Potential performance of a 0 h/1 h algorithm and a single cut-off measure of high-sensitivity troponin T in a diverse population: main results of the IN-HOPE study.

AIMS: Chest pain is a major cause of medical evaluation at emergency department (ED) and demands observation to exclude the diagnosis of acute myocardial infarction (AMI). High-sensitivity cardiac troponin assays used as isolated measure and by 0- and 1-h algorithms are accepted as a rule-in/rule-out strategy, but there is a lack of validation in specific populations. METHODS AND RESULTS: The IN-HOspital Program to systematizE Chest Pain Protocol (IN-HOPE study) is a multicentre study that prospectively included patients admitted to the ED due to suspected symptoms of AMI at 16 sites in Brazil. Medical decisions of all patients followed the standard approach of 0 h/3 h protocol, but, in addition, blood samples were also collected at 0 and 1 h and sent to a central laboratory (core lab) to measure high-sensitivity cardiac troponin T (hs-cTnT). To assess the theoretical performance of 0 h/1 h algorithm, troponin < 12 ng/L with a delta < 3 was considered rule-out while a value ≥ 52 or a delta ≥ 5 was considered a rule-in criterion (the remaining were considered as observation group). The main objective of the study was to assess, in a population managed by the 0 h/3 h protocol, the accuracy of 0 h/1 h algorithm overall and in groups with a higher probability of AMI. All patients were followed up for 30 days, and potential events were adjudicated. In addition to the prospective cohort, a retrospective analysis was performed assessing all patients with hs-cTnT measured during the year of 2021 but not included in the prospective cohort, regardless of the indication of the test. A total of 5.497 patients were included (583 in the prospective and 4.914 in the retrospective analysis). The prospective cohort had a mean age of 57.3 (± 14.8) and 45.6% of females with a mean HEART score of 4.0 ± 2.2. By the core lab analysis, 74.4% would be eligible for a rule-out approach (45.3% of them with a HEART score > 3) while 7.3% would fit the rule-in criteria. In this rule-out group, the negative predictive value for index AMI was 100% (99.1-100) overall and regardless of clinical scores. At 30 days, no death or AMI occurred in the rule-out group of both 0/1 and 0/3 h algorithms while 52.4% of the patients in the rule-in group (0 h/1 h) were considered as AMI by adjudication. In the observation group (grey zone) of 0 h/1 h algorithm, GRACE discriminated the risk of these patients better than HEART score. In the retrospective analysis, 1.091 patients had a troponin value of <5 ng/L and there were no cardiovascular deaths at 30 days in this group. Among all 4.914 patients, the 30-day risk of AMI or cardiovascular death increased according to the level of troponin: 0% in the group < 5 ng/L, 0.6% between 5 and 14 ng/L, 2.2% between 14 and 42 ng/L, 6.3% between 42 and 90 ng/L, and 7.7% in the level ≥ 90 ng/L. CONCLUSION: In this large multicentre study, a 0 h/1 h algorithm had the potential to classify as rule-in or rule-out in almost 80% of the patients. The rule-out protocol had high negative predictive value regardless of clinical risk scores. Categories of levels of hs-cTn T also showed good accuracy in discriminating risk of the patients with a very favourable prognosis for cardiovascular death in the group with value < 5 ng/L. CLINICALTRIALS.GOV: NCT04756362.

Potential performance of a 0 h/1 h algorithm and a single cut-off measure of high-sensitivity troponin T in a diverse population: main results of the IN-HOPE study

BACKGROUND: Chest pain is a major cause of medical evaluation at emergency department (ED) and demands observation to exclude the diagnosis of acute myocardial infarction (AMI). High-sensitivity cardiac troponin assays used as isolated measure and by 0 h and 1 h algorithms are accepted as a rule-in/rule-out strategy but there is a lack of validation in specific populations. METHODS: The IN-HOspital Program to systematizE chest pain protocol (In Hope study) is a multicentre study that prospectively included patients admitted to the ED due to suspected symptoms of AMI at 16 sites in Brazil. Medical decisions of all patients followed the standard approach of 0/3-h protocol but, in addition, blood samples were also collected at 0 and 1 hour and sent to a central laboratory (core lab) to measure high-sensitivity troponin T (hs-cTnT). To assess the theoretical performance of 0/1-h algorithm, troponin < 12 ng/L with a delta <--- 3 was considered rule out while a value ≥ 52 and/or a delta ≥ 5 was considered a rule in criteria (the remaining were considered as observation group). The main objective of the study was to assess, in a population managed by the 0/3-h protocol, the accuracy of 0/1-h algorithm overall and in groups with higher probability of AMI. All patients were followed for 30 days, and potential events were adjudicated. In addition to the prospective cohort, a retrospective analysis was performed assessing all patients with hs-cTnT measured during the year of 2021 but not included in the prospective cohort, regardless the indication of the test. RESULTS: A total of 5.497 patients were included (583 in the prospective and 4.914 in the retrospective analysis). The prospective cohort had a mean age of 57.3 (± 14.8) and 45.6% of females with a mean HEART score of 4.0 ± 2.2. By the core lab analysis, 74.4% would be eligible for a rule-out approach (45.3% of HEART score > 3) while 7.3% would fit the rule-in criteria. In this rule-out group, the negative predictive value for index AMI was 100% (99.1-100) overall and regardless clinical scores. At 30 days, no death or AMI occurred in the rule-out group of both 0/1 and 0/3-hour while 52.4% of the patients in the rule-in group (0/1-hour) were considered as AMI by adjudication. In the observation group (grey zone) of 0/1- hour algorithm, GRACE discriminated the risk of these patients better than HEART score. In the retrospective analysis, 1.091 patients had a troponin value < 5 ng/L and there were no cardiovascular deaths at 30 days in this group. Among all 4.914 patients, the 30-day risk of AMI or cardiovascular death increased according to the level of troponin: 0% in the group < 5 ng/L, 0.6% between 5 and 14 ng/L, 2.2% between 14 and 42 ng/L, 6.3% between 42 and 90 ng/L and 7.7% in the level ≥ 90 ng/L. CONCLUSIONS: In this large multicentre study, a 0/1-h algorithm had the potential to classify as rule in or out almost 80% of the patients. The rule-out protocol had high negative predictive value regardless of clinical risk scores. Categories of levels of hs-cTn T also showed good accuracy in discriminating risk of the patients with a very favourable prognosis for cardiovascular death in the group with values < 5 ng/L.

