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1.
JAMA Netw Open ; 7(3): e240809, 2024 Mar 04.
Artigo em Inglês | MEDLINE | ID: mdl-38446482

RESUMO

Importance: The MOSCA-FRAIL randomized clinical trial compared invasive and conservative treatment strategies in patients with frailty with non-ST-segment elevation myocardial infarction (NSTEMI). It showed no differences in the number of days alive and out of the hospital at 1 year. Objective: To assess the outcomes of the MOSCA-FRAIL trial during extended follow-up. Design, Setting, and Participants: The MOSCA-FRAIL randomized clinical trial was conducted at 13 hospitals in Spain between July 7, 2017, and January 9, 2021, and included 167 adults (aged ≥70 years) with frailty (Clinical Frailty Scale score ≥4) and NSTEMI. In this preplanned secondary analysis, follow-up was extended to January 31, 2023. Data analysis was performed from April 5 to 29, 2023, using the intention-to-treat principle. Interventions: Patients were randomized to a routine invasive (coronary angiography and revascularization if feasible [n = 84]) or a conservative (medical treatment with coronary angiography only if recurrent ischemia [n = 83]) strategy. Main outcomes and measures: The primary end point was the difference in restricted mean survival time (RMST). Secondary end points included readmissions for any cause, considering recurrent readmissions. Results: Among the 167 patients included in the analysis, the mean (SD) age was 86 (5) years; 79 (47.3%) were men and 88 (52.7%) were women. A total of 93 deaths and 367 readmissions accrued. The RMST for all-cause death over the entire follow-up was 3.13 (95% CI, 2.72-3.60) years in the invasive and 3.06 (95% CI, 2.84-3.32) years in the conservative treatment groups. The RMST analysis showed inconclusive differences in survival time (invasive minus conservative difference, 28 [95% CI, -188 to 230] days). Patients under invasive treatment tended to have shorter survival in the first year (-28 [95% CI, -63 to 7] days), which improved after the first year (192 [95% CI, 90-230] days). Kaplan-Meier mortality curves intersected, displaying higher mortality to 1 year in the invasive group that shifted to a late benefit (landmark analysis hazard ratio, 0.58 [95% CI, 0.33-0.99]; P = .045). Early harm was more evident in the subgroup with a Clinical Frailty Scale score greater than 4. No differences were found for the secondary end points. Conclusions and Relevance: In this extended follow-up of a randomized clinical trial of patients with frailty and NSTEMI, an invasive treatment strategy did not improve outcomes at a median follow-up of 1113 (IQR, 443-1441) days. However, a differential distribution of deaths was observed, with early harm followed by later benefit. The phenomenon of depletion of susceptible patients may be responsible for this behavior. Trial registration: ClinicalTrials.gov Identifier: NCT03208153.


Assuntos
Fragilidade , Infarto do Miocárdio sem Supradesnível do Segmento ST , Infarto do Miocárdio com Supradesnível do Segmento ST , Feminino , Humanos , Masculino , Tratamento Conservador , Angiografia Coronária , Análise de Dados , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Idoso , Idoso de 80 Anos ou mais , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto
2.
JAMA Intern Med ; 183(5): 407-415, 2023 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-36877502

