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Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study): a multicentre, open-label, randomised superiority trial

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Standard

Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study) : a multicentre, open-label, randomised superiority trial. / Maeng, Michael; Tilsted, Hans Henrik; Jensen, Lisette Okkels; Krusell, Lars Romer; Kaltoft, Anne; Kelbæk, Henning Skov; Villadsen, Anton B; Ravkilde, Jan; Hansen, Knud Nørregaard; Christiansen, Evald Høj; Aarøe, Jens; Jensen, Jan Skov; Kristensen, Steen Dalby; Bøtker, Hans Erik; Thuesen, Leif; Madsen, Morten; Thayssen, Per; Sørensen, Henrik Toft; Lassen, Jens Flensted.

I: Lancet, Bind 383, Nr. 9934, 14.06.2014, s. 2047-2056.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Harvard

Maeng, M, Tilsted, HH, Jensen, LO, Krusell, LR, Kaltoft, A, Kelbæk, HS, Villadsen, AB, Ravkilde, J, Hansen, KN, Christiansen, EH, Aarøe, J, Jensen, JS, Kristensen, SD, Bøtker, HE, Thuesen, L, Madsen, M, Thayssen, P, Sørensen, HT & Lassen, JF 2014, 'Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study): a multicentre, open-label, randomised superiority trial', Lancet, bind 383, nr. 9934, s. 2047-2056. https://doi.org/10.1016/S0140-6736(14)60405-0

APA

Maeng, M., Tilsted, H. H., Jensen, L. O., Krusell, L. R., Kaltoft, A., Kelbæk, H. S., ... Lassen, J. F. (2014). Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study): a multicentre, open-label, randomised superiority trial. Lancet, 383(9934), 2047-2056. https://doi.org/10.1016/S0140-6736(14)60405-0

Vancouver

Maeng M, Tilsted HH, Jensen LO, Krusell LR, Kaltoft A, Kelbæk HS o.a. Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study): a multicentre, open-label, randomised superiority trial. Lancet. 2014 jun 14;383(9934):2047-2056. https://doi.org/10.1016/S0140-6736(14)60405-0

Author

Maeng, Michael ; Tilsted, Hans Henrik ; Jensen, Lisette Okkels ; Krusell, Lars Romer ; Kaltoft, Anne ; Kelbæk, Henning Skov ; Villadsen, Anton B ; Ravkilde, Jan ; Hansen, Knud Nørregaard ; Christiansen, Evald Høj ; Aarøe, Jens ; Jensen, Jan Skov ; Kristensen, Steen Dalby ; Bøtker, Hans Erik ; Thuesen, Leif ; Madsen, Morten ; Thayssen, Per ; Sørensen, Henrik Toft ; Lassen, Jens Flensted. / Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study) : a multicentre, open-label, randomised superiority trial. I: Lancet. 2014 ; Bind 383, Nr. 9934. s. 2047-2056.

