.05 to 3.50; P = 0.03; low-certainty evidence) and extracranial haemorrhage (6.38% versus 2.81%, RR 2.25, 95% CI 1.88 to 2.70; P < 0.001; high-certainty evidence) with multiple antiplatelet agents. On secondary analysis of dual versus single antiplatelet agent therapy, benefit for stroke recurrence (5.73% versus 8.06%, RR 0.71, 95% CI 0.62 to 0.80; P < 0.001; moderate-certainty evidence) was maintained as well as risk of extracranial haemorrhage (1.24% versus 0.40%, RR 3.08, 95% CI 1.74 to 5.46; P < 0.001; high-certainty evidence). The composite outcome of stroke, myocardial infarction, and vascular death (6.37% versus 8.77%, RR 0.72, 95% CI 0.64 to 0.82; P < 0.001; moderate-certainty evidence) and ischaemic stroke (6.30% versus 8.94%, RR 0.70, 95% CI 0.61 to 0.81; P < 0.001; high-certainty evidence) were significantly in favour of dual antiplatelet therapy, whilst the risk of intracranial haemorrhage became less significant (0.34% versus 0.21%, RR 1.53, 95% CI 0.76 to 3.06; P = 0.23; low-certainty evidence). AUTHORS' CONCLUSIONS: Multiple antiplatelet agents are more effective in reducing stroke recurrence but increase the risk of haemorrhage compared to one antiplatelet agent. The benefit in reduction of stroke recurrence seems to outweigh the harm for dual antiplatelet agents initiated in the acute setting and continued for one month. There is lack of evidence regarding multiple versus multiple antiplatelet agents. Further studies are required in different populations to establish comprehensive safety profiles and long-term outcomes to establish duration of therapy.


Assuntos
Ataque Isquêmico Transitório/prevenção & controle , Inibidores da Agregação de Plaquetas/uso terapêutico , Prevenção Secundária/métodos , Acidente Vascular Cerebral/prevenção & controle , Viés , Causas de Morte , Intervalos de Confiança , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/métodos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Análise de Intenção de Tratamento , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/epidemiologia , Infarto do Miocárdio/epidemiologia , Razão de Chances , Inibidores da Agregação de Plaquetas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/epidemiologia , Fatores de Tempo
13.
Cochrane Database Syst Rev ; 8: CD011737, 2020 08 21.
Artigo em Inglês | MEDLINE | ID: mdl-32827219

