Two-Year FAME 2 Data Show Sustained Benefits of FFR-Guided PCI

September 2, 2014—St. Jude Medical, Inc. announced primary outcome 2-year data from the FAME 2 trial that demonstrated sustained superiority with fractional flow reserve- (FFR-) guided percutaneous coronary intervention (PCI) using St. Jude Medical’s PressureWire technology in patients with stable coronary artery disease (CAD) compared to standard medical therapy (MT) alone. The data were presented during a late-breaking session at the European Society of Cardiology Congress 2014 in Barcelona, Spain; also, Bernard De Bruyne, MD, et al published the data online in The New England Journal of Medicine.

FAME 2, which began enrolling patients in May 2010, was designed to evaluate FFR-guided PCI using drug-eluting stents and MT (PCI + MT) versus MT alone in patients with stable CAD. The study sought to assess reductions in death from any cause and a difference in rates of nonfatal myocardial infarction (MI) or unplanned hospitalization leading to urgent revascularization over the first 2 years. FFR was measured using St. Jude Medical products, the PressureWire Aeris or PressureWire Certus intravascular pressure sensors. MT included daily aspirin, a beta blocker alone or in combination with a calcium channel-blocker and/or long-acting nitrate, and medication to control and lower blood pressure.

According to St. Jude Medical, the results of FAME 2 show patients with stable CAD who received FFR-guided PCI using drug-eluting stents and medical therapy (PCI + MT) had reduced rates of death, MI, or urgent revascularization compared to patients who received MT alone. In particular, in patients who had at least one significant coronary blockage with an FFR value = 0.8, FFR-guided PCI + MT reduced urgent revascularization by 77% compared to MT alone.

Specifically, the 2-year data from FAME 2 show that patients who received FFR-guided PCI + MT had a significantly lower rate of death, MI, or urgent revascularization than patients who received MT alone (8.1% vs 19.5%). In a landmark analysis, patients who received FFR-guided PCI + MT had a lower rate of death or MI than patients who received MT alone after 7 days (4.6% vs 8%). Patients who received FFR-guided PCI + MT had fewer urgent revascularizations than patients who received MT alone (4% vs 16.3%).

Dr. De Bruyne, who served as coordinating clinical investigator of the FAME 2 trial, commented in the company’s press release, “As physicians, we’re beginning to understand the challenges of basing treatment decisions on coronary angiograms that simply do not provide the full battery of information needed to properly assess lesions blocking blood flow to the heart. The FAME 2 trial demonstrates that for patients with stable CAD, FFR-guided PCI is the favorable strategy as we look to improve treatment outcomes, reduce adverse health events, and better assess which lesions require medical intervention.” Dr. De Bruyne is from the OLV Clinic in Aalst, Belgium.

Preliminary results of the FAME 2 trial were originally presented at the ESC Congress 2012 and published in The New England Journal of Medicine (2012; 367:991–1001).

Preliminary results revealed that in patients with stable CAD, FFR-guided PCI relying on St. Jude Medical’s PressureWire yielded an 87% relative risk reduction for unplanned readmission to the hospital with urgent revascularization. At the time, analysis suggested the benefits of PCI + MT may increase over time.

St. Jude Medical noted that because of a highly significant between-group difference favoring FFR-guided PCI + MT, recruitment to the FAME 2 trial was stopped prematurely by the trial’s independent data safety monitoring board. The board believed there was increased patient risk of major adverse cardiac events among patients randomized to medical therapy alone. At the time enrollment was stopped in January 2012, 1,220 patients with stable CAD were enrolled at 28 centers across Europe, the United States, and Canada.