PT - JOURNAL ARTICLE AU - Philpott, Andrew C. AU - Southern, Danielle A. AU - Clement, Fiona M. AU - Galbraith, P. Diane AU - Traboulsi, Mouhieddin AU - Knudtson, Merril L. AU - Ghali, William A. ED - , TI - Long-term outcomes of patients receiving drug-eluting stents AID - 10.1503/cmaj.080050 DP - 2009 Jan 20 TA - Canadian Medical Association Journal PG - 167--174 VI - 180 IP - 2 4099 - http://www.cmaj.ca/content/180/2/167.short 4100 - http://www.cmaj.ca/content/180/2/167.full SO - CMAJ2009 Jan 20; 180 AB - Background: We sought to establish the long-term safety of drug-eluting stents compared with bare-metal stents in a usual care setting. Methods: Using data from a prospective multicentre registry, we compared rates of death and of death or repeat revascularization during 3 years of follow-up of 6440 consecutive patients who underwent angioplasty with either drug-eluting or bare-metal stents between Apr. 1, 2003, and Mar. 31, 2006. Results: Drug-eluting stents were inserted in 1120 patients and bare-metal stents in 5320. The drug-eluting stents were selected for patients who had a greater burden of comorbid illness, including diabetes mellitus (32.8% v. 20.8% in the bare-metal group, p < 0.001) and renal disease (7.4% v. 5.0%, p = 0.001). At 1-year follow-up, the drug-eluting stents were associated with a mortality of 3.0%, as compared with 3.7% with the bare-metal stents (adjusted odds ratio [OR] 0.62, 95% confidence interval [CI] 0.46–0.83). The rate of the composite outcome of death or repeat revascularization was 12.0% for the drug-eluting stents and 15.8% for the bare-metal stents (adjusted OR 0.40, 95% CI 0.33–0.49). In the subgroup of patients who had acute coronary syndromes, the adjusted OR for this composite outcome was 0.46 (95% CI 0.35–0.61). During the 3 years of observation, the relative risks for death and repeat revascularization varied over time. In year 1, there was an initial period of lower risk in the group with drug-eluting stents than in the group with bare-metal stents; this was followed by a shift toward outcome rates favouring bare-metal stents in years 2 and 3. The adjusted relative risk of the composite outcome of death or repeat revascularization associated with drug-eluting stents relative to bare-metal stents was 0.73 early in the first year of follow-up; it then rose gradually over time, to a peak of 2.24 at 3 years. Interpretation: Drug-eluting stents are safe and effective in the first year following insertion. Thereafter, the possibility of longer term adverse events cannot be ruled out.