Earlier today, the opening day of EuroPCR, Dr. Bernard De Bruyne presented preliminary results from the FAME II trial which tested the diagnostic power of Fractional Flow Reserve to guide PCI (stenting) of the coronary arteries. I wrote about FAME II back in January, when enrollment in the trial was halted for ethical reasons because the results of the ongoing FAME II trial were showing that the outcomes for stents in patients with stable angina were clearly superior to those in patients who were being treated with medications (a.k.a. Optimal Medical Therapy or OMT) alone. An independent Data Safety Monitoring Board advised that continuing the randomization would not change the findings and so, it was unethical to withhold the option of stents from this patient population.
At the time I wrote that this was “pretty big news!” since the use of stents in stable patients has been a topic of controversy since the publication of the COURAGE Trial back in 2007. And the burning issue of “stent or no stent” gets rekindled every year or so when a new set of Guidelines or Appropriate Use Criteria gets published. Sometimes doctors get accused of over-stenting. Sometimes they lose their licenses and get sued. So wouldn’t it be nice if there were a better, more accurate way to determine whether to stent or not to stent?
Well, according to the original FAME trial and now FAME II, there is. Dr. De Bruyne concluded in his remarks today:
Whether a patient needs PCI, or is better off with medical treatment, the data thus far reveal that treatments based on FFR guidance provide superior outcomes.
A brief mention of the COURAGE Trial is warranted here, since virtually every news story today quotes Dr. De Bruyne as stating, “FAME II is NOT the anti-COURAGE Trial”. Again, I wrote about this in a January post, titled, oddly enough, FAME II Is Not the “Anti-COURAGE”: Stents and Angioplasty in the Spotlight.
Briefly, the differences in the two studies are numerous. Both trials randomized patients to OMT or OMT plus PCI (stenting). COURAGE looked at a wider range of patients with stable angina. The severity of their blockages were judged by angiography alone — no intracoronary pressure measurements via FFR were done. So many of the patients in COURAGE were not as significantly ischemic as the FAME II population. And, as one might expect, there was no significant difference in outcomes between the two groups — which generated headlines like, “Medicines As Good As Stents” and “Stents Unnecessary in Most Heart Patients”, and so on.
Another big difference is that the stents used in COURAGE were the older bare metal stents, which have higher rates of restenosis (re-blocking) than the newer drug-eluting stents, the type used in FAME II.
But the really big difference was that in FAME II, the selection of patients was determined not by angiography alone, but by Fractional Flow Reserve (FFR) measurement. Only patients who had a significant ischemic blockage as measured by FFR were randomized and again, as one might expect, the patients didn’t fare so well on OMT alone.
The presentation today was only a preliminary look at some of the outcomes. The data from FAME II is being analyzed and Dr. De Bruyne told me that more complete conclusions will be presented later this year, possibly at TCT or AHA, and then published in a peer-reviewed journal at a later date.
But a clear message comes through: decision-making is more accurate and leads to better outcomes for patients, when stenting is guided by FFR and not by angiography alone.
Dr. De Bruyne also told me, as have his colleagues Dr. Nico Pijls and Stanford cardiologist Dr. William Fearon, that FFR isn’t necessary in all cases. There is really no uncertainty in a patient who has clear symptoms of angina, a positive stress test and a single high grade blockage. It’s when there are multiple lesions that you want to make sure you aren’t stenting a blockage that is not causing a problem — because doing so may wind up causing a new problem. Or a patient with triple vessel disease that is being considered for bypass surgery — yet FFR might show only one lesion is significant, so a well-placed stent would do the trick.
Worldwide, it is estimated that FFR, also called Functional Measurement (FM), is only utilized in less than 10% of cases. So, given the results of FAME II as reported so far, what do you think is the answer to my question, specifically in patients where there is any uncertainty about stenting:
“Should Fractional Flow Reserve (FFR) Be Mandatory?”
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