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1.
Helicobacter ; 29(2): e13076, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38680067

RESUMEN

BACKGROUND: The systematic use of susceptibility testing and tailored first-line treatment for Helicobacter pylori eradication has yet to be established. AIM: To compare 14-day tailored PCR-guided triple therapy to 14-day non-Bismuth concomitant quadruple therapy for first-line Helicobacter pylori eradication. PATIENTS AND METHODS: We performed a multicenter, parallel-group, randomized noninferiority controlled trial. Naive adult patients with Helicobacter pylori infection were treated with 14-day tailored PCR-guided triple therapy (esomeprazole 40 mg and amoxicillin 1000 mg b.d. plus clarithromycin 500 mg or levofloxacin 500 mg b.d. according to clarithromycin susceptibility) or 14-day non-Bismuth concomitant quadruple therapy (esomeprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and metronidazole 500 mg b.d.). The primary endpoint was H. pylori eradication. RESULTS: We screened 991 patients for eligibility and randomized 241 patients. The first-line eradication rate was 99.2% in the tailored PCR-guided group and 95.9% in the control group (ITT population; absolute difference of +3.30%, with a lower bound of CI at -0.68%). Both first-line therapies were well tolerated, with a formally significant difference in favor of the tailored PCR-guided group (61.4% vs. 41.2%, p = 0.003). Economic analyses revealed a lower cost of the tailored PCR-guided arm, with a 92% chance of being jointly more effective and less expensive than the control arm in the ITT population. CONCLUSION: In a country with a high level of clarithromycin resistance, the results of our study demonstrated the noninferiority of 14-day tailored PCR-guided triple therapy as a first-line H. pylori eradication therapy compared to 14-day non-Bismuth quadruple therapy (ClinicalTrials.gov NCT02576236).


Asunto(s)
Antibacterianos , Claritromicina , Quimioterapia Combinada , Infecciones por Helicobacter , Helicobacter pylori , Humanos , Infecciones por Helicobacter/tratamiento farmacológico , Infecciones por Helicobacter/microbiología , Masculino , Femenino , Persona de Mediana Edad , Helicobacter pylori/efectos de los fármacos , Antibacterianos/uso terapéutico , Antibacterianos/administración & dosificación , Adulto , Claritromicina/uso terapéutico , Claritromicina/administración & dosificación , Reacción en Cadena de la Polimerasa/métodos , Amoxicilina/uso terapéutico , Amoxicilina/administración & dosificación , Anciano , Resultado del Tratamiento , Metronidazol/uso terapéutico , Metronidazol/administración & dosificación , Levofloxacino/uso terapéutico , Levofloxacino/administración & dosificación , Adulto Joven
2.
BMC Psychiatry ; 24(1): 215, 2024 Mar 19.
Artículo en Inglés | MEDLINE | ID: mdl-38504185

RESUMEN

BACKGROUND: With 11,558 deaths and 200,000 suicide attempts in 2019, France is among the European countries most affected. The aim of this study was to determine the costs and burden of suicides and suicide attempts in France (population 67 million). METHODS: We estimated direct costs, comprising healthcare, as well as post-mortem costs including autopsy, body removal, funeral expenses, police intervention and support groups; indirect costs comprised lost productivity, daily allowances; the burden of disease calculations used a monetary value for death and disability based on incidence data. Data was obtained from the national statistics, health and social care database, registries, global burden of disease, supplemented by expert opinion. We combined top down and bottom up approaches. RESULTS: The total costs and burden of suicides and suicide attempts was estimated at €18.5 billion and €5.4 billion, respectively. Direct costs were €566 million and €75 million; indirect costs were €3.8 billion and €3.5 billion; monetary value for death and disability was €14.6 billion and €1.3. The monetary value for death and disability represented 79.1% and 24.8% of total costs for suicide and suicide attempt respectively. Some costs were based upon expert opinion, caregivers' burden was not counted and pre COVID data only is reported. CONCLUSIONS: In France, the total cost and burden of suicides and suicide attempts was several billion €, suggesting major potential savings from public health interventions.


