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

August 28, 2012 by MassDevice staff

More findings and analysis from St. Jude Medical's Fame II trial, studying fractional flow reserve-directing coronary stenting, leave some with "more questions than answers."

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.

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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.