10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents

Anders M. Galløe; Henning Kelbæk; Leif Thuesen; Henrik Steen Hansen; Jan Ravkilde; Peter R. Hansen; Evald H. Christiansen; Ulrik Abildgaard; Ghita Stephansen; Jens F. Lassen; Thomas Engstrøm; Jan Skov Jensen; Jørgen L. Jeppesen; Niels Bligaard; SORT OUT II Investigators; Leif Thuesen; Henning Kelbæk; Per Thayssen; Jens Aarøe; Peter R. Hansen; Jens F. Lassen; Kari Saunamäki; Anders Junker; Jan Ravkilde; Ulrik Abildgaard; Hans H. Tilsted; Thomas Engstrøm; Jan S. Jensen; Hans E. Bøtker; Søren Galatius; Carsten T. Larsen; Steen D. Kristensen; Lars R. Krusell; Steen Z. Abildstrøm; Evald H. Christiansen; Michael Meng; Lisette Okkels; Ghita Stephansen; Jørgen L. Jeppesen; Anders M. Galløe

doi:10.1016/j.jacc.2016.11.055

10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents

Anders M. Galløe, Henning Kelbæk, Leif Thuesen, Henrik Steen Hansen, Jan Ravkilde, Peter R. Hansen, Evald H. Christiansen, Ulrik Abildgaard, Ghita Stephansen, Jens F. Lassen, Thomas Engstrøm, Jan Skov Jensen, Jørgen L. Jeppesen, Niels Bligaard, SORT OUT II Investigators, Leif Thuesen, Henning Kelbæk, Per Thayssen, Jens Aarøe, Peter R. HansenJens F. Lassen, Kari Saunamäki, Anders Junker, Jan Ravkilde, Ulrik Abildgaard, Hans H. Tilsted, Thomas Engstrøm, Jan S. Jensen, Hans E. Bøtker, Søren Galatius, Carsten T. Larsen, Steen D. Kristensen, Lars R. Krusell, Steen Z. Abildstrøm, Evald H. Christiansen, Michael Meng, Lisette Okkels, Ghita Stephansen, Jørgen L. Jeppesen, Anders M. Galløe

Department of Clinical Medicine

42 Citations (Scopus)

Abstract

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)

Original language	English
Journal	Journal of the American College of Cardiology
Volume	69
Issue number	6
Pages (from-to)	616-624
Number of pages	9
ISSN	0735-1097
DOIs	https://doi.org/10.1016/j.jacc.2016.11.055
Publication status	Published - 14 Feb 2017

Keywords

angioplasty
coronary disease
stent thrombosis
survival

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10.1016/j.jacc.2016.11.055

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Galløe, A. M., Kelbæk, H., Thuesen, L., Hansen, H. S., Ravkilde, J., Hansen, P. R., Christiansen, E. H., Abildgaard, U., Stephansen, G., Lassen, J. F., Engstrøm, T., Jensen, J. S., Jeppesen, J. L., Bligaard, N., SORT OUT II Investigators, Thuesen, L., Kelbæk, H., Thayssen, P., Aarøe, J., ... Galløe, A. M. (2017). 10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents. Journal of the American College of Cardiology, 69(6), 616-624. https://doi.org/10.1016/j.jacc.2016.11.055

Galløe, AM, Kelbæk, H, Thuesen, L, Hansen, HS, Ravkilde, J, Hansen, PR, Christiansen, EH, Abildgaard, U, Stephansen, G, Lassen, JF, Engstrøm, T, Jensen, JS, Jeppesen, JL, Bligaard, N, SORT OUT II Investigators, Thuesen, L, Kelbæk, H, Thayssen, P, Aarøe, J, Hansen, PR, Lassen, JF, Saunamäki, K, Junker, A, Ravkilde, J, Abildgaard, U, Tilsted, HH, Engstrøm, T, Jensen, JS, Bøtker, HE, Galatius, S, Larsen, CT, Kristensen, SD, Krusell, LR, Abildstrøm, SZ, Christiansen, EH, Meng, M, Okkels, L, Stephansen, G, Jeppesen, JL & Galløe, AM 2017, '10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents', Journal of the American College of Cardiology, vol. 69, no. 6, pp. 616-624. https://doi.org/10.1016/j.jacc.2016.11.055

@article{05f8b1ec474f4a46b8851c3dd85a5e8c,

title = "10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents",

abstract = "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)",

keywords = "angioplasty, coronary disease, stent thrombosis, survival",

author = "Gall{\o}e, {Anders M.} and Henning Kelb{\ae}k and Leif Thuesen and Hansen, {Henrik Steen} and Jan Ravkilde and Hansen, {Peter R.} and Christiansen, {Evald H.} and Ulrik Abildgaard and Ghita Stephansen and Lassen, {Jens F.} and Thomas Engstr{\o}m and Jensen, {Jan Skov} and Jeppesen, {J{\o}rgen L.} and Niels Bligaard and {SORT OUT II Investigators} and Leif Thuesen and Henning Kelb{\ae}k and Per Thayssen and Jens Aar{\o}e and Hansen, {Peter R.} and Lassen, {Jens F.} and Kari Saunam{\"a}ki and Anders Junker and Jan Ravkilde and Ulrik Abildgaard and Tilsted, {Hans H.} and Thomas Engstr{\o}m and Jensen, {Jan S.} and B{\o}tker, {Hans E.} and S{\o}ren Galatius and Larsen, {Carsten T.} and Kristensen, {Steen D.} and Krusell, {Lars R.} and Abildstr{\o}m, {Steen Z.} and Christiansen, {Evald H.} and Michael Meng and Lisette Okkels and Ghita Stephansen and Jeppesen, {J{\o}rgen L.} and Gall{\o}e, {Anders M.}",

year = "2017",

month = feb,

day = "14",

doi = "10.1016/j.jacc.2016.11.055",

language = "English",

volume = "69",

pages = "616--624",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier",

number = "6",

}

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 -

10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents

Abstract

Keywords

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