In the world of coronary artery disease treatment, if you blink, you will miss the latest development, so stent your eyes open for this latest piece of the puzzle. The latest question that keeps getting a new answer with every study is whether optimum medical therapy (OMT) or percutaneous coronary interventions (PCI) provides the best results for patients with coronary artery disease. With the introduction of fractional flow reserve (FFR) technology, the question had to be asked anew.
In case you haven’t heard of it, FFR is an index that compares the pressure proximal to a coronary artery obstruction to the pressure distal to that obstruction. In other words, it measures how much a given lesion actually impairs flow to the myocardium. Previously, the decision about whether to stent a given vessel was more subjective, and lesions that looked “suspicious” on angiograms were stented. FFR gives a more objective component to this judgment, and it was hoped that this would improve outcomes.
The FAME II trial compared PCI guided by FFR technology to optimal medical therapy alone, and it was stopped upon interim analysis based on the recommendations of the Data Safety Monitoring Board. The DSM recommended that St. Jude Medical stop enrollment in the trial because the patients in the medication-only group had an increased risk of major adverse cardiac events, particularly the need for hospital readmission and urgent revascularization. It should be noted, however, that there were no observed differences in rates of death or heart attacks at this point.
“The FAME II trial is unprecedented in its ability to provide further answers and evidence regarding the optimal way to treat patients with coronary artery disease and myocardial ischemia,” said Bernard De Bruyne, M.D., Ph.D., of the OLV Clinic in Aalst, Belgium, and coordinating clinical investigator of the FAME II trial. “What we 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 coronary artery disease.”
Flashbacks: SJM Enhances Usability of Company’s FFR Measurement Technology; Philips Unveils Compact Xper Flex Cardio Physiomonitoring; St. Jude’s new ILUMIEN Brings OCT and FFR Together to Improve Diagnosis and Treatment of Coronary Artery Disease; St. Jude Medical Receives European CE Mark Approval for its ILUMIEN System