Heart disease is the leading cause of death in the United States, according to the Centers for Disease Control and Prevention, causing one in every four deaths. This broad category, also called cardiovascular disease, includes conditions that damage the heart’s structure or its ability to pump enough blood, as well as conditions affecting arteries and veins throughout the body. As many other organizations do, PCORI considers this category also to include stroke, a condition in which blood flow to the brain is blocked, impairing brain function.

PCORI-funded studies are comparing strategies designed to improve care for people with heart disease and improve their quality of life, providing the information that can empower them to make better-informed decisions about their healthcare options. To date, PCORI has invested $195 million in 51 such patient-centered comparative clinical effectiveness research studies and related methods projects to advance that work.

Treating Disease, Maintaining Quality of Life

Here are some examples of PCORI-funded studies that compare treatments for heart disease:

• Researchers have compared the benefits and risks of several types of medications that people often take after having a stroke. The Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research study (PROSPER) found that in the first two years after a stroke, patients who took cholesterol-lowering drugs called statins were less likely to have a heart attack and spent more time at home—not hospitalized or in a skilled nursing facility—than patients who didn’t take statins. The researchers also assessed another treatment, the veteran blood thinner warfarin, in patients with atrial fibrillation, an abnormal heart rhythm. In comparing patients who took warfarin with those who did not take a blood thinner, the study revealed an association between taking the drug and better health outcomes, as well as more time at home. All the patients in PROSPER were 65 or older. (Read more about this study in Finding the Keys to a Longer, Better Life after Stroke.)
• Another project compares long-term treatments for preventing blood clots. Patients who have previously experienced a clot in a vein deep in a leg or the pelvis, or in an artery of the lungs, are at high risk for additional blood clots. Such clots can cause a stroke or even death. Researchers are comparing the effectiveness of warfarin and two newer oral drugs (apixaban and rivaroxaban) at reducing the risk of clots. They are also measuring the risk of bleeding introduced by those drugs.
• A study examines all of the five oral blood-thinning drugs now on the market, comparing their safety and effectiveness in long-term treatment of blood clots. The researchers are using patient data from electronic healthcare records in databases that include information on millions of Americans.
• A study involving up to 20,000 people with heart disease seeks to determine which of two daily doses of aspirin is most effective in preventing a recurrence of heart attacks or strokes without causing bleeding problems. The study, called ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness), recruits participants through a patient portal or in their healthcare clinic and randomly assigns them to receive either 81 or 325 milligrams of aspirin daily. The participating clinics are a part of a larger network of hospital systems. That larger network is one of the clinical data research networks within PCORnet, PCORI’s National Patient-Centered Clinical Research Network.

Improving Conversations between Patients and Clinicians

Health outcomes depend, in part, upon how well clinicians and patients communicate.

• One study focuses on how to communicate the risks and benefits of surgery and a less-invasive treatment for patients with aortic valve disease, a heart condition that interferes with heart function. The disease can cause chest pain and fainting, and it may lead to heart failure, in which the heart muscle can’t pump enough blood to the body. Using information collected from large groups of patients, researchers are building a website that will engage patients and clinicians in a personalized discussion of treatment alternatives.
• In another study, researchers are collaborating with patients and healthcare providers to develop a shared decision-making tool for patients who need a stent, a small tube that opens blocked heart arteries. The required surgery, performed 600,000 times a year in the United States, inserts one of two types of stent. The decision-making tool will present information about each type of stent to the patient along with an individualized risk assessment. According to the researchers, less than one-third of patients currently discuss stent choices with their doctors.

Heart disease comes in many forms, but patients share the challenge of finding the treatment plan that provides them with the best outcomes and quality of life. By comparing the effectiveness of treatments, and of how healthcare professionals and patients communicate about healthcare decisions, we can make a difference in the lives of patients with heart disease.

Editor's note: At the time that this blog post was published, Diane E. Bild, MD, MPH served as associate director in the Clinical Effectiveness and Decision Science program. In June 2018, she assumed her current role as Acting Chief Science Officer.