Purpose: The FAME Study, an international multicenter RCT (n=1005), demonstrated significant health benefits for patients undergoing multivessel percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) measurement compared with PCI guided by angiography alone (ANGIO). The aim of our study was to determine the cost-effectiveness as well as the public health and budget impact for six European countries.
Method: All analyses were performed for patients with multivessel disease comparing FFR vs. ANGIO, based on the original patient-level data of the FAME Study (Tonino et al., NEJM2009). The following analyses were performed for Germany, UK, Italy, France, Belgium and Switzerland. In the prospective cost-effectiveness analyses, we calculated the incremental cost-effectiveness ratios (ICER) in Euro/QALY gained during 1 year adopting the societal perspective. Utilities were measured with country-specific EQ-5D or Torrance-transformed European weights, respectively. Costs were based on country-specific prices and DRGs. The public health and budget impact analysis was based on national PCI registries and performed from the national payer’s perspective over a budget period of two years. Variability was estimated using the Bootstrap method (n=5000 samples) and extensive sensitivity analysis.
Result: In the FAME trial, major adverse cardiac events at 1 year occurred in 13.2% of patients in the FFR arm and 18.3% of patients in the ANGIO arm (p=0.02). For all six countries, FFR was cost-saving compared to ANGIO. Bootstrap simulation indicated FFR being cost saving in 52-73% and cost effective in 89-92% at a threshold of 50,000 EUR/QALY gained. Mean savings per patient range from 300 EUR (Germany) to 900 EUR (France). The 2-year public health impact due to the use of FFR ranged was largest for Germany with more than 500 deaths avoided, more than 2000 major cardiac events avoided, and 380 QALYs gained. The 2-year budget impact ranges from less than 1 million to more than 27 million EUR total cost savings depending on the country. Sensitivity analyses showed that prices of FFR pressure wire and drug-eluting stents were most influential, determining whether FFR is cost-effective or cost-saving.
Conclusion: In the health care systems of Germany, UK, Italy, France, Belgium and Switzerland, FFR-guided PCI in patients with multivessel coronary disease substantially reduces cardiac events, improves QALYs and is cost saving.