- PURPOSE Although several prospective studies have examined the safety and efficacy of stent placement for femoropopliteal arterial disease, the current cost of these procedures is unknown. To estimate and compare hospital costs associated with conventional balloon angioplasty (percutaneous transluminal angioplasty [PTA]) and stent placement for patients with symptomatic peripheral arterial disease, the authors performed a prospective economic evaluation in conjunction with the Intracoil Femoropopliteal Stent Trial (VascuCoil). MATERIALS AND METHODS Between May 1997 and December 1999, 266 patients with stenotic or occluded superficial femoral or popliteal arteries were prospectively randomized to treatment with the IntraCoil stent or PTA. Detailed resource use and cost data for each patient's initial revascularization procedure and ensuing hospitalization were collected and analyzed on an intention-to-treat basis. RESULTS Compared with conventional balloon angioplasty, stent placement did not improve clinical outcomes but increased procedure duration, equipment costs, and physician services. As a result, initial hospital costs were approximately $3,500 higher for patients randomized to the IntraCoil stent, compared with PTA ($8,435 vs $4,980; P < .001). CONCLUSION As performed in the VascuCoil trial, primary stent placement for femoropopliteal disease did not improve clinical outcomes but increased initial treatment costs by more than $3,000. Because there were no substantial differences in subsequent clinical outcomes between the two treatments, it is unlikely that these increased initial costs would be offset by savings in follow-up costs. These findings suggest that a strategy of routine stent implantation for patients undergoing femoropopliteal PTA is not optimal on economic grounds and that PTA with provisional stent implantation is preferred.