Asunto(s)
Costos de la Atención en Salud , Intento de Suicidio , Humanos , Costo de Enfermedad , Francia/epidemiología , Europa (Continente)/epidemiología
3.
BMJ Open ; 14(2): e083701, 2024 Feb 17.
Artículo en Inglés | MEDLINE | ID: mdl-38367972

RESUMEN

INTRODUCTION: The surveillance of hepatocellular carcinoma (HCC) using semi-annual liver ultrasound (US) is justified in patients with cirrhosis. In this context, US has a low sensitivity (<30%) for the detection of HCC at the very early stage (ie, Barcelona clinic liver cancer (BCLC) 0, uninodular tumour <2 cm). The sensitivity of abbreviated liver MRI (AMRI) is reported to exceed 80%, but its use is hampered by costs and availability. Our hypothesis is that AMRI used as a screening examination in patients at high risk of HCC (>3% per year) could increase the rates of patients with a tumour detected at an early stage accessible to curative-intent treatment, and demonstrate its cost-effectiveness in this population. METHODS AND ANALYSIS: The FASTRAK trial is a multicentre, randomised controlled trial with two parallel arms, aiming for superiority and conducted on patients at high risk for HCC (yearly HCC incidence >3%). Randomisation will be conducted on an individual basis with a centralised approach and stratification by centre. After inclusion in the trial, each patient will be randomly assigned to the experimental group (semi-annual US and AMRI) or the control group (semi-annual US alone). The main objective is to assess the cost/quality-adjusted life year and cost/patient detected with a BCLC 0 HCC in both arms. A total of 944 patients will be recruited in 37 tertiary French centres during a 36-month period and will be followed-up during 36 months. ETHICS AND DISSEMINATION: The FASTRAK trial received ethical approval on 4 April 2022. Results will be disseminated via publication in peer-reviewed journals as well as presentation at international conferences. TRIAL REGISTRATION NUMBER: Clinical trial number (ClinicaTrials.gov) NCT05095714.


Asunto(s)
Carcinoma Hepatocelular , Neoplasias Hepáticas , Humanos , Carcinoma Hepatocelular/diagnóstico por imagen , Carcinoma Hepatocelular/etiología , Neoplasias Hepáticas/diagnóstico por imagen , Neoplasias Hepáticas/etiología , Imagen por Resonancia Magnética/métodos , Cirrosis Hepática/complicaciones , Cirrosis Hepática/diagnóstico por imagen , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como Asunto
4.
Clin Genitourin Cancer ; 22(2): 295-304.e6, 2024 04.
Artículo en Inglés | MEDLINE | ID: mdl-38105152

RESUMEN

BACKGROUND: Treatment landscape for advanced renal cell carcinoma (aRCC) has evolved quickly and few data about the real-world treatment patterns are available. This study aimed at describing the real-world treatment patterns and effectiveness of all systemic treatments available for aRCC in first and second-line treatment. MATERIALS AND METHODS: A cohort of patients initiating a first-line systemic treatment for aRCC in 2016 was extracted from the French nationwide healthcare insurance system database (SNDS). The first-line treatment initiation date constituted the index date and patients were followed until death, loss to follow-up, or December 31, 2019, whichever occurred first. aRCC was identified using hospital diagnosis, long-term disease, or renal biopsy before index date. All analyses were performed for first and second-line treatment. Overall survival (OS) and time-to-next treatment or death (TNT-D) were estimated using Kaplan-Meier approach. RESULTS: In 2016, 1629 patients initiated a first-line treatment for aRCC. Most of them were male (75.9%) and the median age was 67 years. Most of patients (91.7%) had received a tyrosine kinase inhibitor as first-line treatment, mainly sunitinib (64.4%), and 53.5% received a second-line, among which 43.7% nivolumab. Median OS (95% confidence interval [CI]) was 20.7 (95% CI:18.2-22.4) months from first-line treatment initiation and 15.4 (13.9-17.5) months from second-line treatment initiation. Median TNT-D were respectively 9.3 (9.7-12.1) months and 6.9 (5.9-7.7) months. CONCLUSION: This study highlights the limited survival of aRCC patients These results provide a valuable baseline and highlight the need for innovation, such as immune checkpoint inhibitor-based combinations that have recently became first-line standard of care.


