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Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial
IMPORTANCE: Patients with shorter ischemic times have a greater viable myocardium and may derive greater benefit from thrombus aspiration. OBJECTIVE: To study the association of thrombus aspiration with outcomes among patients presenting with ST-segment elevation myocardial infarction (STEMI) based...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Medical Association
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7998077/ https://www.ncbi.nlm.nih.gov/pubmed/33769510 http://dx.doi.org/10.1001/jamanetworkopen.2021.3505 |
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author | Moxham, Rachel Džavík, Vladimír Cairns, John Natarajan, Madhu K. Bainey, Kevin R. Akl, Elie Tsang, Michael B. Lavi, Shahar Cantor, Warren J. Madan, Mina Liu, Yan Yun Jolly, Sanjit S. |
author_facet | Moxham, Rachel Džavík, Vladimír Cairns, John Natarajan, Madhu K. Bainey, Kevin R. Akl, Elie Tsang, Michael B. Lavi, Shahar Cantor, Warren J. Madan, Mina Liu, Yan Yun Jolly, Sanjit S. |
author_sort | Moxham, Rachel |
collection | PubMed |
description | IMPORTANCE: Patients with shorter ischemic times have a greater viable myocardium and may derive greater benefit from thrombus aspiration. OBJECTIVE: To study the association of thrombus aspiration with outcomes among patients presenting with ST-segment elevation myocardial infarction (STEMI) based on time. DESIGN, SETTING, AND PARTICIPANTS: The TOTAL (Thrombectomy With PCI vs PCI Alone in Patients with STEMI) trial was an international randomized clinical trial of 10 732 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) within 12 hours of symptom onset. Patients were recruited between August 5, 2010, and July 25, 2014, and were followed up for 1 year. Data analysis was performed from February 22, 2019, to January 5, 2021. INTERVENTIONS: Thrombus aspiration vs PCI alone. MAIN OUTCOMES AND MEASURES: Post hoc subgroup analyses were performed for total ischemic time and first medical contact (FMC)–to–device time for the primary outcomes (cardiovascular [CV] mortality, myocardial Infarction [MI], cardiogenic shock, and New York Heart Association class IV heart failure) and angiographically determined distal embolization. In addition, a multivariable analysis was performed to assess the association of total ischemic time and FMC-to-device time with CV mortality at 1 year. RESULTS: The study randomized 10 732 patients, and 9986 underwent primary PCI and had time data available (7737 men [77.5%]; mean [SD] age, 61.0 [12.0] years). For the randomized comparison of thrombus aspiration, there was a reduction in angiographic distal embolization with thrombus aspiration that was more pronounced in patients with short ischemic times (<2 hours: odds ratio [OR], 0.23 [95% CI, 0.09-0.62]; 2-6 hours: OR, 0.54 [95% CI, 0.39-0.73]; >6 hours: OR, 0.70 [95% CI, 0.33-1.50]; P = .12 for interaction). However, for the primary composite outcome, there was no benefit based on (1) total ischemic time (<2 hours: hazard ratio [HR], 0.77 [95% CI, 0.46-1.28]; 2-6 hours: HR, 1.03 [95% CI, 0.85-1.25]; >6 hours: HR, 0.87 [95% CI, 0.60-1.27]; P = .46 for interaction) or (2) FMC-to-device time (<60 minutes: HR, 1.14 [95% CI, 0.66-1.95]; 60-90 minutes: HR, 0.94 [95% CI, 0.67-1.32]; >90-120 minutes: HR, 1.19 [95% CI, 0.85-1.67]; >120 minutes: HR, 0.89 [95% CI, 0.70-1.14]; P = .54 for interaction). In a multivariable analysis, both total ischemic time (>2 hours: HR, 1.26 [95% CI, 1.00-1.58) and FMC-to-device time (>120 minutes: HR, 1.45 [95% CI, 1.18-1.79]) were independently associated with CV mortality. CONCLUSIONS AND RELEVANCE: This analysis suggests that thrombus aspiration does not appear to be associated with an improvement in clinical outcomes regardless of ischemic time. In the current STEMI era, both total ischemic time and FMC-to-device times continue to be important factors associated with mortality. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01149044 |
format | Online Article Text |
id | pubmed-7998077 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | American Medical Association |
record_format | MEDLINE/PubMed |
