St. Jude Medical announced today that an interim analysis of the FAME II
trial has found a highly statistically significant reduction in the need for
hospital readmission and urgent revascularization when fractional flow
reserve-guided assessment was used to direct treatment in patients with
coronary artery disease. As a result of the positive interim analysis, the FAME
II independent Data Safety Monitoring Board has recommended investigators stop
patient enrollment of this trial as the Data Safety Monitoring Board considers
it unethical to continue to randomize patients to optimal medical therapy
alone.
The Fractional Flow Reserve-Guided Percutaneous Coronary Intervention
Plus Optimal Medical Treatment vs. Optimal Medical Treatment Alone in Patients
with Stable Coronary Artery Disease (FAME II) trial is a follow-up to the
landmark
FAME
trial. The goal is to further study the role of fractional flow reserve
(FFR) in the treatment of stable CAD by comparing percutaneous coronary
intervention guided by FFR plus optimal medical therapy with optimal medical
therapy alone.
The DSMB recommended that St. Jude Medical stop patient enrollment in
the trial due to increased patient risk for major adverse cardiac events among
patients randomized to optimal medical therapy alone compared with patients
randomized to optimal medical therapy plus FFR-guided PCI. Patients receiving
optimal medical therapy alone experienced a highly significant increased risk
for hospital readmission and urgent
revascularization, and the DSMB determined that this
difference was highly unlikely to change with inclusion of more patients.
“The FAME II trial is unprecedented in its ability to provide
further answers and evidence regarding the optimal way to treat patients with
CAD and myocardial ischemia,” Bernard De Bruyne, MD, PhD, of the
OLV Clinic in Aalst, Belgium, and coordinating clinical investigator of the
FAME II trial, said in a
news release. “What was observed to date regarding
urgent revascularizations validates the profound role that FFR-guided therapy
has in improving patient outcomes. This is further evidence that FFR should be
considered the standard of care for patients with CAD.”
The FAME II trial will continue following patients currently enrolled
according to the trial protocol and will not enroll any new patients. The trial
randomized 1,219 patients with stable
CAD
at 28 centers in the United States, Canada and Europe. Data will be published
as information is analyzed, with initial results expected to be presented in
2012, according to the press release.