RESUMO

Importance: To our knowledge, no randomized clinical trial has compared the invasive and conservative strategies in frail, older patients with non-ST-segment elevation acute myocardial infarction (NSTEMI). Objective: To compare outcomes of invasive and conservative strategies in frail, older patients with NSTEMI at 1 year. Design, Setting, and Participants: This multicenter randomized clinical trial was conducted at 13 Spanish hospitals between July 7, 2017, and January 9, 2021, and included 167 older adult (≥70 years) patients with frailty (Clinical Frailty Scale score ≥4) and NSTEMI. Data analysis was performed from April 2022 to June 2022. Interventions: Patients were randomized to routine invasive (coronary angiography and revascularization if feasible; n = 84) or conservative (medical treatment with coronary angiography for recurrent ischemia; n = 83) strategy. Main Outcomes and Measures: The primary end point was the number of days alive and out of the hospital (DAOH) from discharge to 1 year. The coprimary end point was the composite of cardiac death, reinfarction, or postdischarge revascularization. Results: The study was prematurely stopped due to the COVID-19 pandemic when 95% of the calculated sample size had been enrolled. Among the 167 patients included, the mean (SD) age was 86 (5) years, and mean (SD) Clinical Frailty Scale score was 5 (1). While not statistically different, DAOH were about 1 month (28 days; 95% CI, -7 to 62) greater for patients managed conservatively (312 days; 95% CI, 289 to 335) vs patients managed invasively (284 days; 95% CI, 255 to 311; P = .12). A sensitivity analysis stratified by sex did not show differences. In addition, we found no differences in all-cause mortality (hazard ratio, 1.45; 95% CI, 0.74-2.85; P = .28). There was a 28-day shorter survival in the invasive vs conservatively managed group (95% CI, -63 to 7 days; restricted mean survival time analysis). Noncardiac reasons accounted for 56% of the readmissions. There were no differences in the number of readmissions or days spent in the hospital after discharge between groups. Neither were there differences in the coprimary end point of ischemic cardiac events (subdistribution hazard ratio, 0.92; 95% CI, 0.54-1.57; P = .78). Conclusions and Relevance: In this randomized clinical trial of NSTEMI in frail older patients, there was no benefit to a routine invasive strategy in DAOH during the first year. Based on these findings, a policy of medical management and watchful observation is recommended for older patients with frailty and NSTEMI. Trial Registration: ClinicalTrials.gov Identifier: NCT03208153.


Assuntos
COVID-19 , Fragilidade , Infarto do Miocárdio , Infarto do Miocárdio sem Supradesnível do Segmento ST , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Idoso , Idoso de 80 Anos ou mais , Infarto do Miocárdio sem Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Infarto do Miocárdio/mortalidade , Tratamento Conservador , Assistência ao Convalescente , Pandemias , Angina Instável/terapia , Alta do Paciente , Angiografia Coronária
3.
J Geriatr Cardiol ; 19(5): 377-392, 2022 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-35722032

RESUMO

In recent decades, life expectancy has been increasing significantly. In this scenario, health interventions are necessary to improve prognosis and quality of life of elderly with cardiovascular risk factors and cardiovascular disease. However, the number of elderly patients included in clinical trials is low, thus current clinical practice guidelines do not include specific recommendations. This document aims to review prevention recommendations focused in patients ≥ 75 years with high or very high cardiovascular risk, regarding objectives, medical treatment options and also including physical exercise and their inclusion in cardiac rehabilitation programs. Also, we will show why geriatric syndromes such as frailty, dependence, cognitive impairment, and nutritional status, as well as comorbidities, ought to be considered in this population regarding their important prognostic impact.

4.
BMC Med ; 20(1): 15, 2022 01 20.
Artigo em Inglês | MEDLINE | ID: mdl-35045843

RESUMO

BACKGROUND: Sex influences outcome of patients with acute coronary syndrome (ACS). If there is a relationship between sex and physical performance is unknown. METHODS: The analysis is based on older (≥70 years) ACS patients included in the FRASER, HULK, and LONGEVO SCA prospective studies. Physical performance was assessed by Short Physical Performance Battery (SPPB). The primary outcome was all-cause mortality. RESULTS: The study included 1388 patients, and 441 (32%) were women. At presentation, women were older and more compromised than men. After a median follow-up of 998 [730-1168] days, all-cause death occurred in 334 (24.1%) patients. At univariate analysis, female sex was related to increased risk of death. After adjustments for confounding factors, female sex was no longer associated with mortality. Women showed poor physical performance compared with men (p < 0.001). SPPB values emerged as an independent predictor of death. Including clinical features and SPPB in the multivariable model, we observed a paradigm shift in the prognostic role of female sex that becomes a protective factor (HR 0.73, 95% CI 0.56-0.96). Sex and physical performance showed a significant interaction (p = 0.03). For lower SPPB values (poor physical performance), sex-related changes in mortality were not recorded, while in patients with higher SPPB values (preserved physical performance), female sex was associated with better survival. CONCLUSIONS: Two key findings emerged from the present real-life cohort of older ACS patients: (i) physical performance strongly influences long-term mortality; (ii) women with preserved physical performance have a better outcome compared to men. TRIAL REGISTRATION: www.clinicaltrials.gov NCT02386124 and NCT03021044.


