Researchers at NYU Grossman School of Medicine and Stanford University say that recently released findings from the landmark International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) study reveal that there is no evidence of lower cardiac event rates in patients with percutaneous coronary intervention (PCI), but the medical procedure offered a better quality of life.
After 12 years of collecting data, the study’s findings, released on November 19, 2019, showed that patients significant, but stable, coronary artery disease are better off with lifestyle changes and medications when compared to stents or bypass surgery. However, those patients who underwent revascularization procedures felt better and reported a better quality of life, the study found.
The late-breaking research international trial was presented Nov. 16 at the 2019 American Heart Association (AHA) scientific sessions. The researchers found that patients that underwent routine, invasive procedures—such as PCI stent implants or coronary artery bypass graft (CABG) surgery fared no better than patients that received only medications. This included optimal medical therapy (OMT) such as aspirin and/or statins, and lifestyle advice. Data show no reduction in the rate of occurrence for a group of five events: cardiovascular death, heart attack, hospitalization for unstable angina, hospitalization for heart failure, or resuscitation after cardiac arrest.
The research trial, which began in 2012, also compared the two treatment strategies in terms of their ability to provide symptom relief from angina and quality of life improvements. The study, funded by the National Heart, Lung, and Blood Institute (NHLBI) randomly assigned 5,179 patients in 37 countries to receive one of the two treatment strategies, making the collaborative effort twice as large as any previous study of its kind. The study provides important new considerations for physicians and patients as they make treatment decisions together based on each patient’s symptoms, disease severity, and preferences.
Looking at the Data
“In line with evidence from prior studies, our results suggest that routine use of heart procedures was not superior in reducing risk for the five-part disease endpoint or death overall compared to treatment only with optimal medical therapy,” says Judith Hochman, M.D., ISCHEMIA study chair, who presented the data at AHA. She is the Harold Snyder Family Professor of Medicine and Senior Associate Dean for Clinical Sciences at NYU Langone Health. “On the other hand, patients symptomatic to start that got heart procedures, over the years, had fewer symptoms and felt better,” she adds.
According to the researchers, by the second year, the event rate for the study disease endpoints was roughly the same between the two approaches (9 percent versus 9.5 percent). After four years, the rate of events was two percentage points lower in patients treated with heart procedures than in those that received medications and lifestyle advice alone (13.3 percent with invasive versus 15.5 percent), they say, noting that this trend shifts over time showed no significant evidence of a difference in rates between strategies.
The research team expressed surprise to see that the overall rate of heart-related events over the duration of the ISCHEMIA trial was lower than projected 10 years ago. They believe that this is a sign of evidence to recent advances in drug therapies and revascularization techniques.
“Based on our results, we recommend that all patients take medications proven to reduce the risk of a heart attack, be physically active, eat a healthy diet, and quit smoking,” says ISCHEMIA co-chair David Maron, M.D., director of preventive cardiology and the Stanford Prevention Research Center at Stanford University. “Patients without angina will not see an improvement, but those with angina of any severity will tend to have a greater, lasting improvement in quality of life if they have an invasive heart procedure. They should talk with their physicians to decide whether to undergo revascularization,” adds Maron.
The researchers plan to follow the study patients for another five years, to verify which strategy is associated with better survival over a longer observation period.