The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial EXTENDed Follow-up (EXTEND)

医疗和侵入性方法的比较健康有效性国际研究 (ISCHEMIA) 试验延长随访 (EXTEND)

• 批准号: 10379246
• 负责人: Judith S Hochman
• 金额: $ 198.41万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10379246
• 关键词: Adherence; Anatomy; Angiography; Arteries; Biological Markers; Cardiac Catheterization Procedures; Cardiopulmonary Resuscitation; Cardiovascular system; Categories; Cause of Death; Cessation of life; Clinical; Clinical Research; Comparative Study; Consensus; Consent; Coronary; Coronary Arteriosclerosis; Coronary Artery Bypass; Data; Databases; Development; Effectiveness; Electronic Mail; Event; Failure; Goals; Guidelines; Health; Health Policy; Heart; Heart Arrest; Heart Diseases; Heart failure; Hospitalization; International; Intervention; Investments; Ischemia; Lead; Left Ventricular Dysfunction; Letters; Life Style; Light; Longterm Follow-up; Medical; Myocardial Infarction; Myocardial Ischemia; National Heart, Lung, and Blood Institute; Online Systems; Operative Surgical Procedures; Outcome; Participant; Patients; Persons; Pharmaceutical Preparations; Pharmacology; Phase; Phenotype; Practice Guidelines; Procedures; Protocol Compliance; Protocols documentation; Proxy; Quality of life; Randomized; Research; Risk; Scientist; Secure; Selection for Treatments; Societies; Source; Stents; Stress Tests; Subgroup; Symptoms; Telephone; Testing; Unstable angina; Vital Status; Writing; acute coronary syndrome; base; cardiovascular risk factor; clinical diagnosis; clinical practice; cohort; diagnostic criteria; electronic data capture system; follow-up; healthy lifestyle; heart disease risk; high risk; improved; mortality; mortality risk; participant retention; phenotypic data; primary endpoint; primary outcome; prognostic; prognostic significance; programs; randomized trial; secondary endpoint; survival prediction; treatment group

PROJECT SUMMARY/ ABSTRACT The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) EXTENDed Follow-up (EXTEND) is the long-term follow-up of randomized, surviving participants in ISCHEMIA. This NHLBI-supported trial randomized 5,179 participants with stable ischemic heart disease to two different management strategies: 1) an initial invasive strategy (INV) of cardiac catheterization and revascularization when feasible plus guidelines-based medical therapy (GBMT), or 2) an initial conservative strategy of GBMT. The trial did not demonstrate a reduction in the primary endpoint with an initial invasive strategy. There was an excess of peri-procedural myocardial infarction (MI) and a reduction in spontaneous MI in the INV group. Prior evidence demonstrates that spontaneous MI carries a higher risk of subsequent death than peri-procedural MI. There was a late separation in the cardiovascular (CV) mortality curves, over a median of 3.2 years follow-up in ISCHEMIA. The overall reduction in MI rates with an INV strategy did not emerge until after 2 years. Therefore, based on the observed reduction in spontaneous MI, it is imperative to ascertain long-term vital status to provide patients and clinicians with robust evidence on whether INV strategy reduces CV and all-cause death over the long-term. With projected 728 CV deaths (1000 total) we have adequate power to detect a between group difference. It is equally important to improve precision around the point estimate to rule out a benefit if none exists. Regardless of the study findings, robust long-term mortality data have enormous implications for clinical guidelines and practice, as affirmed by independent experts who write and oversee the development of national guidelines, and who provided letters of support. We will also quantify the impact of nonfatal CV events on subsequent mortality in ISCHEMIA-EXTEND, construct a risk score for mortality using baseline deep phenotypic data, and provide estimates of the impact of INV in the highest risk subgroup – those with severe coronary artery disease for whom current practice guidelines recommend coronary artery bypass (CABG) to improve survival. We have obtained all required approvals and 99% of consents. We are ready to conduct extended follow-up of death, including cause of death, on >99% of surviving participants resulting in 10-year median follow-up. We will ascertain vital status by participant/proxy contact every 6 months via telephone or email, or by searching high-quality national/regional health/death databases. Participant last contact date, date of death, cause of death, and source of information will be collected and entered into a web-based electronic data capture system. Our excellent participant retention, adherence to protocol, data completeness and quality during the initial trial phase, and our subsequent progress, with required approvals and consents secured, assure confidence that the study will meet its goals.

项目摘要/摘要 国际对医疗和侵入性方法比较健康有效性的研究 （缺血）扩展随访（扩展）是随机，幸存的参与者的长期随访 在缺血中。这项NHLBI支持的试验随机分配了5,179名患有稳定缺血性心脏病的参与者 两种不同的管理策略：1）心脏导管插入术的初始侵入性策略（INV） 可行加上基于准则的医疗疗法（GBMT）或2）初始保守的血运重建 GBMT的策略。该试验并未证明主要侵入性的主要终点减少 战略。超过过多的心脏旁心肌梗死（MI）和赞助MI的减少 在Inv组中。先前的证据表明，赞助MI随后死亡的风险更高 比围周的MI。心血管（CV）死亡率曲线的分离很晚 缺血中的3。2年随访。通过INV策略，MI率的总体降低没有 出现直到两年后。因此，基于观察到的赞助MI的减少，必须 确定长期至关重要的状态，可为患者和临床医生提供有关INV策略是否存在的强有力的证据 长期减少简历和全因死亡。预计728 CV死亡（总共1000）我们有 足够的能力来检测群体差异。提高精确度同样重要 如果不存在，则要估计排除利益。无论研究结果如何，强大的长期死亡率 数据对临床准则和实践具有巨大影响，这是受独立专家的影响 编写并监督国家准则的制定，并提供支持信。我们也会 量化非致命CV事件对缺血扩展中随后死亡率的影响，建立风险 使用基线深度表型数据的死亡率得分，并估算了INV在 最高风险亚组 - 患有严重冠状动脉疾病的患者当前实践指南 推荐的冠状动脉旁路（CABG）以提高生存率。我们已经获得了所有需要的批准， 99％的同意。我们准备进行延长的死亡随访，包括死因，> 99％ 幸存的参与者导致了10年中位随访。我们将确定参与者/代理人的生命状况 每6个月通过电话或电子邮件联系一次，或搜索高质量的国家/地区健康/死亡 数据库。参与者上次接触日期，死亡日期，死亡原因和信息来源将是 收集并进入基于Web的电子数据捕获系统。我们出色的参与保留率， 在初始试验阶段遵守协议，数据完整性和质量，以及我们随后的 在获得确保确保的批准和同意的情况下，进步确保了该研究将达到其目标的信心。