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FAME II Trial Demonstrates FFR-Guided PCI Superior to Medical Treatment in Preliminary Findings
St. Jude Medical PressureWire helped reduce the risk of urgent revascularization by more than eleven times in patients with stable coronary artery disease compared to medical treatment alone
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Dr. Bernard De Bruyne
Dr. Bernard De Bruyne
May 15, 2012 -- St. Paul, Minn and Paris -- St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that data from the FAME II trial demonstrated a significant difference in the need for urgent revascularization when Fractional Flow Reserve (FFR)-guided assessment was used to direct treatment in patients with stable coronary artery disease. These highly statistically significant results validate the profound role that FFR-guided therapy has in improving patient outcomes. The preliminary data were presented at a late breaking trial session at EuroPCR.

The FAME II (Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment vs. Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease) trial began enrolling patients in May 2010 with the goal of further studying the role of FFR in the treatment of stable coronary artery disease in one or more vessels. The trial compared clinical outcomes, safety and cost effectiveness of percutaneous coronary intervention (PCI) guided by FFR plus optimal medical treatment (OMT) to OMT alone in patient with stable coronary artery disease.

Earlier this year, St. Jude Medical announced that it was stopping enrollment in the FAME II trial after an Independent Data Safety Monitoring Board (DSMB) deemed it unethical to continue to randomize patients into the arm of the trial receiving optimal medical treatment alone. The DSMB found a highly statistically significant reduction in the need for unplanned hospital readmission and urgent revascularization when FFR-guided assessment was used to direct treatment in patients with coronary artery disease. The data presented today provided background into why the decision was made to stop the trial.

Preliminary results from the FAME II trial reveal that of patients with one or more significant lesions as determined by FFR guidance, those treated with PCI plus OMT experienced superior outcomes. For patients with one or more significant lesions there was a 7.6 times greater risk of hospital readmission with revascularization for patients who received OMT alone. Further, there was an 11.2 times greater risk of the need of unplanned hospital readmission with urgent revascularization.

"While we are still analyzing the full data, what we have seen to date confirms that an FFR-guided treatment strategy reduces the rate of re-hospitalization, which has the potential to benefit the health of patients and the bottom line of health care providers," 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. "Whether a patient needs PCI, or is better off with medical treatment, the data thus far reveal that treatments based on FFR guidance provide superior outcomes."

With additional data, the trial may provide new insights about the benefits of coronary intervention and answer questions raised by the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial, which demonstrated no difference in the outcomes between PCI plus OMT compared to OMT alone. However, the COURAGE trial did not require use of PressureWire™ FFR measurement technology.

"Through FAME II, we now have additional evidence that PCI can help improve patient outcomes when a treatment strategy is guided by FFR," said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. "Going to the hospital a second or third time is both a burden for patients and a burden on a hospital's resources. We expect additional data will continue to reveal the important role that FFR plays in developing an optimal treatment strategy."

The data to-date reveal that patients treated based on FFR guidance had a lower risk for events and a reduced risk of readmission for treatment. These positive preliminary findings help demonstrate that stenting ischemic lesions and medical treatment of non-ischemic ones can improve outcomes in patients with single or multivessel disease. Further data are expected to be presented later this year.

About FFR
FFR is a physiological index used to determine the hemodynamic severity of narrowings 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.

St. Jude Medical is sponsoring a symposium on the clinical evidence provided by the FAME-Trials on Tuesday, May 15 from 17:00 to 18:30 p.m. in Room 252AB.

  • FAME-Trials Family: Physiology, Decision-Making and Clinical Outcomes – This session will provide an update on clinical evidence offered by the FAME-Trials offering a better understanding of the link between coronary physiology and clinical outcomes. The session will include presentations and discussion on why findings from the FAME-Trials should help change clinical practice.

Attendees can also visit St. Jude Medical at booth F8 and F9 on Level 1 of the exhibition hall during EuroPCR or visit us on the web for show-specific information at:

EuroPCR is the official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), a leading international course for interventional cardiovascular specialists.

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

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 March 31, 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.

Source: St. Jude Medical