Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI)

a randomised non-inferiority trial

Bent Raungaard, Lisette Okkels Jensen, Hans-Henrik Tilsted, Evald Høj Christiansen, Michael Maeng, Christian Juhl Terkelsen, Lars Romer Krusell, Anne Kaltoft, Steen Dalby Kristensen, Hans Erik Bøtker, Leif Thuesen, Jens Aarøe, Svend Eggert Jensen, Anton Boel Villadsen, Per Thayssen, Karsten Tange Veien, Knud Nørregaard Hansen, Anders Junker, Morten Madsen, Jan Ravkilde & 2 andre Jens Flensted Lassen, Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT)

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

BACKGROUND: New-generation drug-eluting coronary stents have reduced the risk of coronary events, especially in patients with complex disease or lesions. To what extent different stent platforms, polymers, and antiproliferative drugs affect outcomes, however, is unclear. We investigated the safety and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent.

METHODS: This open-label, randomised, multicentre, non-inferiority trial was done at three sites across western Denmark. All patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion (more than 50% stenosis) from March, 2011, to August, 2012, were assessed for eligibility. Patients were randomly assigned in a 1:1 ratio to receive either the durable-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent. The primary endpoint was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target-lesion revascularisation) at 12 months, analysed by intention to treat. The trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of 0·025. This trial is registered with ClinicalTrials.gov, number NCT01956448.

FINDINGS: Of 7103 screened, 1502 patients with 1883 lesions were assigned to receive the durable-polymer zotarolimus-eluting stent and 1497 patients with 1791 lesions to receive the biodegradable-polymer biolimus-eluting stent. 79 (5·3%) and 75 (5·0%) patients, respectively, met the primary endpoint (absolute risk difference 0·0025, upper limit of one-sided 95% CI 0·016%; p=0·004). The individual components of the primary endpoint did not differ significantly between stent types at 12 months.

INTERPRETATION: The durable-polymer-coated zotarolimus-eluting stent was non-inferior to the biodegradable-polymer-coated biolimus-eluting stent in unselected patients.

FUNDING: Medtronic Cardiovascular and Biosensors Interventional Technologies.

OriginalsprogEngelsk
TidsskriftLancet Oncology
Vol/bind385
Udgave nummer9977
Sider (fra-til)1527-35
ISSN1470-2045
DOI
StatusUdgivet - 18. apr. 2015

Fingeraftryk

Stents
zotarolimus
Safety
Biosensing Techniques
Denmark
Acute Coronary Syndrome
Coronary Artery Disease
Pathologic Constriction

