ISCHEMIA-EXTENDed Follow-up

Summary

Participation Requirements

Description

The primary goals of all therapies are to enable patients to feel better and/or live longer. ISCHEMIA provided definitive data on the benefit of INV on quality of life. However, mortality is the most objective and compelling clinical outcome. Strategies that reduce deaths over the long term are of g...

The primary goals of all therapies are to enable patients to feel better and/or live longer. ISCHEMIA provided definitive data on the benefit of INV on quality of life. However, mortality is the most objective and compelling clinical outcome. Strategies that reduce deaths over the long term are of greatest interest to patients and physicians. Long-term follow-up of the ISCHEMIA trial cohort to assess CV and all-cause mortality by treatment group is particularly important given that the primary results show relatively late crossing of the event curves, an overall reduction in spontaneous MI with INV, and late divergence of CV death curves in favor of the INV strategy. DESIGN NARRATIVE, INCLUDING MODIFICATIONS DURING THE TRIAL: We will conduct a long-term ascertainment of CV and all-cause mortality for surviving ISCHEMIA participants. The limited follow-up after the observed reduction in spontaneous MI events suggests that the completed period of follow-up was not long enough to observe a mortality benefit, and makes it imperative to assess long-term CV and all-cause mortality to provide patients and clinicians with robust evidence regarding whether an initial invasive strategy reduces the risk of death years later, as seen in other trials with crossing curves, e.g., STICH, a randomized trial comparing a strategy of surgical revascularization to GDMT alone in patients with SIHD and LVEF <35%. Furthermore, with additional accrual of deaths, we will provide estimates on the impact of INV in the highest risk subgroup, those with coronary artery anatomy for whom current practice guidelines recommend CABG to improve survival (3-vessel CAD and 2-vessel CAD with proximal LAD stenosis). Equally important is to improve precision around the point estimate of the treatment effect for CV and all-cause mortality for the trial overall and in important subgroups to efficiently maximize the substantial investment by of NHLBI, patients, and study teams for relatively small additional investment. Furthermore, understanding of the impact of nonfatal events on subsequent CV and all-cause mortality among patients with SIHD will influence the design of CV clinical trials for years to come. MI is the most frequently occurring endpoint in CV trials and with the ever-increasing sensitivity of biomarker assays for MI, it is of paramount importance to understand the relationship between MI type and definition and subsequent death. The ISCHEMIA-EXTEND dataset will thus afford a unique opportunity to inform patients, physicians, and researchers about multiple aspects of the care of patients with SIHD. Primary Endpoint: CV mortality. Vital status data will be collected in a rigorous manner either 1) from high-quality vital statistics registries, or 2) by contacting participants and their next of kin PARTICIPATING COUNTRIES: North America: Canada; Mexico; USA South America: Argentina; Brazil; Peru Asia: China; India; Japan; Malaysia; Singapore;; Thailand; Russian Federation Pacifica: Australia; New Zealand Europe: Austria; Belgium; France; Germany; Hungary; Italy; Lithuania; Macedonia; Netherlands; Poland; Portugal; Romania; Serbia; Spain; Sweden; Switzerland; UK Middle East: Egypt; Israel; Saudi Arabia Africa: South Africa

Tracking Information