Bibtex

@article{826b6245b9a84590bb41cb9226f8726b,
title = "Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study): a multicentre, open-label, randomised superiority trial",
abstract = "BACKGROUND: In head-to-head comparisons of coronary drug-eluting stents, the primary endpoint is traditionally assessed after 9-12 months. However, the optimum timepoint for this assessment remains unclear. In this study, we assessed clinical outcomes at up to 5 years' follow-up in patients who received two different types of drug-eluting stents.METHODS: We undertook this multicentre, open-label, randomised superiority trial at five percutaneous coronary intervention centres in Denmark. We randomly allocated 2332 eligible adult patients (≥18 years of age) with an indication for drug-eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone allocation service. The primary endpoint of the SORT OUT III study was a composite of major adverse cardiac events-cardiac death, myocardial infarction, and target vessel revascularisation-at 9 months' follow-up. In this study, endpoints included the occurrence of major adverse cardiac events and definite stent thrombosis at follow-up times of up to 5 years. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00660478.FINDINGS: We randomly allocated 1162 patients to receive the zotarolimus-eluting stent and 1170 to the sirolimus-eluting stent. At 5-year follow-up, rates of major adverse cardiac events were similar in patients treated with both types of stents (zotarolimus-eluting stents 197/1162 [17.0{\%}] vs sirolimus-eluting stents 182/1170 [15.6{\%}]; odds ratio [OR] 1.10, 95{\%} CI 0.88-1.37; p=0.40). This finding was indicative of the directly contrasting results for rates of major adverse cardiac events at 1-year follow up (zotarolimus 93/1162 [8.0{\%}] vs sirolimus 46/1170 [3.9{\%}]; OR 2.13, 95{\%} CI 1.48-3.07; p<0.0001) compared with those at follow-up between 1 and 5 years (104 [9.0{\%}] vs 136 [11.6{\%}]; OR 0.78, 95{\%} CI 0.59-1.02; p=0.071). At 1-year follow-up, definite stent thrombosis was more frequent after implantation of the zotarolimus-eluting stent (13/1162 [1.1{\%}]) than the sirolimus-eluting stent (4/1170 [0.3{\%}]; OR 3.34, 95{\%} CI 1.08-10.3; p=0.036), whereas the opposite finding was recorded for between 1 and 5 years' follow-up (zotarolimus-eluting stent 1/1162 [0.1{\%}] vs sirolimus-eluting stent 21/1170 [1.8{\%}], OR 0.05, 95{\%} CI 0.01-0.36; p=0.003). 26 of 88 (30{\%}) target lesion revascularisations in the zotarolimus-eluting stent group occurred between 1 and 5 years' follow-up, whereas 54 of 70 (77{\%}) of those in the sirolimus-eluting stent group occurred during this follow-up period.INTERPRETATION: The superiority of sirolimus-eluting stents compared with zotarolimus-eluting stents at 1-year follow-up was lost after 5 years. The traditional 1-year primary endpoint assessment therefore might be insufficient to predict 5-year clinical outcomes in patients treated with coronary drug-eluting stent implantation.FUNDING: Cordis and Medtronic.",
keywords = "Aged, Coronary Artery Disease, Coronary Restenosis, Coronary Thrombosis, Cytostatic Agents, Drug-Eluting Stents, Female, Follow-Up Studies, Humans, Male, Middle Aged, Myocardial Infarction, Percutaneous Coronary Intervention, Research Design, Single-Blind Method, Sirolimus, Time Factors, Treatment Outcome",
author = "Michael Maeng and Tilsted, {Hans Henrik} and Jensen, {Lisette Okkels} and Krusell, {Lars Romer} and Anne Kaltoft and Kelb{\ae}k, {Henning Skov} and Villadsen, {Anton B} and Jan Ravkilde and Hansen, {Knud N{\o}rregaard} and Christiansen, {Evald H{\o}j} and Jens Aar{\o}e and Jensen, {Jan Skov} and Kristensen, {Steen Dalby} and B{\o}tker, {Hans Erik} and Leif Thuesen and Morten Madsen and Per Thayssen and S{\o}rensen, {Henrik Toft} and Lassen, {Jens Flensted}",
note = "Copyright {\circledC} 2014 Elsevier Ltd. All rights reserved.",
year = "2014",
month = "6",
day = "14",
doi = "10.1016/S0140-6736(14)60405-0",
language = "English",
volume = "383",
pages = "2047--2056",
journal = "Lancet",
issn = "0140-6736",
publisher = "TheLancet Publishing Group",
number = "9934",

}

RIS

TY - JOUR

T1 - Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study)

T2 - a multicentre, open-label, randomised superiority trial

AU - Maeng, Michael

AU - Tilsted, Hans Henrik

AU - Jensen, Lisette Okkels

AU - Krusell, Lars Romer

AU - Kaltoft, Anne

AU - Kelbæk, Henning Skov

AU - Villadsen, Anton B

AU - Ravkilde, Jan

AU - Hansen, Knud Nørregaard

AU - Christiansen, Evald Høj

AU - Aarøe, Jens

AU - Jensen, Jan Skov

AU - Kristensen, Steen Dalby

AU - Bøtker, Hans Erik

AU - Thuesen, Leif

AU - Madsen, Morten

AU - Thayssen, Per

AU - Sørensen, Henrik Toft

AU - Lassen, Jens Flensted

N1 - Copyright © 2014 Elsevier Ltd. All rights reserved.

PY - 2014/6/14

Y1 - 2014/6/14

N2 - BACKGROUND: In head-to-head comparisons of coronary drug-eluting stents, the primary endpoint is traditionally assessed after 9-12 months. However, the optimum timepoint for this assessment remains unclear. In this study, we assessed clinical outcomes at up to 5 years' follow-up in patients who received two different types of drug-eluting stents.METHODS: We undertook this multicentre, open-label, randomised superiority trial at five percutaneous coronary intervention centres in Denmark. We randomly allocated 2332 eligible adult patients (≥18 years of age) with an indication for drug-eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone allocation service. The primary endpoint of the SORT OUT III study was a composite of major adverse cardiac events-cardiac death, myocardial infarction, and target vessel revascularisation-at 9 months' follow-up. In this study, endpoints included the occurrence of major adverse cardiac events and definite stent thrombosis at follow-up times of up to 5 years. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00660478.FINDINGS: We randomly allocated 1162 patients to receive the zotarolimus-eluting stent and 1170 to the sirolimus-eluting stent. At 5-year follow-up, rates of major adverse cardiac events were similar in patients treated with both types of stents (zotarolimus-eluting stents 197/1162 [17.0%] vs sirolimus-eluting stents 182/1170 [15.6%]; odds ratio [OR] 1.10, 95% CI 0.88-1.37; p=0.40). This finding was indicative of the directly contrasting results for rates of major adverse cardiac events at 1-year follow up (zotarolimus 93/1162 [8.0%] vs sirolimus 46/1170 [3.9%]; OR 2.13, 95% CI 1.48-3.07; p<0.0001) compared with those at follow-up between 1 and 5 years (104 [9.0%] vs 136 [11.6%]; OR 0.78, 95% CI 0.59-1.02; p=0.071). At 1-year follow-up, definite stent thrombosis was more frequent after implantation of the zotarolimus-eluting stent (13/1162 [1.1%]) than the sirolimus-eluting stent (4/1170 [0.3%]; OR 3.34, 95% CI 1.08-10.3; p=0.036), whereas the opposite finding was recorded for between 1 and 5 years' follow-up (zotarolimus-eluting stent 1/1162 [0.1%] vs sirolimus-eluting stent 21/1170 [1.8%], OR 0.05, 95% CI 0.01-0.36; p=0.003). 26 of 88 (30%) target lesion revascularisations in the zotarolimus-eluting stent group occurred between 1 and 5 years' follow-up, whereas 54 of 70 (77%) of those in the sirolimus-eluting stent group occurred during this follow-up period.INTERPRETATION: The superiority of sirolimus-eluting stents compared with zotarolimus-eluting stents at 1-year follow-up was lost after 5 years. The traditional 1-year primary endpoint assessment therefore might be insufficient to predict 5-year clinical outcomes in patients treated with coronary drug-eluting stent implantation.FUNDING: Cordis and Medtronic.