Assuntos
Síndrome Coronariana Aguda , Infarto do Miocárdio , Síndrome Coronariana Aguda/diagnóstico , Idoso , Feminino , Humanos , Masculino , Desempenho Físico Funcional , Prognóstico , Estudos Prospectivos , Fatores Sexuais
8.
J Am Med Dir Assoc ; 19(4): 296-303, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29153753

RESUMO

BACKGROUND: Information about the impact of frailty in patients with acute coronary syndromes (ACS) is scarce. No study has assessed the prognostic impact of frailty as measured by the FRAIL scale in very elderly patients with ACS. METHODS: The prospective multicenter LONGEVO-SCA registry included unselected patients with ACS aged 80 years or older. A comprehensive geriatric assessment was performed during hospitalization, including frailty assessment by the FRAIL scale. The primary endpoint was mortality at 6 months. RESULTS: A total of 532 patients were included. Mean age was 84.3 years, 61.7% male. Most patients had positive troponin levels (84%) and high GRACE risk score values (mean 165). A total of 205 patients were classified as prefrail (38.5%) and 145 as frail (27.3%). Frail and prefrail patients had a higher prevalence of comorbidities, lower left ventricle ejection fraction, and higher mean GRACE score value. A total of 63 patients (11.8%) were dead at 6 months. Both prefrailty and frailty were associated with higher 6-month mortality rates (P < .001). After adjusting for potential confounders, this association remained significant (hazard ratio [HR] 2.71; 95% confidence interval [CI] 1.09-6.73 for prefrailty and HR 2.99; 95% CI 1.20-7.44 for frailty, P = .024). The other independent predictors of mortality were age, Charlson Index, and GRACE risk score. CONCLUSIONS: The FRAIL scale is a simple tool that independently predicts mortality in unselected very elderly patients with ACS. The presence of prefrailty criteria also should be taken into account when performing risk stratification of these patients.


Assuntos
Síndrome Coronariana Aguda/epidemiologia , Causas de Morte , Fragilidade/diagnóstico , Fragilidade/epidemiologia , Sistema de Registros , Síndrome Coronariana Aguda/diagnóstico , Idoso de 80 Anos ou mais , Comorbidade , Feminino , Idoso Fragilizado/estatística & dados numéricos , Humanos , Estimativa de Kaplan-Meier , Masculino , Prevalência , Prognóstico , Modelos de Riscos Proporcionais , Estudos Prospectivos , Medição de Risco , Espanha , Análise de Sobrevida , Fatores de Tempo
11.
J Cardiol ; 69(6): 883-887, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27644859

