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COST-EFFECTIVENESS AND CARDIAC INTERVENTIONS

Cost-effectiveness of distal embolic protection for patients undergoing percutaneous intervention of saphenous vein bypass grafts

Results from the SAFER trial

David J. Cohen, MD, MSc^*,,*, Sabina A. Murphy, MSc^*, Donald S. Baim, MD, Tara A. Lavelle, BS^*, Ronna H. Berezin, MPH^*, Donald E. Cutlip, MD^*,, Kalon K.L. Ho, MD, MSc^*,, Richard E. Kuntz, MD, MSc^*, the SAFER Trial Investigators

^* Harvard Clinical Research Institute, Boston, Massachusetts, USA
Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
theDivision of Cardiovascular Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA

Manuscript received January 23, 2004; revised manuscript received May 1, 2004, accepted May 4, 2004.

^* Reprint requests and correspondence: Dr. David J. Cohen, Cardiovascular Division, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, Massachusetts 02215 (Email: dcohen{at}caregroup.harvard.edu).

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 $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.

Abbreviations and Acronyms   CK-MB = creatinine kinase-MB   MI = myocardial infarction   PCI = percutaneous coronary intervention   SAFER = Saphenous Vein Graft Angioplasty Free of Emboli Randomized trial   SVG = saphenous vein bypass graft

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