RESUMO

BACKGROUND: Reducing saturated fat reduces serum cholesterol, but effects on other intermediate outcomes may be less clear. Additionally, it is unclear whether the energy from saturated fats eliminated from the diet are more helpfully replaced by polyunsaturated fats, monounsaturated fats, carbohydrate or protein. OBJECTIVES: To assess the effect of reducing saturated fat intake and replacing it with carbohydrate (CHO), polyunsaturated (PUFA), monounsaturated fat (MUFA) and/or protein on mortality and cardiovascular morbidity, using all available randomised clinical trials. SEARCH METHODS: We updated our searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid) and Embase (Ovid) on 15 October 2019, and searched Clinicaltrials.gov and WHO International Clinical Trials Registry Platform (ICTRP) on 17 October 2019. SELECTION CRITERIA: Included trials fulfilled the following criteria: 1) randomised; 2) intention to reduce saturated fat intake OR intention to alter dietary fats and achieving a reduction in saturated fat; 3) compared with higher saturated fat intake or usual diet; 4) not multifactorial; 5) in adult humans with or without cardiovascular disease (but not acutely ill, pregnant or breastfeeding); 6) intervention duration at least 24 months; 7) mortality or cardiovascular morbidity data available. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed inclusion, extracted study data and assessed risk of bias. We performed random-effects meta-analyses, meta-regression, subgrouping, sensitivity analyses, funnel plots and GRADE assessment. MAIN RESULTS: We included 15 randomised controlled trials (RCTs) (16 comparisons, 56,675 participants), that used a variety of interventions from providing all food to advice on reducing saturated fat. The included long-term trials suggested that reducing dietary saturated fat reduced the risk of combined cardiovascular events by 17% (risk ratio (RR) 0.83; 95% confidence interval (CI) 0.70 to 0.98, 12 trials, 53,758 participants of whom 8% had a cardiovascular event, I² = 67%, GRADE moderate-quality evidence). Meta-regression suggested that greater reductions in saturated fat (reflected in greater reductions in serum cholesterol) resulted in greater reductions in risk of CVD events, explaining most heterogeneity between trials. The number needed to treat for an additional beneficial outcome (NNTB) was 56 in primary prevention trials, so 56 people need to reduce their saturated fat intake for ~four years for one person to avoid experiencing a CVD event. In secondary prevention trials, the NNTB was 53. Subgrouping did not suggest significant differences between replacement of saturated fat calories with polyunsaturated fat or carbohydrate, and data on replacement with monounsaturated fat and protein was very limited. We found little or no effect of reducing saturated fat on all-cause mortality (RR 0.96; 95% CI 0.90 to 1.03; 11 trials, 55,858 participants) or cardiovascular mortality (RR 0.95; 95% CI 0.80 to 1.12, 10 trials, 53,421 participants), both with GRADE moderate-quality evidence. There was little or no effect of reducing saturated fats on non-fatal myocardial infarction (RR 0.97, 95% CI 0.87 to 1.07) or CHD mortality (RR 0.97, 95% CI 0.82 to 1.16, both low-quality evidence), but effects on total (fatal or non-fatal) myocardial infarction, stroke and CHD events (fatal or non-fatal) were all unclear as the evidence was of very low quality. There was little or no effect on cancer mortality, cancer diagnoses, diabetes diagnosis, HDL cholesterol, serum triglycerides or blood pressure, and small reductions in weight, serum total cholesterol, LDL cholesterol and BMI. There was no evidence of harmful effects of reducing saturated fat intakes. AUTHORS' CONCLUSIONS: The findings of this updated review suggest that reducing saturated fat intake for at least two years causes a potentially important reduction in combined cardiovascular events. Replacing the energy from saturated fat with polyunsaturated fat or carbohydrate appear to be useful strategies, while effects of replacement with monounsaturated fat are unclear. The reduction in combined cardiovascular events resulting from reducing saturated fat did not alter by study duration, sex or baseline level of cardiovascular risk, but greater reduction in saturated fat caused greater reductions in cardiovascular events.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Gorduras na Dieta/administração & dosagem , Ácidos Graxos/administração & dosagem , Adulto , Doenças Cardiovasculares/mortalidade , Causas de Morte , Colesterol/sangue , Carboidratos da Dieta/administração & dosagem , Gorduras Insaturadas na Dieta/administração & dosagem , Proteínas na Dieta/administração & dosagem , Ingestão de Energia , Feminino , Humanos , Masculino , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/prevenção & controle
14.
Int Heart J ; 61(4): 695-704, 2020 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-32684604

RESUMO

The "on-therapy range" of direct oral anticoagulants is the 90% interval of drug concentration. Previously, we reported the on-therapy range of rivaroxaban in a single-center cohort. The present study aimed to confirm the range and intraindividual reproducibility in a multicenter cohort.Eligible patients with non-valvular atrial fibrillation under rivaroxaban treatment for prevention of ischemic stroke were enrolled from nine institutes in Tokyo, Japan, between June 2016 and May 2017 (n = 324). The first and second (three months later) blood samples both taken within 1-5 hours after rivaroxaban intake were analyzed (n = 219). Plasma concentration of rivaroxaban (PC-Riv) and prothrombin time (PT) with five reagents were measured.The 90% interval of PC-Riv was 47.3-532.9 ng/mL. The 90% interval of PT measured with RecombiPlasTin 2G was 11.8-22.3 seconds, the widest range among the five reagents examined. PC-Riv reproducibility within a 90% interval was evaluated bidirectionally (first-to-second and second-to-first), and 92.4% of samples were reproducible. The change rate (CR) of PC-Riv between two samplings ranged widely, and high CR (≥54.3%, cutoff for predicting non-reproducibility) was predicted by concomitant drugs (non-dihydropyridine calcium antagonist and thiazide) and mitral regurgitation.We reported the on-therapy range of rivaroxaban in a multicenter cohort. This range was consistent with that of a single-center cohort and was highly reproducible within three months in daily clinical practice. However, caution is necessary regarding several factors that may affect the intraindividual variation of PC-Riv.


