The safety profile of mesenchymal stem cell therapy administered through intrathecal injections for treating neurological disorders: a systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Based on previous in vivo studies and human trials, intrathecal cell delivery is a safe and relevant therapeutic tool for improving patient's quality of life with neurological conditions. We aimed to characterise the safety profile of intrathecally delivered Mesenchymal stem cells (MSCs). METHODS: Ovid MEDLINE, Embase, Scopus, Cochrane Library, KCI-Korean Journal Database, and Web of Science. Databases were searched from their inception until April 13, 2023. Randomised Controlled Trials (RCTs) that compared intrathecal delivery of MSCs to controls in adult populations were included. Adverse events (AEs) were pooled and meta-analysed using DerSimonian-Laird random effects models with a correction factor 0.5 added to studies with zero count cells. Pooled AEs were described using Risk ratio (RR) and 95% confidence intervals (95% CI). Then, a random-effects meta-regress model on study-level summary data was performed to explore the relationship between the occurrence of AEs and covariates thought to modify the overall effect estimate. Finally, publication bias was assessed. RESULTS: 303 records were reviewed, and nine RCTs met the inclusion criteria and were included in the quantitative synthesis (n = 540 patients). MSCs delivered intrathecally, as compared to controls, were associated with an increased probability of AEs of musculoskeletal and connective tissue disorders (categorised by Common Terminology Criteria for Adverse Events-CTCAE version 5.0) (RR: 1.61, 95% CI 1.19-2.19, I2 = 0%). The random-effects meta-regress model suggested that fresh MSCs increased the probability of occurrence of AEs compared to cryopreserved MSCs (RR: 1.554; p-value = 0.048; 95% CI 1.004-2.404), and the multiple-dose, decreased the probability of AEs by 36% compared to single doses (RR: 0.644; p-value = 0.048; 95% CI 0.416-0.996); however, univariate random effects meta-regression models revealed a not significant association between the occurrence of AEs from MSCs intrathecal delivery and each covariate. CONCLUSIONS: Intrathecal delivery of MSCs was associated with a slight increase in AEs associated with musculoskeletal and connective tissue disorders, albeit without serious AEs. We conclude that intrathecal MSCs delivery is safe for patients with neurological conditions. However, further high-quality, large-scale RCTs are needed to confirm these findings.

Increased incidence of rheumatoid arthritis after COVID-19.

An increase in the incidence of inflammatory arthritis after COVID-19 has been reported. Since many diseases exhibit population-specific causal effect sizes, we aimed to evaluate the incidence trends of inflammatory arthritis, including rheumatoid arthritis (RA), after COVID-19 in a large admixed Colombian population. Data analysis for this retrospective, population-based cohort study was carried out using the COOSALUD EPS registry. The following codes were selected for analyses: M059, seropositive RA, M069, unspecified RA, M060 seronegative RA, and other RA-related diagnoses: M064, M139, M068, M058, M130 and M053. The study period was limited to January 01, 2018, through December 31, 2022. Incidence rates (IRs) and incidence rate ratios (IRRs) were assessed. A Cox survival model was built to evaluate the influence of age, gender, and COVID-19 vaccination status on the development of inflammatory arthritis. A bioinformatic analysis was performed to evaluate the homology between SARS-CoV-2 and autoantigen peptides related to RA. The entire population study comprised 3,335,084 individuals. During the pandemic period (2020-2022) the total IIR for seropositive and unspecified RA were 1.60 (95% CI, 1.16-2.22) and 2.93 (95% CI, 2.04-4.19), respectively, and the IIR for overall RA-related diagnosis was 2.01 (95% CI 1.59-2.53). The age groups hazard ratios (HRs) were increased until the age group of 51-60 years (HR: 9.16; 95% CI, 7.24-11.59) and then decreased slightly in the age group 61 years or older (HR: 5.364; 95% CI, 4.24-6.78) compared to those within 18-30 years. Men were less at risk than women to develop inflammatory arthritis (HR: 0.21; 95% CI, 0.18-0.24). The greater time since COVID-19 diagnosis was associated with a lower likelihood of developing inflammatory arthritis (HR: 0.99; 95% CI:0.998-0.999). Vaccination (all types of COVID-19 vaccines included) did not prevent the development of inflammatory arthritis after COVID-19. Low identity was found between the SARS-CoV-2 ORF1ab antigen and the human antigens Poly ADP-ribose polymerase 14 and Protein mono-ADP-ribosyltransferase PARP9 isoform D (39% and 29%, respectively). In conclusion, our study confirms increased incidence of inflammatory arthritis, including RA, after COVID-19, with the greatest increase occurring before the first year post-covid. Women in their fifties were more susceptible. Further research is required to examine the effectiveness of vaccination in preventing post-COVID inflammatory arthritis and the mechanisms implicated in the development of RA after COVID-19.

