In the latest results from St. Jude Medical’s (NYSE:STJ) FAME 2 study, researchers found that fractional flow reserve-guided percutaneous coronary intervention (FFR-guided PCI) was associated with a significant 2-year reduction in composite rates of death, heart attack and urgent revascularization compared with patients who received drugs and medical management alone for treating stable coronary artery disease.
The FAME 2 study randomized CAD patients to receive either FFR-guided PCI with medical therapy or medical therapy alone. The PCI group, which received drug-eluting stents to open blockages in blood vessels, fared better at 7 days and all the way out to 2 years following the procedure, according to results published this week in the New England Journal of Medicine.
The difference in outcomes was driven primarily by a surge in "urgent revascularizations" among the medical therapy group. The PCI patients were 77% less likely to require unplanned hospital visits to conduct urgent revascularizations, which were spurred in large part by heart attacks, electrocardiograms showing unstable angina or clinical features only.
Only 18 patients in the PCI group (out of 447 total) had urgent revascularizations compared with 79 in the medical therapy group (out of 441 total). FFR-guided PCI made the most significant impact in patients with functionally significant stenoses, researchers added.
"As physicians, we’re beginning to understand the challenges of basing treatment decisions on coronary angiograms that simply do not provide the full battery of information needed to properly assess lesions blocking blood flow to the heart," coordinating clinical investigator Dr. Bernard De Bruyne said on behalf of St. Jude. "The FAME 2 trial demonstrates that for patients with stable CAD, FFR-guided PCI is the favorable strategy as we look to improve treatment outcomes, reduce adverse health events and better assess which lesions require medical intervention."
FFR is used to measure narrowing of an artery, allowing cardiologists to get a sense of the severity of a blockage and make more informed treatment decisions. The FAME 2 study examined the use of St. Jude’s PressureWire Aeris and PressureWire Certus FFR devices during PCI, counting more than 1,200 enrolled patients before the study was cut short in January 2012 on strongly positive results.
Continued analyses from the FAME 2 study are good news for St. Jude, for FFR rival Volcano (NSDQ:VOLC) and for makers of drug-eluting stents. The positive results could help roll back some of the conclusions drawn after the 2006-2007 COURAGE trial, which did not include FFR technology, found no significant difference between stenting and medical management.
The data is also a boon to Volcano, which recently agreed to put to rest all legal battles with St. Jude, including a long-standing war over FFR patents.
STJ shares were flat today, down just 0.2% to $65.49 as of about 1:25 p.m. EST. The stock has gained 5.7% since the start of the year.