The results of this great multicenter “real-life” registry are similar to those of randomized clinical trials that studied fractional flow reserve (FFR).
Lesion deferral based on FFR is a very safe strategy, even for lesions located in the proximal anterior descending artery.
Randomized controlled studies FAME and DEFER convincingly showed the safety of lesion revascularization deferral based on FFR. However, we needed a prospective full-scale real-world study to confirm it.
This came with the J-CONFIRM registry conducted by Dr. Shoichi Kuramitsu and colleagues, recently published in Circulation Cardiovascular Interventions.
Prestigious researchers such as Dr. William Fearon (main author of the FAME trial) said that this real-world registry with a long-term follow-up finally closes our information breach and confirms in a definitive way the safety of FFR.
The J-CONFIRM registry included 1263 patients in 28 Japanese sites between 2013 and 2015.
All of them were assessed through FFR and revascularized according to its result.
At 2 years, the rate of target vessel failure (the primary study endpoint) was 5.5% in deferred lesions. Almost all of these events were revascularizations justified by clinically driven target vessel revascularization (5.2%), i.e., plaque progression. Cardiac deaths or infarctions related to deferred lesions were very infrequent during follow-up (0.42%), enough to determine that deferred lesions are not a safety concern.
Notably, events were conversely associated with FFR value: the lower the value of this measurement, the higher the risk of events at 2 years. This was particularly true with proximal lesions. FFR has a cutoff value, but it is not a binary variable at all: it is a continuous variable.
Independent predictors of events in deferred lesions were baseline FFR value (observing it as a continuous variable), left main coronary artery lesions, moderate to severe calcification, need for hemodialysis, or right coronary artery lesions. With these factors, lesions can still be deferred, but we should conduct a closer follow-up.
As an example of that, we could say that a patient with baseline FFR 0.81 will present a higher rate of events than a patient with FFR 0.95; however, both can be deferred safely. We would simply need to plan a closer clinical follow-up for the first patient.
Original Title: Two-year outcomes after deferral of revascularization based on fractional flow reserve: the J-CONFIRM registry.
Reference: Kuramitsu S et al. Circ Cardiovasc Interv. 2020;12:e008355.
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