St. Jude Medical (NYSE:STJ) is once again touting results from its Fame II study, this time citing data showing the cost-effectiveness of its PressureWire fractional flow reserve device.
The St. Paul, Minn.-based medical device company funded the trial, comparing patients who underwent percutaneous coronary intervention guided by FFR and "optimal medical therapy" (an anti-platelet and beta blocker drug regimen) with patients treated with drug therapy alone.
St. Jude lauded earlier data from the trial in August, saying Fame II demonstrated that the FFR-guided PCI arm patients fared better than the control arm. Now the company said the data also show that the procedure is less expensive than medical therapy alone over the long term.
Using a measure called the "incremental cost-effectiveness ratio," or the ratio of the change in costs to incremental benefits of a therapy, St. Jude claimed today that the FFR-guided arm posted an ICER value of $32,000 per quality-adjusted life year, enough to mark it "highly cost effective," according to a press release.
"While FFR-guided PCI had a higher initial cost than patients treated by medical therapy alone, after 1 year the cost gap narrowed by more than 50% due to a higher number of hospital re-admissions for patients treated only with medical therapy," according to the release.
Early this year, St. Jude cut short the Fame II study due to the overwhelming success of the findings, prompting
But the shortened duration of the study poses a problem for skeptics including Dr. William Boden, who wrote an editorial for the New England Journal of Medicine, "What is More Enduring – Fame or Courage?," questioning the study’s validity due to its shortened term.
"Clearly, FFR holds potential promise for a more targeted approach to PCI that might be more clinically effective and cost-effective than visually directed PCI for all angiographically significant stenoses," Boden wrote. "Unfortunately, the early termination of the FAME II trial before full enrollment and follow-up were achieved, the neutral effects on the rate of death or myocardial infarction, and the lack of a significant, sustained treatment effect on the reduction of angina beyond 6 months leave more questions than answers."
The Fame II study proved to be important, not just for St. Jude, but for FFR rival Volcano Corp. (NSDQ:VOLC). Those companies are embroiled in a bitter patent dispute over FFR technology. The study could also help boost the sagging stents businesses of the major players in the market, Boston Scientific (NYSE:BSX), Abbott (NYSE:ABT) and Medtronic (NYSE:MDT).
