FAME II: Additional Thoughts About FFR in the Real World 3

Earlier today I reported the news that enrollment in the FAME II study had been stopped early by the DSMB. From the initial presentation of the first FAME trial several years ago, I’ve been fascinated by the potential of this technology, since it offers the tantalizing prospect of helping identify atherosclerotic lesions that actually will benefit from an intervention. But FFR is not a free ride. The downside is that you have to perform a lesser intervention (angiography) in order to determine the validity of the greater intervention (PCI).

FAME II was designed, and will be promoted, as an answer to COURAGE, suggesting that PCI can be generally used in a stable CAD population if FFR detects an ischemic lesion. But it is important to remember that everyone in the trial underwent angiography and FFR prior to randomization, and only those with ischemic lesions were randomized. So it’s fair to conclude that yes, IF someone undergoes angiography it would make sense to give FFR, and if an ischemic lesion is found it would make sense to implant a stent.

BUT it doesn’t say anything about which patients actually should undergo angiography in the first place, and the use (or overuse) of angiography is probably the most important unresolved problem in cardiology today. So we’re back to the floodgate problem. If the floodgates (angiography) are open, then FAME II makes a lot of sense and is widely applicable. But if the floodgates are closed or only opened selectively,the trial really doesn’t help very much.

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3 comments

  1. Larry — I agree that too many patients are sent to angiography, but it’s for lack of a better pre-screening tool. The false positives with stress testing are high…and CTA is good, but limited in patients with high calcium scores. The NCDR reports that 37% of cardiac caths show no CAD! If only half of those could be eliminated through pre-screening that would be great.

    However, I disagree with you about FFR and FAME II. It’s a very important trial because it shows that FFR is a better diagnostic tool than angiography alone. Yes, it needs to be done as part of the angiogram but, using FAME I as a measure, 1/3 of lesions that look “significant” on angiography do not need to be stented. Perhaps at some future point a non-invasive FFR technology will be developed (some CT and MRI versions are being worked on) but until then, FFR is a very solid tool.

    Burt Cohen
    Angioplasty.Org

  2. The ISCHEMIA trial may provide some clues about the need for invasive studies in the presence of ischemia.

    Sure wish that PCI saved lives or made people live longer (outside of the setting of primary PCI for STEMI). FRISCII mortality benefit was not apparent at 5 years.

  3. if more doctors took the time to ask the right questions and intergrate the patients responses about the pattern of the chest pain they have and utilize a duke treadmill score properly, many fewer caths would happen and far fewer mild to moderate lesions would ever be seen at angiography
    one big reason that these intermediate lesions get to the ffr scenario is that the threshold for cath is so low ,

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