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1.
Eur Heart J Cardiovasc Pharmacother ; 9(7): 647-657, 2023 11 02.
Artigo em Inglês | MEDLINE | ID: mdl-37609995

RESUMO

BACKGROUND: Higher rates of thrombotic events have been reported in myocardial infarction (MI) patients requiring blood transfusion. The impact of blood transfusion strategy on thrombosis and inflammation is still unknown. OBJECTIVE: To compare the impact of a liberal vs. a restrictive transfusion strategy on P2Y12 platelet reactivity and biomarkers in the multicentric randomized REALITY trial. METHODS: Patients randomized to a liberal (hemoglobin ≤10 g/dL) or a restrictive (hemoglobin ≤8 g/dL) transfusion strategy had VASP-PRI platelet reactivity measured centrally in a blinded fashion and platelet reactivity unit (PRU) measured locally using encrypted VerifyNow; at baseline and after randomization. Biomarkers of thrombosis (P-selectin, PAI-1, vWF) and inflammation (TNF-α) were also measured. The primary endpoint was the change in the VASP-PRI (difference from baseline and post randomization) between the randomized groups. RESULTS: A total of 100 patients randomized were included in this study (n = 50 in each group). Transfused patients received on average 2.4 ± 1.6 units of blood. We found no differences in change of the VASP PRI (difference 1.2% 95% CI (-10.3-12.7%)) or by the PRU (difference 13.0 95% CI (-21.8-47.8)) before and after randomization in both randomized groups. Similar results were found in transfused patients (n = 71) regardless of the randomized group, VASP PRI (difference 1.7%; 95% CI (-9.5-1.7%)) or PRU (difference 27.0; 95% CI (-45.0-0.0)). We did not find an impact of transfusion strategy or transfusion itself in the levels of P-selectin, PAI-1, vWF, and TNF-α. CONCLUSION: In this study, we found no impact of a liberal vs. a restrictive transfusion strategy on platelet reactivity and biomarkers in MI patients with anemia. A conclusion that should be tempered due to missing patients with exploitable biological data that has affected our power to show a difference.


Assuntos
Anemia , Infarto do Miocárdio , Trombose , Humanos , Agregação Plaquetária , Selectina-P , Inibidor 1 de Ativador de Plasminogênio , Fator de Necrose Tumoral alfa , Fator de von Willebrand , Transfusão de Sangue , Hemoglobinas , Biomarcadores , Inflamação
2.
Eur Heart J Qual Care Clin Outcomes ; 9(2): 194-202, 2023 02 28.
Artigo em Inglês | MEDLINE | ID: mdl-35612990

RESUMO

AIMS: To estimate the cost-effectiveness and cost-utility ratios of a restrictive vs. liberal transfusion strategy in acute myocardial infarction (AMI) patients with anaemia. METHODS AND RESULTS: Patients (n = 666) with AMI and haemoglobin between 7-8 and 10 g/dL recruited in 35 hospitals in France and Spain were randomly assigned to a restrictive (n = 342) or a liberal (n = 324) transfusion strategy with 1-year prospective collection of resource utilization and quality of life using the EQ5D3L questionnaire. The economic evaluation was based on 648 patients from the per-protocol population. The outcomes were 30-day and 1-year cost-effectiveness, with major adverse cardiovascular events (MACEs) averted as the effectiveness outcome. and a 1-year cost-utility ratio.The 30-day incremental cost-effectiveness ratio was €33 065 saved per additional MACE averted with the restrictive vs. liberal strategy, with an 84% probability for the restrictive strategy to be cost-saving and MACE-reducing (i.e. dominant). At 1 year, the point estimate of the cost-utility ratio was €191 500 saved per quality-adjusted life year gained; however, the cumulated MACE was outside the pre-specified non-inferiority margin, resulting in a decremental cost-effectiveness ratio with a point estimate of €72 000 saved per additional MACE with the restrictive strategy. CONCLUSION: In patients with AMI and anaemia, the restrictive transfusion strategy was dominant (cost-saving and outcome-improving) at 30 days. At 1 year, the restrictive strategy remained cost-saving, but clinical non-inferiority on MACE was no longer maintained. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02648113. ONE SENTENCE SUMMARY: The use of a restrictive transfusion strategy in patients with acute myocardial infarction is associated with lower healthcare costs, but more evidence is needed to ascertain its long-term clinical impact.