Citer dette

Raungaard, Bent ; Jensen, Lisette Okkels ; Tilsted, Hans-Henrik ; Christiansen, Evald Høj ; Maeng, Michael ; Terkelsen, Christian Juhl ; Krusell, Lars Romer ; Kaltoft, Anne ; Kristensen, Steen Dalby ; Bøtker, Hans Erik ; Thuesen, Leif ; Aarøe, Jens ; Jensen, Svend Eggert ; Villadsen, Anton Boel ; Thayssen, Per ; Veien, Karsten Tange ; Hansen, Knud Nørregaard ; Junker, Anders ; Madsen, Morten ; Ravkilde, Jan ; Lassen, Jens Flensted ; Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT). / Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI) : a randomised non-inferiority trial. I: Lancet Oncology. 2015 ; Bind 385, Nr. 9977. s. 1527-35.
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title = "Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial",
abstract = "BACKGROUND: New-generation drug-eluting coronary stents have reduced the risk of coronary events, especially in patients with complex disease or lesions. To what extent different stent platforms, polymers, and antiproliferative drugs affect outcomes, however, is unclear. We investigated the safety and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent.METHODS: This open-label, randomised, multicentre, non-inferiority trial was done at three sites across western Denmark. All patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion (more than 50{\%} stenosis) from March, 2011, to August, 2012, were assessed for eligibility. Patients were randomly assigned in a 1:1 ratio to receive either the durable-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent. The primary endpoint was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target-lesion revascularisation) at 12 months, analysed by intention to treat. The trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of 0·025. This trial is registered with ClinicalTrials.gov, number NCT01956448.FINDINGS: Of 7103 screened, 1502 patients with 1883 lesions were assigned to receive the durable-polymer zotarolimus-eluting stent and 1497 patients with 1791 lesions to receive the biodegradable-polymer biolimus-eluting stent. 79 (5·3{\%}) and 75 (5·0{\%}) patients, respectively, met the primary endpoint (absolute risk difference 0·0025, upper limit of one-sided 95{\%} CI 0·016{\%}; p=0·004). The individual components of the primary endpoint did not differ significantly between stent types at 12 months.INTERPRETATION: The durable-polymer-coated zotarolimus-eluting stent was non-inferior to the biodegradable-polymer-coated biolimus-eluting stent in unselected patients.FUNDING: Medtronic Cardiovascular and Biosensors Interventional Technologies.",
keywords = "Absorbable Implants, Aged, Coated Materials, Biocompatible, Denmark, Drug-Eluting Stents, Equipment Design, Female, Humans, Immunosuppressive Agents, Intention to Treat Analysis, Male, Middle Aged, Myocardial Ischemia, Percutaneous Coronary Intervention, Polymers, Sirolimus, Treatment Outcome",
author = "Bent Raungaard and Jensen, {Lisette Okkels} and Hans-Henrik Tilsted and Christiansen, {Evald H{\o}j} and Michael Maeng and Terkelsen, {Christian Juhl} and Krusell, {Lars Romer} and Anne Kaltoft and Kristensen, {Steen Dalby} and B{\o}tker, {Hans Erik} and Leif Thuesen and Jens Aar{\o}e and Jensen, {Svend Eggert} and Villadsen, {Anton Boel} and Per Thayssen and Veien, {Karsten Tange} and Hansen, {Knud N{\o}rregaard} and Anders Junker and Morten Madsen and Jan Ravkilde and Lassen, {Jens Flensted} and {Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT)}",
note = "Copyright {\circledC} 2015 Elsevier Ltd. All rights reserved.",
year = "2015",
month = "4",
day = "18",
doi = "10.1016/S0140-6736(14)61794-3",
language = "English",
volume = "385",
pages = "1527--35",
journal = "The Lancet Oncology",
issn = "1470-2045",
publisher = "TheLancet Publishing Group",
number = "9977",

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Raungaard, B, Jensen, LO, Tilsted, H-H, Christiansen, EH, Maeng, M, Terkelsen, CJ, Krusell, LR, Kaltoft, A, Kristensen, SD, Bøtker, HE, Thuesen, L, Aarøe, J, Jensen, SE, Villadsen, AB, Thayssen, P, Veien, KT, Hansen, KN, Junker, A, Madsen, M, Ravkilde, J, Lassen, JF & Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) 2015, 'Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial', Lancet Oncology, bind 385, nr. 9977, s. 1527-35. https://doi.org/10.1016/S0140-6736(14)61794-3

Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI) : a randomised non-inferiority trial. / Raungaard, Bent; Jensen, Lisette Okkels; Tilsted, Hans-Henrik; Christiansen, Evald Høj; Maeng, Michael; Terkelsen, Christian Juhl; Krusell, Lars Romer; Kaltoft, Anne; Kristensen, Steen Dalby; Bøtker, Hans Erik; Thuesen, Leif; Aarøe, Jens; Jensen, Svend Eggert; Villadsen, Anton Boel; Thayssen, Per; Veien, Karsten Tange; Hansen, Knud Nørregaard; Junker, Anders; Madsen, Morten; Ravkilde, Jan; Lassen, Jens Flensted; Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT).

I: Lancet Oncology, Bind 385, Nr. 9977, 18.04.2015, s. 1527-35.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI)

T2 - a randomised non-inferiority trial

AU - Raungaard, Bent

AU - Jensen, Lisette Okkels

AU - Tilsted, Hans-Henrik

AU - Christiansen, Evald Høj

AU - Maeng, Michael

AU - Terkelsen, Christian Juhl

AU - Krusell, Lars Romer

AU - Kaltoft, Anne

AU - Kristensen, Steen Dalby

AU - Bøtker, Hans Erik

AU - Thuesen, Leif

AU - Aarøe, Jens

AU - Jensen, Svend Eggert

AU - Villadsen, Anton Boel

AU - Thayssen, Per

AU - Veien, Karsten Tange

AU - Hansen, Knud Nørregaard

AU - Junker, Anders

AU - Madsen, Morten

AU - Ravkilde, Jan

AU - Lassen, Jens Flensted

AU - Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT)

N1 - Copyright © 2015 Elsevier Ltd. All rights reserved.