spelling | pubmed-79980772021-04-19 Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial Moxham, Rachel Džavík, Vladimír Cairns, John Natarajan, Madhu K. Bainey, Kevin R. Akl, Elie Tsang, Michael B. Lavi, Shahar Cantor, Warren J. Madan, Mina Liu, Yan Yun Jolly, Sanjit S. JAMA Netw Open Original Investigation IMPORTANCE: Patients with shorter ischemic times have a greater viable myocardium and may derive greater benefit from thrombus aspiration. OBJECTIVE: To study the association of thrombus aspiration with outcomes among patients presenting with ST-segment elevation myocardial infarction (STEMI) based on time. DESIGN, SETTING, AND PARTICIPANTS: The TOTAL (Thrombectomy With PCI vs PCI Alone in Patients with STEMI) trial was an international randomized clinical trial of 10 732 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) within 12 hours of symptom onset. Patients were recruited between August 5, 2010, and July 25, 2014, and were followed up for 1 year. Data analysis was performed from February 22, 2019, to January 5, 2021. INTERVENTIONS: Thrombus aspiration vs PCI alone. MAIN OUTCOMES AND MEASURES: Post hoc subgroup analyses were performed for total ischemic time and first medical contact (FMC)–to–device time for the primary outcomes (cardiovascular [CV] mortality, myocardial Infarction [MI], cardiogenic shock, and New York Heart Association class IV heart failure) and angiographically determined distal embolization. In addition, a multivariable analysis was performed to assess the association of total ischemic time and FMC-to-device time with CV mortality at 1 year. RESULTS: The study randomized 10 732 patients, and 9986 underwent primary PCI and had time data available (7737 men [77.5%]; mean [SD] age, 61.0 [12.0] years). For the randomized comparison of thrombus aspiration, there was a reduction in angiographic distal embolization with thrombus aspiration that was more pronounced in patients with short ischemic times (<2 hours: odds ratio [OR], 0.23 [95% CI, 0.09-0.62]; 2-6 hours: OR, 0.54 [95% CI, 0.39-0.73]; >6 hours: OR, 0.70 [95% CI, 0.33-1.50]; P = .12 for interaction). However, for the primary composite outcome, there was no benefit based on (1) total ischemic time (<2 hours: hazard ratio [HR], 0.77 [95% CI, 0.46-1.28]; 2-6 hours: HR, 1.03 [95% CI, 0.85-1.25]; >6 hours: HR, 0.87 [95% CI, 0.60-1.27]; P = .46 for interaction) or (2) FMC-to-device time (<60 minutes: HR, 1.14 [95% CI, 0.66-1.95]; 60-90 minutes: HR, 0.94 [95% CI, 0.67-1.32]; >90-120 minutes: HR, 1.19 [95% CI, 0.85-1.67]; >120 minutes: HR, 0.89 [95% CI, 0.70-1.14]; P = .54 for interaction). In a multivariable analysis, both total ischemic time (>2 hours: HR, 1.26 [95% CI, 1.00-1.58) and FMC-to-device time (>120 minutes: HR, 1.45 [95% CI, 1.18-1.79]) were independently associated with CV mortality. CONCLUSIONS AND RELEVANCE: This analysis suggests that thrombus aspiration does not appear to be associated with an improvement in clinical outcomes regardless of ischemic time. In the current STEMI era, both total ischemic time and FMC-to-device times continue to be important factors associated with mortality. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01149044 American Medical Association 2021-03-26 /pmc/articles/PMC7998077/ /pubmed/33769510 http://dx.doi.org/10.1001/jamanetworkopen.2021.3505 Text en Copyright 2021 Moxham R et al. JAMA Network Open. http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the CC-BY License. |
spellingShingle | Original Investigation Moxham, Rachel Džavík, Vladimír Cairns, John Natarajan, Madhu K. Bainey, Kevin R. Akl, Elie Tsang, Michael B. Lavi, Shahar Cantor, Warren J. Madan, Mina Liu, Yan Yun Jolly, Sanjit S. Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial |
title | Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial |
title_full | Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial |
title_fullStr | Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial |
title_full_unstemmed | Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial |
title_short | Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial |
title_sort | association of thrombus aspiration with time and mortality among patients with st-segment elevation myocardial infarction: a post hoc analysis of the randomized total trial |
topic | Original Investigation |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7998077/ https://www.ncbi.nlm.nih.gov/pubmed/33769510 http://dx.doi.org/10.1001/jamanetworkopen.2021.3505 |
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