Mortality and clinical characteristics of multisystem inflammatory syndrome in children (MIS-C) associated with covid-19 in critically ill patients: an observational multicenter study (MISCO study).

BACKGROUND: The clinical presentation and severity of Multisystem Inflammatory Syndrome in Children associated with COVID-19 (MIS-C) is widespread and presents a very low mortality rate in high-income countries. This research describes the clinical characteristics of MIS-C in critically ill children in middle-income countries and the factors associated with the rate of mortality and patients with critical outcomes. METHODS: An observational cohort study was conducted in 14 pediatric intensive care units (PICUs) in Colombia between April 01, 2020, and January 31, 2021. Patient age ranged between one month and 18 years, and each patient met the requirements set forth by the World Health Organization (WHO) for MIS-C. RESULTS: There were seventy-eight children in this study. The median age was seven years (IQR 1-11), 18 % (14/78) were under one year old, and 56 % were male. 35 % of patients (29/78) were obese or overweight. The PICU stay per individual was six days (IQR 4-7), and 100 % had a fever upon arrival to the clinic lasting at least five days (IQR 3.7-6). 70 % (55/78) of patients had diarrhea, and 87 % (68/78) had shock or systolic myocardial dysfunction (78 %). Coronary aneurysms were found in 35 % (27/78) of cases, and pericardial effusion was found in 36 %. When compared to existing data in high-income countries, there was a higher mortality rate observed (9 % vs. 1.8 %; p=0.001). When assessing the group of patients that did not survive, a higher frequency of ferritin levels was found, above 500 ngr/mL (100 % vs. 45 %; p=0.012), as well as more cardiovascular complications (100 % vs. 54 %; p = 0.019) when compared to the group that survived. The main treatments received were immunoglobulin (91 %), vasoactive support (76 %), steroids (70.5 %) and antiplatelets (44 %). CONCLUSIONS: Multisystem Inflammatory Syndrome in Children due to SARS-CoV-2 in critically ill children living in a middle-income country has some clinical, laboratory, and echocardiographic characteristics similar to those described in high-income countries. The observed inflammatory response and cardiovascular involvement were conditions that, added to the later presentation, may explain the higher mortality seen in these children.

[High frequency of endoluminal thrombus in patients with ischaemic stroke following COVID-19]. / Alta Frecuencia de Trombo Endoluminal en pacientes con ictus isquémico tras la infección por Coronavirus 2019.