Asunto(s)
Carcinoma de Células Renales , Neoplasias Renales , Humanos , Masculino , Anciano , Femenino , Carcinoma de Células Renales/patología , Neoplasias Renales/tratamiento farmacológico , Resultado del Tratamiento , Estudios Retrospectivos , Sunitinib/uso terapéutico
5.
Eye (Lond) ; 38(10): 1917-1925, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38555401

RESUMEN

BACKGROUND/OBJECTIVES: Diabetic macular oedema (DMO) is a leading cause of blindness in developed countries, with significant disease burden associated with socio-economic deprivation. Distributional cost-effectiveness analysis (DCEA) allows evaluation of health equity impacts of interventions, estimation of how health outcomes and costs are distributed in the population, and assessments of potential trade-offs between health maximisation and equity. We conducted an aggregate DCEA to determine the equity impact of faricimab. METHODS: Data on health outcomes and costs were derived from a cost-effectiveness model of faricimab compared with ranibizumab, aflibercept and off-label bevacizumab using a societal perspective in the base case and a healthcare payer perspective in scenario analysis. Health gains and health opportunity costs were distributed across socio-economic subgroups. Health and equity impacts, measured using the Atkinson inequality index, were assessed visually on an equity-efficiency impact plane and combined into a measure of societal welfare. RESULTS: At an opportunity cost threshold of £20,000/quality-adjusted life year (QALY), faricimab displayed an increase in net health benefits against all comparators and was found to improve equity. The equity impact increased the greater the concerns for reducing health inequalities over maximising population health. Using a healthcare payer perspective, faricimab was equity improving in most scenarios. CONCLUSIONS: Long-acting therapies with fewer injections, such as faricimab, may reduce costs, improve health outcomes and increase health equity. Extended economic evaluation frameworks capturing additional value elements, such as DCEA, enable a more comprehensive valuation of interventions, which is of relevance to decision-makers, healthcare professionals and patients.


Asunto(s)
Inhibidores de la Angiogénesis , Análisis Costo-Beneficio , Retinopatía Diabética , Equidad en Salud , Edema Macular , Años de Vida Ajustados por Calidad de Vida , Ranibizumab , Proteínas Recombinantes de Fusión , Humanos , Retinopatía Diabética/tratamiento farmacológico , Retinopatía Diabética/economía , Edema Macular/tratamiento farmacológico , Edema Macular/economía , Inhibidores de la Angiogénesis/economía , Inhibidores de la Angiogénesis/uso terapéutico , Reino Unido , Equidad en Salud/economía , Proteínas Recombinantes de Fusión/economía , Proteínas Recombinantes de Fusión/uso terapéutico , Ranibizumab/economía , Ranibizumab/uso terapéutico , Ranibizumab/administración & dosificación , Masculino , Receptores de Factores de Crecimiento Endotelial Vascular/uso terapéutico , Inyecciones Intravítreas , Femenino , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Bevacizumab/economía , Bevacizumab/uso terapéutico , Costos de los Medicamentos , Persona de Mediana Edad , Análisis de Costo-Efectividad
6.
Open Heart ; 11(1)2024 Jan 19.
Artículo en Inglés | MEDLINE | ID: mdl-38242557

RESUMEN

BACKGROUND: In patients with distal bifurcation left main stem lesions requiring intervention, the European Bifurcation Club Left Main Coronary Stent Study trial found a non-significant difference in major adverse cardiac events (MACEs, composite of all-cause death, non-fatal myocardial infarction and target lesion revascularisation) favouring the stepwise provisional strategy, compared with the systematic dual stenting. AIMS: To estimate the 1-year cost-effectiveness of stepwise provisional versus systematic dual stenting strategies. METHODS: Costs in France and the UK, and MACE were calculated in both groups to estimate the incremental cost-effectiveness ratio (ICER). Uncertainty was explored by probabilistic bootstrapping. The analysis was conducted from the perspective of the healthcare provider with a time horizon of 1 year. RESULTS: The cost difference between the two groups was €-755 (€5700 in the stepwise provisional group and €6455 in the systematic dual stenting group, p value<0.01) in France and €-647 (€6728 and €7375, respectively, p value=0.08) in the UK. The point estimates for the ICERs found that stepwise provisional strategy was cost saving and improved outcomes with a probabilistic sensitivity analysis confirming dominance with an 80% probability. CONCLUSION: The stepwise provisional strategy at 1 year is dominant compared with the systematic dual stenting strategy on both economic and clinical outcomes.


Asunto(s)
Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Humanos , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/etiología , Análisis Costo-Beneficio , Intervención Coronaria Percutánea/efectos adversos , Resultado del Tratamiento , Factores de Tiempo , Stents
7.
J Gynecol Obstet Hum Reprod ; 53(9): 102821, 2024 Jul 20.
Artículo en Inglés | MEDLINE | ID: mdl-39038739