Assuntos
Anemia , Infarto do Miocárdio , Humanos , Análise Custo-Benefício , Qualidade de Vida , Estudos Prospectivos , Transfusão de Eritrócitos/efeitos adversos , Transfusão de Eritrócitos/métodos , Anemia/etiologia , Infarto do Miocárdio/terapia , Infarto do Miocárdio/etiologia
3.
Eur Heart J Cardiovasc Pharmacother ; 3(2): 77-81, 2017 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-27533953

RESUMO

Aims: To determine antiplatelet efficacy after desensitization in patients with a history of aspirin hypersensitivity. Methods and results: We conducted a case-control study to evaluate the efficacy of aspirin 1 day (D1) and 6-8 weeks (W6-8) after desensitization. We also assessed ex vivo basophil reactivity to aspirin after desensitization. Cases were patients with coronary artery disease (CAD) and documented history of aspirin hypersensitivity who underwent rapid successful oral desensitization to aspirin. Controls were patients with stable CAD without hypersensitivity and receiving aspirin. Among 56 cases, 27 received aspirin for acute coronary syndromes and 29 were treated for stable CAD. Aspirin was effective (defined as light transmission aggregometry induced by arachidonic acid ≤20%) at D1 in 86% of cases (P = 0.045 vs. controls) and in 95% at W6-8, vs. 100% of controls (P = 0.39). Urinary excretion of thromboxane B2 diminished substantially in cases (P < 0.0001, D0 vs. W6-8) but remained higher than in controls (P = 0.03). Platelet reactivity (defined by platelet P-selectin expression, activated glycoprotein IIb/IIIa inhibitors, and platelet-monocyte aggregates) was similar in cases between D0 and D1 but decreased at W6-8. Basophil activation (quantified by upregulation of CD203c in response to aspirin) was higher in cases at W6-8 than in controls (P = 0.0002). Conclusion: Thus, following rapid desensitization, aspirin achieves rapid biological efficacy, which is slightly lower at D1, but becomes indistinguishable from chronically treated patients at W6-8. Persistent basophil activation several weeks after desensitization suggests infraclinical hypersensitivity and the need to continue aspirin to maintain desensitization.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Aspirina/efeitos adversos , Basófilos/metabolismo , Plaquetas/efeitos dos fármacos , Dessensibilização Imunológica/métodos , Hipersensibilidade a Drogas/imunologia , Síndrome Coronariana Aguda/sangue , Idoso , Basófilos/efeitos dos fármacos , Feminino , Humanos , Masculino , Ativação Plaquetária/efeitos dos fármacos , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Retrospectivos
4.
Eur J Prev Cardiol ; 22(8): 1056-65, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25147344

RESUMO

AIM: To determine the current prevalence and control of major cardiovascular risk factors in stable CAD outpatients worldwide. METHODS: We analysed variations in cardiovascular risk factors in stable CAD outpatients from CLARIFY, a 5-year observational longitudinal cohort study, in seven geographical zones (Western/Central Europe; Canada/South Africa/Australia/UK; Eastern Europe; Central/South America; Middle East; East Asia; and India). RESULTS: Patient presentation (N=32,954, mean age 64.2 years, 78% male) varied between zones, as did prevalence of risk factors (all p < 0.0001). Obesity ranged from 20% (East Asia) to 42% (Middle East), raised blood pressure from 28% (Central/South America and East Asia) to 48% (Eastern Europe), raised LDL cholesterol from 24% (Canada/South Africa/Australia/UK) to 65% (Eastern Europe), elevated heart rate (≥70 bpm) from 38% (Western/Central Europe) to 78% (India), diabetes from 17% (Eastern Europe) to 60% (Middle East), and smoking from 6% (Central/South America) to 19% (Eastern Europe). Aspirin and lipid-lowering drugs were widely used everywhere (≥84% and ≥88%, respectively). Rates of risk factor control varied geographically (all p < 0.0001). Rate of controlled blood pressure in hypertension varied from 47% (Eastern Europe) to 66% (Central/South America), glucose control in diabetes from 23% (India) to 51% (Western/Central Europe and East Asia), controlled LDL cholesterol and dyslipidaemia from 32% (Eastern Europe) to 75% (Canada/South Africa/Australia/UK), heart rate <70 bpm from 22% (India) to 62% (Western/Central Europe), and heart rate ≤60 bpm in angina patients from 2% (India) to 29% (Canada/South Africa/Australia/UK and Central/South America). CONCLUSION: Prevalence and control of major cardiovascular risk factors in stable CAD vary markedly worldwide. Many stable CAD outpatients are being treated suboptimally.


