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Background: Randomized trials demonstrate reduced restenosis and need for repeat revascularization with drug-eluting stents (DES) compared with bare-metal stents (BMS). Increased supply costs are of serious economic concern to providers and healthcare organizations, and the full impact of commercial release of DES on providers is unknown.
Purpose: We assessed the clinical and economic outcomes of patients who underwent percutaneous coronary intervention (PCI) with either DES (sirolimus-eluting) or BMS by physician preference following commercial release of DES in the United States.
Methods: We considered all patients who received 2.5 to 3.5 mm stents between 4/22/03 and 11/30/03 in analysis. Clinical, angiographic, and follow-up data were prospectively recorded in the Mayo PCI Registry. Administrative data was used to estimate total procedural costs (hospital and physician) and length of stay (LOS). A standardized, year 2003 constant-dollar cost estimate was used to value health care services. Logistic regression and Cox proportional models were used to estimate risk of adverse events; generalized linear modeling was used to estimate costs adjusting for clinical and angiographic characteristics.
Results: 569 PCI patients received DES (mean 1.51 stents) and 204 patients received BMS (mean 1.61 stents). BMS patients were more likely to have urgent PCI (31% vs 11%), recent MI (37% vs 11%), shock (10% vs 1%), old MI (60% vs 44%), B2 or C lesion (83% vs 75%), thrombus (40% vs 19%), and stents in native arteries (97.1% vs 95.6%). We observed fewer in-hospital complications among DES-treated patients (1.9% versus 7.4%; p<0.001) but this difference was not significant in adjusted models (OR 0.66; 95% CI: 0.26, 1.70). The adjusted hazard ratio for major adverse cardiovascular events during a median follow-up of 176 days was 0.69 (p=0.14). Cost prediction models suggest DES treated patients incur $1,328 more, on average, in cath lab expenses ($4,561 vs $3,233). Adjusted mean total costs were $654 higher for DES treated patients (95% CI of cost difference: $299, $1,009). Adjusted LOS was similar at 1.9 days.
Conclusions: Adoption of DES was extremely rapid following commercial release. BMS continue to be used among higher risk patients. Hospital costs are significantly higher with DES. Without adequate technology reimbursement, healthcare organizations may face an ethical dilemma: controlled access to what may be optimal patient care in order to maintain financial stability.
See more of Oral Concurrent Session A - Clinical Strategies and Guidelines
See more of The 26th Annual Meeting of the Society for Medical Decision Making (October 17-20, 2004)