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1.
Arch Cardiovasc Dis ; 2024 Apr 12.
Artigo em Inglês | MEDLINE | ID: mdl-38644068

RESUMO

Around 10% of patients with acute coronary syndrome are treated by vitamin K antagonists or non-vitamin K antagonist oral anticoagulants for various indications. The initial management of these patients is highly complex, and new guidelines specify that, only during percutaneous coronary intervention, a bolus of unfractionated heparin is recommended in one of the following circumstances: (1) if the patient is receiving a non-vitamin K antagonist oral anticoagulant; or (2) if the international normalized ratio is<2.5 in a patient being treated with a vitamin K antagonist. In this review, we report on five key messages essential for the management of these patients. There are no randomized studies to date, and we propose two diagnostic and/or therapeutic decision algorithms. However, randomized studies are needed to validate these strategies.

2.
Circ Cardiovasc Qual Outcomes ; : e010685, 2024 Apr 29.
Artigo em Inglês | MEDLINE | ID: mdl-38682335

RESUMO

BACKGROUND: Older people are underrepresented in randomized trials. The association between lipid-lowering therapy (LLT) and its intensity after acute myocardial infarction and long-term mortality in this population deserves to be assessed. METHODS: The FAST-MI (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) program consists of nationwide French surveys including all patients admitted for acute myocardial infarction ≤48 hours from onset over a 1- to 2-month period in 2005, 2010, and 2015, with long-term follow-up. Numerous data were collected and a centralized 10-year follow-up was organized. The present analysis focused on the association between prescription of LLT (atorvastatin ≥40 mg or equivalent, or any combination of statin and ezetimibe) and 5-year mortality in patients aged ≥80 years discharged alive. Cox multivariable analysis and propensity score matching were used to adjust for baseline differences. RESULTS: Among the 2258 patients aged ≥80 years (mean age, 85±4 years; 51% women; 39% ST-segment elevation myocardial infarction; 58% with percutaneous coronary intervention), 415 were discharged without LLT (18%), 866 with conventional doses (38%), and 977 with high-dose LLT (43%). Five-year survival was 36%, 47.5%, and 58%, respectively. Compared with patients without LLT, high-dose LLT was significantly associated with lower 5-year mortality (adjusted hazard ratio, 0.78 [95% CI, 0.66-0.92]), whereas conventional-intensity LLT was not (adjusted hazard ratio, 0.93 [95% CI, 0.80-1.09]). In propensity score-matched cohorts (n=278 receiving high-intensity LLT and n=278 receiving no statins), 5-year survival was 52% with high-intensity LLT at discharge and 42% without statins (hazard ratio, 0.78 [95% CI, 0.62-0.98]). CONCLUSIONS: In these observational cohorts, high-intensity LLT at discharge after acute myocardial infarction was associated with reduced all-cause mortality at 5 years in an older adult population. These results suggest that high-intensity LLT should not be denied to patients on the basis of old age. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT00673036, NCT01237418, and NCT02566200.

3.
Arch Cardiovasc Dis ; 117(2): 128-133, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38267319

RESUMO

BACKGROUND: Because of their high morbidity and mortality, patients with acute pulmonary oedema (APE) require early recognition of symptoms, identification of precipitating factors and admission to specialized care units (cardiac critical care or intensive care). APE is at the crossroads of different specialties (cardiology, emergency medicine and intensive care medicine). Although multidisciplinary expertise and management may be a strength, it can also be a source of confusion, with unexpected heterogeneity in patient care. We hypothesized that the management of severe APE may be heterogeneous between specialties and, in some situations, may differ from international recommendations. AIM: We designed a survey to compare management of different APE phenotypes according to the physicians' medical specialty, and to compare the results with what experts would do and European guidelines. METHODS: Four clinical cases of typical APE with questions pertaining to the latest guidelines were designed by a Scientific Committee designated by the French Scientific Societies for Cardiology, Emergency Medicine and Intensive Care Medicine. We focused on oxygenation and ventilation strategies, management of precipitating factors, including timing of coronary revascularization, use of diuretics and management of diuretic resistance, and discharge coverage. From 20 June 2022 until 09 September 2022, the four cases of APE (two during hypertensive crises, two during acute coronary syndromes) were proposed to French physicians involved in APE care, and to experts, using an open online survey. To avoid any diagnostic ambiguity, the diagnosis of APE was given at the beginning of each clinical case. RESULTS: The intention is to present the results at national and international conferences and publish them in a peer-reviewed journal. CONCLUSIONS: The results of this survey are intended to pave the way for the generation of novel hypotheses for future clinical trials in case of equipoise between subsets of therapeutic procedures in APE.


