Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents.
BACKGROUND
The long-term effects of treatment with sirolimus-eluting stents, as compared with bare-metal stents, have not been established.


METHODS
We performed an analysis of individual data on 4958 patients enrolled in 14 randomized trials comparing sirolimus-eluting stents with bare-metal stents (mean follow-up interval, 12.1 to 58.9 months). The primary end point was death from any cause. Other outcomes were stent thrombosis, the composite end point of death or myocardial infarction, and the composite of death, myocardial infarction, or reintervention.


RESULTS
The overall risk of death (hazard ratio, 1.03; 95% confidence interval [CI], 0.80 to 1.30) and the combined risk of death or myocardial infarction (hazard ratio, 0.97; 95% CI, 0.81 to 1.16) were not significantly different for patients receiving sirolimus-eluting stents versus bare-metal stents. There was a significant reduction in the combined risk of death, myocardial infarction, or reintervention (hazard ratio, 0.43; 95% CI, 0.34 to 0.54) associated with the use of sirolimus-eluting stents. There was no significant difference in the overall risk of stent thrombosis with sirolimus-eluting stents versus bare-metal stents (hazard ratio, 1.09; 95% CI, 0.64 to 1.86). However, there was evidence of a slight increase in the risk of stent thrombosis associated with sirolimus-eluting stents after the first year.


CONCLUSIONS
The use of sirolimus-eluting stents does not have a significant effect on overall long-term survival and survival free of myocardial infarction, as compared with bare-metal stents. There is a sustained reduction in the need for reintervention after the use of sirolimus-eluting stents. The risk of stent thrombosis is at least as great as that seen with bare-metal stents.
Kastrati
Adnan
A
Deutsches Herzzentrum, Technische Universität, Munich, Germany. kastrati@dhm.mhn.de
Mehilli
Julinda
J
Pache
Jürgen
J
Kaiser
Christoph
C
Valgimigli
Marco
M
Kelbaek
Henning
H
Menichelli
Maurizio
M
Sabaté
Manel
M
Suttorp
Maarten J
MJ
Baumgart
Dietrich
D
Seyfarth
Melchior
M
Pfisterer
Matthias E
ME
Schömig
Albert
A
D015906:Angioplasty, Balloon, Coronary; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology / Q000628:therapy; D003328:Coronary Thrombosis / Q000453:epidemiology / Q000209:etiology*; D016503:Drug Delivery Systems; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D009203:Myocardial Infarction / Q000453:epidemiology / Q000209:etiology; D011474:Prosthesis Design; D011475:Prosthesis Failure; D016032:Randomized Controlled Trials as Topic; D012044:Regression Analysis; D012306:Risk; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents / Q000009:adverse effects*; D016019:Survival Analysis
D007166:Immunosuppressive Agents; D020123:Sirolimus