The $ 100 million trial presented on Saturday at the annual meeting of the American Heart Association before being published in a peer-reviewed journal is the latest entry into a long and controversial argument about how to treat arterial obstruction, one of which He discovered the powerful factions of the American heart specialists against one another. This is a repetition of such a study 1
2 years ago, which has been heavily disputed by interventional cardiologists, physicians performing invasive procedures.
"This is an important event that people will talk about and write about for years to come," says Elliott Antman, a cardiologist from Brigham and Women's Hospital who does not participate in the study and praises him for the richness of the information collected and the rigor and complexity of analyzes.
"The ISCHEMIA trial shows that an early invasive approach does not protect patients against death or the overall chance of heart attack, but effectively relieves chest pain – the more breast pain a patient has, the greater the likelihood that they will benefit from it. "Says Antman.
The ability to implant stents using a catheter inserted through the blood vessels into the arm or groin has transformed cardiology over the last three decades. It is clearly demonstrated that stents save the lives of people suffering from a heart attack.
But as cardiac drugs such as statins have improved, there is an active debate about whether stents and other invasive procedures are more effective for people who are not in a heart attack but have a stable heart disease – generally defined such as obstructed arteries, sometimes accompanied by chest pain or angina when exercised.
A major study more than a decade ago found stents did not work better than medicines, but it provoked criticism and the proper use of stents has become one of the most heated debates in medicine – in part because so much is at stake. Coronary heart disease affects 17.6 million Americans; stent companies are multi-billion dollar businesses; procedures are a major stream of income to interventional cardiologists and hospitals; and many people who have stents credit their health for the procedure.
"If you go to the big medical centers that do these procedures, you really talk to anyone and they say that after many unusual stress tests, there is a rush to schedule a cardiac catheterization because people are afraid of being at immediate risk of cardiac catheterization. stroke or sudden death, "says Judith Hohman, senior associate professor of clinical sciences at New York University's Grossman School of Medicine and head of the trial. The new results show that "there is absolutely no risk of trying drugs and seeing if the patient improves – they may become angina-free, and if not, then they have to decide if they want to take medication and have angina. time "or have a more invasive procedure.
The new study is intended to conclusively address the question of whether stents are better for patients with stable heart disease – and may change the way tens of thousands of hospitals are treated, transform how cardiologists talk to patients about their options and save hundreds of millions of dollars in health care costs each year.
About 500,000 heart stent procedures are performed annually in the United States, and researchers estimate that about one-fifth of them are for people with stable heart disease. Of those, about a quarter – or about 23,000 procedures – are for people with no chest pain. If these procedures were avoided, according to researchers, this could save about $ 570 million each year. But the researchers believe this is a conservative assessment, and as doctors and patients discuss options, even more procedures may be delayed or missed depending on each patient's circumstances, preferences, and activity level.
Doctors "have very strong emotional beliefs, and they practice in a way that sends those patients straight to the lab for generations, and that won't change overnight," says John Spertus, a cardiologist at St. Luke's Heart Institute of America and one of the study leaders. "I think it is incredibly important in this age where we are trying to improve the value of healthcare, to improve patient outcomes at a lower cost."
But the debate over the results of the process began before it even ended. More than a year ago, there was heated debate and criticism on social media pages in medical journals. Critics have compared the change in test design to the shifting of the goals to the goals in the middle and feared that this would make the results of the process difficult to interpret.
A year ago, one of the test leaders, Shripal Bangalore of New York's Langon Health University, said in an interview that researchers spend considerable time trying to decide how to respond to criticism and misinformation on Twitter.
"What we felt was that it was different, unprecedented in some way, because the test was not complete. No one knows the results. We spent literature lly hundreds of hours discussing this when we were in the midst of having a difficult test – trying to deal with this thing on social media, "Bangalore said.
The debate can now begin on the evidence. More than 5000 patients with moderate to severely stable heart disease from 320 sites in 37 countries were randomly assigned following a stress test showing heart disease. Half received self-medication and lifestyle and the other half received stents or bypass surgery plus medicine. There was a slight shift in the experience of the two groups of five disease-related events during the trial: in the first year, people who received an invasive strategy were at a slightly higher risk of cardiac output than those of the medicine itself. By the end of the four-year trial, they were at a slightly lower risk of cardiac output. The researchers found that this did not lead to a significant difference between the overall incidence of clinical events between the two groups. They hope to follow patients for another five years.
The new study, Antman said, will provide patients and physicians with a solid framework for discussing the benefits and risks. For example, an adult patient with stable heart disease who is not very active but suffers from some chest pain may decide to take drug therapy. A younger patient who has more frequent chest pain that interferes with active daily life might choose an invasive strategy.
"As a clinician, I would feel comfortable advising my patient not to undergo an invasive strategy if angina is absent or controlled or tolerated. I would feel good – sometimes you struggle with that decision, "says Alice Jacobs, a professor of medicine at Boston University Medical School who did not participate in the study.
Barry Brady, 69, of Hollister, California, had several difficulties sign up for the test and was glad to be in the medical treatment group Brady suffered a heart attack in 2008 and received four stents that saved his life. In 2016, he went to his doctor, feeling lethargic. and poor cardiac studies have shown that blood his blood pressure and cholesterol were dangerously high, and his echocardiogram (ECG) "did not perform so well," Brady recalled. by switching to a predominantly vegan diet, taking pills and continuing with exercise, including using an elliptical machine three times a week and golf, he said he felt much better – and was glad he avoided more extreme interventions.
"It's so invasive to me that I just didn't feel like I wanted to relive it," Brady said. "I thought if I could just do it through diet, medication and exercise, it would be so much better."
He was able to hike in Bryce Canyon National Park and take a golf trip to Hawaii, and said that while diet changes took some discipline, they were relatively easy considering the benefits he felt in energy. your levels.
"We want patients to understand that it is good to take a break and it is not urgent to have a procedure," said David Maron, director of preventive cardiology at Stanford University, one of the study leaders. "It is important for physicians to understand how symptomatic the patient is – and what the patient deserves to go forward and do the procedure."