Time dependency of outcomes for drug-eluting vs bare-metal stents.

BACKGROUND Previous research suggests that the early benefit from revascularization with drug-eluting stents might diminish over time. METHODS We performed an extended analysis of a previously identified cohort of 6440 patients who underwent percutaneous coronary intervention between April 1, 2003 and March 31, 2005 using a prospective provincial clinical registry in Alberta, Canada. We compared rates of death, and of death or repeat revascularization among the 6440 patients receiving either drug-eluting (sirolimus- and paclitaxel) stents or bare-metal stents. We determined risk-adjusted hazard ratios at moments in time with a spline analysis using Cox proportional hazards modelling. RESULTS During the 8 years of observation, the relative risks for death or the composite outcome of death or repeat revascularization varied over time. There was an early finding of better outcomes associated with drug-eluting stents in the first year after implantation. Thereafter, there was no significant benefit associated with drug-eluting stents compared with bare-metal stents with 8 years of follow-up. At 30 days, the adjusted hazard ratio was 0.38 (95% confidence interval [CI], 0.18-0.81) for death and 0.27 (95% CI, 0.14-0.54) for the composite outcome of death or repeat revascularization. By 8 years, the adjusted hazard ratio of death or the composite outcome was 1.15 (95% CI, 0.97-1.36) and 1.01 (95% CI, 0.87-1.17), respectively. CONCLUSIONS Revascularization with first-generation drug-eluting stents is associated with better outcomes within the first year only. Thereafter, the risk of death or repeat revascularization is similar between drug-eluting stents and bare-metal stents.