BACKGROUND: Ischaemic stroke may be a major complication of SARS-CoV-2 infection.Studying and characterising the different aetiological subtypes, clinical characteristics, and functional outcomes may be valuable in guiding patient selection for optimal management and treatment. METHODS: Data were collected retrospectively on consecutive patients with COVID-19 who developed acute focal brain ischaemia (between 1 March and 19 April 2020) at a tertiary university hospital in Madrid (Spain). RESULTS: During the study period, 1594 patients were diagnosed with COVID-19. We found 22 patients with ischaemic stroke (1.38%), 6 of whom did not meet the inclusion criteria. The remaining 16 patients were included in the study (15 cases of ischaemic stroke and one case of transient ischaemic attack).Median baseline National Institutes of Health Stroke Scale score was 9 (interquartile range: 16), and mean (standard deviation) age was 73 years (12.8). Twelve patients (75%) were men. Mean time from COVID-19 symptom onset to stroke onset was 13 days. Large vessel occlusion was identified in 12 patients (75%).We detected elevated levels of D-dimer in 87.5% of patients and C-reactive protein in 81.2%. The main aetiology was atherothrombotic stroke (9 patients, 56.3%), with the predominant subtype being endoluminal thrombus (5 patients, 31.2%), involving the internal carotid artery in 4 cases and the aortic arch in one. The mortality rate in our series was 44% (7 of 16 patients). CONCLUSIONS: In patients with COVID-19, the most frequent stroke aetiology was atherothrombosis, with a high proportion of endoluminal thrombus (31.2% of patients). Our clinical and laboratory data support COVID-19-associated coagulopathy as a relevant pathophysiological mechanism for ischaemic stroke in these patients.

COVID-19 convalescent plasma composition and immunological effects in severe patients.

Convalescent plasma (CP) has emerged as a treatment for COVID-19. However, the composition and mechanism of action are not fully known. Therefore, we undertook a two-phase controlled study in which, first the immunological and metabolomic status of recovered and severe patients were evaluated. Secondly, the 28-day effect of CP on the immune response in severe patients was assessed. Nineteen recovered COVID-19 patients, 18 hospitalized patients with severe disease, and 16 pre-pandemic controls were included. Patients with severe disease were treated with CP transfusion and standard therapy (i.e., plasma recipients, n = 9) or standard therapy alone (n = 9). Clinical and biological assessments were done on day 0 and during follow-up on days 4, 7, 14, and 28. Clinical parameters, viral load, total immunoglobulin (Ig) G and IgA anti-S1-SARS-CoV-2 antibodies, neutralizing antibodies (NAbs), autoantibodies, cytokines, T and B cells, and metabolomic and lipidomic profiles were examined. Total IgG and IgA anti-S1-SARS-CoV-2 antibodies were key factors for CP selection and correlated with NAbs. In severe COVID-19 patients, mostly interleukin (IL)-6 (P = <0.0001), IL-10 (P = <0.0001), IP-10 (P = <0.0001), fatty acyls and glycerophospholipids were higher than in recovered patients. Latent autoimmunity and anti-IFN-α antibodies were observed in both recovered and severe patients. COVID-19 CP induced an early but transient cytokine profile modification and increases IgG anti-S1-SARS-CoV-2 antibodies. At day 28 post-transfusion, a decrease in activated, effector and effector memory CD4+ (P < 0.05) and activated and effector CD8+ (P < 0.01) T cells and naïve B cells (P = 0.001), and an increase in non-classical memory B cells (P=<0.0001) and central memory CD4+ T cells (P = 0.0252) were observed. Moreover, IL-6/IFN-γ (P = 0.0089) and IL-6/IL-10 (P = 0.0180) ratios decreased in plasma recipients compared to those who received standard therapy alone. These results may have therapeutic implications and justify further post-COVID-19 studies.

Facial growth changes in a Colombian Mestizo population: An 18-year follow-up longitudinal study using linear mixed models.

INTRODUCTION: Currently, a standard of reference for longitudinal facial growth parameters for South American mestizos is lacking. Therefore, in this study, we describe an 18-year follow-up of craniofacial growth from 6 to 24 years of age in a Colombian mestizo population, and an analysis of facial growth beyond 18 years of age. METHODS: This 18-year follow-up longitudinal study was conducted in Medellín, Colombia. The study sample consisted of 49 mestizo subjects with normal facial features and no history of orthodontic treatment. Measurements of cranial base length, maxillary and mandibular length, posterior and anterior facial height, lower anterior facial height, and mandibular plane angle were documented at an X-ray magnification of 10%. Data were subjected to linear mixed model analysis. RESULTS: Changes in cephalometric measurements were detected during the 18-year follow-up and were significantly affected by age and sex. Pubertal growth spurts were between 12 and 14 years for females, and between 14 and 16 years of age for males. Mandibular plane angle decreased in both females and males during the 18-year follow-up. CONCLUSIONS: Age and sex significantly affect craniofacial growth in mestizos in Columbia. Beyond 18 years of age, craniofacial growth is important. Our data do not support sexual dimorphism in mandibular rotation in young adults.

