FREEDOM Trial Results Misleading at AHA

The American Heart Association Sessions are underway in Los Angeles, California this week, presenting a record 28 late-breaking trials, many with potential to impact clinical practice. Director of the Cardiac & Interventional Laboratories at Oklahoma Heart Institute, Dr. Wayne Leimbach is attending sessions and reporting findings as they break. One trial receiving early attention and discussion is the FREEDOM trial, a study of 1,900 diabetic patients with multivessel coronary disease comparing results of bypass surgery to drug-eluting stents.

Combining the outcomes of death, stroke and heart attack over five years, the FREEDOM trial results showed a decrease among those who had the bypass surgery versus multivessel stenting. Dr. Leimbach explains there are some factors that need to be more clearly stated to understand these results accurately.

Of the more than 30,000 patients screened, only 1,900 were randomized for the trial, a narrow sub-category for results to change clinical practice.

The trial looked predominately at triple vessel disease patients with 83 percent of patients having triple vessel disease (three of the major arteries pumping blood to the heart have blockage) and the remaining 17 percent of patients having double vessel disease. The study does not answer the question regarding recommending bypass surgery or stenting for single or double vessel disease patients. Many of these patients don’t choose to have bypass surgery and did not in this trial.

Dr. Leimbach recommends diabetic patients with triple vessel disease patients, who are eligible for surgery, should preferentially be treated with bypass surgery following a diagnostic catheterization. However, single and double vessel disease patients should discuss the option of stenting with their doctor, as this procedure is effective and carries less risk if subsequent stenting is required (versus the risks of multiple bypasses).

Dr. Leimbach warns we don’t have long-term data for greater than 10 years on coronary artery bypass grafts. If additional bypass surgeries are required to replace grafts, Dr. Leimbach says the risk for multiple bypasses are much greater than multiple stenting.

Bypass surgery costs more than stenting.

How will the FREEDOM trial influence treatment recommendations for patients with coronary artery disease? Dr. Leimbach agrees those with the worst CAD, or triple vessel disease should be recommended and treated with bypass surgery, which he says is the current practice at Oklahoma Heart Institute. However, for those with less severe CAD, drug-eluting stents provide an effective, less invasive option to maintain healthy blood flow to the heart. Always discuss your specific situation with your physician to best understand your options and which treatment plan is best for you.