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.

项目总结/摘要 医疗和侵入性方法的健康效果比较国际研究 （缺血）延长随访（EXTEND）是对随机化存活受试者的长期随访 在缺血。这项由NHLBI支持的试验将5,179名稳定性缺血性心脏病患者随机分为 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）， 可行时进行血运重建加基于指南的药物治疗（GBMT），或2）初始保守治疗 GBMT战略。该试验并未证明初始侵入性治疗的主要终点降低 战略围手术期心肌梗死（MI）过多，自发性MI减少 在INV组。先前的证据表明自发性MI具有较高的后续死亡风险 而不是围手术期心肌梗死心血管（CV）死亡率曲线出现晚期分离， 缺血中位随访时间为3.2年。INV策略的MI发生率总体降低并没有 直到2年后才出现。因此，根据观察到的自发性MI减少，必须 确定长期生命状态，为患者和临床医生提供关于INV策略是否有效的强有力证据 长期减少CV和全因死亡。预计有728例CV死亡（总计1000例）， 检测组间差异的充分把握度。同样重要的是要提高周围的精度 点估计，以排除一个好处，如果不存在。无论研究结果如何， 数据对临床指南和实践具有巨大的影响，正如独立专家所证实的那样， 编写和监督国家指导方针的制定，并由世卫组织提供支持信。我们还将 量化非致死性CV事件对缺血-延长期患者后续死亡率的影响，构建风险 使用基线深度表型数据进行死亡率评分，并提供INV对 最高风险亚组-患有严重冠状动脉疾病的患者， 推荐冠状动脉旁路移植术（CABG）以提高生存率。我们已经获得了所有必要的批准， 99%的同意。我们准备对死亡进行长期随访，包括死亡原因， 存活的参与者，中位随访时间为10年。我们将通过参与者/代理人确定生命状态 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 数据库。受试者最后一次联系日期、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。我们出色的参与者保留率， 在初始试验阶段遵守方案，数据完整性和质量，以及我们随后的 随着所需的批准和同意得到落实，研究取得了进展，这使人们相信研究将实现其目标。