Evaluación de la costo-efectividad de un modelo integral de tratamiento ambulatorio en pacientes con síndrome coronario agudo: aplicación de un modelo de Markov probabilístico

[RESUMEN]. Objetivo. Evaluar la costo-efectividad de un modelo integral de tratamiento ambulatorio en pacientes que presentaron un síndrome coronario agudo. Métodos. Se realizó una evaluación económica a partir de un estudio de intervención cuasi-experimental, que incluyó 442 pacientes con edades entre 30 y 70 años, quienes presentaron un síndrome coronario agudo. El grupo de intervención (n = 165) recibió un modelo integral de tratamiento ambulatorio fundamentado en el cuidado gestionado (disease management), mientras que el grupo control (n = 277) recibió rehabilitación cardiovascular convencional. Durante un año de seguimiento, se evaluó la presentación de reeventos cardiovasculares y hospitalizaciones. Se desarrolló un modelo de Markov probabilístico. La perspectiva de estudio se aplicó dentro del Sistema General de Seguridad Social en Salud Colombiano, incluidos los costos sanitarios directos; el horizonte temporal fue de 50 años con descuentos de 3,42% para costos y efectividades; y la medida de efectividad fue los años de vida ganados ajustados por calidad. Se realizó un análisis de sensibilidad probabilístico y multivariante mediante de la simulación de Montecarlo. Resultados. Durante el año de seguimiento, los costos directos relacionados con el valor pagado fueron en promedio de USD 2 577 para el grupo control y USD 2 245 para el grupo de intervención. En el análisis de sensibilidad probabilístico, 91,3% de las simulaciones se ubicaron en el cuadrante correspondiente a costos incrementales negativos y efectividades incrementales positivas (intervención evaluada de menor costo, más efectiva). En las simulaciones, se observó un ahorro promedio anual por paciente de USD 1 215 por cada año de vida ganado ajustado por calidad. Conclusiones. El modelo integral de tratamiento ambulatorio implementado en pacientes que sufrieron un síndrome coronario agudo mostró ser menos costoso y más efectivo en comparación con el cuidado convencional. Por ser una alternativa dominante, se recomienda como modelo de cuidado en esta población.

[ABSTRACT]. Objective. To evaluate the cost-effectiveness of an integral model of ambulatory treatment in patients who presented an acute coronary syndrome. Methods. An economic evaluation was made from a quasi-experimental intervention study, which included 442 patients aged 30 to 70 years who presented an acute coronary syndrome. The intervention group (n = 165) received an integral model of ambulatory treatment based on managed care (disease management), while the control group (n = 277) received conventional cardiovascular rehabilitation. During one year of follow-up, the presentation of cardiovascular events and hospitalizations was evaluated. A probabilistic Markov model was developed. The study perspective was applied within the General System of Health Social Security in Colombia, including the direct health costs; the time horizon was 50 years with discounts of 3.42% for costs and effectiveness; and the measure of effectiveness was quality-adjusted life years (QALYs). A probabilistic and multivariate sensitivity analysis was performed using the Montecarlo simulation. Results. During the year of follow-up, the direct costs related to the value paid were, on average, USD 2 577 for the control group and USD 2 245 for the intervention group. In the probabilistic sensitivity analysis, 91.3% of the simulations were located in the quadrant corresponding to incremental negative costs and positive incremental effectiveness (evaluated intervention at a lower cost, more effective). In the simulations, an average annual savings per patient of USD 1 215 per QALY was observed. Conclusions. The integral model of ambulatory treatment implemented in patients who suffered an acute coronary syndrome was found to be less expensive and more effective compared to conventional care. Considering it is a dominant alternative, it is recommended as a model of care in this population.

