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)

Michael Maeng; Evald Høj Christiansen; Bent Raungaard; Johnny Kahlert; Christian Juhl Terkelsen; Steen Dalby Kristensen; Steen Carstensen; Jens Aarøe; Svend Eggert Jensen; Anton Boel Villadsen; Jens Flensted Lassen; Troels Thim; Ashkan Eftekhari; Karsten Tange Veien; Knud Nørregaard Hansen; Anders Junker; Hans Erik Bøtker; Lisette Okkels Jensen; SORT OUT VIII Investigators

doi:10.1016/j.jcin.2018.12.036

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)

Michael Maeng^*, Evald Høj Christiansen, Bent Raungaard, Johnny Kahlert, Christian Juhl Terkelsen, Steen Dalby Kristensen, Steen Carstensen, Jens Aarøe, Svend Eggert Jensen, Anton Boel Villadsen, Jens Flensted Lassen, Troels Thim, Ashkan Eftekhari, Karsten Tange Veien, Knud Nørregaard Hansen, Anders Junker, Hans Erik Bøtker, Lisette Okkels Jensen, SORT OUT VIII Investigators

^*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

31 Citationer (Scopus)

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)

Originalsprog	Engelsk
Tidsskrift	JACC: Cardiovascular Interventions
Vol/bind	12
Nummer	7
Sider (fra-til)	624-633
Antal sider	10
ISSN	1936-8798
DOI	https://doi.org/10.1016/j.jcin.2018.12.036 https://doi.org/10.1016/j.jcin.2018.12.036
Status	Udgivet - 2019

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Citationsformater

Maeng, M., Christiansen, E. H., Raungaard, B., Kahlert, J., Terkelsen, C. J., Kristensen, S. D., Carstensen, S., Aarøe, J., Jensen, S. E., Villadsen, A. B., Lassen, J. F., Thim, T., Eftekhari, A., Veien, K. T., Hansen, K. N., Junker, A., Bøtker, H. E., Jensen, L. O., & SORT OUT VIII Investigators (2019). 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). JACC: Cardiovascular Interventions, 12(7), 624-633. https://doi.org/10.1016/j.jcin.2018.12.036, https://doi.org/10.1016/j.jcin.2018.12.036

Maeng, Michael ; Christiansen, Evald Høj ; Raungaard, Bent et al. / 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). I: JACC: Cardiovascular Interventions. 2019 ; Bind 12, Nr. 7. s. 624-633.

@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 = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "7",

}

Maeng, M , Christiansen, EH, Raungaard, B, Kahlert, J, Terkelsen, CJ , Kristensen, SD, Carstensen, S, Aarøe, J, Jensen, SE, Villadsen, AB, Lassen, JF, Thim, T, Eftekhari, A, Veien, KT, Hansen, KN, Junker, A, Bøtker, HE, Jensen, LO & SORT OUT VIII Investigators 2019, '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)', JACC: Cardiovascular Interventions, bind 12, nr. 7, s. 624-633. https://doi.org/10.1016/j.jcin.2018.12.036, https://doi.org/10.1016/j.jcin.2018.12.036

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 et al.
I: JACC: Cardiovascular Interventions, Bind 12, Nr. 7, 2019, s. 624-633.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

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

SN - 1936-8798

VL - 12

SP - 624

EP - 633

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 7

ER -

Maeng M , Christiansen EH, Raungaard B, Kahlert J, Terkelsen CJ , Kristensen SD et al. 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). JACC: Cardiovascular Interventions. 2019;12(7):624-633. doi: 10.1016/j.jcin.2018.12.036, 10.1016/j.jcin.2018.12.036