In the healthcare systems of Germany, France, Italy and the U.K., fractional flow reserve (FFR)-guided stenting is cost saving compared with aniography-guided procedure in patients with multivessel coronary artery disease (CAD), according to a late-breaking clinical trial presented last week at EuroPCR in Paris. Uwe Siebert, MD, MPH, told Cardiovascular Business: “Even in Germany, where stents are quite inexpensive, FFR not only improves patient outcomes, but also reduces costs.”

For this cost-effectiveness study, the researchers based their analysis on the FAME study, which showed FFR testing is effective in multivessel CAD patients and reduced composite endpoint death or MI by 34 percent. Siebert, from UMIT – University for Health Sciences in Austria, said that there could have been a potential "cost-effective tradeoff" with employing FFR. “Providers must pay for the FFR test in all patients, and they only save on stents and follow-up costs in some patients—those who are FFR negative,” he said. Therefore, there was a need to compare net incremental benefits and costs.

Using the FAME data, Siebert and colleagues sought to perform a cost-effectiveness analysis and a public health and budget impact analysis of FFR-guided stenting versus stenting-guided by angiography alone in multi-vessel patients in the context of different European healthcare systems. They assessed Germany, France, U.K., Italy, and performed a preliminary analysis for Belgium and Switzerland.
 
“Currently, we don’t know if the cost benefits in one country will translate into other countries, so we compared the varied European centers that contributed to the trial,” Siebert says. “Because we didn’t find any significant difference in clinical benefits between the countries, we felt we could confidently extrapolate the data across the varied populations.”
 
However, there are different healthcare systems and stent costs in each of these European countries. For instance, in Germany, stents are much less expensive compared with France and Belgium. “Therefore, we were unsure if the cost-effective findings would be applicable across all the countries,” he said.

In the context of the current healthcare model for each respective country, the analysis found:

• In the U.K., FFR use potentially reduces treatment cost for PCI per patient by an average of about £600 ($971.95 U.S.).
• In France, FFR use could save the French healthcare system more than EUR5 million ($7.06 million U.S.) in 2011 and more than EUR11 million ($15.52 million U.S.) in 2012; and could potentially reduce treatment cost for PCI per patient by an average of about EUR900 ($1,270 U.S.).
• In Italy, FFR use could save the Italian healthcare system more than EUR800,000 ($1.23 million U.S.)  in 2011 and more than EUR3 million ($4.23 million U.S.) in 2012; and could potentially reduce treatment cost for PCI per patient by an average of about EUR500 ($705.39 U.S.).

Overall, the expected mean cost savings per patient ranged from approximately EUR300 ($423 U.S.) in Germany to approximately EUR900 ($1,270 U.S.) in France.

The authors noted that it is “rare situation in cardiology that new technology not only prevents major adverse coronary events, MIs, saves lives and improves quality of life, but also substantially saves resources.”

The researchers now are undertaking further studies in two areas: a cost-effective analyses for additional countries (e.g., Canada) and an evaluation of long-term cost-effecitveness (two and five years).

The study was funded by a research grant from St. Jude Medical.