September 3rd, 2014
FAME 2 at 2 Years: Better with Time?
CardioExchange Editors, Staff
Two years ago at the ESC meeting in Munich, initial findings from the FAME 2 randomized trial, which was stopped early for apparent benefit, were presented and simultaneously published in the New England Journal of Medicine. In a blog for CardioExchange, Rick Lange and David Hillis posed 7 concerns about the trial and asked, “Should we be performing PCI in all stable CAD patients who have abnormal FFR?”
Now, the FAME 2 investigators have presented and published their 2-year findings:
|
Endpoints |
PCI + Medical Therapy |
Medical Therapy Alone |
P value |
| Composite of death, MI, or urgent revascularization |
8.1% |
19.5% |
<0.001 |
| Death |
1.3% |
1.8% |
0.58 |
| Myocardial infarction |
5.8% |
6.8% |
0.56 |
| Urgent revascularization |
4.0% |
16.3% |
<0.001 |
The numbers have changed, but the between-group differences are largely the same.
Asked to comment, Hillis responded:
It is interesting that FFR-driven PCI reduced only the need for urgent revascularization, not the other components of the combined primary end-point. One could argue that this is not terribly surprising, since these flow-limiting stenoses will probably be more likely than less severe ones to cause limiting symptoms that do not respond adequately to medical therapy, thereby requiring revascularization.
What do you think? Are the 2-year findings more convincing than the 7-month findings?
To view all of our coverage from the ESC meeting, go to our ESC.14 Headquarters page.
5 Responses to “FAME 2 at 2 Years: Better with Time?”
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No, I agree with Dr Hillis that FFR-driven PCI reduced only the need for urgent revascularization, not the other components of the combined primary end-point. This could be explain for the severity of the stenoses but other explanation is the possibility presented by Dr. Sanjay Kaul “‘unplanned hospitalization leading to urgent revascularization’ might be biased in favor of the FFR + PCI treatment group. This is especially relevant given that nearly half of the urgent revascularizations were driven by symptoms alone without objective evidence of ischemia or injury”
Many physicians, cardiologists and non-cardiologists, and some of their patients, are not comfortable treating severe stenoses without revascularization. Although the patients may have been randomized, there remained a strong bias to PCI, I suspect. Therefore, the results become a self fulfilling prophecy. Without a benefit for MI or death, the benefit for PCI is limited to symptom relief. We already knew that after COURAGE.
The benefit of FFR +PCI strategy in reducing urgent revascularization in controversial as the revascularisation was performed for not MI, but for symptoms. These subjects knowing about their coronaries status might chose PCI because of various reasons: might have psychologically driven chest discomfort, there is third party coverage. Knowing the status of coronaries which are stenosed and not corrected might put them in agony and discomfort and look for reasons to open it. Similar behaviour is also obvious in cardiologist too and they go for revascularisation. So, it is still unclear whether the FFR + PCI strategy is beneficial.
If clinical cardiologist was aware of FFR results and patient became aware of same, that would introduce significant bias to hospitalize any possible change in symptoms with PCI of known significant lesions. How often was repeat FFR measured and was a change the cause of the increase in symptoms?
FAME 2 results retierate the fact, that the value of PCI in stable ischemic heart disease lies only in improvement of symptoms. However, the generalizability of the fact that a patient with 70-80% proximal LAD with symptoms is going to have same long term prognosis as a patient with 80% distal LAD (Based on COURAGE and BARI2D trials) is a difficult concept to digest. In addition, as far as FAME 2 results are concerned, it shows that the only benefit of revascularizing any lesion as a matter of fact is improvement in urgent revascularization rates.
I wonder, if anyone has input, Are outcomes in terms of long term development of incident HF looked at in patients who got revascularized + OMT vs. just OMT (in patients with SIHD with normal EF)
With results of FAME2, I also wonder what the results of ISCHEMIA trial are going to be. The end points of the trial include cardiovascular death/nonfatal MI. Now FAME 2 did exactly the same thing pretty much
( Revascularization based on ischemia on invasive testing) which ISCHEMIA is planned to do non-invasively (Revascularization Mod-severe ischemia on non invasive testing). The major difference is blinding as patients are randomized based on ischemia burden and not on angiographic findings. I guess, ISCHEMIA trial will help us to determine how much the familiarity of angiographic findings to the patient confounded the results of FAME2.