RESUMEN

BACKGROUND: Hysterectomy for benign pathologies is one of the most common gynecological surgeries. In recent years, robotic surgery has become an alternative to traditional surgery, but at a higher cost. OBJECTIVE: Estimate the cost of benign robot-assisted hysterectomy for the purpose of supporting public decision-making, as well as the additional cost per major postoperative complication (ClavienDindo score ≥ 3) avoided one month after surgery robotic versus traditional laparoscopic. METHODS: Single-center retrospective study including patients operated on for benign hysterectomy at La Pitié Salpêtrière hospital between January 2016 and December 2019: 99 by robotic approach, and 86 by laparoscopic approach. Comparison of robotic surgery to laparoscopy. Calculation of a cost-effectiveness ratio (ICER). Use of the propensity score inverse weighting method to ensure comparability of groups. RESULTS: Robotic surgery has a total cost of € 6,615 at 1 month per patient compared to € 3,859 for laparoscopic surgery with an additional cost of € 377,534 per major postoperative complication avoided, longer operating time and an absence of significant difference in terms of complications and length of hospitalization. CONCLUSION: In terms of cost-effectiveness, according to this study, the robot does not appear to be better than laparoscopy. In the years to come, we can expect a development of robotic surgery with rationalization of the practice, with appropriate selection of patients for robotic surgery, development of outpatient surgery and a reduction in the cost of the equipment.

8.
J Robot Surg ; 18(1): 124, 2024 Mar 16.
Artículo en Inglés | MEDLINE | ID: mdl-38492119

RESUMEN

Robotic-assisted thoracic surgery (RATS) is an effective treatment of non-small cell lung cancer (NSCLC) but the effects of its implementation in university hospital networks has not been described. We analyzed the early clinical outcomes, estimated costs, and revenues associated with three robotic systems implemented in the Paris Public Hospital network. A retrospective study included patients who underwent RATS for NSCLC in 2019 and 2020. Ninety-day morbidity, mortality, hospital costs, and hospital revenues were described. Economic analyses were conducted either from the hospital center or from the French health insurance system perspectives. Cost drivers were tested using univariate and multivariable analyses. Sensitivity analyses were performed to assess uncertainty over in-hospital length of stay (LOS), number of robotic surgeries per year, investment cost, operating room occupancy time, maintenance cost, and commercial discount. The study included 188 patients (65.8 ± 9.3 years; Charlson 4.1 ± 1.4; stage I 76.6%). Median in-hospital LOS was 6 days [5-9.5], 90-day mortality was 1.6%. Mean hospital expenses and revenues were €12,732 ± 4914 and €11,983 ± 5708 per patient, respectively. In multivariable analysis, factors associated with hospital costs were body mass index, DLCO, major complications, and transfer to intensive care unit. Sensitivity analyses showed that in-hospital LOS (€11,802-€15,010) and commercial discounts on the list price (€11,458-€12,732) had an important impact on costs. During the first 2 years following the installation of three robotic systems in Paris Public Hospitals, the clinical outcomes of RATS for NSCLC have been satisfactory. Without commercial discount, hospital expenses would have exceeded hospital revenues.Clinical registration number CNIL, N°2221601, CERC-SFCTCV-2021-07-20-Num17_MOPI_robolution.


Asunto(s)
Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Procedimientos Quirúrgicos Robotizados , Cirugía Torácica , Humanos , Procedimientos Quirúrgicos Robotizados/métodos , Carcinoma de Pulmón de Células no Pequeñas/cirugía , Estudios Retrospectivos , Neoplasias Pulmonares/cirugía , Tiempo de Internación , Hospitales Públicos
9.
Eur J Heart Fail ; 26(5): 1201-1214, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38450858

RESUMEN

AIMS: Evaluating the benefit of telemonitoring in heart failure (HF) management in real-world settings is crucial for optimizing the healthcare pathway. The aim of this study was to assess the association between a 6-month application of the telemonitoring solution Chronic Care Connect™ (CCC) and mortality, HF hospitalizations, and associated costs compared with standard of care (SOC) in patients with a diagnosis of HF. METHODS AND RESULTS: From February 2018 to March 2020, a retrospective cohort study was conducted using the largest healthcare insurance system claims database in France (Système National des Données de Santé) linked to the CCC telemonitoring database of adult patients with an ICD-10-coded diagnosis of HF. Patients from the telemonitoring group were matched with up to two patients from the SOC group based on their high-dimensional propensity score, without replacement, using the nearest-neighbour method. A total of 1358 telemonitored patients were matched to 2456 SOC patients. The cohorts consisted of high-risk patients with median times from last HF hospitalization to index date of 17.0 (interquartile range: 7.0-66.0) days for the telemonitoring group and 27.0 (15.0-70.0) days for the SOC group. After 6 months, telemonitoring was associated with mortality risk reduction (hazard ratio [HR] 0.71, 95% confidence interval [CI] 0.56-0.89), a higher risk of first HF hospitalization (HR 1.81, 95% CI 1.55-2.13), and higher HF healthcare costs (relative cost 1.38, 95% CI 1.26-1.51). Compared with the SOC group, the telemonitoring group experienced a shorter average length of overnight HF hospitalization and fewer emergency visits preceding HF hospitalizations. CONCLUSION: The results of this nationwide cohort study highlight a valuable role for telemonitoring solutions such as CCC in the management of high-risk HF patients. However, for telemonitoring solutions based on weight and symptoms, consideration should be given to implement additional methods of assessment to recognize imminent worsening of HF, such as impedance changes, as a way to reduce mortality risk and the need for HF hospitalizations. Further studies are warranted to refine selection of patients who could benefit from a telemonitoring system and to confirm long-term benefits in high-risk and stable HF patients.


