3-year comparison of drug-eluting versus bare-metal stents.

ABSTRACT

OBJECTIVES: The aim of this study was to compare 3-year cumulative outcomes to landmark second- and third-year outcomes with the routine use of drug-eluting stents (DES) (>75% "off-label") with a comparable group treated with bare-metal stents (BMS). BACKGROUND: Long-term safety concerns after "off-label" DES use persist, despite recent 2-year data showing comparable safety to BMS use. METHODS: Clinical outcomes (nonfatal myocardial infarction, all-cause mortality) were assessed in 1,147 consecutive patients who received a BMS in the year before the introduction of DES at Wake Forest University Baptist Medical Center and 1,246 consecutive patients that received a DES after it became our routine choice with equivalent complete 3-year follow-up. RESULTS: Stents were used for "off-label" indications in 80% of DES patients. At 3 years, the hazard ratio for DES compared with BMS for cumulative target vessel revascularization was 0.65 (95% confidence interval [CI] 0.51 to 0.82), nonfatal myocardial infarction or death was 0.85 (95% CI 0.71 to 1.03), and all-cause mortality 0.80 (95% CI 0.64 to 1.01). The DES clinical benefits occurred entirely within the first year, with similar rates of these clinical end points in the second and third year. The cumulative hazard ratio of stent thrombosis DES compared with BMS was 1.07 (95% CI 0.57 to 2.01), with similar rates of stent thrombosis in the third year (p = 0.70). CONCLUSIONS: The routine clinical use of DES for "off-label" indications was associated with lower clinical end points at 3 years than treatment with BMS in a comparable group of patients, with similar cumulative rates of stent thrombosis. There was no evidence of late "catch-up" of adverse DES events.