July 9, 2020 by Carol Higgins
‘Stents vs. Drugs’ Debate: Shared Decision-Making for Best Outcomes
Recent headlines across the nation have referred to a major new study that compared procedures to unclog blocked arteries using stents to a medication-only approach. “Stents vs. drugs” is a new phrase being bandied about.
The study found that people with stable heart disease, often without chest pain, had the same rate of major health events, such as heart attacks and hospitalizations from heart failure, after stent procedures as patients who received only medications, such as aspirin or statins, along with advice on lifestyle changes.
However, the U.S.-funded, international study also found that patients with symptoms of angina — the chest pain caused by restricted blood flow to heart muscle — had better symptom relief and quality of life that persisted for four years as a result of stent procedures.
Percutaneous Coronary Intervention (PCI), formerly known as angioplasty with stent, uses a catheter (a thin flexible tube) to place the stent, a tiny tube made of either metal or plastic, to open up blood vessels in the heart that have been narrowed by plaque buildup, a condition known as atherosclerosis. The study found that PCI is still beneficial for reducing angina in stable heart disease patients.
What is the main takeaway from this major study for heart disease patients?
A more extensive “shared decision-making” between patients and their multidisciplinary medical teams should take place before treatment is applied, whether it involves PCI or solely medication therapy, says Marcus St. John, M.D., an interventional cardiologist and medical director of the Cardiac Catheterization Lab at Miami Cardiac & Vascular Institute.
“If you have options, then we need to discuss them with the patient, so-called shared decision-making,” explains. Dr. St. John. “There’s the conservative approach, which may involve taking more medicines and making lifestyle changes including a healthier diet and an exercise program, but there still may be a need for a PCI in the future. The invasive approach does have some upfront risks because there are some possible complications from having a PCI. But PCI is good mostly for reducing angina and it can do that better than medication in some patients.”
The study randomly assigned 5,179 patients at 320 sites in 37 countries to receive one of the two treatment strategies. That makes it more than twice as large as any previous study of its kind. The study was led by researchers at NYU Grossman School of Medicine and Stanford University. The data management and statistics was handled by the Duke Clinical Research Institute (DCRI).
“It’s important to note that the study did not apply to patients who had recently had or were having a heart attack, and it did not include very symptomatic patients with chest pain at rest or during minimal activity,” points out Dr. St. John.
The study was funded by the National Heart, Lung, and Blood Institute and it goes by the short title of ISCHEMIA, which stands for International Study of Comparative Health Effectiveness with Medical and Invasive Approaches.
ISCHEMIA involved patients with stable ischemic heart disease (SIHD), which occurs when not enough oxygen-rich blood is supplied to heart muscle. Most patients in the study had moderate or severe ischemia caused by atherosclerosis, cholesterol deposits that narrow arteries. Ischemic heart disease affects 17.6 million Americans, resulting in about 450,000 deaths annually.
Patients should not feel “pushed into one position or another” — the invasive approach vs. medication only, says Dr. St. John.
“This is a reasonable study that says you can do quite well with an invasive approach and you are likely to be on fewer anti-angina medicines,” he adds. “But if you prefer not to undergo the procedure, we’re not increasing your risk of death. Having these options is important.”