December 13th, 2012
Diabetics with Multivessel Disease: FREEDOM with CABG?
FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease), a large NIH-sponsored study presented at AHA 2012 and published simultaneously in the New England Journal of Medicine, showed that diabetics with multivessel disease had lower rates of death and MI with CABG than with PCI, but a higher rate of stroke. Study author Dr. Valentin Fuster answered CardioExchange’s questions about FREEDOM and what it means for patients.
Click here to listen to the original audio interview.
Q: What will you tell your patients with diabetes who would have met inclusion criteria for FREEDOM? How will you help them to understand their options?
A: The problem is that most patients with diabetes who undergo cardiac catheterization already have two- or three-vessel disease. We have to tell the patients prior to the catheterization that the angiogram will probably show disease for which surgical intervention is the option of choice. This is a different approach from what we’ve been doing, which is when catheterization is often immediately followed by a decision to do an angioplasty or insert a stent. Patients need to be informed of their options beforehand.
Q: So the point here is to prevent ad hoc PCI?
A: Yes, it’s beyond whether a patient is a candidate or not. It usually begins in the cath lab. The main reason that people were rejected from our study was because they indicated at the time of the procedure that they would prefer an angioplasty over surgery, which ruled them out as a participant.
Q: What was the nature of the strokes in FREEDOM?
A: Of the patients who had them, 60% of those in the PCI group and 70% of those in the CABG group experienced some degree of disability , and 27% of those in the PCI group and 55% of those in the CABG group experienced a significant degree of disability. The number of strokes was relatively small and they occurred throughout the study, rather than only at the time of the procedure. We actually believe that there were fewer strokes in the PCI group over the long term because they were taking clopidogrel and aspirin together, whereas the majority of the CABG group were taking aspirin alone. We are planning to test this hypothesis.
Q: Was there any heterogeneity in outcome by the diabetes severity?
A: Most of the patients had type-2 diabetes, and the average hemoglobin A1c level was 7.8%, however, there was a large group that had more than 7% and another group that had less than 7%. Regardless of the degree of diabetes control, the results were equal in favor of CABG.
Q: Do you think the results are relevant to patients in their 80s — for whom CABG might be a bigger deal?
A: There were very few patients who were age 80 or older. I would say that at that advanced age the concern of survivorship, myocardial infarction, and stroke are secondary compared with whether or not you can relieve the patient’s angina. For a patient at that age, I would perhaps give a second thought to a stent for specific individuals after full discussion. I’m not necessarily in favor of stenting, but, depending on what your goal is, it should be discussed. If the goal is to relieve angina that might be accomplished with simple stenting.