Assuntos
Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/terapia , Disparidades em Assistência à Saúde/tendências , Pacientes Ambulatoriais , Padrões de Prática Médica/tendências , Características de Residência , Comportamento de Redução do Risco , África/epidemiologia , Idoso , Ásia/epidemiologia , Austrália/epidemiologia , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Estudos Transversais , Europa (Continente)/epidemiologia , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Prevalência , Sistema de Registros , Medição de Risco , Fatores de Risco , América do Sul/epidemiologia , Resultado do Tratamento
5.
Am Heart J ; 168(6): 940-7.e5, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25458659

RESUMO

BACKGROUND: Previous studies, which compared the prevalence of high on-clopidogrel platelet reactivity (HCPR) in type 2 diabetes mellitus (T2DM) versus non-T2DM and obese versus nonobese patients provided conflicting results. METHODS: We compared the prevalence of HCPR in patients with T2DM, metabolic syndrome (MS), or neither T2DM nor MS undergoing drug-eluting stent implantation for stable coronary artery disease. Platelet functions were measured after a 600-mg clopidogrel loading dose and after 4 months on clopidogrel 75 mg/d. RESULTS: The prevalence of HCPR was significantly higher in 63 T2DM and 50 MS patients than in 43 patients with neither T2DM nor MS (46.0% and 52.0% vs 20.9%) after clopidogrel loading dose, whereas, at 4 months, only T2DM patients had a significantly higher prevalence of HCPR (50.8% and 31.3% vs 23.8%). By multivariable analysis, T2DM (odds ratio [OR] 3.62, 95% CI, 1.34-9.80, P = .011), MS (OR 4.00, 95% CI 1.39-11.46, P = .010), and previous chronic treatment with clopidogrel (OR 0.22, 95% CI 0.09-0.49; P < .001) were the main independent predictors of HCPR after clopidogrel loading dose, whereas only T2DM (OR 2.98, 95% CI 1.20-7.41, P = .017) was an important independent predictor of HCPR at 4 months. CONCLUSIONS: Both MS and T2DM were independent predictors of HCPR after clopidogrel loading dose. On clopidogrel maintenance therapy, only T2DM remained an independent predictor. This observation may be clinically relevant in the current era of antiplatelet therapy.


Assuntos
Angioplastia Coronária com Balão/métodos , Doença da Artéria Coronariana , Diabetes Mellitus Tipo 2 , Síndrome Metabólica , Ativação Plaquetária/efeitos dos fármacos , Ticlopidina/análogos & derivados , Idoso , Clopidogrel , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/metabolismo , Doença da Artéria Coronariana/terapia , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/metabolismo , Relação Dose-Resposta a Droga , Monitoramento de Medicamentos , Stents Farmacológicos , Feminino , França , Humanos , Israel , Masculino , Síndrome Metabólica/complicações , Síndrome Metabólica/metabolismo , Pessoa de Meia-Idade , Razão de Chances , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/farmacocinética , Testes de Função Plaquetária/métodos , Prognóstico , Estudos Prospectivos , Ticlopidina/administração & dosagem , Ticlopidina/efeitos adversos , Ticlopidina/farmacocinética
6.
Int J Cardiol ; 176(1): 119-24, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25042656