PY - 2015/4/18

Y1 - 2015/4/18

N2 - BACKGROUND: New-generation drug-eluting coronary stents have reduced the risk of coronary events, especially in patients with complex disease or lesions. To what extent different stent platforms, polymers, and antiproliferative drugs affect outcomes, however, is unclear. We investigated the safety and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent.METHODS: This open-label, randomised, multicentre, non-inferiority trial was done at three sites across western Denmark. All patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion (more than 50% stenosis) from March, 2011, to August, 2012, were assessed for eligibility. Patients were randomly assigned in a 1:1 ratio to receive either the durable-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent. The primary endpoint was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target-lesion revascularisation) at 12 months, analysed by intention to treat. The trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of 0·025. This trial is registered with ClinicalTrials.gov, number NCT01956448.FINDINGS: Of 7103 screened, 1502 patients with 1883 lesions were assigned to receive the durable-polymer zotarolimus-eluting stent and 1497 patients with 1791 lesions to receive the biodegradable-polymer biolimus-eluting stent. 79 (5·3%) and 75 (5·0%) patients, respectively, met the primary endpoint (absolute risk difference 0·0025, upper limit of one-sided 95% CI 0·016%; p=0·004). The individual components of the primary endpoint did not differ significantly between stent types at 12 months.INTERPRETATION: The durable-polymer-coated zotarolimus-eluting stent was non-inferior to the biodegradable-polymer-coated biolimus-eluting stent in unselected patients.FUNDING: Medtronic Cardiovascular and Biosensors Interventional Technologies.

AB - BACKGROUND: New-generation drug-eluting coronary stents have reduced the risk of coronary events, especially in patients with complex disease or lesions. To what extent different stent platforms, polymers, and antiproliferative drugs affect outcomes, however, is unclear. We investigated the safety and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent.METHODS: This open-label, randomised, multicentre, non-inferiority trial was done at three sites across western Denmark. All patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion (more than 50% stenosis) from March, 2011, to August, 2012, were assessed for eligibility. Patients were randomly assigned in a 1:1 ratio to receive either the durable-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent. The primary endpoint was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target-lesion revascularisation) at 12 months, analysed by intention to treat. The trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of 0·025. This trial is registered with ClinicalTrials.gov, number NCT01956448.FINDINGS: Of 7103 screened, 1502 patients with 1883 lesions were assigned to receive the durable-polymer zotarolimus-eluting stent and 1497 patients with 1791 lesions to receive the biodegradable-polymer biolimus-eluting stent. 79 (5·3%) and 75 (5·0%) patients, respectively, met the primary endpoint (absolute risk difference 0·0025, upper limit of one-sided 95% CI 0·016%; p=0·004). The individual components of the primary endpoint did not differ significantly between stent types at 12 months.INTERPRETATION: The durable-polymer-coated zotarolimus-eluting stent was non-inferior to the biodegradable-polymer-coated biolimus-eluting stent in unselected patients.FUNDING: Medtronic Cardiovascular and Biosensors Interventional Technologies.

KW - Absorbable Implants

KW - Aged

KW - Coated Materials, Biocompatible

KW - Denmark

KW - Drug-Eluting Stents

KW - Equipment Design

KW - Female

KW - Humans

KW - Immunosuppressive Agents

KW - Intention to Treat Analysis

KW - Male

KW - Middle Aged

KW - Myocardial Ischemia

KW - Percutaneous Coronary Intervention

KW - Polymers

KW - Sirolimus

KW - Treatment Outcome

U2 - 10.1016/S0140-6736(14)61794-3

DO - 10.1016/S0140-6736(14)61794-3

M3 - Journal article

VL - 385

SP - 1527

EP - 1535

JO - The Lancet Oncology

JF - The Lancet Oncology

SN - 1470-2045

IS - 9977

ER -