Positive news today from St. Jude Medical (NYSE:STJ) about FFR as a clinical decision-making tool. The company announced that it is stopping enrollment in its FAME II trial after only 2/3 of the planned patients were included. Why? Because the interim data so clearly favor the use of Fractional Flow Reserve (FFR) to guide stenting (PCI) in stable angina patients that the independent Data Safety Monitoring Board (DSMB) for the trial has concluded that it would be unethical to continue to randomize patients to optimal medical therapy (OMT) alone. Turns out that patients receiving OMT only experienced a highly statistically significant increased risk of hospital readmission and urgent revascularization.
Wait a minute! Did they say that using optimal medical therapy alone was unethical for the treatment of stable angina patients? That’s pretty big news! Continue reading