ISCHEMIA: Internation Study of Comparative Health Effectiveness with Medical and Invasive Approaches

Project Description

Primary objective is to determine whether an invasive (INV) strategy of routine early cardiac catheterization with intent for optimal revascularization in addition to optimal medical therapy in patients with stable ischemic heart disease (SIHD) and at least moderate ischemia on stress imaging reduces the incidence of the composite of cardiovascular death or nonfatal myocardial infarction compared with a conservative (CON) strategy of optimal medical therapy alone with cardiac catheterization and revascularization reserved for patients with refractory angina, acute coronary syndrome, acute ischemic heart failure or resuscitated cardiac arrest. 
Secondary objective is to determine whether an INV strategy is more effective than CON strategy in improving angina control, as assessed by the Seattle Angina Questionnaire (SAQ) Angina Frequency scale, and disease-specific quality of life, as assessed by the SAQ Quality of Life scale.
Other secondary objectives include comparing the incidence of the composite of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure; individual components of this endpoint; all-cause death; stroke; as well as comparing health resource utilization, cost, and cost-effectiveness between the two randomized strategies.