November 16, 2019 –The DCRI served as the statistical and data coordinating center for ISCHEMIA, a late-breaking clinical trial that indicated invasive heart procedures may not reduce the chance of experiencing a major, disease-related event for patients with severe but stable heart disease.
The DCRI played an important role as the statistical and data coordinating center for a late-breaking clinical trial presented today at the American Heart Association’s Scientific Sessions 2019.
Results from ISCHEMIA, which were shared today in Philadelphia via four presentations, indicate that invasive heart procedures may not result in lower rates of major, disease-related events for patients with severe but stable heart disease.
DCRI faculty Sean O’Brien, PhD and Karen Alexander, MD, served as co-principal investigators for the statistical and data coordinating center, participating in all of the data structure and cleaning efforts, as well as data analysis and project oversight. The DCRI’s Frank Rockhold, PhD, also supported statistical work on the trial. Data analysis for the data safety monitoring board was provided by Vanderbilt University’s Frank Harrell, PhD.
The DCRI’s Daniel Mark, MD, oversaw the quality of life outcome assessments, in partnership with John Spertus, MD, at Mid-America Heart Institute.
ISCHEMIA, funded by the NIH’s Heart, Lung, and Blood Institute, sought to determine the most effective course of treatment for patients with ischemia, a chronic, symptomatic condition that is characterized by reduced blood flow to the heart muscle. All patients enrolled in the trial received medication and lifestyle advice, but half of patients underwent routine, invasive procedures—such as stent implants or bypass surgery—while the other half did not. Because intervention can be both risky and costly, the goal of ISCHEMIA was to ascertain whether intervention led to improved outcomes for this group of patients.
Trial results showed that patients who received invasive therapy saw no reduction in five disease-related events when compared to patients who received only medications and lifestyle advice. The five events measured were cardiovascular death, heart attack, hospitalization for unstable angina, hospitalization for heart failure, and resuscitation after cardiac arrest.
However, for patients with symptoms of angina, or chest pain, invasive treatments resulted in improved long-term symptom relief and better quality of life.
To learn more about ISCHEMIA and its results, read the news release.