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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

2023; Oxford University Press; Volume: 12; Issue: 11 Linguagem: Inglês

10.1093/ehjacc/zuad082

2048-8734

Pedro Gabriel Melo de Barros e Silva, Ana Amaral Ferreira, Felipe Lopes Malafaia, Antonielle Figueiredo Macedo Tavares Reis, Henry Sznejder, Augusto C. Lopes, Camila Anacleto Agostinho, Luiz Henrique de Oliveira Fonseca, Débora Vieira Donini Okitoi, Celso Musa Correa, Eduardo Zincone, Marcelo Paiva Cury, Gustavo Augusto Lopes Rosa, Henrique Barbosa Ribeiro, Alexandre de Matos Soeiro, Carlos Alexandre Lemes de Oliveira, Guilherme Capelli Kuusberg, Louis Nakayama Ohe, Douglas de Oliveira Souza, Adriana Bertolami Manfredi, Amanda Francisco Martins, Pedro Paulo Noguères Sampaio, Thiago Baganha Vaz, Luciana F. Franco, Carlos Eduardo dos Santos Ferreira, Renato D. Lópes, Camila Anacleto Agostinho, Mariana Silveira de Alcântara Chaud, Luisa Carvalho Benedito, Raul Cordeiro Pessanha, L Rossi, Rafael Brufatto Tognoli, Felipe Lopes Malafaia, Mireya Raiza Mendonza Lazarte, Roberta Porreca Azzolini, Márcio Santos Sampaio, Patricia de Oliveira Roveri, Bruno Rayder de Oliveira Barros, Fabio Quartieri Alves, Giovana Fioravante Romualdo, Aline Nogueira Rabaça, Carolina Miranda, Aline Oliveira Silva, Aliana Guimaraes Mathieu, Clarissa Gutiérrez Carvalho, Luiz Henrique de Oliveira Fonseca, Alessandra Arnez Pacheco, J. Medeiros, Luis Fernando Bruzzi Porto, Roberta Pereira dos Santos Coelho, Susan Sant'Anna Pires, Lilian Maria Dos Santos Farjala, Débora Vieira Donini Okitoi, Sarah Isabel Rodrigues Dias, Ana Isabel Machado Tavares, Renata Ramos de Freitas, Kleber Nuno de Souza Oliveira Neto, Thiago Andersib Fernandes, Gabriela Maria De Nicola Bechara, Helio Kawakami, Aline Gesualdo Prata, Vessia Carvalho, Juliana Oliveira Ferreira, Eliana Vieira do Nascimento Martins, Natália Lima, Erika Frias Paulino Damasceno, Bruno Oliveira Alves, Leonardo Afonso Cortezi Rodrigues, Mariane Oliveira da Silva Gonçalves, Roberta dos Santos Valle Said, Evytuanne Carvalho Epaminondas, Beatriz Nascimento Sampaio Soares, Sandra Alves da Silva, Roberta Magalhães de Lemos, Katarina Katia Silva de Lima Gonçalves, Renata Garcia Placido de Santana, Maira Massena Pessoa da Silva, Alvaro Corado Castro, Christiane Escalhuze, Tatiane Oliveira Luiz, Andreia Pinheiro Glorio, Paloma Candian Galaskis, Camila Januário de Oliveira, Amanda Pereira de Sousa, Tatiana Guimarães, Patrícia Brito de Souza, Eloá Nascimento da Silva, Aline Daniela Rangel Lisboa dos Reis, Luciana Zimiani, Paulo Rogério Soares, Tatiana de Carvalho Andreuci Torres Leal, José Roberto de Oliveira Silva Filho, Juliana Brandão de Oliveira, Amanda Paula Pedroso, Eddio Pedro Leveck Guimarães, Fabrício Costa Fontainha, Alinemara Jordão Dantas da Silva, Alessandra Brandão de Souza, Ana Carla Fernandes de Melo, Débora Pereira Vaccari Eliel Faria, Fabyane de Oliveira Teixeira Garcia, Glauber Preusse, Juliana Souza da Silva, Layse Munin Ferreira, Paloma Sousa da Silva, Perla de Mello Andrade, Sandra Maria Freitas Galvão, Tatiana Lessa Ocelli Valério, Vanessa Beatriz dos Santos Ventura Nunes, Wender Charles do Nascimento Gomes, Matheus Henrique Marangoni, Márcio Augusto dos Santos, Newton Teruo Nakashiro, Eliete Melo Silva, T V Souza, Débora Silveira Lima, Isleid Lima Rocha, N Vita, V Bicalho, Vitor Sobreira Souza Santos, Vinicius Salim Gouvea, Thaysa Louzada Carvalho, José Henrique Herrmann Delamain, Murilo Meneses Nunes, Mateus Arantes Prata, Patrícia Maria Guedes Paiva, Milena Torres Almeida, Renata Andréa Pietro Pereira Viana, Edmundo Vieira Prado Filho, Cristiane Ferreira Serra dos Santos, Andrea Franco Cavalcante de Souza, Evelize Pereira Caldeira, Anthony Gueratto Klepp, Jéssica Tomps Correa, Raissa Gabrielle Reis dos Santos, Rafaella Araujo Cordino, Juliana Guimaro, Abraão Alves dos Reis, Aline Romélia dos Santos Lima, Adriana Ribeiro Andrade, Aline Maria Gomes Veludo, V. Canella, Flávio Guilherme Pereira lima, Kleber Monteiro Lima, Tainan Araujo da Silva, Vanessa dos Santos, Cesár Vilela, Lucimar Casemiro de Souza, Gisele Cabral, Paulo Ricardo Castellucci Bressan, Victor Ales Rodrigues, Dayanne Lopes Chaves de Assis, Anderson Martins de Souza,

Emergency and Acute Care Studies

Abstract 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