RESUMO

BACKGROUND: Despite current recommendations, a high percentage of patients with severe symptomatic aortic stenosis are managed conservatively. The aim of this study was to study symptomatic patients undergoing conservative management from the IDEAS registry, describing their baseline clinical characteristics, mortality, and the causes according to the reason for conservative management. METHODS: Consecutive patients with severe aortic stenosis diagnosed at 48 centers during January 2014 were included. Baseline clinical characteristics, echocardiographic data, Charlson index, and EuroSCORE-II were registered, including vital status and performance of valve intervention during one-year follow-up. For the purpose of this substudy we assessed symptomatic patients undergoing conservative management, including them in 5 groups according to the reason for performing conservative management [I: comorbidity/frailty (128, 43.8%); II: dementia 18 (6.2%); III: advanced age 34 (11.6%); IV: patients' refusal 62 (21.2%); and V: other reasons 50 (17.1%)]. RESULTS: We included 292 patients aged 81.5±9 years. Patients from group I had higher Charlson index (4±2.3), higher EuroSCORE-II (7.5±6), and a higher overall (42.2%) and non-cardiac mortality (16.4%) than the other groups. In contrast, patients from group III had fewer comorbidities, lower EuroSCORE-II (4±2.5), and low overall (20.6%) and non-cardiac mortality (5.9%). CONCLUSIONS: Patients with severe symptomatic aortic stenosis managed conservatively have different baseline characteristics and clinical course according to the reason for performing conservative management. A prospective assessment of comorbidity and other geriatric syndromes might contribute to improve therapeutic strategy in this clinical setting.


Assuntos
Estenose da Valva Aórtica/cirurgia , Tratamento Conservador , Implante de Prótese de Valva Cardíaca , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/epidemiologia , Comorbidade , Ecocardiografia , Feminino , Humanos , Masculino , Sistema de Registros , Índice de Gravidade de Doença , Resultado do Tratamento
12.
Cardiovasc Pathol ; 23(3): 126-30, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24582379

RESUMO

INTRODUCTION: Autopsy studies show that dynamic coronary thrombosis leads to infarction. We studied intracoronary thrombus age in ST-segment elevation myocardial infarction (STEMI) and its relationship with clinical presentation and epicardial reperfusion grade. METHODS AND RESULTS: Intracoronary thrombectomy was performed in 131 STEMI patients within 24 h after symptom onset, and material sufficient for pathological analysis was retrieved from 81 patients. Thrombus age was classified as fresh (<1day), lytic (1 to 5 days), or organized (>5days). A fresh thrombus was found in 48 patients (60%), whereas the thrombus showed lytic or organized changes in 33 patients (40%). Both thrombus and plaque material were aspirated in 40% of cases. Lytic or organized thrombi were aspirated in one third of the cases early (<12h) after symptom onset, and fresh thrombi were also aspirated in one third of STEMI of>12h evolution. In multivariable analysis, fresh thrombus was associated with both persistent ST-segment elevation (even after 12 h of onset) during percutaneous coronary intervention [odds ratio (OR) 4.23, 95% confidence interval (CI) 1.05-17.42, P=.042) and a previous history of ischemic heart disease (OR 4.54, 95% CI 1.41-14.64, P=.011). There were no associations between thrombus composition and epicardial reperfusion grade or the presence of the no-reflow phenomenon. Plaque components were found in all cases of distal embolization (5%). CONCLUSION: Intracoronary thrombi aspirated in STEMI frequently show more than one stage of maturation. Fresh thrombi predominate in patients with known ischemic heart disease or persistent ST-segment elevation. SUMMARY: In STEMI, thromboaspiration revealed thrombi at different stages of maturation, supporting a dynamic process of rupture and repair of the atherosclerotic plaque. Fresh thrombi were present more frequently within 12 h of infarction onset but also in patients with symptoms beyond 12 h. When containing plaque material, thrombi were often associated with macroscopic distal embolization during angioplasty.


Assuntos
Doença da Artéria Coronariana/patologia , Circulação Coronária , Trombose Coronária/patologia , Infarto do Miocárdio/etiologia , Idoso , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/fisiopatologia , Doença da Artéria Coronariana/terapia , Trombose Coronária/complicações , Trombose Coronária/fisiopatologia , Trombose Coronária/terapia , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Infarto do Miocárdio/patologia , Infarto do Miocárdio/fisiopatologia , Infarto do Miocárdio/terapia , Razão de Chances , Intervenção Coronária Percutânea , Placa Aterosclerótica , Estudos Prospectivos , Recuperação de Função Fisiológica , Fatores de Risco , Ruptura Espontânea , Trombectomia , Fatores de Tempo , Resultado do Tratamento
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