Long-term outcomes of patients receiving drug-eluting stents.
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.


CONCLUSIONS
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.
Philpott
Andrew C
AC
Department of Medicine, University of Calgary, Calgary, Alberta.
Southern
Danielle A
DA
Clement
Fiona M
FM
Galbraith
P Diane
PD
Traboulsi
Mouhieddin
M
Knudtson
Merril L
ML
Ghali
William A
WA
D054058:Acute Coronary Syndrome / Q000401:mortality; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation* / Q000401:mortality; D002170:Canada / Q000453:epidemiology; D003257:Consumer Product Safety; D023903:Coronary Restenosis / Q000453:epidemiology / Q000517:prevention & control; D003328:Coronary Thrombosis / Q000453:epidemiology / Q000209:etiology; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012086:Reoperation / Q000706:statistics & numerical data; D012306:Risk; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome