FAME probably won’t live forever but it’s still going strong at 2 years. Long term results of the Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation (FAME) trial were presented on Wednesday at TCT.
One year results of the trial were published last winter in the NEJM, and concluded that “routine measurement of FFR in patients with multivessel coronary artery disease who are undergoing PCI with drug-eluting stents significantly reduces the rate of the composite end point of death, nonfatal myocardial infarction, and repeat revascularization at 1 year.” MACE-free survival at one year was 18.4% in the routinely treated group versus 13.2% in the FFR group, an absolute difference of 5.1%.
Now, at 2 years, the investigators report that FFR-guided patients had increasing benefits over time. The absolute difference in death and MI of 3.8% at one year grew to 4.3% at two years. They found “no signal to suggest that deferred lesions are likely to be responsible for late myocardial infarctions or to progress and require repeat revascularizations.” They reported that only one out of 513, or 0.2%, of deferred lesions resulted in a late myocardial infarction.
The FAME investigators say the results “support the evolving paradigm of “functionally complete revascularization, which they define as “stenting of ischemic lesions and medical treatment of non-ischemic ones.”
“The two-year data from the FAME study continue to show improved outcomes when multivessel coronary stenting is guided by measurement of FFR,” said co-principal investigator of the FAME study William F. Fearon, in a St. Jude press release. “Use of FFR technology represents a rare opportunity in medicine in which an innovative product not only improves clinical outcomes but also saves money.”
Editorial Comment (reprinted from previous coverage of FFR): Since it was first presented at TCT last year I’ve been fascinated by this technology, and (perhaps naively) somewhat surprised that it hasn’t achieved greater traction in the cardiology community. In fact, one prominent interventional cardiologist told me that to his knowledge FAME has had “zero impact.” He noted that FAME “challenges decades of conventional wisdom and clinical experience” by calling into question “angiographically significant lesions” which are exactly the ones “that most interventionalists would go after.” Precisely. As I wrote when FAME was first published, if FFR in fact can predict which lesions will benefit from PCI, it’s hard to avoid the conclusion that PCI for non-FFR indicated lesions may actually be harmful. I wonder if anyone will have the COURAGE to pursue this line of thought…
Click here to read an interesting commentary on FFR by Emory University cardiologist Habib Samady in Cardiovascular Business.
Click here to download the PDF of the St. Jude press release.
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