Results from the Fame II study comparing St. Jude Medical‘s (NYSE:STJ) PressureWire fractional flow reserve device with optimal medical care show that FFR-guided coronary interventions are more cost-effective, sending STJ shares up nearly 2% today on Wall Street.
The St. Paul, Minn.-based medical device company funded the trial, which earlier this year 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.
Dr. William Fearon of Stanford University, presenting data at the Transcatheter Cardiovascular Therapeutics conference today in Miami, said that the previous Courage trial influences cardiologists to let optimal medical therapy run its course before attempting PCI, according to heartwire.
"Based on Courage, people have argued that up-front optimal medical therapy should be achieved before proceeding to PCI, but what we showed in FAME II was that if you can identify ischemia-producing lesions and isolate those, patients [with those lesions] benefit from PCI up front as compared with optimal medical therapy, by decreasing urgent revascularization and improving quality of life," Fearon said, according to the website.
During the 1st year, optimal medical therapy costs about $2,508 less than FFR-guided PCI. But reduced incidence of angina and urgent revascularization make FFR-guided PCI more cost-effective over time. Angiography-guided PCI posted a cost-effectiveness ratio of $168,000 per quality-adjusted life-year; for FFR-guided PCI in Fame II, that number was $53,000 – comparable to other widely accepted therapies, Fearon said.
"We want to be conservative and not overstate things," he said, according to heartwire. "We don’t have longer follow-up at this time, but … the benefit of PCI lasted more than 1 year in Courage, and freedom from angina [in the PCI group] lasted out to 3 years."
"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," St. Jude Medical said in a press release.
The news sent STJ shares up 1.6% to a $39.71 close today. Shares were up slightly at $39.73 in after-hours trading.
"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 after an interim analysis showed that 11.1% of the optimal-medical-management arm needed urgent revascularization, compared with 1.6% of the PCI cohort, according to heartwire.
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).
