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Those who were excluded after consent and enrollment are indicated in the right side box. Incidental findings were defined as incidental findings on study CCTA of sufficient clinical importance that site investigators did not find randomization appropriate. JAMA Cardiol. Importance It is unknown whether coronary revascularization, when added to optimal medical therapy, improves prognosis in patients with stable ischemic heart disease SIHD at increased risk of cardiovascular events owing to moderate or severe ischemia.
The study included enrolling sites randomizing in 38 countries and patients with SIHD and moderate or severe ischemia on stress testing. Data presented were extracted on December 17, No clinical outcomes are reported. Results A total of patients were enrolled, and were randomized. Randomized participants had a median age of 64 years, with women Among the participants randomized after stress imaging, core laboratory assessment of ischemia severity in participants was severe in Among the of randomized participants who underwent coronary computed tomography angiography, Trial Registration ClinicalTrials.
Prior strategy trials in patients with stable ischemic heart disease SIHD that evaluated routine revascularization added to optimal medical therapy OMT , as compared with an initial conservative strategy of OMT alone, did not show a reduction in death or myocardial infarction MI with early revascularization. Moreover, patients were not selected based on a predefined threshold of baseline ischemia. It is possible that randomization prior to cardiac catheterization to minimize selection bias and inclusion of patients at higher cardiovascular risk such as those with moderate or severe ischemia may increase the likelihood of demonstrating that an initial invasive strategy improves prognosis in patients with SIHD, if any such benefit exists.
The primary aim of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches ISCHEMIA trial is to assess whether, in addition to OMT, an initial invasive strategy of cardiac catheterization and revascularization when feasible reduces clinical events as compared with an initial conservative strategy of OMT, with catheterization and revascularization reserved for failure of medical therapy, in patients with SIHD with moderate or severe ischemia on stress testing.
