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Research In Brief

This article was originally published in The Gray Sheet

Executive Summary

Test improves DES outcomes: Routine measurement of fractional flow reserve (FFR) - the ratio of maximal blood flow in a stenotic artery to normal maximal flow - with St. Jude's PressureWire Certus guidewire-mounted sensor improves outcomes of drug-eluting stent implants in patients with multivessel coronary artery disease, according to results of the FAME trial published in the Jan. 15 New England Journal of Medicine. The 20-center trial randomized 1,005 patients with multivessel disease to undergo implantation of drug-eluting stents guided by angiography and FFR or drug-eluting stent implantation guided by angiography alone. The overall composite adverse event rates were 18.3% in the angiography-alone group and 13.2% in the FFR group. Adverse events included death, non-fatal myocardial infarction and repeat revascularization. The trial also showed that including FFR in the procedure saved money and only added one minute to the average procedure time (71 minutes versus 70 minutes). The average procedure cost was $6,007 in the angiography-alone group compared to $5,332 for the FFR group, partly because FFR measurement led to the implant of fewer stents. The FFR group received an average of 1.9 stents per patient compared to 2.7 for the angiography-alone group, even though patients in the FFR group had an average of 2.8 coronary lesions compared to 2.7 for the angiography-alone group. The study was sponsored by Medtronic, Friends of the Heart Foundation and St. Jude Medical/Radi Medical Systems

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Fewer Stents, Less Spending: Fractional Flow Reserve Cost Savings Validated

Performing a percutaneous coronary intervention on a patient and providing one year of follow-up care costs, on average, $2,385 less if fractional flow reserve screening is used along with standard coronary angiography to help guide stent placement, researchers concluded in the Dec. 14 issue of the journal Circulation. What's more, outcomes are significantly better using FFR.

Fewer Stents, Less Spending: Fractional Flow Reserve Cost Savings Validated

Performing a percutaneous coronary intervention on a patient and providing one year of follow-up care costs, on average, $2,385 less if fractional flow reserve screening is used along with standard coronary angiography to help guide stent placement, researchers concluded in the Dec. 14 issue of the journal Circulation. What's more, outcomes are significantly better using FFR.

EuroPCR In Brief

MitraClip: Abbott's transcatheter mitral valve repair device kept well within the non-inferiority margin compared to surgery on the composite endpoint of freedom from death, from follow-up mitral valve surgery and from greater-than-mild mitral regurgitation after two years of follow-up, EVEREST II trial investigator Ted Feldman, M.D., NorthShore University Health System, reported May 25 at the EuroPCR conference in Paris. And in a one-year subgroup analysis, there was no statistical difference in safety and similar efficacy outcome in MitraClip patients with either functional or degenerative mitral regurgitation, he said. MitraClip attracted significant attention in March when Feldman reported it has met its one-year non-inferiority efficacy endpoint and 30-day superiority safety endpoint versus open surgery at the American College of Cardiology annual meeting (1"The Gray Sheet" March 22, 2010). The EuroPCR MR subgroup analysis is particularly important, said Michael Weinstein, a J.P. Morgan analyst, because it "suggests that Abbott will be able to target the entire [MR] market, significantly increasing the potential opportunity.

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