Assuntos
Inibidores do Fator Xa/farmacocinética , Rivaroxabana/farmacocinética , Idoso , Fibrilação Atrial/complicações , Inibidores do Fator Xa/sangue , Inibidores do Fator Xa/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Reprodutibilidade dos Testes , Rivaroxabana/sangue , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle
15.
Lancet ; 396(10244): 129-142, 2020 07 11.
Artigo em Inglês | MEDLINE | ID: mdl-32653056

RESUMO

Stroke is a major cause of death and disability globally. Diagnosis depends on clinical features and brain imaging to differentiate between ischaemic stroke and intracerebral haemorrhage. Non-contrast CT can exclude haemorrhage, but the addition of CT perfusion imaging and angiography allows a positive diagnosis of ischaemic stroke versus mimics and can identify a large vessel occlusion target for endovascular thrombectomy. Management of ischaemic stroke has greatly advanced, with rapid reperfusion by use of intravenous thrombolysis and endovascular thrombectomy shown to reduce disability. These therapies can now be applied in selected patients who present late to medical care if there is imaging evidence of salvageable brain tissue. Both haemostatic agents and surgical interventions are investigational for intracerebral haemorrhage. Prevention of recurrent stroke requires an understanding of the mechanism of stroke to target interventions, such as carotid endarterectomy, anticoagulation for atrial fibrillation, and patent foramen ovale closure. However, interventions such as lowering blood pressure, smoking cessation, and lifestyle optimisation are common to all stroke subtypes.


Assuntos
Encéfalo/diagnóstico por imagem , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/prevenção & controle , Administração Intravenosa , Idoso , Idoso de 80 Anos ou mais , Amilose/uso terapêutico , Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/prevenção & controle , Encéfalo/irrigação sanguínea , Encéfalo/patologia , Isquemia Encefálica/diagnóstico por imagem , Isquemia Encefálica/tratamento farmacológico , Isquemia Encefálica/fisiopatologia , Isquemia Encefálica/cirurgia , Hemorragia Cerebral/complicações , Hemorragia Cerebral/tratamento farmacológico , Hemorragia Cerebral/fisiopatologia , Hemorragia Cerebral/cirurgia , Angiografia por Tomografia Computadorizada/métodos , Intervenção Médica Precoce/métodos , Endarterectomia das Carótidas/métodos , Procedimentos Endovasculares/métodos , Forame Oval Patente/cirurgia , Humanos , Pessoa de Meia-Idade , Seleção de Pacientes , Imagem de Perfusão/métodos , Polímeros/uso terapêutico , Recidiva , Acidente Vascular Cerebral/epidemiologia , Succinatos/uso terapêutico , Trombectomia/métodos , Terapia Trombolítica/métodos , Tomografia Computadorizada por Raios X/métodos
16.
Medicine (Baltimore) ; 99(29): e21209, 2020 Jul 17.
Artigo em Inglês | MEDLINE | ID: mdl-32702889

RESUMO

Patients aged ≥75 years with the diagnosis of atrial fibrillation (AF) are at a higher risk of stroke and, according to recent recommendations, should receive oral anticoagulant (OAC) therapy. This study aimed to assess the recommended prophylactic antithrombotic therapy among patients with AF aged ≥ 75 years and its compliance with current guidelines. We also aimed to identify predisposing factors associated with the administration of non-vitamin K antagonist oral anticoagulants (NOACs) in elderly patients with AF.This was a retrospective, single-center observational study. Patients with AF aged ≥75 years hospitalized at a reference cardiology center from 2014 to 2017 were included in the analysis.Among the 1236 eligible patients (43.4% male; mean age, 82 years), OACs were recommended in 90.1% of cases. Of these, 59.8% of patients used NOACs and 40.2% used vitamin K antagonists. Additionally, 3.3% of patients received antiplatelet (AP) therapy and 2.5% were administered low molecular weight heparin. Only 4.5% of patients did not receive any anticoagulant treatment. The majority (89.9%) of patients received relevant prophylactic antithrombotic therapy according to current guidelines; only 1.4% were overtreated and 8.7% were undertreated. The significant predictors of NOAC therapy among patients treated with anticoagulants were non-permanent AF (odds ratio [OR] = 1.68, 95% confidence interval [CI] = 1.30-2.18, P = .0001), age-by 5 years (OR = 1.33, 95% CI = 1.16-1.52, P = .0001), and glomerular filtration rate-by 5 units (OR = 1.06, 95% CI = 1.02-1.10, P = .0066).A high percentage of AF patients aged ≥75 years receive OACs, mainly NOACs. Most patients are treated according to the current guidelines; under treatment is primarily observed in patients receiving AP therapy. Non-permanent AF, age, and preservation of renal function are significant predictors of NOAC use.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial , Idoso Fragilizado , Padrões de Prática Médica/normas , Acidente Vascular Cerebral/prevenção & controle , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Humanos , Masculino , Polônia , Guias de Prática Clínica como Assunto , Estudos Retrospectivos
17.
Medicine (Baltimore) ; 99(27): e21025, 2020 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-32629725