[RESUMO]. Objetivo. Avaliar a relação custo-eficácia de um modelo integral de tratamento ambulatorial em pacientes que apresentaram síndrome coronariana aguda. Métodos. Uma avaliação econômica foi feita a partir de um estudo de intervenção quase experimental, que incluiu 442 pacientes com idade entre 30 a 70 anos que apresentaram síndrome coronariana aguda. O grupo de intervenção (n = 165) recebeu um modelo integral de tratamento ambulatorial com base em cuidados gerenciados (gerenciamento de doenças), enquanto o grupo controle (n = 277) recebeu reabilitação cardiovascular convencional. Durante um ano de acompanhamento, foi avaliada a apresentação de eventos cardiovasculares e hospitalizações. Um modelo probabilístico de Markov foi desenvolvido. A perspectiva do estudo foi aplicada no Sistema Geral de Segurança Social na Saúde da Colômbia, incluindo os custos diretos de saúde; o horizonte temporal foi de 50 anos com descontos de 3,42% em custos e efetividade; e a medida de eficácia foi os anos de vida ajustados pela qualidade (QALY). Uma análise de sensibilidade probabilística e multivariada foi realizada utilizando a simulação de Montecarlo. Resultados. Durante o ano de acompanhamento, os custos diretos relacionados ao valor pago foram, em média, USD 2 577 para o grupo controle e USD 2 245 para o grupo de intervenção. Na análise de sensibilidade probabilística, foram localizadas 91,3% das simulações no quadrante correspondente a custos negativos incrementais e eficácia incremental positiva (intervenção avaliada a menor custo, mais efetiva). Nas simulações, observou-se uma economia anual média por paciente de US $ 1 215 por QALY. Conclusões. O modelo integral de tratamento ambulatorial implementado em pacientes que sofreram síndrome coronariana aguda foi considerado menos caro e mais eficaz em comparação com os cuidados convencionais. Por ser uma alternativa dominante, é recomendado como modelo de cuidados nesta população.

[Evaluation of the cost-effectiveness of an integral model of ambulatory treatment in patients with acute coronary syndrome: application of a probabilistic Markov modelAvaliação da relação custo-eficácia de um modelo integral de tratamento ambulatorial em pacientes com síndrome coronariana aguda: aplicação de um modelo probabilístico de Markov]. / Evaluación de la costo-efectividad de un modelo integral de tratamiento ambulatorio en pacientes con síndrome coronario agudo: aplicación de un modelo de Markov probabilístico.

OBJECTIVE: To evaluate the cost-effectiveness of an integral model of ambulatory treatment in patients who presented an acute coronary syndrome. METHODS: An economic evaluation was made from a quasi-experimental intervention study, which included 442 patients aged 30 to 70 years who presented an acute coronary syndrome. The intervention group (n = 165) received an integral model of ambulatory treatment based on managed care (disease management), while the control group (n = 277) received conventional cardiovascular rehabilitation. During one year of follow-up, the presentation of cardiovascular events and hospitalizations was evaluated. A probabilistic Markov model was developed. The study perspective was applied within the General System of Health Social Security in Colombia, including the direct health costs; the time horizon was 50 years with discounts of 3.42% for costs and effectiveness; and the measure of effectiveness was quality-adjusted life years (QALYs). A probabilistic and multivariate sensitivity analysis was performed using the Montecarlo simulation. RESULTS: During the year of follow-up, the direct costs related to the value paid were, on average, USD 2 577 for the control group and USD 2 245 for the intervention group. In the probabilistic sensitivity analysis, 91.3% of the simulations were located in the quadrant corresponding to incremental negative costs and positive incremental effectiveness (evaluated intervention at a lower cost, more effective). In the simulations, an average annual savings per patient of USD 1 215 per QALY was observed. CONCLUSIONS: The integral model of ambulatory treatment implemented in patients who suffered an acute coronary syndrome was found to be less expensive and more effective compared to conventional care. Considering it is a dominant alternative, it is recommended as a model of care in this population.

