Five-Year Data Presented From FAME 2 Study of Abbott's PressureWire for FFR-Guided PCI
June 4, 2018—Abbott Vascular recently announced that 5-year results from the FAME 2 study were presented in a late-breaking session at EuroPCR, held May 22–25 in Paris, France. The data were simultaneously published online by Panagiotis Xaplanteris, MD, et al in The New England Journal of Medicine.
According to the company, the study's findings showed that patients had fewer major adverse cardiac events (MACEs; defined as need for urgent revascularization, heart attack, and death) when they underwent a percutaneous coronary intervention (PCI) guided by Abbott's PressureWire fractional flow reserve (FFR) diagnostic tool in combination with medical therapy compared to patients who only received medical therapy.
FAME 2 Principal Investigator Bernard De Bruyne, MD, commented in Abbott's announcement, "For the first time, a study has shown that patients with stable coronary artery disease who received a stent guided by an FFR diagnostic had a benefit over medical therapy alone, including fewer heart attacks and needs for urgent revascularization. Data from this study confirm the importance of FFR-guided stenting decisions combined with medical therapy over medical therapy alone." Dr. De Bruyne is with the Cardiovascular Center Aalst at Onze Lieve Vrouw Ziekenhuis in Aalst, Belgium.
The 5-year follow-up from the FAME 2 study included 733 patients with stable coronary artery disease who had significant blockages or narrowing of the arteries as determined by FFR. Analysis showed that 13.9% of patients (62) in the FFR-guided PCI group experienced a MACE, whereas almost twice as many patients in the medical therapy group experienced a MACE (27% (119); P ≤ .001). The lower rate of MACEs in the PCI group was largely driven by reduced urgent revascularization (6.3% vs 21.1%; P < .001).
Abbott reported that patients who underwent FFR-guided PCI in combination with medical therapy had fewer heart attacks than those who received medical therapy alone, with 8.1% of patients (36) in the FFR-guided PCI group experiencing a heart attack compared to 12% (53) in the medical therapy alone group (P = .049). Death from any cause occurred in 5.1% of patients in the FFR-PCI group (23) and in 5.2% of patients (23) in the medical therapy only group.
Abbott also announced that in a separate study presented at EuroPCR, promising data were presented for the company's Resting Full-Cycle Ratio (RFR) diagnostic test, which uses a different approach to FFR that assesses the heart at rest rather than during stress. The VALIDATE RFR study results were presented by Ziad Ali, MD, who is with Columbia University Medical Center in New York, New York.
According to the company, RFR has the potential to identify significant narrowing of arteries that would be missed by other resting measures because of differences in its algorithm. RFR may be more convenient for patients than FFR as it does not require the use of vasodilators.
The VALIDATE RFR study included 672 coronary artery narrowings in 504 patients and compared RFR with an instant wave-free ratio (iFR) diagnostic test that also measures blood flow while the heart is at rest. The study aimed to validate the RFR algorithm, which identifies critical narrowings by taking measurements across the full heart cycle.
Analysis showed that RFR was highly correlated to iFR (R2 = 0.99; P < .001) and was diagnostically equivalent within 1% to iFR (P = .03), suggesting that both tests would lead to the same clinical decision most of the time. RFR is currently pending US Food and Drug Administration 510(k) clearance and European CE Mark approval, noted Abbott.