AB - BACKGROUND: In head-to-head comparisons of coronary drug-eluting stents, the primary endpoint is traditionally assessed after 9-12 months. However, the optimum timepoint for this assessment remains unclear. In this study, we assessed clinical outcomes at up to 5 years' follow-up in patients who received two different types of drug-eluting stents.METHODS: We undertook this multicentre, open-label, randomised superiority trial at five percutaneous coronary intervention centres in Denmark. We randomly allocated 2332 eligible adult patients (≥18 years of age) with an indication for drug-eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone allocation service. The primary endpoint of the SORT OUT III study was a composite of major adverse cardiac events-cardiac death, myocardial infarction, and target vessel revascularisation-at 9 months' follow-up. In this study, endpoints included the occurrence of major adverse cardiac events and definite stent thrombosis at follow-up times of up to 5 years. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00660478.FINDINGS: We randomly allocated 1162 patients to receive the zotarolimus-eluting stent and 1170 to the sirolimus-eluting stent. At 5-year follow-up, rates of major adverse cardiac events were similar in patients treated with both types of stents (zotarolimus-eluting stents 197/1162 [17.0%] vs sirolimus-eluting stents 182/1170 [15.6%]; odds ratio [OR] 1.10, 95% CI 0.88-1.37; p=0.40). This finding was indicative of the directly contrasting results for rates of major adverse cardiac events at 1-year follow up (zotarolimus 93/1162 [8.0%] vs sirolimus 46/1170 [3.9%]; OR 2.13, 95% CI 1.48-3.07; p<0.0001) compared with those at follow-up between 1 and 5 years (104 [9.0%] vs 136 [11.6%]; OR 0.78, 95% CI 0.59-1.02; p=0.071). At 1-year follow-up, definite stent thrombosis was more frequent after implantation of the zotarolimus-eluting stent (13/1162 [1.1%]) than the sirolimus-eluting stent (4/1170 [0.3%]; OR 3.34, 95% CI 1.08-10.3; p=0.036), whereas the opposite finding was recorded for between 1 and 5 years' follow-up (zotarolimus-eluting stent 1/1162 [0.1%] vs sirolimus-eluting stent 21/1170 [1.8%], OR 0.05, 95% CI 0.01-0.36; p=0.003). 26 of 88 (30%) target lesion revascularisations in the zotarolimus-eluting stent group occurred between 1 and 5 years' follow-up, whereas 54 of 70 (77%) of those in the sirolimus-eluting stent group occurred during this follow-up period.INTERPRETATION: The superiority of sirolimus-eluting stents compared with zotarolimus-eluting stents at 1-year follow-up was lost after 5 years. The traditional 1-year primary endpoint assessment therefore might be insufficient to predict 5-year clinical outcomes in patients treated with coronary drug-eluting stent implantation.FUNDING: Cordis and Medtronic.

KW - Aged

KW - Coronary Artery Disease

KW - Coronary Restenosis

KW - Coronary Thrombosis

KW - Cytostatic Agents

KW - Drug-Eluting Stents

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Male

KW - Middle Aged

KW - Myocardial Infarction

KW - Percutaneous Coronary Intervention

KW - Research Design

KW - Single-Blind Method

KW - Sirolimus

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1016/S0140-6736(14)60405-0

DO - 10.1016/S0140-6736(14)60405-0

M3 - Journal article

C2 - 24631162

VL - 383

SP - 2047

EP - 2056

JO - Lancet

JF - Lancet

SN - 0140-6736

IS - 9934

ER -

ID: 138105375