Results suggest that a subset of high-risk patients may benefit from an initial invasive treatment strategy.
The ISCHEMIA trial made headlines last year at the American Heart Association 2019 Scientific Sessions, where primary results were presented indicating that invasive heart procedures may not reduce the chance of experiencing a major, disease-related event for patients with severe but stable heart disease.
A sub-analysis led by the DCRI drilled down further into the data, and results presented today at the European Society of Cardiology (ESC) Congress 2020 suggest that an invasive approach may help a small subset of patients—those with stable ischemic heart disease, at least moderate ischemia, and a history of heart failure or left ventricular dysfunction. These findings were published simultaneously in Circulation.
Of the 5,179 patients randomized into the ISCHEMIA study, 7.7 percent had heart failure or left ventricular dysfunction at baseline. These patients were likely to have more comorbidities than other patients in the study and were more likely to experience major cardiovascular events ranging from hospitalization for unstable angina to cardiovascular death or heart attack.
“Ischemic heart disease is a common cause of heart failure, and heart failure puts these patients at a higher risk for adverse events,” said DCRI’s Renato Lopes, MD, PhD, who led the study, presented the results at ESC 2020, and was a member of the trial steering committee. “Although the number of patients that fell into this population was relatively small in this trial, we knew it was important to look closely at this question to guide our treatment of this high-risk group.”
In the study, patients were randomized to an invasive treatment strategy or a conservative one. Those patients with heart failure or left ventricular dysfunction assigned to the invasive strategy had a lower rate of cardiovascular death (17.2 percent) versus those with the same medical conditions assigned to the conservative strategy (29.3 percent). There was also a 12.1 percent difference in the 4-year event rate between the two groups. In the patients who did not have heart failure or left ventricular dysfunction, there was no significant difference in event rates between the conservative and invasive strategies.
“These results, although hypothesis-generating, suggest that an initial invasive approach may improve event-free survival in patients with heart failure or left ventricular dysfunction,” Lopes said. “This deserves further study, and we hope these results generate future investigation. These patients will benefit from diligent efforts to optimize evidence-based medical therapy.”
This analysis was conducted in collaboration with the NYU School of Medicine Cardiovascular Clinical Research Center, NYU Langone Health and Stanford University. DCRI’s Karen Alexander, MD, also contributed to this study, with DCRI’s Frank Rockhold, PhD, and Susanna Stevens, MS, providing statistical support. The study was supported by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health.