Assuntos
Cardiologistas , Hominidae , Médicos , Edema Pulmonar , Humanos , Animais , Fidelidade a Diretrizes , Edema Pulmonar/diagnóstico , Edema Pulmonar/terapia
4.
Artigo em Inglês | MEDLINE | ID: mdl-38273719

RESUMO

OBJECTIVES: To examine the association between life-course body silhouette changes and oral conditions in adulthood. METHODS: At study recruitment (2008-2012), 5430 adults underwent a full-mouth clinical examination and recalled their body silhouettes at ages 8, 15, 25, 35 and 45. Life-course trajectories of body silhouettes were computed using group-based trajectory modelling. Gingival inflammation, dental plaque, masticatory units, numbers of healthy, missing, decayed and filled teeth at study recruitment were clustered. The associations between body silhouette trajectories and clusters of oral conditions were assessed by multinomial logistic regression. RESULTS: The final analysis included 4472 participants. Five body silhouette trajectories were established: lean-stable (30.0%), lean-increased (19.3%), moderate stable (18.1%), lean-marked increased (25.8%) and heavy stable (6.7%). Three clusters of oral conditions were identified: optimal oral health and preserved masticatory capacity (70.0%, cluster 1), moderate oral health and moderately impaired masticatory capacity (25.4%, cluster 2) and poor oral health and severely impaired masticatory capacity (4.7%, cluster 3). Participants with a lean-increased trajectory were 58% more likely than those with a lean-stable trajectory to be in cluster 3 (aOR 1.58 [95% CI 1.07; 2.35]) relative to cluster 1, independently of covariates measured at study recruitment and including age, sex, smoking, socioeconomic status, BMI, hypertension, type 2 diabetes, cholesterol and triglycerides. CONCLUSIONS: A life-course lean-increased body silhouette trajectory is associated with higher likelihood of poor oral health and severely impaired masticatory capacity in adulthood.

5.
Am J Med ; 137(2): 137-146.e10, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37838236

RESUMO

OBJECTIVE: We aimed to evaluate the applicability of the eligibility criteria of randomized controlled trials (RCTs) cited in guideline recommendations in a real-world cohort of patients receiving secondary prevention after acute myocardial infarction from the EPICOR registries. METHODS: Recommendations provided by American and European guidelines for acute myocardial infarction were classified into general (applying to all patients) and specific (applying to patients with left ventricular dysfunction or heart failure). Randomized controlled trials cited in these recommendations were selected, and their entry criteria were applied to our international cohort of 18,117 patients. RESULTS: There were 91.5% patients eligible for beta blockers (84.6% for general, and 5.9% for specific recommendations), 97.7% eligible for renin-angiotensin system inhibitor (angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers [ACEI/ARB]) recommendations (69.9% for general, 27.9% for specific) and 4.1% eligible for mineralocorticoid receptor antagonists (only specific recommendations). The percentages of patients with eligibility criteria who were discharged with a prescription of the recommended therapies were 80%-85% for beta blockers, 70%-75% for ACEI/ARB, and 29% for mineralocorticoid receptor antagonists. There were large regional variations in the percentage of eligible patients and in those receiving the medications (eg, 95% in Northern Europe and 57% in Southeast Asia for beta blockers). CONCLUSION: Most real-world acute myocardial infarction patients are eligible for secondary prevention therapy in both general and specific guideline recommendations, and the percentage of those on beta blockers and ACEI/ARB at hospital discharge is high. There are large regional variations in the proportion of patients receiving recommended therapies. Local targeted interventions are needed for quality improvement.


