This article is more than 5 years old. Information may no longer be current.
FAME II: FFR-guided PCI cost effective vs. medical therapy
MIAMI — Results of a cost-effectiveness subanalysis of the FAME II trial suggest that fractional flow reserve-guided PCI was cost effective in terms of quality-adjusted life years compared with standard medical therapy alone in patients with stable CAD.
William F. Fearon, MD, of Stanford University, reported that FFR-guided PCI had higher initial cost than medical therapy — $8,790 vs. $3,350 — but the cost gap narrowed by more than half at 12 months to $11,374 for FFR-guided PCI vs. $8,866 for medical therapy. According to Fearon, baseline costs were higher in the FFR-guided PCI arm because those patients received drug-eluting stents. Follow-up costs were higher in the medical therapy arm because of the higher revascularization rate. Despite this, at 12 months, costs remained higher in the FFR-guided PCI arm, Fearon said during a late-breaking clinical trial session.
At 12 months, the cost of FFR-guided PCI was $2,508 more than medical therapy, but due to quality of life improvements observed with PCI, the overall cost effectiveness of FFR-guided PCI was $53,000 per quality-adjusted life year. The 3-year projected cost for FFR-guided PCI was $32,000 per quality-adjusted life year, according to a press release.
Fearon also presented data on quality of life at 1 month. The percent of patients with mild or no angina was significantly greater at 1 month after FFR-guided PCI (P<.001). This resulted in a significantly greater change in utility from baseline to 1 month of 0.054 after FFR-guided PCI compared with little improvement (0.003) with medical therapy (P<.001).
“FFR-guided PCI appears to be economically attractive in this cost-effectiveness analysis,” Fearon said. – by Katie Kalvaitis
For more information:
Fearon WF. Plenary session VI. Late breaking clinical trials I. Presented at: TCT 2012; Oct. 22-26, 2012; Miami.
Disclosure: Fearon reports receiving institutional research grant support from St. Jude Medical. The trial was funded by St. Jude Medical.
Perspective
Back to Top
Once you have a pressure wire down a vessel in the first place, which was a prerequisite for entering this trial, in a fairly symptomatic and ischemic patient it is quite reasonably cost effective to perform PCI with a DES. This contrasts with the COURAGE results. I suspect this reflects the fact that physiologically proven ischemia is a far more rigorous standard and identifies a group of patients who are much more likely to derive symptomatic benefit from PCI than the patients who were enrolled in COURAGE.
It is also important to recognize what [this trial] does not prove. It doesn’t prove that it is cost effective to do the pressure wire study in the first place because the randomization here occurred after the pressure wire was already performed. Fortunately, that procedure is already justified based on the DEFER and FAME I trials. Second, the study does not prove that the results apply in any way to patients with mild or no angina symptoms. You may recall that the benefit [in FAME II] was driven entirely by quality of life improvement in this study. In order to have a quality of life improvement you must have moderately impaired patients to begin with. Finally, it is important to recognize that this study does not demonstrate that it is cost effective to screen for and treat ischemia in patients with mild symptoms or asymptomatic coronary disease. That question will be one of the questions that are going to be addressed by the ISCHEMIA trial. Nonetheless, this is a very important contribution to our understanding of the value of this technology and the value of PCI in these types of patients.
Perspective
Back to TopI think we have underestimated the importance of quality of life. We’ve never thought with stable coronary disease that we’re going to reduce mortality or reduce risk for infarction. But, what we are doing is improving quality of life. If you look at the number one surgeries being done in the world, which is cataract surgery and knee replacements, they are improving quality of life. That is a very important endpoint. I think this is additional evidence that allows us to treat these lesions.