[Analysis of barriers to the use of thrombolytics in ischemic stroke in a private hospital in Rio de Janeiro, Brazil]. / Análise das barreiras à utilização de trombolíticos em casos de acidente vascular cerebral isquêmico em um hospital privado do Rio de Janeiro, Brasil.

Ischemic stroke is a major cause of neurological sequelae and death. The correct use of thrombolytic therapy faces several barriers. The objective was to discuss barriers to thrombolytic therapy in a private hospital. This was a retrospective cohort study of patients with symptoms of acute ischemic stroke entering the emergency department of a private hospital in Rio de Janeiro, Brazil, from 2009 to 2011. 257 patients were admitted with suspected ischemic stroke. Among the 156 patients with confirmed diagnosis of ischemic stroke, 18 (11.5%) received thrombolytic therapy. Of the 30 patients with ischemic stroke within the therapeutic window and meeting NIHSS criteria for thrombolysis, 20 were not thrombolysed. Nine of these were due to administrative barriers (45%). In the current study, the thrombolysis rate was higher than in the United States, but barriers prevented treating 47.6% of patients with indication for thrombolysis. Importantly, this study was conducted in a private hospital, and the situation may be even more unfavorable in the public health system.

Análise das barreiras à utilização de trombolíticos em casos de acidente vascular cerebral isquêmico em um hospital privado do Rio de Janeiro, Brasil / Analysis of barriers to the use of thrombolytics in ischemic stroke in a private hospital in Rio de Janeiro, Brazil / Análisis de las barreras para el uso de trombolíticos en los casos de accidente cerebrovascular isquémico en un hospital privado de Río de Janeiro, Brasil

O acidente vascular cerebral isquêmico (AVCi) é uma importante causa de sequela e morte. A correta utilização do trombolítico enfrenta várias barreiras. O objetivo foi discutir as barreiras à terapia trombolítica em pacientes que chegam, com sintomas de AVCi agudo, à emergência de um hospital privado do Rio de Janeiro, Brasil. Coorte retrospectiva de pacientes entre 2009 e 2011. Foram admitidos 257 pacientes com suspeita de AVCi. Dos pacientes com diagnóstico confirmado (156), 11,5% (18) foram trombolisados. Dos 30 pacientes com diagnóstico de AVCi, dentro da janela terapêutica e com NIHSS na faixa para trombólise, 20 não foram trombolisados, 9 por barreiras administrativas (45%). Neste trabalho o percentual de trombólise foi superior ao observado nos Estados Unidos, mas barreiras impediram o tratamento de 45% dos pacientes com indicação à trombólise. Imagina-se que na rede pública brasileira a situação seja ainda mais desfavorável.

Ischemic stroke is a major cause of neurological sequelae and death. The correct use of thrombolytic therapy faces several barriers. The objective was to discuss barriers to thrombolytic therapy in a private hospital. This was a retrospective cohort study of patients with symptoms of acute ischemic stroke entering the emergency department of a private hospital in Rio de Janeiro, Brazil, from 2009 to 2011. 257 patients were admitted with suspected ischemic stroke. Among the 156 patients with confirmed diagnosis of ischemic stroke, 18 (11.5%) received thrombolytic therapy. Of the 30 patients with ischemic stroke within the therapeutic window and meeting NIHSS criteria for thrombolysis, 20 were not thrombolysed. Nine of these were due to administrative barriers (45%). In the current study, the thrombolysis rate was higher than in the United States, but barriers prevented treating 47.6% of patients with indication for thrombolysis. Importantly, this study was conducted in a private hospital, and the situation may be even more unfavorable in the public health system.

El accidente cerebrovascular isquémico (AVCi) es una causa importante de daño en tejidos y muerte. El uso correcto de trombolíticos se enfrenta a varios obstáculos. El objetivo fue analizar las barreras para el tratamiento trombolítico en pacientes que llegaran con síntomas de AVCi agudo al servicio de urgencias de un hospital privado de Río de Janeiro, Brasil. Se realizó un estudio de cohorte retrospectivo de los pacientes, entre los años 2009 y 2011. 257 pacientes fueron ingresados con sospecha de AVCi. De los pacientes con casos confirmados (156), 11,5% (18) fueron trombolizados. De los 30 pacientes con un accidente cerebrovascular isquémico dentro de la ventana terapéutica y NIHSS correcto para la trombólisis, 20 no se trombolizaron, 9 por obstáculos. En nuestro estudio el porcentaje de trombólisis fue mayor que en los Estados Unidos, pero las barreras impidieron el tratamiento de un 45% de los pacientes con una indicación de trombólisis.