Assuntos
Antagonistas de Receptores de Mineralocorticoides , Infarto do Miocárdio , Humanos , Estados Unidos , Prevenção Secundária , Antagonistas de Receptores de Mineralocorticoides/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/prevenção & controle , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Antagonistas de Receptores de Angiotensina/uso terapêutico , Antagonistas Adrenérgicos beta/uso terapêutico
6.
Eur Heart J ; 44(47): 4968-4978, 2023 Dec 14.
Artigo em Inglês | MEDLINE | ID: mdl-37860848

RESUMO

BACKGROUND AND AIMS: Evidence on the link between sleep patterns and cardiovascular diseases (CVDs) in the community essentially relies on studies that investigated one single sleep pattern at one point in time. This study examined the joint effect of five sleep patterns at two time points with incident CVD events. METHODS: By combining the data from two prospective studies, the Paris Prospective Study III (Paris, France) and the CoLaus|PsyCoLaus study (Lausanne, Switzerland), a healthy sleep score (HSS, range 0-5) combining five sleep patterns (early chronotype, sleep duration of 7-8 h/day, never/rarely insomnia, no sleep apnoea, and no excessive daytime sleepiness) was calculated at baseline and follow-up. RESULTS: The study sample included 11 347 CVD-free participants aged 53-64 years (44.6% women). During a median follow-up of 8.9 years [interquartile range (IQR): 8.0-10.0], 499 first CVD events occurred (339 coronary heart disease (CHD) and 175 stroke). In multivariate Cox analysis, the risk of CVD decreased by 18% [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.76-0.89] per one-point increment in the HSS. After a median follow-up of 6.0 years (IQR: 4.0-8.0) after the second follow-up, 262 first CVD events occurred including 194 CHD and 72 stroke. After adjusting for baseline HSS and covariates, the risk of CVD decreased by 16% (HR 0.84, 95% CI 0.73-0.97) per unit higher in the follow-up HSS over 2-5 years. CONCLUSIONS: Higher HSS and HSS improvement over time are associated with a lower risk of CHD and stroke in the community.


Assuntos
Doenças Cardiovasculares , Doença das Coronárias , Acidente Vascular Cerebral , Humanos , Feminino , Masculino , Doenças Cardiovasculares/epidemiologia , Estudos Prospectivos , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Doença das Coronárias/epidemiologia , Sono
7.
Am Heart J ; 266: 98-105, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37716448

RESUMO

BACKGROUND: Anterior acute myocardial infarction (AMI) is associated with an increased risk of left ventricular (LV) thrombus formation. We hypothesized that adding low-dose oral rivaroxaban to the usual antiplatelet regimen would reduce the risk of LV thrombus in patients with large AMI. STUDY DESIGN: APERITIF is an investigator-initiated, multicenter randomized open-label, blinded end-point (PROBE) trial, nested in the ongoing "FRENCHIE" registry, a French multicenter prospective observational study, in which all consecutive patients admitted within 48 hours of symptom onset in a cardiac Intensive Care Unit (ICU) for AMI are included (NCT04050956). Among them, patients with anterior ST-elevation-myocardial infarction (STEMI) or very high-risk non- ST-elevation-myocardial infarction (NSTEMI) patients with involvement of the left anterior descending artery are randomized into 2 groups: Dual Antiplatelet Therapy (DAPT) alone or DAPT plus rivaroxaban 2.5mg twice daily for 4 weeks, started as soon as possible after completion of the initial percutaneous coronary intervention/angiography procedure. The primary endpoint is the presence of LV thrombus at 1 month, as detected by contrast enhanced CMR (CE-CMR). Secondary endpoints include LV thrombus dimension (greatest diameter), the rate of major bleedings and major cardiovascular events at 1 month. Based on estimated event rates, a sample size of 560 patients is needed to show superiority of DAPT plus rivaroxaban therapy versus DAPT alone, with 80% power. CONCLUSION: The APERITIF trial will determine whether, in patients with large AMIs, the use of rivaroxaban 2.5mg twice daily in addition to DAPT reduces LV thrombus formation, compared with DAPT alone. CLINICALTRIALS: gov Identifier: NCT05077683.


