French Registry: FFR Safely Reclassifies Almost Half of Revascularization Patients

DALLAS, TX—The use of fractional flow reserve (FFR) leads to reclassification of the revascularization decision determined by angiography alone in about half of patients, according to French registry results presented November 19, 2013, at the annual American Heart Association Scientific Sessions. Further, FFR-guided angiography results in acceptable safety out to 1 year.

For the Registre Français de la FFR (R3F) study, researchers led by Eric Van Belle, MD, PhD, of Hôpital Cardiologique (Lille, France), enrolled 1,075 consecutive patients undergoing diagnostic FFR-guided angiography at 20 French centers from October 2008 to June 2010. Investigators recorded their revascularization strategy based on angiography before performing FFR as well as the final revascularization strategy after determining FFR measurements.

The majority of patients were stable (80%), while the rest were unstable with a recorded STEMI (3%) or NSTEMI (17%) within 15 days. A noninvasive test was performed in 61% of patients, and positive results were seen in about half (48%).

Higher Accuracy With FFR

The strategy based on angiography alone was medical therapy in 55% and revascularization in 45% (PCI 38%; CABG 7%). Overall, FFR changed the ultimate strategy in 43% of cases (table 1).

Table 1. Revascularization Strategy Changes After FFR

^aNo change in strategy after FFR.
^bChange in strategy after FFR.

Hence, the applied strategies after FFR were medical therapy in 58% and revascularization in 42% (PCI 32%; CABG 10%). Almost half (45%) of those with a positive noninvasive test changed revascularization strategies after FFR.

In reclassified patients treated based on FFR and in disagreement with the angiography alone-based decision (n = 464), 1-year MACE (11.2%) was as good as in patients who were not reclassified (n = 611; 11.9%; log-rank P = 0.78). Subgroup analyses confirmed these results. At 1 year, at least 93% of patients were asymptomatic without difference between reclassified and nonreclassified patients (P = 0.75).

Safety Established, Focus Shifts to More Complex Patients

Dr. Van Belle said the study “demonstrates that it is safe to pursue a revascularization strategy divergent to that suggested by angiography alone but guided by FFR measurements. The present data further support and extend the concept of a ‘physiology-guided’ decision of coronary revascularization.”

Discussing the trial, Young-Hak Kim, MD, of Asan Medical Center (Seoul, South Korea), said that FFR “can provide objective evidence of coronary ischemia that requires revascularization irrespective of each operator’s threshold to revascularization by visual assessment,” adding that the technique is safe and feasible for stable CAD.

He noted that because the study was a single-arm cohort, “it is still not clear whether global utilization of function-guided treatment improves CAD prognosis compared with anatomy-guided treatment.” Additionally, the study subjects were relatively healthy, Dr. Kim commented, and a population of more complex patients may lead to an increased rate of “downgrade treatment.”

Future research should focus on clinician behavior, patient outcomes, and cost-effectiveness, he concluded.

Study Details

Three-quarters of patients were men, and the mean age was 65 years. Slightly more than one-third had diabetes and 46% had a previous MACE, including 25% with prior MI and 40% with a history of coronary revascularization.

In each patient, a mean of 1.32 ± 0.66 lesions were investigated by FFR. Most of the procedures were performed radially (68%), and adenosine was almost exclusively administered as an intracoronary high-dose bolus (99.2%).

 

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Source:
Van Belle E, Rioufol G, Pouillot C, et al. Outcome impact of coronary revascularization strategy reclassification with fractional flow reserve at time of diagnostic angiography: Insights from a large French multicenter fractional flow reserve registry. Circulation. 2013;Epub ahead of print.

 

 

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