UMKC School of Medicine researcher John Spertus, M.D., M.P.H., is part of two large NIH-funded clinical studies published in the New England Journal of Medicine, Monday, March 30. The studies indicate eliminating unnecessary revascularization treatments for cardiac patients could save the United States hundreds of millions of dollars annually.
Spertus serves as professor of medicine and Daniel J. Lauer, M.D., Endowed Chair in Metabolism and Vascular Disease Research at the School of Medicine, and Clinical Director of Outcomes Research at Saint Luke’s Hospital.
The studies looked specifically at coronary artery disease patients who had high-risk blockages with least 10 percent or more of the heart muscle being at risk. One focused on patients with preserved kidney function and the other targeted patients with end-stage kidney failure. That latter group has largely been excluded from almost all cardiovascular trials, despite having a high prevalence of coronary artery disease and death, Spertus said.
Both studies, conducted in unison, examined the most important outcomes for patients, clinical events (e.g. heart attacks, death) and patients’ symptoms, function and quality of life. Participants were randomized to undergo invasive angiography and revascularization with aggressive medical therapy or aggressive medical therapy alone. The goals of the medical treatment were cholesterol reduction, blood pressure control, aspirin and medications to treat chest pain.
The studies in patients with preserved kidney function showed that invasive medical procedures provided no reduction in clinical events, but did improve patients’ symptoms and quality of life, if they had chest pain within a month of entering the trial. These health status benefits were evident within three months and sustained out to four years.
“Importantly, this benefit was only observed in patients who had angina, chest pain, and not in asymptomatic patients,” Spertus said. “There is no indication for these procedures in patients whose symptoms are well-controlled with medications alone. If we avoided revascularization in asymptomatic patients, we could potentially save about $500 million to $750 million a year in the United States alone.”
Among patients with very severe kidney disease, there was no significant difference in clinical events or in patients’ symptoms and quality of life.
“While disappointing, this is a very ill patient population for whom an aggressive, invasive treatment strategy does not seem to offer much benefit,” Spertus said.
The NEJM is publishing four papers from these studies on March 30, one for each trial focusing on the clinical events and another for each trial focusing on the quality of life outcomes. Spertus was involved in writing all four and is the lead author on the two quality of life papers. He and his team designed, analyzed and led the health status, quality of life components of both trials.
Spertus is the author of the Seattle Angina Questionnaire (SAQ) that used in the studies. It is widely recognized throughout the world as the gold standard for quality of life measurement in cardiac medicine.
“Our group has led its use and analyses in multiple studies and quality improvement efforts,” Spertus said. “In light of these findings, the SAQ may start becoming a routine part of clinical care in cardiology.”