RESUMO

BACKGROUND: Given the huge burden of atrial fibrillation (AF) and AF-related stroke in Asia, stroke prevention represents an urgent issue in this region. We herein performed a network meta-analysis to examine the role of non-vitamin K antagonist oral anticoagulants (NOACs) in Asian patients with AF. METHODS: A systematic search of the publications was conducted in PubMed and Embase databases for eligible studies until July 2019. The odds ratios (ORs) and 95% confidence intervals (CIs) were regarded as the effect estimates. The surface under the cumulative ranking area (SUCRA) for the ranking probabilities was calculated. RESULTS: A total of 17 studies were included. For comparisons of NOACs vs warfarin, dabigatran (OR = 0.77, 95% CI 0.68-0.86), rivaroxaban (OR = 0.72, 95% CI 0.65-0.81), apixaban (OR = 0.56, 95% CI 0.49-0.65), but not edoxaban reduced the risk of stroke or systemic embolism, wheres dabigatran (OR = 0.56, 95% CI 0.41-0.76), rivaroxaban (OR = 0.66, 95% CI 0.50-0.86), apixaban (OR = 0.49, 95% CI 0.36-0.66), and edoxaban (OR = 0.34, 95% CI 0.24-0.49) decreased the risk of major bleeding. In reducing the risk of stroke or systemic embolism, apixaban and rivaroxaban ranked the best and second best (SUCRA 0.2% and 31.4%, respectively), followed by dabigatran (50.2%), edoxaban (75.2%), and warfarin (93.0%). In reducing the risk of major bleeding, edoxaban, and apixaban ranked the best and second best (1.5% and 30.8%, respectively), followed by dabigatran (48.4%), rivaroxaban (69.2%), and warfarin (100%). CONCLUSION: NOACs were at least as effective as warfarin, but more safer in Asians with AF. Apixaban was superior to other NOACs for reducing stroke or systemic embolism, while edoxaban showed a better safety profile than other NOACs.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Acidente Vascular Cerebral/prevenção & controle , Varfarina/uso terapêutico , Administração Oral , Idoso , Antitrombinas/uso terapêutico , Ásia/epidemiologia , Grupo com Ancestrais do Continente Asiático/etnologia , Efeitos Psicossociais da Doença , Dabigatrana/uso terapêutico , Embolia/prevenção & controle , Inibidores do Fator Xa/uso terapêutico , Feminino , Hemorragia/prevenção & controle , Humanos , Masculino , Metanálise em Rede , Pirazóis/uso terapêutico , Piridinas/uso terapêutico , Piridonas/uso terapêutico , Rivaroxabana/uso terapêutico , Segurança , Acidente Vascular Cerebral/epidemiologia , Tiazóis/uso terapêutico
18.
N Engl J Med ; 383(3): 207-217, 2020 07 16.
Artigo em Inglês | MEDLINE | ID: mdl-32668111