RESUMO

BACKGROUND: To use CLARIFY, a prospective registry of patients with stable CAD (45 countries), to explore heart rate (HR) control and beta-blocker use. METHODS: We analyzed the CLARIFY population according to beta-blocker use via descriptive statistics with Pearson's χ(2) test for comparisons, as well as a multivariable stepwise model. RESULTS: Data on beta-blocker use was available for 32,914 patients, in whom HR was 68 ± 11 bpm; patients with angina, previous myocardial infarction, and heart failure had HRs of 69 ± 12, 68 ± 11, and 70 ± 12 bpm, respectively. 75% of these patients were receiving beta-blockers. Bisoprolol (34%), metoprolol tartrate (16%) or succinate (13%), atenolol (15%), and carvedilol (12%) were mostly used; mean dosages were 49%, 76%, 35%, 53%, and 45% of maximum doses, respectively. Patients aged <65 years were more likely to receive beta-blockers than patients ≥ 75 years (P<0.0001). Gender had no effect. Subjects with HR ≤ 60 bpm were more likely to be on beta-blockers than patients with HR ≥ 70 bpm (P<0.0001). Patients with angina, previous myocardial infarction, heart failure, and hypertension were more frequently receiving beta-blockers (all P<0.0001), and those with PAD and asthma/COPD less frequently (both P<0.0001). Beta-blocker use varied according to geographical region (from 87% to 67%). CONCLUSIONS: Three-quarters of patients with stable CAD receive beta-blockers. Even so, HR is insufficiently controlled in many patients, despite recent guidelines for the management of CAD. There is still much room for improvement in HR control in the management of stable CAD.


Assuntos
Antagonistas Adrenérgicos beta/farmacologia , Assistência Ambulatorial/tendências , Doença da Artéria Coronariana/tratamento farmacológico , Frequência Cardíaca/efeitos dos fármacos , Internacionalidade , Sistema de Registros , Antagonistas Adrenérgicos beta/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial/métodos , Estudos de Coortes , Doença da Artéria Coronariana/fisiopatologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
7.
Int J Cardiol ; 167(6): 2938-43, 2013 Sep 10.
Artigo em Inglês | MEDLINE | ID: mdl-22985742

RESUMO

INTRODUCTION: Contemporary generalizable data on the demographics and management of outpatients with stable coronary artery disease (CAD) in routine clinical practice are sparse. Using the data from the CLARIFY registry we describe gender- and age-related differences in baseline characteristics and management of these patients across broad geographic regions. METHODS: This international, prospective, observational, longitudinal registry enrolled stable CAD outpatients from 45 countries in Africa, Asia, Australia, Europe, the Middle East, and North, Central, and South America. RESULTS: Baseline data were available for 33280 patients. Mean (SD) age was 64 (10.5) years and 22.5% of patients were female. The prevalence of CAD risk factors was generally higher in women than in men. Women were older (66.6 vs 63.4 years), more frequently diagnosed with diabetes (33% vs 28%), hypertension (79% vs 69%), and higher resting heart rate (69 vs 67 bpm), and were less physically active. Smoking and a history of myocardial infarction were more common in men. Women were more likely to have angina (28% vs 20%), but less likely to have undergone revascularization procedures. CAD was more likely to be asymptomatic in older patients perhaps because of reduced levels of physical activity. Prescription of evidence-based medication for secondary prevention varied with age, with patients ≥ 75 years treated less often with beta blockers, aspirin and angiotensin-converting enzyme inhibitors than patients <65 years. CONCLUSIONS: Important gender-related differences in clinical characteristics and management continue to exist in all age groups of outpatients with stable CAD.


