10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents.
BACKGROUND
First-generation drug-eluting coronary stents (DES) were introduced in 2003 to 2004, and their use resulted in a considerable reduction in the development of in-stent restenosis at the cost of an increased risk of late stent thromboses.


OBJECTIVE
This study followed clinical outcomes of patients included in a large randomized trial for 10 years to enable detection of late changes in annual event rates that could necessitate medical attention.


METHODS
A total of 2,098 unselected all-comer patients (50% with acute coronary syndrome) were randomly assigned to have a first-generation DES implanted. This study recorded the occurrence of a major adverse cardiac event (MACE) assessed as the composite of cardiac death, myocardial infarction, and target vessel revascularization. Stent thromboses were also assessed.


RESULTS
Of the 2,098 unselected patients, 73.1% were still alive after 10 years. During the follow-up period, MACE occurred in 346 (32.5%) in the group receiving a sirolimus-eluting stent and in 342 (33.1%) in the group receiving a paclitaxel-eluting stent (hazard ratio: 0.96; 95% confidence interval: 0.83 to 1.11; p = 0.60), with a steady annual rate of 2.6% after the first year. Definite, probable, and possible stent thrombosis appeared in 279 patients (13.3%), with no difference between stent types and with a steady annual rate of 1.3% after the first year.


CONCLUSIONS
Among the surviving patients, the long-term annual MACE rate and the stent thrombosis rate appeared constant for both stent types, with no apparent late changes. Although there is no need for extraordinary medical attention for these patients, the absence of declines in annual event rates calls for continuous surveillance. (Danish Organization on Randomized Trials With Clinical Outcome II [SORT OUT II]; NCT00388934).
Department of Cardiology, Zealand University Hospital, Roskilde, Denmark. Electronic address: anders@galloe.dk.
Anders M
AM
Galløe
Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.
Henning
H
Kelbæk
Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
Leif
L
Thuesen
Department of Cardiology, Odense University Hospital, Odense, Denmark.
Henrik S
HS
Hansen
Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
Jan
J
Ravkilde
Department of Cardiology, Copenhagen University Hospital, Gentofte, Denmark.
Peter R
PR
Hansen
Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.
Evald H
EH
Christiansen
Department of Cardiology, Copenhagen University Hospital, Gentofte, Denmark.
Ulrik
U
Abildgaard
Department of Cardiology, Copenhagen University Hospital, Gentofte, Denmark.
Ghita
G
Stephansen
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Jens F
JF
Lassen
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Thomas
T
Engstrøm
Department of Cardiology, Copenhagen University Hospital, Gentofte, Denmark.
Jan Skov
JS
Jensen
Department of Medicine, Amager Hvidovre Hospital, Glostrup, University of Copenhagen, Copenhagen, Denmark.
Jørgen L
JL
Jeppesen
Department of Cardiology, Copenhagen University Hospital, Bispebjerg, Denmark.
Niels
N
Bligaard
D000368:Aged; D003324:Coronary Artery Disease / Q000601:surgery*; D023903:Coronary Restenosis / Q000453:epidemiology*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000453:epidemiology*; D006801:Humans; D007166:Immunosuppressive Agents; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel; D020123:Sirolimus; D013997:Time Factors; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D017239:Paclitaxel; D020123:Sirolimus
angioplasty; coronary disease; stent thrombosis; survival