RESUMO

BACKGROUND: Trials have evaluated the use of clopidogrel and aspirin to prevent stroke after an ischemic stroke or transient ischemic attack (TIA). In a previous trial, ticagrelor was not better than aspirin in preventing vascular events or death after stroke or TIA. The effect of the combination of ticagrelor and aspirin on prevention of stroke has not been well studied. METHODS: We conducted a randomized, placebo-controlled, double-blind trial involving patients who had had a mild-to-moderate acute noncardioembolic ischemic stroke, with a National Institutes of Health Stroke Scale (NIHSS) score of 5 or less (range, 0 to 42, with higher scores indicating more severe stroke), or TIA and who were not undergoing thrombolysis or thrombectomy. The patients were assigned within 24 hours after symptom onset, in a 1:1 ratio, to receive a 30-day regimen of either ticagrelor (180-mg loading dose followed by 90 mg twice daily) plus aspirin (300 to 325 mg on the first day followed by 75 to 100 mg daily) or matching placebo plus aspirin. The primary outcome was a composite of stroke or death within 30 days. Secondary outcomes were first subsequent ischemic stroke and the incidence of disability within 30 days. The primary safety outcome was severe bleeding. RESULTS: A total of 11,016 patients underwent randomization (5523 in the ticagrelor-aspirin group and 5493 in the aspirin group). A primary-outcome event occurred in 303 patients (5.5%) in the ticagrelor-aspirin group and in 362 patients (6.6%) in the aspirin group (hazard ratio, 0.83; 95% confidence interval [CI], 0.71 to 0.96; P = 0.02). Ischemic stroke occurred in 276 patients (5.0%) in the ticagrelor-aspirin group and in 345 patients (6.3%) in the aspirin group (hazard ratio, 0.79; 95% CI, 0.68 to 0.93; P = 0.004). The incidence of disability did not differ significantly between the two groups. Severe bleeding occurred in 28 patients (0.5%) in the ticagrelor-aspirin group and in 7 patients (0.1%) in the aspirin group (P = 0.001). CONCLUSIONS: Among patients with a mild-to-moderate acute noncardioembolic ischemic stroke (NIHSS score ≤5) or TIA who were not undergoing intravenous or endovascular thrombolysis, the risk of the composite of stroke or death within 30 days was lower with ticagrelor-aspirin than with aspirin alone, but the incidence of disability did not differ significantly between the two groups. Severe bleeding was more frequent with ticagrelor. (Funded by AstraZeneca; THALES ClinicalTrial.gov number, NCT03354429.).


Assuntos
Aspirina/uso terapêutico , Ataque Isquêmico Transitório/tratamento farmacológico , Inibidores da Agregação de Plaquetas/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Ticagrelor/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Aspirina/efeitos adversos , Avaliação da Deficiência , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Hemorragia/induzido quimicamente , Humanos , Ataque Isquêmico Transitório/complicações , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Prevenção Secundária , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/prevenção & controle , Ticagrelor/efeitos adversos
20.
Medicine (Baltimore) ; 99(28): e20694, 2020 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-32664066

RESUMO

INTRODUCTION: Recurrent ischemic strokes (IS) make up to one-third of all strokes. Nine out of 10 strokes are due to modifiable risk factors. Thus, it seems that standard management strategies of modifiable risk factors are yet to improve. Hence, we planned a randomized controlled trial assessing nurses or pharmacists-led aggressive control of comorbidities and their prognostic impact on IS and transient ischemic attacks (TIA). METHODS/DESIGN: Prospective study to optimize the health of patients with TIAs and stroke admitted to the Hamad General Hospital (PROMOTE HEALTH) is an assessor-blinded, open-label, randomized, two-arm, controlled trial. Eligible patients have IS or TIA, and an additional modifiable risk factor (Hypertension or dyslipidemia) attending the stroke ward or clinic at the Weill Cornell-affiliated Hamad General Hospital. Stroke specialists will offer the control group the currently practiced best risk factor management strategies. Whereas, in the intervention arm, with the assistance of a nurse and a pharmacist, we will make aggressive attempts to meet targets of defined risk factors. The primary outcomes are the mean difference in blood pressure (BP) and low-density lipoprotein. Whereas myocardial infarction, recurrent stroke events, and mortality serve as the study's secondary outcomes. We require 200 patients per study arm to achieve a power of 80% and an alpha level of <0.05. The Medical Research Center and the Institutional Review Board have approved the study, and it was prospectively registered in a trial registry. DISCUSSION: A significant proportion of strokes are due to modifiable preventable risk factors. Despite having the right preventive strategies aimed at mitigating these risk factors, a sizeable proportion of strokes are due to recurring events. This prompted the medical community to evaluate aggressive means of addressing these risk factors. The nurse or pharmacist-led management of comorbidities has been proven to be of value in the management of diabetes and hypertension. It will be of value to demonstrate the effectiveness of utilizing this additional task force in aggressively managing IS or TIA patients with an overarching goal of improving their prognosis. If our intervention proves to be efficacious, this would have a substantial impact on the current stroke practices and guidelines. Additionally, it will invite further research in the area. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT02868723, last updated on September 2018.


Assuntos
Ataque Isquêmico Transitório/prevenção & controle , Acidente Vascular Cerebral/prevenção & controle , Humanos , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Prevenção Secundária
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