Asunto(s)
Insuficiencia Cardíaca , Hospitalización , Telemedicina , Humanos , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/mortalidad , Femenino , Masculino , Hospitalización/estadística & datos numéricos , Anciano , Estudios Retrospectivos , Francia/epidemiología , Nivel de Atención , Persona de Mediana Edad
10.
Trials ; 25(1): 273, 2024 Apr 22.
Artículo en Inglés | MEDLINE | ID: mdl-38649937

RESUMEN

BACKGROUND: Macular edema (ME) results from hyperpermeability of retinal vessels, leading to chronic extravasation of plasma components into the retina and hence potentially severe visual acuity loss. Current standard of care consists in using intravitreal injections (IVI), which results in a significant medical and economic burden. During diabetic retinopathy (DR) or retinal vein occlusion (RVO), it has recently been shown that focal vascular anomalies (capillary macro-aneurysms, also termed TelCaps) for telangiectatic capillaries may play a central role in the onset, early recurrence, and/or persistence of ME. Since targeted photocoagulation of TelCaps may improve vision, identification, and photocoagulation of TelCaps, it may represent a way to improve management of ME. OBJECTIVE: The Targeted Laser in (Diabetic) Macular Edema (TalaDME) study aims to evaluate whether ICG-guided targeted laser (IGTL), in association with standard of care by IVI, allows reducing the number of injections during the first year of treatment compared with IVI only, while remaining non-inferior for visual acuity. METHODS: TalaDME is a French, multicentric, two-arms, randomized, sham laser-controlled, double-masked trial evaluating the effect of photocoagulation of TelCaps combined to IVI in patients with ME associated with TelCaps. Patients with vision loss related to center involved ME secondary to RVO or DR and presenting TelCaps are eligible. Two hundred and seventy eyes of 270 patients are randomized in a 1:1 ratio to standard care, i.e., IVI of anti-VEGF solely (control group) or combined with IGTL therapy (experimental group). Stratification is done on the cause of ME (i.e., RVO versus diabetes). Anti-VEGF IVI are administered to both groups monthly for 3 months (loading dose) and then with a pro re nata regimen with a monthly follow-up for 12 months. The primary endpoint will be the number of IVI and the change in visual acuity from baseline to 12 months. Secondary endpoints will be the changes in central macular thickness, impact on quality of life, cost of treatment, and incremental cost-utility ratio in each groups. KEY SAFETY: Rare but severe AE linked to the use of IVI and laser, and previously described, are expected. In the sham group, rescue laser photocoagulation may be administered by the unmasked investigator if deemed necessary at month 3. DISCUSSION: The best management of ME associated with TelCaps is debated, and there have been no randomized study designed to answer this question. Given the fact that TelCaps may affect 30 to 60% of patients with chronic ME due to DR or RVO, a large number of patients could benefit from a specific management of TelCaps. TalaDME aims to establish the clinical and medico-economic benefits of additional targeted laser. The results of TalaDME may raise new recommendations for managing ME and impact healthcare costs. TRIAL REGISTRATION: EudraCT: 2018-A00800-55/ NCT03751501. Registration date: Nov. 23, 2018.


