Mixed reactions to St. Jude’s latest Fame II stent study

St. Jude Medical's Fame II FFR study

St. Jude Medical (NYSE:STJ) again touted results from its Fame II stenting study, reporting that patients who received percutaneous coronary intervention in addition to drug therapy were better off than patients who took drugs alone, but not all voices in the crowd were ready to accept the results.

DR. William Boden, the principal investigator for the 2007 Courage stent trial, had grave concerns about the results of the study, waxing poetically that "these results call to mind the famous line from Shakespeare’s Henry V that ‘all fame is fleeting,’ " according to his published critique.

Earlier this year St. Jude Medical’s (NYSE:STJ) cut short its Fame II study, which was evaluating fractional flow reserve-directed coronary artery stenting with drug therapy against drug therapy alone and was planned for 2 years, due to the overwhelming success of the findings.

Patients in one arm of the study received percutaneous coronary intervention guided by fractional flow reserve technology to measure and identify blood vessel narrowings and determine which are obstructing blood flow to the heart. Those patients also received "optimal medical therapy," an anti-platelet and beta blocker drug regimen.

The randomized, unblinded trial compared those patients to ones receiving drug therapy alone, finding that patients who received drugs plus PCI were "significantly less likely to undergo any revascularization" and experienced greater symptom relief than patients in the control group.

"Urgent revascularization" was performed in 49 patients in the control group, compared with only 7 for the PCI patients, an 86% reduction that spurred the study’s independent Data Safety Monitoring Board to recommended investigators stop patient enrollment.

There was no significant difference in the incidence of death or heart attack between the patient groups, according to a St. Jude report, but analysis suggested that the benefits of PCI plus drug therapy may increase over time.

But the shortened duration of the study poses a problem for skeptics like Boden, who wrote an article accompanying today’s Fame II report, which he entitled "What is More Enduring – Fame or Courage?".

"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 Society for Cardiovascular Angiography & Interventions was quick to defend the Fame results, which aimed to respond to criticisms that the original Fame study needed a control arm in order to substantiate its findings that 2-year death and heart attack rates were lower in FFR-guided PCI patients.

"The findings from Fame II are now the best data currently available to inform treatment decisions for patients with stable coronary artery disease," according to an SCAI press release. "These data clearly demonstrate that the benefit of PCI plus medical therapy in stable patients with ischemia-producing lesions extends beyond symptom relief and quality of life."

The Fame II study, the latests results of which were published in the New England Journal of Medicine and concurrently presented at the 2012 European Society of Cardiology Congress in Munich, Germany, has proven to be an important one, not just for St. Jude, but for FFR rival, Volcano Corp. (NSDQ:VOLC) and for the major players in the drug-eluting stent market, Boston Scientific (NYSE:BSX), Abbott (NYSE:ABT) and Medtronic (NYSE:MDT).

The results could roll back some of the conclusions drawn after the 2006-2007 Courage trial found no significant difference between stenting and drug therapy. But, because that trial did not include the use of FFR technology, the Fame II results may partially refute the Courage conclusions.

"These Fame II results could essentially ‘repeal’ the Courage trial data," Leerink Swann analyst Rick Wise wrote in a note to investors in January. "[S]ince Courage did not include the use of a pressure-wire, the Fame II data … possibly invalidates some Courage conclusions and suggests that using the right diagnostic tool like FFR as well as DES (PCI procedure) provides patients a better outcome."

"It was hoped that this trial would extend our scientific knowledge far beyond previously published studies," Boden wrote in his article. "But the only enduring finding of the Fame II trial appears to be that of a reduced short-term rate of unplanned revascularization with FFR-guided PCI, with little evidence of long-term, incremental benefit on prognostically important clinical outcomes."

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