American Heart Association Late-Breaking Clinical Trial Report – Embargoed until 4:58 p.m. PT/ 7:58 p.m. ET
November 04, 2012
Study Highlights:
- Patients with diabetes who have multiple clogged heart arteries fared significantly better when treated with bypass surgery than drug-covered stents.
- These patients were less likely to die or have a heart attack within five years if they underwent bypass surgery compared to treatment with drug-coated stents.
LOS ANGELES, Nov. 4, 2012 — Patients with diabetes 
who have multiple heart blockages fare significantly better if they undergo bypass surgery instead of being treated with drug-covered stents , according to late-breaking trial results presented at the American Heart Association’s Scientific Sessions 2012.
who have multiple heart blockages fare significantly better if they undergo bypass surgery instead of being treated with drug-covered stents , according to late-breaking trial results presented at the American Heart Association’s Scientific Sessions 2012.
The full manuscript for the the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial is published in the New England Journal of Medicine.
Researchers studied1,900 patients with diabetes, about 19 percent of those who underwentbypass surgery suffered a heart attack or stroke or died within five years, as compared to almost 27 percent of those who received a drug-covered stent .
suffered a heart attack or stroke or died within five years, as compared to almost 27 percent of those who received a drug-covered stent .
“These results were very striking,” said Valentin Fuster, M.D., the study’s lead researcher and director of Mount Sinai Heart at the Mount Sinai Medical Center in New York. “In a majority of places in the world, these patients were receiving stents. This is going to change practice.”
The type of patients in the study — those with diabetes and heart disease that affected more than one coronary artery — represents about a quarter of the patients seen in catheterization labs for heart procedures.
In the study, researchers randomly assigned patients at 140 centers globally to receive either bypass surgery or drug-eluting stents, which are tiny, medicine-coated mesh tubes that prop open clogged arteries. All study patients were prescribed medications to control their blood pressure, cholesterol and blood sugar based on current treatment guidelines.
Researchers followed patients’ progress from 2005- 2010. Those undergoing bypass surgery had fewer deaths and heart attacks. However, they had more strokes — 5.2 percent versus 2.4 percent — not enough to negate the net significant benefits of fewer deaths and heart attacks, Fuster said.
Earlier studies in this group of patients showed that bypass was favorable compared to angioplasty. However, many of those studies did not use stents that were covered in medicine that helps prevent the risk of new blockages within the stents themselves.
“But the cardiology community didn’t know if that held true when compared exclusively to newer, drug-covered stents,” said Fuster. “So we are so excited to find the answer.”
In the trial, 29 percent of the patients were female, the average age was about 63 years and the average time since receiving the diagnosis of diabetes was about 10 years. The majority, 83 percent, had coronary disease in three arteries.
“We always want to know how long the effects last.” Fuster said. “The gap could begin to close or the results could get better and better. So, longer follow-up is critical.”
His team is seeking additional funding to continue follow-up of these patients.
Co-author is Michael E. Farkouh, M.D.
The National Institutes of Health funded the study.
Disclosures are here http://newsroom.heart.org/pr/aha/document/DISCLOSURES.pdf
