For patients with moderate to severe reversible ischemic cardiac disease, does adding an initial invasive strategy to optimal medical therapy reduce mortality more than optimal medical therapy alone?
We all die of something. An early invasive strategy for patients with moderate to severe ischemic heart disease does not reduce mortality; at best, it shifts mortality from cardiovascular to noncardiovascular for those with multivessel disease.
Randomized controlled trial (single-blinded)
The ISCHEMIA trial randomized 5179 patients with moderate to severe reversible ischemic coronary artery disease to receive initial therapy with angiography plus revascularization (75% percutaneous coronary interventions, 25% bypass surgery) and optimal medical therapy or to optimal medical therapy alone. Patients with left main stenosis, an ejection fraction of less than 35%, recent acute coronary syndrome, or angina that could not be treated medically were excluded. Groups were balanced at the start of the trial and analysis was by intention to treat. Approximately 80% of patients in the early intervention group were revascularized, while only 23% of patients were ultimately revascularized because they failed medical therapy. The original report after 3.2 years found no difference in mortality between groups. This report extends the follow-up to a median of 5.7 years. All-cause mortality was identical between groups (hazard ratio [HR] 1.0; 95% CI 0.85 - 1.18). Although cardiovascular death was less likely for those in the initial invasive group (HR 0.78; 0.63 - 0.96), noncardiovascular mortality was more likely (HR 1.44; 1.08 - 1.91). These mortality numbers were driven by the patients with at least 70% obstruction of 2 or more vessels. For the 48% of patients who did not have multivessel disease there was no difference in all-cause, cardiovascular, or noncardiovascular mortality between groups.
Mark H. Ebell, MD, MS
University of Georgia