Radiology 2001; 218:464 -469Abbreviations: NHB ϭ net health benefit PTA ϭ percutaneous transluminal angioplasty QALY ϭ quality-adjusted life-year To determine the criteria that would make use of an endovascular device cost-effective compared with bypass surgery and percutaneous transluminal angioplasty in the treatment of femoropopliteal arterial disease.
MATERIALS AND METHODS:A decision model was developed to compare treatment with the use of a hypothetical endovascular device with established therapies. Cost-effectiveness from the perspective of the health care system was considered. Outcome measures were lifetime costs and quality-adjusted life-years. With the use of net health benefit calculations and threshold analysis, combinations of costs and patency rates were determined that would make the device cost-effective compared with established therapies. In subgroup and sensitivity analyses, the effect on decision-making of sex, age, indication, lesion type, procedural risk, and society's willingness to pay for incremental gain in health were explored.
RESULTS:Use of a device that costs $3,000 would be cost-effective compared with bypass surgery for critical ischemia if the 5-year patency rate is 29%-46%. Use of the same device would be cost-effective compared with angioplasty for disabling claudication and stenosis if the 5-year patency rate is 69%-86%.
CONCLUSION:The target combinations of costs and patency rates found in this study are probably attainable, and further development of such endovascular devices seems warranted.Although bypass surgery and percutaneous transluminal angioplasty (PTA) are commonly used revascularization procedures in the treatment of femoropopliteal arterial occlusive disease, both procedures have disadvantages (1). Percutaneous transluminal balloon angioplasty is a low-risk and low-cost procedure, but it is associated with a fairly high restenosis rate (2-5). Primary stent placement does not improve the patency rate of PTA performed for femoropopliteal arterial disease and is thus currently used only to salvage a failed balloon angioplasty procedure (6,7). Bypass surgery, on the other hand, has higher long-term patency rates but is also associated with a higher procedural risk, higher cost, and longer convalescence period (4,5). In general, PTA is performed as primary treatment of short focal lesions of the femoropopliteal artery, whereas bypass surgery is the primary treatment in diffuse disease.Endovascular devices are currently being developed as alternative interventions to overcome the problems of established procedures. Important considerations in choosing the optimal treatment strategy are the effectiveness of the device, the risks of the procedures, and the costs. These parameters are generally unknown during the development of a new technology. In particular, the patency and cost estimates associated with endovascular devices are uncertain and may even change with time. It is difficult, if not impossible, to predict what the precise values for the parameters of a new te...