Assuntos
Infarto Miocárdico de Parede Anterior , Infarto do Miocárdio , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Trombose , Humanos , Inibidores da Agregação Plaquetária/uso terapêutico , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Rivaroxabana/uso terapêutico , Resultado do Tratamento , Infarto do Miocárdio/diagnóstico , Trombose/etiologia , Trombose/prevenção & controle , Anticoagulantes/uso terapêutico , Intervenção Coronária Percutânea/efeitos adversos
8.
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
9.
Arch Cardiovasc Dis ; 116(8-9): 382-389, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37524628

RESUMO

BACKGROUND: Conflicting data exist on the association between consumption of coffee or tea and cardiovascular outcomes, and few focus on patients with established coronary artery disease. AIM: To describe the association between coffee or tea consumption and cardiovascular outcomes in patients with stable coronary artery disease, using an extensive contemporary international registry, allowing the identification of multiple potential confounders. METHODS: The Prospective Observational Longitudinal Registry of Patients With Stable Coronary Artery Disease (CLARIFY) registry enrolled in 2009 and 2010 in 45 countries, with a 5-year follow-up. Patients were categorized according to daily consumption of coffee or tea, and were compared with those declaring neither. The primary composite outcome of myocardial infarction, stroke or cardiovascular death was analysed at 5years, as well as all-cause mortality. Sensitivity analyses were performed with a multivariable model. RESULTS: A total of 15,459 and 10,029 patients declared coffee or tea consumption, respectively. At 5years, after full adjustment, no association was found between coffee consumption and the primary outcome: hazard ratio 1.04 (95% confidence interval 0.89-1.21) for 1 cup; 0.94 (0.82-1.08) for 2-3 cups; and 1.04 (0.86-1.27) for ≥4 cups (P=0.51). Drinking tea was not associated with a different incidence of the primary outcome before or after adjustment, with fully adjusted hazard ratios of 1.08 (95% confidence interval 0.84-1.38) for 1 cup, 1.12 (0.96-1.31) for 2-3 cups and 0.95 (0.79-1.14) for ≥4 cups (P=0.30). After full adjustment, neither coffee nor tea drinking was associated with all-cause mortality. CONCLUSIONS: In outpatients with stable coronary artery disease, there was no association between coffee or tea consumption and ischaemic outcomes or all-cause mortality.


Assuntos
Doença da Artéria Coronariana , Infarto do Miocárdio , Humanos , Café/efeitos adversos , Fatores de Risco , Chá/efeitos adversos
10.
Arch Cardiovasc Dis ; 116(6-7): 324-334, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37391340

RESUMO

AIMS: Conflicting data exists about long-term outcomes in young women and men experiencing acute myocardial infarction (AMI). METHODS: The FAST-MI program consists of three nationwide French surveys carried out 5years apart from 2005 to 2015, including consecutive patients with AMI over a 1-month period with up to 10-year follow-up. The present analysis focused on adults≤50 yo according to their gender. RESULTS: Women accounted for 17.5% (335) of the 1912 patients under 50 yo and had a similar age as men (43.9±5.1 vs. 43.9±5.5years, P=0.92). They received less percutaneous coronary interventions (PCI) than men (85.9% vs. 91.3%, P=0.005), even in ST-elevation myocardial infarction (83.6% vs. 93.5%, P<0.001). Recommended secondary prevention medications were less frequently prescribed at discharge in women (40.6% vs. 52.8%, P<0.001), a trend that persisted in 2015 (59.1% vs. 72.8% in 2015, P<0.001). Still, ten-year survival was similar in men (90.5%) and women (92.3%) (crude HR: 0.86 [95% CI: 0.55-1.35], P=0.52, adjusted HR: 0.63 [95% CI: 0.38-1.07], P=0.09); similar results were found for ten-year survival among hospital survivors (91.2% in men vs. 93.7% in women, adjusted HR: 0.87 [95% CI: 0.45-1.66], P=0.66). Of the 1684 patients alive at hospital discharge with morbidity follow-up≥6months available, death, AMI or stroke at 8years occurred in 12.9% men and 11.2% in women (adjusted HR: 0.90 [95% CI: 0.60-1.33], P=0.59). CONCLUSIONS: Young women with AMI undergo less cardiac interventions and are less often prescribed secondary prevention treatment than men, even when significant coronary artery disease is present, but keep a similar long-term prognosis after AMI. Optimal management of these young patients, regardless of gender, is necessary to ensure best outcomes after this major cardiovascular event.


