Cost and patency rate targets for the development of endovascular devices to treat femoropopliteal arterial disease.

PURPOSE 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.