News | September 15, 2014

Two-year FAME 2 Data Shows Sustained Benefits of FFR-guided PCI over Medical Treatment

NEJM publishes data demonstrating St. Jude Medical PressureWire FFR can reduce urgent revascularization and adverse cardiac events

PressureWire St. Jude Medical Two-year FAME 2 Data FFR-guided PCI

September 15, 2014 — St. Jude Medical Inc. announced primary outcome two-year data from the FAME 2 clinical trial, which demonstrated sustained superiority with FFR-guided PCI using St. Jude Medical PressureWire 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 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 2012 and published in The New England Journal of Medicine.

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.

For more information: www.sjm.com 

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init