Assuntos
Doença da Artéria Coronariana , Infarto do Miocárdio , Intervenção Coronária Percutânea , Masculino , Adulto , Humanos , Feminino , Intervenção Coronária Percutânea/efeitos adversos , Resultado do Tratamento , Fatores de Risco , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/terapia , Fatores Sexuais
11.
Am Heart J ; 264: 20-30, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37279841

RESUMO

BACKGROUND: Controversial findings have been reported in the literature regarding the impact of the absence of standard modifiable cardiovascular risk factors (SMuRFs) on long-term mortality risk in patients with acute coronary syndrome (ACS). While the prognostic additive value of SMuRFs has been well described, the prognostic role of prior cardiovascular disease (CVD) by sex is less well-known in patients with and without SMuRFs. METHODS: EPICOR and EPICOR Asia are prospective, observational registries conducted between 2010 and 2014, which enrolled ACS patients in 28 countries across Europe, Latin America, and Asia. Association between SMuRFs (diabetes, dyslipidaemia, hypertension, and smoking) and 2-year postdischarge mortality was evaluated using adjusted Cox models stratified by geographical region. RESULTS: Among 23,489 patients, the mean age was 60.9 ± 11.9 years, 24.3% were women, 4,582 (20.1%) presented without SMuRFs, and 16,055 (69.5%) without prior CVD. Patients with SMuRFs had a higher crude 2-year postdischarge mortality (HR 1.86; 95% CI, 1.56-2.22; P < .001), compared to those without SMuRFs. After adjustment for potential confounding, the association between SMuRFs and 2-year mortality risk was substantially attenuated (HR 1.17, 95% CI 0.98-1.41; P = .087), regardless of the type of ACS. The risk conferred by prior CVD was added to the underlying risk of SMuRFs to provide risk-specific phenotypes (eg, women with SMuRFs and with prior CVD were at higher risk of dying than women without SMuRFs and without CVD; HR 1.67, 95% CI 1.34-2.06). CONCLUSIONS: In this large-scale international ACS cohort the absence of SMuRFs was not associated with a lower adjusted 2-year postdischarge mortality risk. Patients with both SMuRFs and prior CVD had a higher mortality irrespective of their sex.


Assuntos
Síndrome Coronariana Aguda , Doenças Cardiovasculares , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Masculino , Síndrome Coronariana Aguda/complicações , Doenças Cardiovasculares/complicações , Estudos Prospectivos , Assistência ao Convalescente , Fatores de Risco , Alta do Paciente , Fatores de Risco de Doenças Cardíacas
15.
Eur Heart J Acute Cardiovasc Care ; 12(1): 22-37, 2023 Jan 27.
Artigo em Inglês | MEDLINE | ID: mdl-36346109

RESUMO

AIMS: To use quality indicators to study the management of ST-segment elevation myocardial infarction (STEMI) in different regions. METHODS AND RESULTS: Prospective cohort study of STEMI within 24 h of symptom onset (11 462 patients, 196 centres, 26 European Society of Cardiology members, and 3 affiliated countries). The median delay between arrival at a percutaneous cardiovascular intervention (PCI) centre and primary PCI was 40 min (interquartile range 20-74) with 65.8% receiving PCI within guideline recommendation of 60 min. A third of patients (33.2%) required transfer from their initial hospital to one that could perform emergency PCI for whom only 27.2% were treated within the quality indicator recommendation of 120 min. Radial access was used in 56.6% of all primary PCI, but with large geographic variation, from 76.4 to 9.1%. Statins were prescribed at discharge to 98.7% of patients, with little geographic variation. Of patients with a history of heart failure or a documented left ventricular ejection fraction ≤40%, 84.0% were discharged on an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and 88.7% were discharged on beta-blockers. CONCLUSION: Care for STEMI shows wide geographic variation in the receipt of timely primary PCI, and is in contrast with the more uniform delivery of guideline-recommended pharmacotherapies at time of hospital discharge.


