Gilles Barone-Rochette, Gerald Vanzetto, Nicolas Danchin, Philippe Gabriel Steg, Olivier Hanon, Clemence Charlon, Sandra David-Tchouda, Gaetan Gavazzi, Tabassome Simon, Jean-Luc Bosson
{"title":"多中心随机 EVAOLD 试验的原理和设计:评估老年缺血患者的成像指导策略与常规侵入策略。","authors":"Gilles Barone-Rochette, Gerald Vanzetto, Nicolas Danchin, Philippe Gabriel Steg, Olivier Hanon, Clemence Charlon, Sandra David-Tchouda, Gaetan Gavazzi, Tabassome Simon, Jean-Luc Bosson","doi":"10.1016/j.ahj.2024.10.013","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The management of myocardial infarction without ST segment elevation (NSTEMI) in elderly patients remains challenging, in particular the benefit/risk balance of routine revascularization remains uncertain.</p><p><strong>Study design: </strong>EVAOLD is s a multicenter, prospective, open-label trial with 2 parallel arms in NSTEMI patients ≥80 years of age. The aim of the trial is to test whether a strategy of selective invasive management guided by ischemia stress imaging (IMG group) will be noninferior in preventing Major Adverse Cardiac and Cerebrovascular Events (MACCE, ie all-cause death, nonfatal myocardial infarction, nonfatal stroke) rates at 1 year compared with a routine invasive strategy (INV Group). Geriatric assessment and cost- effectiveness analysis will also be performed. A sample size of 1,756 patients (assuming a 10% rate of patients lost to follow-up) is needed to show noninferiority with 80% power. Noninferiority based on exponential survival curves will be declared if the upper limit of the 1-sided 97.5% confidence interval for the hazard ratio is lower than 1.24, corresponding to a noninferiority margin of 7% in absolute difference and an event rate of 40% in the INV group.</p><p><strong>Conclusion: </strong>EVAOLD is a nationwide, prospective, open-label trial testing the noninferiority of a strategy of selective invasive management guided by ischemia stress imaging versus routine invasive strategy in elderly NSTEMI patients.</p><p><strong>Clinicaltrials: </strong>gov Identifier: NCT03289728.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"94-103"},"PeriodicalIF":3.7000,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Rationale and design of the multicentric randomized EVAOLD trial: Evaluation of a strategy guided by imaging versus routine invasive strategy in elderly patients with ischemia.\",\"authors\":\"Gilles Barone-Rochette, Gerald Vanzetto, Nicolas Danchin, Philippe Gabriel Steg, Olivier Hanon, Clemence Charlon, Sandra David-Tchouda, Gaetan Gavazzi, Tabassome Simon, Jean-Luc Bosson\",\"doi\":\"10.1016/j.ahj.2024.10.013\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The management of myocardial infarction without ST segment elevation (NSTEMI) in elderly patients remains challenging, in particular the benefit/risk balance of routine revascularization remains uncertain.</p><p><strong>Study design: </strong>EVAOLD is s a multicenter, prospective, open-label trial with 2 parallel arms in NSTEMI patients ≥80 years of age. The aim of the trial is to test whether a strategy of selective invasive management guided by ischemia stress imaging (IMG group) will be noninferior in preventing Major Adverse Cardiac and Cerebrovascular Events (MACCE, ie all-cause death, nonfatal myocardial infarction, nonfatal stroke) rates at 1 year compared with a routine invasive strategy (INV Group). Geriatric assessment and cost- effectiveness analysis will also be performed. A sample size of 1,756 patients (assuming a 10% rate of patients lost to follow-up) is needed to show noninferiority with 80% power. Noninferiority based on exponential survival curves will be declared if the upper limit of the 1-sided 97.5% confidence interval for the hazard ratio is lower than 1.24, corresponding to a noninferiority margin of 7% in absolute difference and an event rate of 40% in the INV group.</p><p><strong>Conclusion: </strong>EVAOLD is a nationwide, prospective, open-label trial testing the noninferiority of a strategy of selective invasive management guided by ischemia stress imaging versus routine invasive strategy in elderly NSTEMI patients.</p><p><strong>Clinicaltrials: </strong>gov Identifier: NCT03289728.</p>\",\"PeriodicalId\":7868,\"journal\":{\"name\":\"American heart journal\",\"volume\":\" \",\"pages\":\"94-103\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2024-10-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American heart journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.ahj.2024.10.013\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"American heart journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.ahj.2024.10.013","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Rationale and design of the multicentric randomized EVAOLD trial: Evaluation of a strategy guided by imaging versus routine invasive strategy in elderly patients with ischemia.
Background: The management of myocardial infarction without ST segment elevation (NSTEMI) in elderly patients remains challenging, in particular the benefit/risk balance of routine revascularization remains uncertain.
Study design: EVAOLD is s a multicenter, prospective, open-label trial with 2 parallel arms in NSTEMI patients ≥80 years of age. The aim of the trial is to test whether a strategy of selective invasive management guided by ischemia stress imaging (IMG group) will be noninferior in preventing Major Adverse Cardiac and Cerebrovascular Events (MACCE, ie all-cause death, nonfatal myocardial infarction, nonfatal stroke) rates at 1 year compared with a routine invasive strategy (INV Group). Geriatric assessment and cost- effectiveness analysis will also be performed. A sample size of 1,756 patients (assuming a 10% rate of patients lost to follow-up) is needed to show noninferiority with 80% power. Noninferiority based on exponential survival curves will be declared if the upper limit of the 1-sided 97.5% confidence interval for the hazard ratio is lower than 1.24, corresponding to a noninferiority margin of 7% in absolute difference and an event rate of 40% in the INV group.
Conclusion: EVAOLD is a nationwide, prospective, open-label trial testing the noninferiority of a strategy of selective invasive management guided by ischemia stress imaging versus routine invasive strategy in elderly NSTEMI patients.
期刊介绍:
The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.