St Jude Medical reports positive two-year data from FAME II trial of FFR technology

3 September 2014 (Last Updated September 3rd, 2014 18:30)

US-based medical device firm St Jude Medical has reported two-year data from the FAME II trial of its Fractional Flow Reserve (FFR) guided percutaneous coronary intervention (PCI) over medical treatment in patients with stable coronary artery disease (CAD).

US-based medical device firm St Jude Medical has reported two-year data from the FAME II trial of its Fractional Flow Reserve (FFR) guided percutaneous coronary intervention (PCI) over medical treatment in patients with stable coronary artery disease (CAD).

Results from the trial showed sustained superiority with FFR-guided PCI using the company's PressureWire technology in CAD patients compared to standard medical therapy (MT) alone.

During the trial, patients with stable CAD who received FFR-guided PCI using drug-eluting stents and medical therapy (PCI+MT) had reduced rates of death, myocardial infarction (MI) or urgent revascularisation.

Compared with standard MT, FFR-guided PCI+MT reduced urgent revascularisation by 77% in patients who had at least one significant coronary blockage with an FFR value =0.80.

"Compared with people who received MT alone, patients receiving FFR-guided PCI+MT had fewer urgent revascularisations."

OLV Clinic and coordinating clinical investigator of the FAME II trial Dr Bernard De Bruyne said: "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 favourable strategy as we look to improve treatment outcomes, reduce adverse health events and better assess which lesions require medical intervention."

The two year data showed that patients who received FFR-guided PCI+MT had a lower rate of death or MI than patients who received MT alone after seven days.

Compared with people who received MT alone, patients receiving FFR-guided PCI+MT had fewer urgent revascularisations.

St Jude Medical chief medical officer Dr Mark Carlson said: "As a sponsor of the FAME 2 Trial, we are excited that our technology has been shown to provide such profound clinical benefit to patients living with coronary artery disease.

"Our goal in bringing new products to market is to generate a meaningful clinical impact. The FAME family of studies continues to demonstrate that our FFR technology provides meaningful information for physicians, improves patient outcomes, and reduces costs for health care systems."

FFR was measured using the company's two products the PressureWire Aeris or PressureWire Certus intravascular pressure sensors.