Asunto(s)
Inhibidores de la Angiogénesis , Retinopatía Diabética , Coagulación con Láser , Edema Macular , Oclusión de la Vena Retiniana , Factor A de Crecimiento Endotelial Vascular , Agudeza Visual , Humanos , Edema Macular/etiología , Edema Macular/tratamiento farmacológico , Edema Macular/cirugía , Oclusión de la Vena Retiniana/tratamiento farmacológico , Oclusión de la Vena Retiniana/complicaciones , Retinopatía Diabética/tratamiento farmacológico , Coagulación con Láser/métodos , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Inhibidores de la Angiogénesis/administración & dosificación , Inhibidores de la Angiogénesis/efectos adversos , Inhibidores de la Angiogénesis/uso terapéutico , Francia , Resultado del Tratamiento , Estudios Multicéntricos como Asunto , Inyecciones Intravítreas , Factores de Tiempo , Estudios de Equivalencia como Asunto , Terapia Combinada
11.
Am J Cardiovasc Drugs ; 24(1): 117-127, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-38153624

RESUMEN

BACKGROUND: Rivaroxaban 2.5 mg twice daily with aspirin 100 mg daily was shown to be better than aspirin 100 mg daily for preventing cardiovascular (CV) death, stroke or myocardial infarction in patients with either stable coronary artery disease (CAD) or peripheral artery disease (PAD). The cost-effectiveness of this regimen in this population is essential for decision-makers to know. METHODS: US direct healthcare system costs (in USD) were applied to hospitalized events, procedures and study drugs utilized by all patients. We determined the mean cost per participant for the full duration of the trial (mean follow-up of 23 months) plus quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER) over a lifetime using a two-state Markov model with 1-year cycle length. Sensitivity analyses were performed on the price of rivaroxaban and the annual discontinuation rate. RESULTS: The costs of events and procedures were reduced for Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) patients who received rivaroxaban 2.5 mg orally (BID) plus acetylsalicylic acid (ASA) compared with ASA alone. Total costs were higher for the combination group ($7426 versus $4173) after considering acquisition costs of the study drug. Over a lifetime, patients receiving rivaroxaban plus ASA incurred $27,255 more and gained 1.17 QALYs compared with those receiving ASA alone resulting in an ICER of $23,295/QALY. ICERs for PAD only and polyvascular disease subgroups were lower. CONCLUSION: Rivaroxaban 2.5 mg BID plus ASA compared with ASA alone was cost-effective (high value) in the USA. COMPASS ClinicalTrials.gov identifier: NCT01776424.


Asunto(s)
Aspirina , Infarto del Miocardio , Enfermedad Arterial Periférica , Rivaroxabán , Humanos , Aspirina/economía , Aspirina/uso terapéutico , Análisis Costo-Beneficio , Quimioterapia Combinada , Inhibidores del Factor Xa , Infarto del Miocardio/prevención & control , Enfermedad Arterial Periférica/tratamiento farmacológico , Rivaroxabán/economía , Rivaroxabán/uso terapéutico , Accidente Cerebrovascular/prevención & control
12.
Arch Cardiovasc Dis ; 117(6-7): 417-426, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38821761

RESUMEN

BACKGROUND: Despite major advances in prevention and treatment, cardiovascular diseases - particularly acute myocardial infarction - remain a leading cause of death worldwide and in France. Collecting contemporary data about the characteristics, management and outcomes of patients with acute myocardial infarction in France is important. AIMS: The main objectives are to describe baseline characteristics, contemporary management, in-hospital and long-term outcomes of patients with acute myocardial infarction hospitalized in tertiary care centres in France; secondary objectives are to investigate determinants of prognosis (including periodontal disease and sleep-disordered breathing), to identify gaps between evidence-based recommendations and management and to assess medical care costs for the index hospitalization and during the follow-up period. METHODS: FRENCHIE (FRENch CoHort of myocardial Infarction Evaluation) is an ongoing prospective multicentre observational study (ClinicalTrials.gov Identifier: NCT04050956) enrolling more than 19,000 patients hospitalized for acute myocardial infarction with onset of symptoms within 48hours in 35 participating centres in France since March 2019. Main exclusion criteria are age<18 years, lack of health coverage and procedure-related myocardial infarction (types 4a and 5). Detailed information was collected prospectively, starting at admission, including demographic data, risk factors, medical history and treatments, initial management, with prehospital care pathways and medication doses, and outcomes until hospital discharge. The follow-up period (up to 20 years for each patient) is ensured by linking with the French national health database (Système national des données de santé), and includes information on death, hospital admissions, major clinical events, healthcare consumption (including drug reimbursement) and total healthcare costs. FRENCHIE is also used as a platform for cohort-nested studies - currently three randomized trials and two observational studies. CONCLUSIONS: This nationwide large contemporary cohort with very long-term follow-up will improve knowledge about acute myocardial infarction management and outcomes in France, and provide a useful platform for nested studies and trials.


