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FAME II clinical trial enrollment stopped after interim analysis showed benefit of FFR
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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.
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