Invasive methods such as cardiac catheterization and revascularization did not perform better than drug treatment in patients with stable ischemic heart disease, according to a large international study.
Results of the international ISCHEMIA trial, which involved 5100 patients, were presented at the American Heart Association’s Scientific Sessions 2019 in mid-November.
Patients with stable ischemic heart disease and moderate-to-severe ischemia were randomized to routine invasive therapy versus medical therapy.
In the routine invasive therapy group, patients underwent coronary angiography and percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). In the medical therapy groups, patients underwent coronary angiography only where there was a failure of medical therapy.
Most enrolled participants with normal renal function first underwent blinded coronary computed tomography angiography to exclude those with left main coronary artery disease (CAD) and without obstructive CAD.
All of the study’s participants received secondary prevention that included lifestyle and pharmacologic interventions, lead study author Judith Hochman, MD, cardiologist at NYU Langone Health, wrote. The authors did not list the specific medical therapy or pharmacologic interventions provided.
The patients, which were followed for more 3 years, had a mean age of 64 years. The average percentage of those with diabetes was 41%.
Over the entire follow-up period, cardiac catheterization was performed in 96% of the invasive group versus 28% of the medical therapy group. Coronary revascularization was performed in 80% of the invasive group versus 23% of the medical therapy group.
The primary outcome of cardiovascular death, myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure at 3.3 years occurred in 13.3% of the routine invasive group compared with 15.5% of the medical therapy group.
Invasive therapy was associated with harm within the first 6 months and benefit within 4 years.
“Among patients with stable ischemic heart disease and moderate-to-severe ischemia on noninvasive stress testing, routine invasive therapy failed to reduce major adverse cardiac events compared with optimal medical therapy. There was also no benefit from invasive therapy regarding all-cause mortality or cardiovascular mortality/myocardial infarction,” the study authors wrote.
“Invasive therapy for stable ischemic heart disease patients needs to be carefully considered in the context of angina burden and background medical therapy,” they concluded.
1. International Study of Comparative Health Effectiveness With Medical and Invasive Approaches–ISCHEMIA. Presented by Judith S. Hochman at the American Heart Association Annual Scientific Sessions (AHA 2019), Philadelphia, PA. November 16, 2019.