Asunto(s)
Infarto del Miocardio , Proyectos de Investigación , Humanos , Infarto del Miocardio/terapia , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/mortalidad , Infarto del Miocardio/economía , Infarto del Miocardio/epidemiología , Francia/epidemiología , Estudios Prospectivos , Factores de Tiempo , Resultado del Tratamiento , Factores de Riesgo , Femenino , Masculino , Anciano , Mortalidad Hospitalaria , Estudios Multicéntricos como Asunto , Persona de Mediana Edad , Costos de Hospital
13.
Circ Cardiovasc Interv ; 17(6): e013913, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38785084

RESUMEN

BACKGROUND: In patients with multivessel disease with successful primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction, the FLOWER-MI trial (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) showed that a fractional flow reserve (FFR)-guided strategy was not superior to an angiography-guided strategy for treatment of noninfarct-related artery lesions regarding the 1-year risk of death from any cause, myocardial infarction, or unplanned hospitalization leading to urgent revascularization. The extension phase of the trial was planned using the same primary outcome to determine whether a difference in outcomes would be observed with a longer follow-up. METHODS: In this multicenter trial, we randomly assigned patients with ST-segment-elevation myocardial infarction and multivessel disease with successful percutaneous coronary intervention of the infarct-related artery to receive complete revascularization guided by either FFR (n=586) or angiography (n=577). RESULTS: After 3 years, a primary outcome event occurred in 52 of 498 patients (9.40%) in the FFR-guided group and in 44 of 502 patients (8.17%) in the angiography-guided group (hazard ratio, 1.19 [95% CI, 0.79-1.77]; P=0.4). Death occurred in 22 patients (4.00%) in the FFR-guided group and in 23 (4.32%) in the angiography-guided group (hazard ratio, 0.96 [95% CI, 0.53-1.71]); nonfatal myocardial infarction in 23 (4.13%) and 14 (2.56%), respectively (hazard ratio, 1.63 [95% CI, 0.84-3.16]); and unplanned hospitalization leading to urgent revascularization in 21 (3.83%) and 18 (3.36%; hazard ratio, 1.15 [95% CI, 0.61-2.16]), respectively. CONCLUSIONS: Although event rates in the trial were lower than expected, in patients with ST-segment-elevation myocardial infarction undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization up to 3 years. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02943954.


Asunto(s)
Angiografía Coronaria , Reserva del Flujo Fraccional Miocárdico , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Humanos , Masculino , Femenino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Anciano , Resultado del Tratamiento , Infarto del Miocardio con Elevación del ST/mortalidad , Infarto del Miocardio con Elevación del ST/terapia , Infarto del Miocardio con Elevación del ST/fisiopatología , Infarto del Miocardio con Elevación del ST/diagnóstico por imagen , Infarto del Miocardio con Elevación del ST/diagnóstico , Factores de Tiempo , Factores de Riesgo , Valor Predictivo de las Pruebas , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/fisiopatología , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Cateterismo Cardíaco/efectos adversos
17.
Emergencias (Sant Vicenç dels Horts) ; 33(4): 292-298, ag. 2021. ilus, tab, graf
Artículo en Español | IBECS (España) | ID: ibc-216190

RESUMEN

Objetivos. Determinar la eficacia de un protocolo de asesoramiento médico telefónico formalizado (AMTF), realizado por un médico para consultas, para fiebre o gastroenteritis en centros de comunicación médica de emergencia. Método. Ensayo clínico por conglomerado, controlado. Los pacientes fueron aleatorizados al grupo AMTF o al grupo de atención habitual. Participaron 6 centros de comunicación médica de emergencia franceses. Se incluyeron pacientes que solicitaban asistencia telefónica por fiebre o gastroenteritis. El grupo ATMF realizó recomendaciones protocolizadas sobre el manejo terapéutico. Se valoró el número de consultas presenciales o ingreso hospitalario durante los 15 días siguientes a la consulta. También se evaluó la satisfacción del paciente y el coste económico. Resultados. Se incluyeron 2.498 llamadas. El grupo ATMF (n = 1.234) tuvo un riesgo relativo de 0,70 (CI 95% 0,58 a 0,85) de requerir un ingreso hospitalario o de realizar una consulta no programada durante el seguimiento. No hubo diferencias entre los dos grupos en cuanto al uso de ambulancia, el ingreso en cuidados intensivos, la mortalidad o morbilidad y la mejoría de los síntomas. La satisfacción de los pacientes fue del 90%. El coste total fue de 91 euros en el grupo de la ATMF y de 150 euros en el grupo de atención habitual (p < 0,01). Conclusiones. El grupo ATMF se asoció con una disminución de las consultas presenciales no programadas o del ingreso en el hospital. Este procedimiento es seguro y comporta un menor coste que la atención que se realiza habitualmente en la actualidad. (AU)


