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Two Year Data from FAME 2 Trial Shows Sustained Benefits of FFR-Guided PCI over Medical Treatment in Patients with Stable CAD
[September 02, 2014]

Two Year Data from FAME 2 Trial Shows Sustained Benefits of FFR-Guided PCI over Medical Treatment in Patients with Stable CAD

ST. PAUL, Minn. & BARCELONA, Spain --(Business Wire)--

St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, today announced primary outcome two-year data from the FAME 2 Trial which demonstrated sustained superiority with FFR-guided PCI using St. Jude Medical PressureWireTM technology in patients with stable coronary artery disease (CAD) compared to standard medical therapy alone.

The data were published online in The New England Journal of Medicine (NEJM) and presented during a hot line late-breaking session at the European Society of Cardiology Congress 2014.

The results of FAME 2 show patients with stable CAD who received FFR-guided PCI (News - Alert) using drug-eluting stents and medical therapy (PCI+MT) had reduced rates of death, myocardial infarction (MI) or urgent revascularization compared to patients who received medical therapy (MT) alone. In particular, in patients who had at least one significant coronary blockage with an FFR value =0.80, FFR-guided PCI+MT reduced urgent revascularization by 77 percent compared to medical therapy alone.

"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," said Dr. Bernard De Bruyne, of the OLV Clinic in Aalst, Belgium, and coordinating clinical investigator of the FAME 2 Trial. "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."

Specifically, the two year data from FAME 2 shows:

  • 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 percent vs. 19.5 percent).
  • 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 seven days (4.6 percent vs. 8.0 percent).
  • Patients who received FFR-guided PCI+MT had fewer urgent revascularizations than patients who received MT alone (4.0 percent vs. 16.3 percent).

Preliminary results of the FAME 2 trial were originally presented during a hot line session at ESC (News - Alert) 2012 and published in The New England Journal of Medicine.

"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," said Dr. Mark Carlson, chief medical officer at St. Jude Medical. "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."

Coronary artery disease is the most common form of heart disease and the leading cause of death for both women and men worldwide. Diagnosis, management and treatment of this epidemic disease continue to account for hundreds of billions of dollars in global health care expenditures annually. Results from the landmark FAME trials have continued to add to the growing body of evidence demonstrating improved outcomes and cost savings when FFR-guided therapy is used during coronary interventions.

About FAME 2

The FAME 2 trial began enrolling patients in May 2010 and was designed to evaluate FFR-guided PCI+MT (with second generation drug-eluting stents) versus MT alone in patients with stable CAD. The study sought to assess reductions in death from any cause, a difference in rates of nonfatal myocardial infarction (MI) or unplanned hospitalization leading to urgent revascularization over the first two years. FFR was measured using two St. Jude Medical products, the PressureWire™AerisTM or PressureWire™ CertusTM intravascular pressure sensors. Medical therapy 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.

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

Due to 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 (MACE) 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 U.S. and Canada.

About Fractional Flow Reserve (FFR)

FFR is a physiological index used to determine the hemodynamic severity of narrowings (or lesions) in the coronary arteries, and is measured using St. Jude Medical PressureWire™ Aeris and PressureWire™ Certus (News - Alert). FFR specifically identifies which coronary narrowings are responsible for obstructing the flow of blood to a patient's heart muscle (called ischemia), and helps guide the interventional cardiologist in determining which lesions warrant stenting, resulting in improved patient outcomes and reduced health care costs.

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world's most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit or follow us on Twitter (News - Alert) @SJM_Media.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC (News - Alert), including those described in the Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 28, 2013 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 28, 2014. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

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