Assuntos
Assistência Ambulatorial/tendências , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/terapia , Pacientes Ambulatoriais , Caracteres Sexuais , Fatores Etários , Idoso , Assistência Ambulatorial/métodos , Doença da Artéria Coronariana/epidemiologia , Gerenciamento Clínico , Feminino , Seguimentos , Humanos , Internacionalidade , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros , Resultado do Tratamento
8.
Eur Heart J ; 33(22): 2831-40, 2012 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-22922505

RESUMO

AIMS: Men and women differ in terms of presentation and management in coronary artery disease (CAD). Whether these differences translate into different clinical outcomes in stable CAD is unclear. We analysed data from the international prospective CLARIFY registry to compare cardiovascular clinical outcomes in men and women with stable CAD. METHODS AND RESULTS: We analysed 1-year outcomes in 30 977 outpatients with stable CAD [23 975 (77.4%) men; 7002 (22.6%) women]. Women were older than men, more likely to have hypertension and diabetes, and less likely to exercise or smoke. They had more frequent angina, but were less likely to have undergone diagnostic non-invasive testing or coronary angiography. Women received less optimized treatment for stable CAD. One-year outcomes were similar for men and women for the composite of cardiovascular death, non-fatal myocardial infarction, or stroke [adjusted rates 1.7 vs. 1.8%, respectively, odds ratio (OR) 0.93, 95% confidence interval (CI) 0.75-1.15]; all-cause death (adjusted 1.5 vs. 1.6%, OR: 0.91, 95% CI: 0.72-1.13); fatal or non-fatal myocardial infarction (adjusted 1.0 vs. 0.9%, OR: 0.81, 95 CI: 0.60-1.08); and cardiovascular death or non-fatal myocardial infarction (adjusted 1.4 vs. 1.4%, OR: 0.89, 95% CI: 0.70-1.12). Fewer women underwent revascularization (2.6 vs. 2.2%, OR: 0.77, 95% CI: 0.64-0.93), although appropriateness was not analysed. CONCLUSION: The risk profiles of women and men with stable CAD differ substantially. However, 1-year outcomes were similar. Fewer women underwent revascularization. Further research is needed to better understand gender determinants of outcome and devise strategies to minimize bias in the management and treatment of women.


Assuntos
Doença da Artéria Coronariana/mortalidade , Idoso , Fármacos Cardiovasculares/uso terapêutico , Angiografia Coronária/estatística & dados numéricos , Doença da Artéria Coronariana/prevenção & controle , Métodos Epidemiológicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico
9.
PLoS One ; 7(5): e36284, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22570699

RESUMO

BACKGROUND: Heart rate (HR) is an emerging risk factor in coronary artery disease (CAD). However, there is little contemporary data regarding HR and the use of HR-lowering medications, particularly beta-blockers, among patients with stable CAD in routine clinical practice. The goal of the present analysis was to describe HR in such patients, overall and in relation to beta-blocker use, and to describe the determinants of HR. METHODS AND FINDINGS: CLARIFY is an international, prospective, observational, longitudinal registry of outpatients with stable CAD, defined as prior myocardial infarction or revascularization procedure, evidence of coronary stenosis of >50%, or chest pain associated with proven myocardial ischemia. A total of 33,438 patients from 45 countries in Europe, the Americas, Africa, Middle East, and Asia/Pacific were enrolled between November 2009 and July 2010. Most of the 33,177 patients included in this analysis were men (77.5%). Mean (SD) age was 64.2 (10.5) years, HR by pulse was 68.3 (10.6) bpm, and by electrocardiogram was 67.2 (11.4) bpm. Overall, 44.0% had HR ≥ 70 bpm. Beta-blockers were used in 75.1% of patients and another 14.4% had intolerance or contraindications to beta-blocker therapy. Among 24,910 patients on beta-blockers, 41.1% had HR ≥ 70 bpm. HR ≥ 70 bpm was independently associated with higher prevalence and severity of angina, more frequent evidence of myocardial ischemia, and lack of use of HR-lowering agents. CONCLUSIONS: Despite a high rate of use of beta-blockers, stable CAD patients often have resting HR ≥ 70 bpm, which was associated with an overall worse health status, more frequent angina and ischemia. Further HR lowering is possible in many patients with CAD. Whether it will improve symptoms and outcomes is being tested.


Assuntos
Antagonistas Adrenérgicos beta/farmacologia , Antagonistas Adrenérgicos beta/uso terapêutico , Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/fisiopatologia , Frequência Cardíaca/efeitos dos fármacos , Pacientes Ambulatoriais , Idoso , Estudos de Coortes , Depressão Química , Análise Fatorial , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
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