St Jude Medical's Fame II trial has found that fractional flow reserve (FFR)-guided assessment reduces the need for hospital readmission and urgent revascularisation in patients with coronary artery disease.
FFR is a physiological index used to measure the haemodynamic severity of narrowings in the coronary arteries, and is determined using the company's PressureWire Aeris and PressureWire Certus.
The Fame II trial enrolled 1,219 patients with stable coronary artery disease at 28 centres in Europe, the US and Canada. The aim of the trial is to further study the role of FFR in the treatment of stable coronary artery disease by comparing percutaneous coronary intervention (PCI) guided by FFR in combination with optimal medical therapy (OMT) to OMT alone. The trial may provide new insights about the benefits of coronary intervention and answer questions raised by the clinical outcomes utilising revascularisation and aggressive drug evaluation (Courage) trial.
Following positive interim analysis, the Fame II independent data safety monitoring board (DSMB) board recommended stopping patient enrolment in the trial due to increased patient risk of major adverse cardiac events (MACE) among patients randomised to OMT alone compared to patients randomised to OMT plus FFR-guided percutaneous coronary intervention (PCI).
Trial clinical investigator Bernard De Bruyne said the study would provide further information regarding the optimal way to treat patients with coronary artery disease and myocardial ischemia.
St Jude Medical Cardiovascular Division president Frank Callaghan said the original Fame trial showed that FFR guidance improves outcomes in patients with stable coronary artery disease and two or three vessel disease, and now Fame II confirms that PCI is beneficial for patients with one, two and three vessel disease whose ischemia has been documented by FFR.
The original FFR vs angiography in multivessel evaluation (Fame) trial reported that patients whose treatment was guided by FFR showed 28% reduction in the MACE instances and 34% reduction in risk of death or heart attack compared with standard angiography alone.
Image: Micrograph of a coronary artery with the most common form of coronary artery disease (atherosclerosis) and marked luminal narrowing. Photo: Nephron.