Clinical trials and other studies provide important data for you and your doctor to consider when you work together to develop a treatment plan for your angina. Doctors and other healthcare professionals use evidence from these studies to develop guidelines for the most effective treatment for patients whose diagnosis, medical history, age, race, and other characteristics and circumstances are similar to those of patients in the study.
What Is COURAGE?
COURAGE is the name of a large study published in 2007. The purpose of the study was to see if patients with stable angina who received angioplasty and stenting felt better or lived longer than patients who received only medication. The results of the study indicated that the people who took the prescribed medication as directed lived just as long as people who received angioplasty and stents. However, these results did NOT apply to patients with unstable angina or a heart attack. It is widely accepted that these patients would benefit from angioplasty and stenting performed as soon as possible. So, given these results, why would you still consider angioplasty and stenting as a possible treatment if you have stable angina?
- For symptom relief—A close look at the results from COURAGE reveals that although the group who received stents did not live any longer than those who were only given medications, many of them experienced more relief from their angina. For the first few years after angioplasty and stenting, some patients in the study, especially those who had angina one or more times a week, felt better, had fewer symptoms, and were able to do more than those patients who did not receive stents. Quality of life is important and improvement of chest pain symptoms should be one goal of therapy. In this case, stenting is superior to medical therapy for the first few years, according to COURAGE.
- Because your age, sex, race, or medical or family history is different from the people in the study—If you are older, a woman, have other serious medical conditions, or are not white, you may have different treatment needs than the patients in COURAGE. These differences may be significant enough that you may not respond to treatment in the same way as the patients in the study.
- You and your doctor decide that angioplasty and stenting is the best treatment for you—How much you weigh, what you eat, and what you do each day make you uniquely you—and that’s not all. You have your own family and medical history. In other words, what works for your brother-in-law or neighbor could be different from what works for you.
- Medications and lifestyle changes are not enough—If you are still suffering from frequent angina after making lifestyle changes and taking medications, you and your doctor may decide to try angioplasty and stenting.
- You cannot, or will not, take all the medications required for optimal results—Patients in the COURAGE study had access to the type and dosages of drugs recommended as optimal medical treatment for angina. If you cannot take the medications as prescribed, for whatever reason, you may need angioplasty and stenting to treat your angina. By treating angina more definitively with stenting, it is possible that you may not require as many long-term medications for your heart.
FAME-2: A Follow Up to COURAGE
COURAGE continues to influence and guide treatment recommendations made by doctors for their patients with stable angina. But like any study, COURAGE raised as many, if not more, questions than it answered. For stable angina patients and their doctors, at least two very important questions remained unanswered:
- Do some patients benefit more than others from angioplasty and stenting?
- How can we identify these patients?
Published in 2012, another large study, called FAME-2, made great progress toward answering these questions. In FAME-2, patients with the most severely blocked arteries were identified with a test called Fractional Flow Reserve (FFR).
FFR uses a carefully calibrated sensor to measure the blood pressure on either side of a blockage. Because a severe blockage restricts the flow of blood, if the artery is severely blocked, the FFR measurement will show that the pressure downstream from the blockage is much lower than the pressure leading to the blockage.
When used in conjunction with a conventional angiogram, FFR helps cardiologists find the most severe blockages and treat them with angioplasty and stenting in addition to medication. Patients who received this treatment in FAME2 were significantly less likely to require emergency revascularization (angioplasty) to stop a heart attack or control symptoms that had became unstable. In addition, they felt better and were less likely to need medications for their angina.
Clinical Trials and Your Angina
COURAGE, FAME-2, and other studies provide doctors and their patients with important information about angina and how to treat it, but they are only one source of information when it comes to planning your treatment. Learn as much as you can about your condition and communicate openly with your doctor and other medical professionals to develop, monitor, and adjust, as necessary, a treatment plan that’s best for you.