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New England Journal of Medicine Publishes FAME II Trial Results Revealing Better Patient Outcomes with FFR-Guided Cardiac Stenting

Tue, 08/28/2012 - 7:01am
The Associated Press

ST. PAUL, Minn. & MUNICH--(BUSINESS WIRE)--Aug 28, 2012--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced results of the FAME II Trial demonstrating that patients with FFR-guided stenting plus the best available medical therapy had superior outcomes to those treated with medical therapy alone. Results published online in the New England Journal of Medicine (NEJM) and presented during a Hot Line session at the ESC Congress 2012 (European Society of Cardiology) revealed that use of the PressureWire ™ (technology used to measure blood flow restriction in the coronary arteries) yielded an 86 percent relative risk reduction for unplanned re-admission to the hospital with urgent revascularization in patients with stable coronary artery disease.

The FAME II (FFR-Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment vs. Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease) Trial examined the role of Fractional Flow Reserve (FFR) in the treatment of stable coronary artery disease in one or more vessels. FFR specifically identifies which coronary narrowings are responsible for obstructing blood flow to a patient’s heart muscle, and is measured using PressureWire FFR measurement technology from St. Jude Medical. The randomized trial compared percutaneous coronary intervention (PCI) guided by FFR plus the best available medical therapy (MT) to MT alone.

Results from the FAME II Trial: At the time trial enrollment ended, primary endpoint event occurrence (death, heart attack or urgent revascularization) was significantly lower in patients with PCI plus MT than in patients with MT alone (4.3 versus 12.7 percent). Instances of hospital re-admission leading to urgent revascularization were reduced by 86% for patients in the FFR-guided PCI arm of the trial. There was no evidence of significant difference in mortality or heart attack between patients with PCI plus MT and patients with MT alone. Analysis suggests that the benefits of PCI plus MT may increase over time. “The FAME II Trial provides new evidence-based guidance demonstrating the profound role that FFR and second-generation drug eluting stents can have in improving patient care,” said Dr. Bernard De Bruyne, M.D., Ph.D., of the OLV Clinic in Aalst, Belgium, and coordinating clinical investigator of the FAME II Trial. “Though there have been questions in the past about whether a patient should have a stent or is better off with medical treatment, we now know that if a lesion is significant as determined by FFR guidance, the stenting procedure will provide a better outcome. With this new knowledge, I believe that FFR should become the standard of care for treating patients with stable coronary artery disease and significant coronary narrowings.” The FAME II Trial provides insights about the benefits of coronary intervention and answers questions raised by the COURAGE ( C linical O utcomes U tilizing R evascularization and Ag gressive Drug E valuation) trial. The COURAGE trial demonstrated no difference in the outcomes between PCI plus MT compared to MT alone, but did not require use of FFR measurement technology. FAME II demonstrates that use of PressureWire FFR measurement technology has the ability to make a measurable difference in the outcome of patients. Where FFR found no evidence of ischemia-producing narrowings, patients were treated with medical treatment alone and were followed up in a registry. The rate of primary endpoint events for these patients was low (3 percent), indicating that FFR measurements can be beneficial in directing which patients would benefit from medical treatment.

“As the sponsor of the FAME family of studies, St. Jude Medical is proud to provide the medical community with additional evidence supporting the critically important role that the PressureWire FFR measurement technologies play in improving patient outcomes,” said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. “Publication of this groundbreaking research in the New England Journal of Medicine coinciding with a Hot Line session during ESC demonstrates that the role of FFR in guiding medical care has moved to broader and more mainstream acceptance within the cardiology community.” The FAME II Trial began enrolling patients in May 2010. At the time enrollment was stopped in January 2012, 1,220 patients with stable coronary artery disease were enrolled at 28 centers across Europe, the U.S. and Canada. FFR was measured using the PressureWire ™ Aeris or PressureWire ™ Certus from St. Jude Medical.

Enrollment in the St. Jude Medical-sponsored FAME II Trial was halted after an Independent Data Safety Monitoring Board (DSMB) found a highly statistically significant reduction in unplanned hospitalizations and urgent revascularizations in patients enrolled in the PCI plus MT arm of the trial. The DSMB therefore deemed it unethical to continue to randomize patients into the arm of the trial receiving MT alone. As a result, patients already enrolled in the trial continue to be followed, but no additional patients were added.

Health economics data derived from the FAME II Trial are expected to be presented later this year.

About 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. 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 healthcare costs.

About the Original FAME Trial The original FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) Trial compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography using St. Jude Medical PressureWire Certus ™ technology. Results demonstrated improved clinical outcomes in patients with stable coronary artery disease and two or three vessel disease as well as cost savings.

About St. Jude Medical St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

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, 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 31, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2012. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

CONTACT: St. Jude Medical, Inc.

J.C. Weigelt, +1 651 756 4347 Investor Relations jweigelt@sjm.com or Marisa Bluestone, +1 651 236 0837 International Media Relations mbluestone@sjm.com or Sarah Shamla, +1 612 741 8755 U.S. Media Relations sshamla@sjm.com KEYWORD: UNITED STATES EUROPE NORTH AMERICA MINNESOTA INDUSTRY KEYWORD: HEALTH CARDIOLOGY CLINICAL TRIALS HOSPITALS MEDICAL DEVICES RESEARCH SCIENCE SOURCE: St. Jude Medical, Inc. Copyright Business Wire 2012 PUB: 08/28/2012 07:01 AM/DISC: 08/28/2012 07:01 AM http://www.businesswire.com/news/home/20120828005232/

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