Assuntos
Síndrome Coronariana Aguda , Cardiologia , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Indicadores de Qualidade em Assistência à Saúde , Síndrome Coronariana Aguda/terapia , Volume Sistólico , Estudos Prospectivos , Função Ventricular Esquerda , Sistema de Registros , Resultado do Tratamento
16.
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
17.
Eur J Health Econ ; 24(6): 867-875, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-36030485

RESUMO

OBJECTIVES: Compare costs associated with all-cause healthcare resource use (HCRU), stroke/systemic thromboembolism (STE) and major bleedings (MB) between patients with non-valvular atrial fibrillation (NVAF) initiating apixaban or other oral anticoagulants (OACs). METHODS: We performed a retrospective cohort study using the French healthcare claims database, including NVAF patients between 2014/01/01 and 2016/12/31, followed until 2016/12/31. We used 4 sub-cohorts of OAC-naive patients, respectively initiating apixaban, dabigatran, rivaroxaban or VKAs. We matched patients initiating apixaban with patients initiating each other OACs using 1:n propensity score matching. All-cause HCRU and event-related costs by OAC treatment were estimated and compared between matched patients using generalised-linear models with gamma-distribution and two-part models. RESULTS: There were 175,766 patients in the apixaban-VKA, 181,809 in the apixaban-rivaroxaban, and 42,490 in the apixaban-dabigatran matched cohorts. Patients initiating apixaban had significantly lower HCRU costs than patients initiating VKA (€1,105 vs. €1,578, p < 0.0001), dabigatran (€993 vs. €1,140, p < 0.0001) and rivaroxaban (€1,013 vs. €1,088 p < 0.0001). They have had significantly lower costs related to stroke/STE and MB than patients initiating VKA (respectively, €183 vs. €449 and €147 vs. €413; p < 0.0001), rivaroxaban (respectively, €145 vs. €197 and €129 vs. €193; p < 0.0001), and lower costs related to stroke/STE than patients initiating dabigatran (€135 vs. €192, p < 0.02). Costs related to MB were not significantly different in patients initiating apixaban and those initiating dabigatran (€119 vs. €149, p = 0.07). CONCLUSIONS: HCRU and most event-related costs were lower in patients initiating apixaban compared to other OACs. Apixaban may be cost-saving compared to VKAs, and significantly cheaper than other DOACs, although cost differences are limited.


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Anticoagulantes/efeitos adversos , Rivaroxabana/uso terapêutico , Dabigatrana/uso terapêutico , Estudos Retrospectivos , Hemorragia/induzido quimicamente , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , França
18.
Arterioscler Thromb Vasc Biol ; 42(12): 1471-1481, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36325900

RESUMO

BACKGROUND: To examine the association of ultrasensitive cTnI (cardiac troponin I) with incident cardiovascular disease events (CVDs) in the primary prevention setting. METHODS: cTnI was analyzed in the baseline plasma (2008-2012) of CVD-free volunteers from the Paris Prospective Study III using a novel ultrasensitive immunoassay (Simoa Troponin-I 2.0 Kit, Quanterix, Lexington) with a limit of detection of 0.013 pg/mL. Incident CVD hospitalizations (coronary heart disease, stroke, cardiac arrhythmias, deep venous thrombosis or pulmonary embolism, heart failure, or arterial aneurysm) were validated by critical review of the hospital records. Hazard ratios were estimated per log-transformed SD increase of cTnI in Cox models using age as the time scale. RESULTS: The study population includes 9503 participants (40% women) aged 59.6 (6.3) years. cTnI was detected in 99.6% of the participants (median value=0.63 pg/mL, interquartile range, 0.39-1.09). After a median follow-up of 8.34 years (interquartile range, 8.0-10.07), 516 participants suffered 612 events. In fully adjusted analysis, higher cTnI (per 1 SD increase of log cTnI) was significantly associated with CVD events combined (hazard ratio, 1.18 [1.08-1.30]). Among all single risk factors, cTnI had the highest discrimination capacity for incident CVD events (C index=0.6349). Adding log cTnI to the SCORE 2 (Systematic Coronary Risk Evaluation) risk improved moderately discriminatory capacity (C index 0.698 versus 0.685; bootstrapped C index difference: 0.0135 [95% CI, 0.0131-0.0138]), and reclassification of the participants (categorical net reclassification index, 0.0628 [95% CI, 0.023-0.102]). Findings were consistent using the US pooled cohort risk equation. CONCLUSIONS: Ultrasensitive cTnI is an independent marker of CVD events in the primary prevention setting.


