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。

IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Gilles Barone-Rochette, Gerald Vanzetto, Nicolas Danchin, Philippe Gabriel Steg, Olivier Hanon, Clemence Charlon, Sandra David-Tchouda, Gaetan Gavazzi, Tabassome Simon, Jean-Luc Bosson
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引用次数: 0

摘要

研究背景老年无 ST 段抬高心肌梗死(NSTEMI)的治疗仍具有挑战性,尤其是常规血管重建的获益/风险平衡仍不确定:EVAOLD是一项多中心、前瞻性、开放标签试验,在年龄≥80岁的NSTEMI患者中开展2个平行臂试验。试验的目的是检验与常规有创治疗策略(INV 组)相比,缺血应激成像指导下的选择性有创治疗策略(IMG 组)在预防重大心脏和脑血管不良事件(MACCE,即全因死亡、非致死性心肌梗死、非致死性卒中)方面的效果是否优于常规有创治疗策略(INV 组)。此外,还将进行老年评估和成本效益分析。需要 1756 例患者的样本量(假设失去随访的患者比例为 10%)才能以 80% 的功率显示非劣效性。如果危险比的单侧 97.5%置信区间的上限低于 1.24,即非劣效性绝对差值为 7%,INV 组的事件发生率为 40%,则将宣布基于指数生存曲线的非劣效性:EVAOLD是一项全国范围内的前瞻性开放标签试验,检验了在缺血应激成像指导下选择性有创治疗策略与常规有创治疗策略在老年NSTEMI患者中的非劣效性:NCT03289728。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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.

Clinicaltrials: gov Identifier: NCT03289728.

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来源期刊
American heart journal
American heart journal 医学-心血管系统
CiteScore
8.20
自引率
2.10%
发文量
214
审稿时长
38 days
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.
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