OBJETIVO: Avaliar a relação custo-eficácia de um modelo integral de tratamento ambulatorial em pacientes que apresentaram síndrome coronariana aguda. MÉTODOS: Uma avaliação econômica foi feita a partir de um estudo de intervenção quase experimental, que incluiu 442 pacientes com idade entre 30 a 70 anos que apresentaram síndrome coronariana aguda. O grupo de intervenção (n = 165) recebeu um modelo integral de tratamento ambulatorial com base em cuidados gerenciados (gerenciamento de doenças), enquanto o grupo controle (n = 277) recebeu reabilitação cardiovascular convencional. Durante um ano de acompanhamento, foi avaliada a apresentação de eventos cardiovasculares e hospitalizações. Um modelo probabilístico de Markov foi desenvolvido. A perspectiva do estudo foi aplicada no Sistema Geral de Segurança Social na Saúde da Colômbia, incluindo os custos diretos de saúde; o horizonte temporal foi de 50 anos com descontos de 3,42% em custos e efetividade; e a medida de eficácia foi os anos de vida ajustados pela qualidade (QALY). Uma análise de sensibilidade probabilística e multivariada foi realizada utilizando a simulação de Montecarlo. RESULTADOS: Durante o ano de acompanhamento, os custos diretos relacionados ao valor pago foram, em média, USD 2 577 para o grupo controle e USD 2 245 para o grupo de intervenção. Na análise de sensibilidade probabilística, foram localizadas 91,3% das simulações no quadrante correspondente a custos negativos incrementais e eficácia incremental positiva (intervenção avaliada a menor custo, mais efetiva). Nas simulações, observou-se uma economia anual média por paciente de US $ 1 215 por QALY. CONCLUSÕES: O modelo integral de tratamento ambulatorial implementado em pacientes que sofreram síndrome coronariana aguda foi considerado menos caro e mais eficaz em comparação com os cuidados convencionais. Por ser uma alternativa dominante, é recomendado como modelo de cuidados nesta população.

Evaluación de la costo-efectividad de un modelo integral de tratamiento ambulatorio en pacientes con síndrome coronario agudo: aplicación de un modelo de Markov probabilístico / Evaluation of the cost-effectiveness of an integral model of ambulatory treatment in patients with acute coronary syndrome: application of a probabilistic Markov model / Avaliação da relação custo-eficácia de um modelo integral de tratamento ambulatorial em pacientes com síndrome coronariana aguda: aplicação de um modelo probabilístico de Markov

RESUMEN Objetivo Evaluar la costo-efectividad de un modelo integral de tratamiento ambulatorio en pacientes que presentaron un síndrome coronario agudo. Métodos Se realizó una evaluación económica a partir de un estudio de intervención cuasi-experimental, que incluyó 442 pacientes con edades entre 30 y 70 años, quienes presentaron un síndrome coronario agudo. El grupo de intervención (n = 165) recibió un modelo integral de tratamiento ambulatorio fundamentado en el cuidado gestionado (disease management), mientras que el grupo control (n = 277) recibió rehabilitación cardiovascular convencional. Durante un año de seguimiento, se evaluó la presentación de reeventos cardiovasculares y hospitalizaciones. Se desarrolló un modelo de Markov probabilístico. La perspectiva de estudio se aplicó dentro del Sistema General de Seguridad Social en Salud Colombiano, incluidos los costos sanitarios directos; el horizonte temporal fue de 50 años con descuentos de 3,42% para costos y efectividades; y la medida de efectividad fue los años de vida ganados ajustados por calidad. Se realizó un análisis de sensibilidad probabilístico y multivariante mediante de la simulación de Montecarlo. Resultados Durante el año de seguimiento, los costos directos relacionados con el valor pagado fueron en promedio de USD 2 577 para el grupo control y USD 2 245 para el grupo de intervención. En el análisis de sensibilidad probabilístico, 91,3% de las simulaciones se ubicaron en el cuadrante correspondiente a costos incrementales negativos y efectividades incrementales positivas (intervención evaluada de menor costo, más efectiva). En las simulaciones, se observó un ahorro promedio anual por paciente de USD 1 215 por cada año de vida ganado ajustado por calidad. Conclusiones El modelo integral de tratamiento ambulatorio implementado en pacientes que sufrieron un síndrome coronario agudo mostró ser menos costoso y más efectivo en comparación con el cuidado convencional. Por ser una alternativa dominante, se recomienda como modelo de cuidado en esta población.

