Proving Clinical and Economic Outcomes: Statistics from the FAME Trial

Proving Clinical and Economic Outcomes:Statistics from the FAME Trial

Maria Shepherd • Data Decision Group

Do you have a product in your portfolio that can prove superior clinical and/or economic outcomes through a well-designed post-market clinical study? St. Jude Medical Inc. seems to have shown that stent procedures using the company’s PressureWire save money and lives.¹ The technology is a measurement system that measures pressure in the coronary arteries to calculate the fractional flow reserve (FFR), which has been shown to more accurately assess the severity of lesions that cause ischemia (restricted blood flow). The marketing team at St. Jude Medical clearly understood the benefits to the interventional cardiologist in assessing the need to stent a clogged coronary artery, improving clinical outcomes and decreasing costs by reducing unnecessary stent procedures.

Why This Is Important

William F. Fearon, M.D., of the Division of Cardiovascular Medicine at Stanford University Medical Center, was co-principal investigator and led the FAME (Fractional Flow Reserve vs. Angiography in Multivessel Evaluation) trial which determined that FFR is a technology that provides information on the condition of a diseased artery to the interventional cardiologist to support the decision to stent.¹ Data from the trial also demonstrated that use of the PressureWire can save an average of $1,200 per patient in the first year. “The FAME study reveals that FFR-guided percutaneous coronary intervention (PCI) in patients with multi-vessel coronary artery disease (CAD) is one of those rare situations in which a new technology not only improves outcomes, but also saves resources,” Fearon said.

The conclusion of the study provided support for the routine measurement of FFR in patients with multi-vessel coronary artery disease undergoing PCI. FFR uses a coronary pressure guidewire in the diseased vessel instead of or in addition to the traditional interpretation of blockage size using a two-dimensional coronary angiogram. This process identifies which arteries should be stented for patients with CAD.

How Does Your Product Portfolio Stack Up?

“What we found was a combination of savings first at the initial procedure as a result of fewer stents and then further savings due to fewer events during follow-up—fewer heart attacks, fewer blood clots, fewer repeat surgeries,” Fearon said.² After reviewing the data from the FAME trial, what interventional cardiologist wouldn’t use the PressureWire on a routine basis in PCI?

In the FAME study, 1,005 patients randomly were assigned to FFR-guided or angiography-guided PCI. A prospective cost-utility analysis comparing costs and quality-adjusted life-years was performed for one year. Major adverse cardiac events occurred in 13.2 percent in the FFR-guided arm and 18.3 percent in theangiography-guided arm (P < 0.02; see Table 1). Myocardialinfarctions and death rates also decreased in the FFR-Guided arm (Table 2). Mean overall costs were significantly less in the FFR arm ($14,315 versus $16,700; P < 0.001), primarily because fewer drug-eluting stents were used (Table 3).

The PressureWire clinical study results are not an anomaly. Many products have the potential for broader use, longer lifecycles and increased share of market. Three elements are needed to identify the hidden gems in your product line: your hypothesis, a strategic assessment of your product portfolio, and a well-designed, cost-effective post-market clinical study.

Author’s note: Readers are invited to submit market data and trend questions to Maria Shepherd. Periodically, selected questions will be presented in this column, with answers from Maria. Send your questions to [email protected].

References:

1. circ.ahajournals.org/content/122/24/2545

2. http://med.stanford.edu/ism/2010/december/fearon-1213.html

Maria Shepherd, founder of Data Decision Group, has 20years of leadership experience in medical device and life-sciencesmarketing in small startups and top-tier companies. The firmquantitatively and qualitatively sizes opportunities, evaluates newtechnologies, and assesses prospective acquisitions. Shepherd canbe reached at (617) 548-9892 or at [email protected] or

www.ddecisiongroup.com.