Cost-effectiveness of distal embolic protection for patients undergoing percutaneous intervention of saphenous vein bypass grafts: results from the SAFER trial.

OBJECTIVES: The goal of this research was to determine the incremental cost and cost-effectiveness of embolic protection in patients undergoing percutaneous revascularization (PCI) of diseased saphenous vein bypass grafts (SVGs). BACKGROUND: Distal protection using the GuardWire balloon occlusion device has been shown to reduce major ischemic complications in patients undergoing SVG PCI, but the cost-effectiveness of this approach is unknown. METHODS: We prospectively measured medical resource utilization and cost for 801 patients undergoing SVG intervention who were randomized to distal protection using the GuardWire (n = 406) or conventional treatment (n = 395) in the Saphenous Vein Graft Angioplasty Free of Emboli Randomized (SAFER) trial. Long-term survival and cost-effectiveness were projected based on observed 30-day outcomes and a validated survival model for postcoronary artery bypass graft patients. RESULTS: Compared with conventional treatment, distal protection increased initial procedural costs by approximately $1,600 ($6,326 vs. $4,779, p < 0.001). However, by reducing ischemic complications, distal protection reduced mean length of stay by 0.4 days and other hospital costs by nearly $1,000 ($6,846 vs. $7,811, p = 0.018). As a result, overall initial hospital costs were only $582 per patient higher with distal protection. Based on the observed 30-day cost and outcome differences in the trial, the incremental cost-effectiveness ratio for distal protection was $3,718 per year of life saved and remained <$40,000 per year of life saved in 97.3% of bootstrap simulations (95% confidence interval, $0 to $43,079). CONCLUSIONS: For patients undergoing PCI of diseased SVGs, distal protection using the GuardWire system is an attractive use of limited health care resources.