ABSTRACT Objective To evaluate the cost-effectiveness of an integral model of ambulatory treatment in patients who presented an acute coronary syndrome. Methods An economic evaluation was made from a quasi-experimental intervention study, which included 442 patients aged 30 to 70 years who presented an acute coronary syndrome. The intervention group (n = 165) received an integral model of ambulatory treatment based on managed care (disease management), while the control group (n = 277) received conventional cardiovascular rehabilitation. During one year of follow-up, the presentation of cardiovascular events and hospitalizations was evaluated. A probabilistic Markov model was developed. The study perspective was applied within the General System of Health Social Security in Colombia, including the direct health costs; the time horizon was 50 years with discounts of 3.42% for costs and effectiveness; and the measure of effectiveness was quality-adjusted life years (QALYs). A probabilistic and multivariate sensitivity analysis was performed using the Montecarlo simulation. Results During the year of follow-up, the direct costs related to the value paid were, on average, USD 2 577 for the control group and USD 2 245 for the intervention group. In the probabilistic sensitivity analysis, 91.3% of the simulations were located in the quadrant corresponding to incremental negative costs and positive incremental effectiveness (evaluated intervention at a lower cost, more effective). In the simulations, an average annual savings per patient of USD 1 215 per QALY was observed. Conclusions The integral model of ambulatory treatment implemented in patients who suffered an acute coronary syndrome was found to be less expensive and more effective compared to conventional care. Considering it is a dominant alternative, it is recommended as a model of care in this population.

RESUMO Objetivo Avaliar a relação custo-eficácia de um modelo integral de tratamento ambulatorial em pacientes que apresentaram síndrome coronariana aguda. Métodos Uma avaliação econômica foi feita a partir de um estudo de intervenção quase experimental, que incluiu 442 pacientes com idade entre 30 a 70 anos que apresentaram síndrome coronariana aguda. O grupo de intervenção (n = 165) recebeu um modelo integral de tratamento ambulatorial com base em cuidados gerenciados (gerenciamento de doenças), enquanto o grupo controle (n = 277) recebeu reabilitação cardiovascular convencional. Durante um ano de acompanhamento, foi avaliada a apresentação de eventos cardiovasculares e hospitalizações. Um modelo probabilístico de Markov foi desenvolvido. A perspectiva do estudo foi aplicada no Sistema Geral de Segurança Social na Saúde da Colômbia, incluindo os custos diretos de saúde; o horizonte temporal foi de 50 anos com descontos de 3,42% em custos e efetividade; e a medida de eficácia foi os anos de vida ajustados pela qualidade (QALY). Uma análise de sensibilidade probabilística e multivariada foi realizada utilizando a simulação de Montecarlo. Resultados Durante o ano de acompanhamento, os custos diretos relacionados ao valor pago foram, em média, USD 2 577 para o grupo controle e USD 2 245 para o grupo de intervenção. Na análise de sensibilidade probabilística, foram localizadas 91,3% das simulações no quadrante correspondente a custos negativos incrementais e eficácia incremental positiva (intervenção avaliada a menor custo, mais efetiva). Nas simulações, observou-se uma economia anual média por paciente de US $ 1 215 por QALY. Conclusões O modelo integral de tratamento ambulatorial implementado em pacientes que sofreram síndrome coronariana aguda foi considerado menos caro e mais eficaz em comparação com os cuidados convencionais. Por ser uma alternativa dominante, é recomendado como modelo de cuidados nesta população.