Patient enrollment is complete in the fractional flow reserve vs. angiography for multivessel evaluation (FAME) study according to Bernard De Bruyne, MD, PhD, who reported the news at the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C., this week.
The study is the first randomized, prospective, multicenter trial that will compare the clinical outcomes and cost-effectiveness of a physiologic-guided percutaneous coronary intervention (PCI) strategy to an angiographic-guided one in patients with multivessel coronary artery disease (CAD).
The study's primary endpoint is a composite of major adverse cardiac events (MACE), including death, myocardial infarction and repeat coronary revascularization at one year. Secondary endpoints include global cost effectiveness after one year, cardiac death and myocardial infarction rate at one year, functional class at one year, number of anti-anginal drugs after one year, overall MACE rate at one month post-procedure and at six months, and two, three and five years.
"With drug-eluting stents (DES) and lower restenosis rates, interventional cardiologists are performing PCI more often in patients with increasingly complex CAD, including multivessel disease," said De Bruyne. "Furthermore, some physicians are stenting all intermediate lesions with DES regardless of the physiologic significance of those lesions. DES are expensive and have been associated with potential late complications. Therefore, the objective of FAME is to help us identify an approach to PCI that will improve overall clinical outcomes and reduce healthcare expenditure."
One thousand patients at 20 centers worldwide are participating in the FAME study. Participants enrolled in the study meet the following criteria:
• Coronary lesions in at least two of the three major cardiac vessels have narrowing of greater than or equal to 50 percent by visual assessment.
• The lesions that require stenting, according to the investigator.
• The vessels are large enough to accommodate drug-eluting stents.
After an investigator's visual assessment of an angiogram and notation of which lesions appear to require stenting, patients will be assigned randomly to one of the two PCI strategies.
Patients assigned to angiographic guidance will undergo stenting as planned, while patients assigned to physiologic guidance will have fractional flow reserve (FFR) measured in diseased vessels with a coronary pressure wire using a system provided by Radi Medical Systems. If FFR is less than or equal to 0.80, meaning the coronary pressure or flow beyond the narrowing is less than or equal to 80 percent of what it should be, the lesion will be stented.