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: 10611880
• 负责人: Judith S Hochman
• 金额: $ 191.12万
• 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/10611880
• 关键词: Adherence; Anatomy; Angiography; Arteries; Biological Markers; Cardiac Catheterization Procedures; 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; Electrocardiogram; Electronic Mail; Event; Failure; Follow-Up Studies; Goals; Guidelines; Health; Health Policy; Heart; Heart Arrest; Heart Diseases; Heart failure; Hospitalization; International; Intervention; Investments; Ischemia; 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; Phase; Phenotype; Practice Guidelines; Procedures; Protocol Compliance; Protocols documentation; Proxy; Quality of life; Randomized; Recommendation; Research; Risk; Scientist; Secure; Selection for Treatments; Societies; Source; Stents; Stress Tests; Subgroup; Symptoms; Telephone; Testing; Unstable angina; Vascularization; Vital Status; Writing; acute coronary syndrome; 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; pharmacologic; 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.

项目概要/摘要 医疗和侵入性方法比较健康有效性的国际研究 (缺血) 延长随访 (EXTEND) 是对随机存活参与者进行的长期随访 这项由 NHLBI 支持的试验将 5,179 名患有稳定缺血性心脏病的参与者随机分组。 两种不同的管理策略：1）心导管插入术的初始侵入性策略（INV）和 可行时进行血运重建加上基于指南的药物治疗 (GBMT)，或 2) 初始保守治疗 GBMT 策略并未证明初始侵入性治疗可降低主要终点。 围手术期心肌梗死 (MI) 过多，自发性 MI 减少。 在INV组中，先前的证据表明自发性心肌梗死具有较高的随后死亡风险。 与围手术期 MI 相比，心血管 (CV) 死亡率曲线出现较晚的分离。 ISCHEMIA 随访中位数为 3.2 年，但 INV 策略并未降低 MI 发生率。 直到 2 年后才会出现。因此，根据观察到的自发性心梗的减少，有必要进行治疗。 确定患者的长期生命状态，并提供关于 INV 策略是否可行的有力证据 长期减少心血管死亡和全因死亡 预计有 728 例心血管死亡（总共 1000 例）。 足够的能力来检测组间差异同样重要的是提高周围的精度。 无论研究结果如何，都需要进行点估计以排除任何益处（如果不存在的话）。 正如独立专家所确认的那样，数据对临床指南和实践具有巨大影响 我们还将编写并监督国家指南的制定，以及谁提供了支持信。 量化非致命性 CV 事件对 ISCHEMIA-EXTEND 中后续死亡率的影响，构建风险 使用基线深层表型数据对死亡率进行评分，并提供 INV 对死亡率影响的估计 最高风险亚组——当前实践指南针对的患有严重冠状动脉疾病的人群 建议进行冠状动脉搭桥术（CABG）以提高生存率。我们已获得所有必要的批准和批准。 99% 的人同意，我们已准备好对超过 99% 的人进行死亡跟踪，包括死因。 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，或通过搜索高质量的国家/地区健康/死亡信息 参与者最后联系日期、死亡日期、死亡原因和信息来源将是 收集并输入基于网络的电子数据采集系统， 在初始试验阶段以及后续阶段遵守方案、数据完整性和质量 取得必要的批准和同意后取得进展，可以确保研究将实现其目标。