Four-year comparative effectiveness of bare-metal and everolimus-eluting stents in New York.

OBJECTIVES: To study four-year outcomes for patients receiving either bare-metal stents (BMS) or everolimus-eluting stents (EES) and to evaluate the comparative effectiveness of BMS versus EES in six "off-label" and two "high-risk" patient subgroups.

BACKGROUND: BMS and EES (a second generation of drug-eluting stent) are used in contemporary practice to treat coronary artery disease. However, little is known about long-term comparative effectiveness between BMS and EES.

METHODS: Using the New York State (NYS) cardiac registries, statewide hospital discharge data, the National Death Index, and the U.S. Census file, we assessed four-year outcomes of BMS versus EES in patients receiving either BMS or EES from July 2008 through December 2009. The outcomes included all-cause mortality, acute myocardial infarction (AMI), target-lesion PCI (TLPCI), and target-vessel coronary artery bypass graft (TVCABG) surgery for a follow-up period of four years (median follow-up of 3.6 years). We compared 9,290 propensity score matched pairs with further adjustment using Cox proportional hazards regression.

RESULTS: Compared with patients receiving BMS, patients receiving EES had a lower rate of four-year mortality (adjusted hazard ratio <AHR>: 0.58, 95% confidence interval <CI>: 0.54-0.63), AMI (AHR: 0.68, 95% CI: 0.61-0.76), TLPCI (AHR: 0.67, 95% CI: 0.60-0.75), and TVCABG (AHR, 0.53, 95% CI: 0.43-0.65). For "off-label" and "high-risk" subgroups, EES was associated with decreased mortality and generally better AMI, TLPCI, and TVCABG outcomes relative to BMS.

CONCLUSIONS: Compared with BMS use, EES use was associated with better four-year outcomes.