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The sponsor of the FAME II trial, which is assessing the efficacy of fractional flow reserve (FFR) as a tool to improve stenting outcomes, said it is halting enrollment after an analysis revealed a significant benefit for patients in the FFR arm.
An interim analysis revealed a significant reduction in both hospital readmissions and urgent revascularizations among patients treated with FFR-guided percutaneous coronary interventions plus optimum medical therapy compared with optimum medical therapy alone.
The FAME II independent Data Safety Monitoring Board recommended that enrollment be stopped. The board "considers it unethical to continue to randomize patients to optimal medical therapy alone," said trial sponsor St. Jude Medical in a statement.
FFR relies on a pressure wire to determine the hemodynamic severity of stenosis.
The primary endpoint of the study is the major adverse cardiac event rate, which includes a composite of all-cause death, documented myocardial infarction (MI), and unplanned hospitalization leading to urgent revascularization at 24 months.
The original FAME trial compared FFR-guided lesion assessment plus angiography with angiography guidance alone in patients with multivessel disease. Those in the FFR-guided arm had a 35% reduced rate of mortality and MI at one year. The FFR arm also used fewer stents: 1.9 versus 2.7
"What we observed to date regarding urgent revascularizations validates the profound role that FFR-guided therapy has in improving patient outcomes," said Bernard De Bruyne, MD, PhD, of the OLV Clinic in Aalst, Belgium, and coordinating clinical investigator of FAME II, in a statement. "This is further evidence that FFR should be considered the standard of care for patients with coronary artery disease."
St. Jude Medical said that FAME II investigators will continue following patients currently enrolled. The trial has randomized 1,219 patients with stable coronary artery disease in 28 centers in Europe, the U.S. and Canada.