Objectives: To determine the efficacy of emergency medical center physicians' use of a protocol to guide their management of telephone consultations for fever and gastroenteritis. Material and methods: Cluster randomized controlled trial. Participating centers were randomized to use the telephone protocol or provide usual telephone assistance. Six emergency centers in France included calls from patients needing advice on fever or gastroenteritis. Centers assigned to the protocol followed specific guidelines on managing the call and giving advice on treatment. Primary endpoints were the number of in-person visits and hospital admissions required within 15 days of the call. Secondary endpoints were patient satisfaction and costs. Results: A total of 2498 calls were included. Use of the assigned protocol while attending 1234 calls was associated with a relative risk for hospitalization or an unscheduled in-person visit for care of 0.70 (95% CI, 0.58-0.85) versus usual practice. Ambulance use, admission to an intensive care unit, mortality, morbidity, and symptom improvement did not differ significantly between centers using the protocol and those following usual practice. Ninety percent of the patients were satisfied. The cost of care was €91 in centers applying the protocol and €150 in the other centers (P .01). Conclusion: Use of the protocol was associated with fewer unscheduled in-person visits for care and fewer hospital admissions. The protocol is safe and less costly than the centers' usual approaches to giving telephone advice. (AU)


Asunto(s)
Humanos , Servicio de Urgencia en Hospital , Fiebre/terapia , Gastroenteritis/terapia , Protocolos Clínicos , Teléfono
18.
Health Systems in Transition, vol. 17 (3)
Artículo en Inglés | WHOLIS | ID: who-330253

RESUMEN

This analysis of the French health system reviews recent developmentsin organization and governance, health financing, health care provision,health reforms and health system performance. The French populationhas a good level of health, with the second highest life expectancy in theworld for women. It has a high level of choice of providers, and a high level ofsatisfaction with the health system. However, unhealthy habits such as smokingand harmful alcohol consumption remain significant causes of avoidablemortality. Combined with the significant burden of chronic diseases, this hasunderscored the need for prevention and integration of services, although thesehave not historically been strengths of the French system.Although the French health care system is a social insurance system, ithas historically had a stronger role for the state than other Bismarckian socialinsurance systems. Public financing of health care expenditure is amongthe highest in Europe and out-of-pocket spending among the lowest. Publicinsurance is compulsory and covers the resident population; it is financed byemployee and employer contributions as well as increasingly through taxation.Complementary insurance plays a significant role in ensuring equity in access.Provision is mixed; providers of outpatient care are largely private, and hospitalbeds are predominantly public or private non-profit-making.Despite health outcomes being among the best in the European Union, socialand geographical health inequities remain. Inequality in the distribution ofhealth care professionals is a considerable barrier to equity. The rising cost ofhealth care and the increasing demand for long-term care are also of concern.Reforms are ongoing to address these issues, while striving for equity infinancial access; a long-term care reform including public coverage of long-termcare is still pending.


Asunto(s)
Atención a la Salud , Estudio de Evaluación , Financiación de la Atención de la Salud , Reforma de la Atención de Salud , Planes de Sistemas de Salud , Francia
19.
Health Systems in Transition, vol. 12 (6)
Artículo en Inglés | WHOLIS | ID: who-330330

RESUMEN

The Health Systems in Transition (HiT) country profiles provide an analytical description of each health system and of policy initiatives in progress or under development. They aim to provide relevant comparative information to support policy-makers and analysts in the development of health systems and reforms in the countries of the WHO European Region and beyond. The HiT profiles are building blocks that can be used: to learn in detail about different approaches to the financing, organization and delivery of health services; to describe accurately the process, content and implementation of health reform programmes; to highlight common challenges and areas that require more in-depth analysis; and to provide a tool for the dissemination of information on health systems and the exchange of experiences of reform strategies between policy-makers and analysts in countries of the WHO European Region. This series is an ongoing initiative and material is updated at regular intervals.


Asunto(s)
Atención a la Salud , Estudio de Evaluación , Financiación de la Atención de la Salud , Reforma de la Atención de Salud , Planes de Sistemas de Salud , Francia
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