Why the study?
The ISCHEMIA trial was conducted to determine the effect of adding cardiac catheterization and revascularization to medical therapy in stable CAD patients with moderate or severe ischemia, addressing uncertainty about the benefit of an initial invasive strategy.
Does an initial invasive strategy reduce the composite of cardiovascular death, MI, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest in patients with stable CAD and moderate or severe ischemia?
Does an initial invasive strategy reduce the composite of cardiovascular death, MI, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest in patients with stable CAD and moderate or severe ischemia?
The authors argue that methodological limitations and changing endpoint definitions in the ISCHEMIA trial make it premature to change current clinical practice for stable CAD patients.
Answers are grounded in this paper and cite their sources.
Initial invasive strategy does not reduce events in stable CAD with moderate-severe ischemia; challenges routine revascularization and reinforces medical therapy first.
Recently, ISCHEMIA trial was published in order to determine the effect of adding cardiac catheterization and revascularization when feasible to medical therapy in patients with stable CAD and moderate or severe ischemia. Over a median of 3.2 years of follow-up, among patients with stable CAD who had moderate or severe ischemia on stress testing, an initial invasive strategy, as compared with an initial conservative strategy, did not reduce the rates of the primary or key secondary composite outcomes. The primary outcome was the composite of death from cardiovascular causes, myocardial infarction (MI), or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. The key secondary outcomes were the composite of death from cardiovascular causes or MI and angina-related quality of life. Patients in the invasive-strategy group had more procedural myocardial MIs, and they had fewer spontaneous infarctions during follow-up. The incidence of death from any cause was low and similar in the two groups. However, the ISCHEMIA trial was challenging to implement, event rates were low and enrollment fell behind initial milestones. Furthermore, power of the study was compromised, composite end-point definition as well as definitions of crucial individual components were changed amid study progression. There was a "heterobaric" combined end-point with procedural MIs favoring the conservative arm and spontaneous MIs favoring the invasive arm. Finally, the duration of reported follow-up showed signals that findings may shift in favor of invasive treatment and results were sensitive to definition and type of MIs. Therefore, we believe that it is premature to change clinical practice in view of the results of ISCHEMIA trial. As stable CAD patients is a vastly heterogenous patient group, it may be prudent to apply common clinical judgement and individual decision-making according to current guidelines before changing our management strategies.
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Tziakas et al. (2020) conducted a review in Stable CAD and moderate or severe ischemia. Initial invasive strategy (cardiac catheterization and revascularization) vs. Initial conservative strategy (medical therapy) was evaluated on Composite of death from cardiovascular causes, myocardial infarction (MI), or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.
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