Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial)

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Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention : A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial). / Maeng, Michael; Christiansen, Evald Høj; Raungaard, Bent; Kahlert, Johnny; Terkelsen, Christian Juhl; Kristensen, Steen Dalby; Carstensen, Steen; Aarøe, Jens; Jensen, Svend Eggert; Villadsen, Anton Boel; Lassen, Jens Flensted; Thim, Troels; Eftekhari, Ashkan; Veien, Karsten Tange; Hansen, Knud Nørregaard; Junker, Anders; Bøtker, Hans Erik; Jensen, Lisette Okkels; SORT OUT VIII Investigators.

In: JACC: Cardiovascular Interventions, Vol. 12, No. 7, 2019, p. 624-633.

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Maeng, Michael ; Christiansen, Evald Høj ; Raungaard, Bent ; Kahlert, Johnny ; Terkelsen, Christian Juhl ; Kristensen, Steen Dalby ; Carstensen, Steen ; Aarøe, Jens ; Jensen, Svend Eggert ; Villadsen, Anton Boel ; Lassen, Jens Flensted ; Thim, Troels ; Eftekhari, Ashkan ; Veien, Karsten Tange ; Hansen, Knud Nørregaard ; Junker, Anders ; Bøtker, Hans Erik ; Jensen, Lisette Okkels ; SORT OUT VIII Investigators. / Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention : A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial). In: JACC: Cardiovascular Interventions. 2019 ; Vol. 12, No. 7. pp. 624-633.

Bibtex

@article{096002674dab497aab611b2ec3d04670,
title = "Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial)",
abstract = "Objectives: The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES). Background: Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation. Methods: This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%. Results: A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001). Conclusions: At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent—SORT-OUT VIII; NCT02093845)",
keywords = "CLINICAL-OUTCOMES, COATED STENT, COMPARE II, EFFICACY, RANDOMIZED SORT, REGISTRY, RESTENOSIS, SAFETY, SYSTEM, THIN, biodegradable polymer, biolimus, drug-eluting stent(s), everolimus, percutaneous coronary intervention, randomized clinical trial",
author = "Michael Maeng and Christiansen, {Evald H{\o}j} and Bent Raungaard and Johnny Kahlert and Terkelsen, {Christian Juhl} and Kristensen, {Steen Dalby} and Steen Carstensen and Jens Aar{\o}e and Jensen, {Svend Eggert} and Villadsen, {Anton Boel} and Lassen, {Jens Flensted} and Troels Thim and Ashkan Eftekhari and Veien, {Karsten Tange} and Hansen, {Knud N{\o}rregaard} and Anders Junker and B{\o}tker, {Hans Erik} and Jensen, {Lisette Okkels} and {SORT OUT VIII Investigators} and Hansen, {Henrik Steen} and Helle Bargsteen and Helle Pedersen and J{\o}rgensen, {Lars P.} and Pia Ottosen and Pedersen, {Karin M.} and Kristian Thygesen and S{\o}rensen, {Jacob Thorsted} and Andersen, {Henning Rud}",
year = "2019",
doi = "10.1016/j.jcin.2018.12.036",
language = "English",
volume = "12",
pages = "624--633",
journal = "J A C C: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "7",

}

RIS

TY - JOUR

T1 - Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention

T2 - A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial)

AU - Maeng, Michael

AU - Christiansen, Evald Høj

AU - Raungaard, Bent

AU - Kahlert, Johnny

AU - Terkelsen, Christian Juhl

AU - Kristensen, Steen Dalby

AU - Carstensen, Steen

AU - Aarøe, Jens

AU - Jensen, Svend Eggert

AU - Villadsen, Anton Boel

AU - Lassen, Jens Flensted

AU - Thim, Troels

AU - Eftekhari, Ashkan

AU - Veien, Karsten Tange

AU - Hansen, Knud Nørregaard

AU - Junker, Anders

AU - Bøtker, Hans Erik

AU - Jensen, Lisette Okkels

AU - SORT OUT VIII Investigators

AU - Hansen, Henrik Steen

AU - Bargsteen, Helle

AU - Pedersen, Helle

AU - Jørgensen, Lars P.

AU - Ottosen, Pia

AU - Pedersen, Karin M.

AU - Thygesen, Kristian

AU - Sørensen, Jacob Thorsted

AU - Andersen, Henning Rud

PY - 2019

Y1 - 2019

N2 - Objectives: The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES). Background: Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation. Methods: This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%. Results: A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001). Conclusions: At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent—SORT-OUT VIII; NCT02093845)

AB - Objectives: The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES). Background: Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation. Methods: This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%. Results: A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001). Conclusions: At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent—SORT-OUT VIII; NCT02093845)

KW - CLINICAL-OUTCOMES

KW - COATED STENT

KW - COMPARE II

KW - EFFICACY

KW - RANDOMIZED SORT

KW - REGISTRY

KW - RESTENOSIS

KW - SAFETY

KW - SYSTEM

KW - THIN

KW - biodegradable polymer

KW - biolimus

KW - drug-eluting stent(s)

KW - everolimus

KW - percutaneous coronary intervention

KW - randomized clinical trial

UR - http://www.scopus.com/inward/record.url?scp=85063315267&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2018.12.036

DO - 10.1016/j.jcin.2018.12.036

M3 - Journal article

C2 - 30947936

AN - SCOPUS:85063315267

VL - 12

SP - 624

EP - 633

JO - J A C C: Cardiovascular Interventions

JF - J A C C: Cardiovascular Interventions

SN - 1936-8798

IS - 7

ER -