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.