Assuntos
Doenças Cardiovasculares , Troponina I , Feminino , Humanos , Masculino , Biomarcadores , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Prognóstico , Estudos Prospectivos , Fatores de Risco , Pessoa de Meia-Idade
19.
Arch Cardiovasc Dis ; 115(11): 571-577, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36257903

RESUMO

BACKGROUND: Direct oral anticoagulants (DOACs) were developed as an alternative to vitamin K antagonists (VKAs) and are commonly used for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Unlike VKAs, DOACs do not require Internal Normalized Ratio (INR) monitoring, but regular intake is as important for effective anticoagulation. OBJECTIVES: This study examined treatment persistence among patients receiving oral anticoagulants (OACs) for NVAF. METHODS: Within the French healthcare claims database (SNDS), we assessed and compared the rates of non-persistence (≥ 30-day treatment gap) among patients with NVAF initiating an OAC between January 2014 and December 2016. The time-to-event of non-persistence was computed and plotted using a cumulative incidence function accounting for the competing risk of mortality. After adjusting on confounding factors, the risk for non-persistence was compared between apixaban and each other OACs using a Cox proportional hazard model, or Fine and Gray models. RESULTS: In a cohort of 321,501 OAC-naive patients with NVAF, the cumulative incidence of non-persistence at 12 months considering competing risk was 44.3%, 31.0%, 41.3% and 46.8% for VKAs, apixaban, rivaroxaban and dabigatran, respectively. Median therapy duration before non-persistence ranged between 70 and 121 days. Non-persistence was lower with apixaban compared with VKAs (HR=0.63, 95%CI=[0.62-0.64]), rivaroxaban (HR=0.71, 95%CI=[0.70-0.73]), and dabigatran (HR=0.60, 95%CI=[0.59-0.62]). CONCLUSIONS: In this nationwide observational study, non-persistence rates of oral anticoagulant treatment were high in patients treated for NVAF. Apixaban-treated patients seem to experience lowest discontinuation rates 12 months after treatment initiation compared to patients treated with any other OAC.


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Dabigatrana , Rivaroxabana , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Anticoagulantes , Administração Oral , Estudos Retrospectivos
20.
Eur Heart J ; 43(47): 4887-4896, 2022 12 14.
Artigo em Inglês | MEDLINE | ID: mdl-36303402

RESUMO

AIMS: Sudden cardiac arrest remains a major complication of acute myocardial infarction (AMI) and is frequently related to ventricular fibrillation (VF). Incidence and impact of VF among patients hospitalized for AMI were evaluated. METHODS AND RESULTS: Data from the FAST-MI programme consisting of 5 French nationwide prospective cohort studies between 1995 and 2015 were analysed, totally including 14 423 patients with AMI (66 ± 14 years, 72% males, 59% ST-elevation myocardial infarction). Overall, proportion of patients presenting in-hospital VF decreased from 3.9% in 1995 to 1.8% in 2015 (P < 0.001). One-year mortality decreased from 60.7% to 24.6% (P < 0.001). However, compared with patients who did not develop VF, the over-risk of 1-year mortality associated with VF was stable over time [hazard ratio (HR) 6.78, 95% confidence interval (CI) 5.03-9.14 in 1995 and HR 6.64, 95% CI 4.20-10.49 in 2015, P = 0.52]. This increased mortality in the VF group was mainly related to fatal events occurring prior to hospital discharge, representing 86.2% of 1-year mortality, despite the very low rate of implantable cardioverter defibrillator in the VF group (2.6%). CONCLUSION: This study demonstrates that in-hospital VF incidence and mortality in the setting of AMI have significantly decreased over the past 20 years. Nevertheless, VF remained steadily associated with approximately a 10-fold increased relative risk of in-hospital mortality, without an impact on post-discharge mortality. Beyond long-term cardiac defibrillation strategy, these results emphasize the need to identify in-hospital interventions to further reduce mortality in VF patients. STUDY REGISTRATION: ClinicalTrials.gov Identifier: NCT00673036, NCT01237418, NCT02566200.


Assuntos
Infarto do Miocárdio , Fibrilação Ventricular , Masculino , Humanos , Feminino , Fibrilação Ventricular/epidemiologia , Fibrilação Ventricular/etiologia , Fibrilação Ventricular/terapia , Estudos Prospectivos , Assistência ao Convalescente , Alta do Paciente , Infarto do Miocárdio/complicações , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/terapia , Fatores de Risco
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