TY - JOUR
T1 - 10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents
AU - Galløe, Anders M.
AU - Kelbæk, Henning
AU - Thuesen, Leif
AU - Hansen, Henrik Steen
AU - Ravkilde, Jan
AU - Hansen, Peter R.
AU - Christiansen, Evald H.
AU - Abildgaard, Ulrik
AU - Stephansen, Ghita
AU - Lassen, Jens F.
AU - Engstrøm, Thomas
AU - Jensen, Jan Skov
AU - Jeppesen, Jørgen L.
AU - Bligaard, Niels
AU - SORT OUT II Investigators
AU - Thuesen, Leif
AU - Kelbæk, Henning
AU - Thayssen, Per
AU - Aarøe, Jens
AU - Hansen, Peter R.
AU - Lassen, Jens F.
AU - Saunamäki, Kari
AU - Junker, Anders
AU - Ravkilde, Jan
AU - Abildgaard, Ulrik
AU - Tilsted, Hans H.
AU - Engstrøm, Thomas
AU - Jensen, Jan S.
AU - Bøtker, Hans E.
AU - Galatius, Søren
AU - Larsen, Carsten T.
AU - Kristensen, Steen D.
AU - Krusell, Lars R.
AU - Abildstrøm, Steen Z.
AU - Christiansen, Evald H.
AU - Meng, Michael
AU - Okkels, Lisette
AU - Stephansen, Ghita
AU - Jeppesen, Jørgen L.
AU - Galløe, Anders M.
PY - 2017/2/14
Y1 - 2017/2/14
N2 - 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. Objectives 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)
AB - 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. Objectives 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)
KW - angioplasty
KW - coronary disease
KW - stent thrombosis
KW - survival
U2 - 10.1016/j.jacc.2016.11.055
DO - 10.1016/j.jacc.2016.11.055
M3 - Journal article
C2 - 28183505
AN - SCOPUS:85011554691
SN - 0735-1097
VL - 69
SP - 616
EP - 624
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 6
ER -