Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial

Lars Jakobsen; Evald H Christiansen; Phillip Freeman; Johnny Kahlert; Karsten Veien; Michael Maeng; Bent Raungaard; Julia Ellert; Anton B Villadsen; Steen D Kristensen; Martin K Christensen; Christian J Terkelsen; Jens Aaroe; Troels Thim; Jens Flensted Lassen; Mikkel Hougaard; Ashkan Eftekhari; Rebekka V Jensen; Nicolaj B Støttrup; Jeppe G Rasmussen; Anders Junker; Svend E Jensen; Henrik S Hansen; Lisette O Jensen

doi:10.4244/EIJ-D-23-00330

Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial

Lars Jakobsen, Evald H Christiansen, Phillip Freeman, Johnny Kahlert, Karsten Veien, Michael Maeng, Bent Raungaard, Julia Ellert, Anton B Villadsen, Steen D Kristensen, Martin K Christensen, Christian J Terkelsen, Jens Aaroe, Troels Thim, Jens Flensted Lassen, Mikkel Hougaard, Ashkan Eftekhari, Rebekka V Jensen, Nicolaj B Støttrup, Jeppe G RasmussenAnders Junker, Svend E Jensen, Henrik S Hansen, Lisette O Jensen

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

Abstract

BACKGROUND: Target lesion failure (TLF) remains an issue with contemporary drug-eluting stents. The dual-therapy sirolimus-eluting and CD34 antibody-coated COMBO stent (DTS) was designed to improve early healing.

AIMS: We aimed to compare the 3-year outcomes of the DTS and the sirolimus-eluting Orsiro stent (SES) in all-comer patients treated with percutaneous coronary intervention.

METHODS: The SORT OUT X trial is a prospective multicentre randomised clinical trial with a registry-based follow-up comparing DTS and SES. The primary endpoint, TLF, is a composite of cardiac death, myocardial infarction or target lesion revascularisation (TLR).

RESULTS: A total of 3,146 patients were randomised to treatment with the DTS (1,578 patients) or the SES (1,568 patients). At 3 years, an intention-to-treat analysis showed that 155 patients (9.8%) who were assigned the DTS and 118 patients (7.5%) who were assigned the SES met the primary endpoint (incidence rate ratio for TLF=1.33, 95% confidence interval: 1.04-1.70; p=0.02). This difference was caused by a significantly higher TLF rate in the DTS group compared to the SES group within the first year, which was mainly explained by a higher incidence of TLR in the DTS group compared to the SES group. Of note, the TLF rates were almost identical from 1 year to 3 years in both stent groups.

CONCLUSIONS: At 3 years, the SES was superior to the DTS, mainly because the DTS was associated with an increased risk of TLF within the first year but not from 1 to 3 years.

CLINICALTRIALS: gov: NCT03216733.

Originalsprog	Engelsk
Tidsskrift	EuroIntervention
Vol/bind	19
Nummer	8
Sider (fra-til)	676-683
Antal sider	8
ISSN	1774-024X
DOI	https://doi.org/10.4244/EIJ-D-23-00330
Status	Udgivet - okt. 2023

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10.4244/EIJ-D-23-00330

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Citationsformater

Jakobsen, L., Christiansen, E. H., Freeman, P., Kahlert, J., Veien, K., Maeng, M., Raungaard, B., Ellert, J., Villadsen, A. B., Kristensen, S. D., Christensen, M. K., Terkelsen, C. J., Aaroe, J., Thim, T., Lassen, J. F., Hougaard, M., Eftekhari, A., Jensen, R. V., Støttrup, N. B., ... Jensen, L. O. (2023). Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial. EuroIntervention, 19(8), 676-683. https://doi.org/10.4244/EIJ-D-23-00330

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title = "Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial",

abstract = "BACKGROUND: Target lesion failure (TLF) remains an issue with contemporary drug-eluting stents. The dual-therapy sirolimus-eluting and CD34 antibody-coated COMBO stent (DTS) was designed to improve early healing.AIMS: We aimed to compare the 3-year outcomes of the DTS and the sirolimus-eluting Orsiro stent (SES) in all-comer patients treated with percutaneous coronary intervention.METHODS: The SORT OUT X trial is a prospective multicentre randomised clinical trial with a registry-based follow-up comparing DTS and SES. The primary endpoint, TLF, is a composite of cardiac death, myocardial infarction or target lesion revascularisation (TLR).RESULTS: A total of 3,146 patients were randomised to treatment with the DTS (1,578 patients) or the SES (1,568 patients). At 3 years, an intention-to-treat analysis showed that 155 patients (9.8%) who were assigned the DTS and 118 patients (7.5%) who were assigned the SES met the primary endpoint (incidence rate ratio for TLF=1.33, 95% confidence interval: 1.04-1.70; p=0.02). This difference was caused by a significantly higher TLF rate in the DTS group compared to the SES group within the first year, which was mainly explained by a higher incidence of TLR in the DTS group compared to the SES group. Of note, the TLF rates were almost identical from 1 year to 3 years in both stent groups.CONCLUSIONS: At 3 years, the SES was superior to the DTS, mainly because the DTS was associated with an increased risk of TLF within the first year but not from 1 to 3 years.CLINICALTRIALS: gov: NCT03216733.",

keywords = "•clinical trials, •drug-eluting stent, •no specific risk",

author = "Lars Jakobsen and Christiansen, {Evald H} and Phillip Freeman and Johnny Kahlert and Karsten Veien and Michael Maeng and Bent Raungaard and Julia Ellert and Villadsen, {Anton B} and Kristensen, {Steen D} and Christensen, {Martin K} and Terkelsen, {Christian J} and Jens Aaroe and Troels Thim and Lassen, {Jens Flensted} and Mikkel Hougaard and Ashkan Eftekhari and Jensen, {Rebekka V} and St{\o}ttrup, {Nicolaj B} and Rasmussen, {Jeppe G} and Anders Junker and Jensen, {Svend E} and Hansen, {Henrik S} and Jensen, {Lisette O}",

year = "2023",

month = oct,

doi = "10.4244/EIJ-D-23-00330",

language = "English",

volume = "19",

pages = "676--683",

journal = "EuroIntervention",

issn = "1774-024X",

publisher = "Europa Digital & Publishing",

number = "8",

}

Jakobsen, L , Christiansen, EH, Freeman, P, Kahlert, J, Veien, K, Maeng, M, Raungaard, B, Ellert, J, Villadsen, AB, Kristensen, SD, Christensen, MK, Terkelsen, CJ, Aaroe, J, Thim, T, Lassen, JF, Hougaard, M, Eftekhari, A, Jensen, RV , Støttrup, NB, Rasmussen, JG, Junker, A, Jensen, SE, Hansen, HS & Jensen, LO 2023, 'Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial', EuroIntervention, bind 19, nr. 8, s. 676-683. https://doi.org/10.4244/EIJ-D-23-00330

Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial. / Jakobsen, Lars ; Christiansen, Evald H; Freeman, Phillip et al.
I: EuroIntervention, Bind 19, Nr. 8, 10.2023, s. 676-683.

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

TY - JOUR

T1 - Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention

T2 - the three-year outcomes of the SORT OUT X randomised clinical trial

AU - Jakobsen, Lars

AU - Christiansen, Evald H

AU - Freeman, Phillip

AU - Kahlert, Johnny

AU - Veien, Karsten

AU - Maeng, Michael

AU - Raungaard, Bent

AU - Ellert, Julia

AU - Villadsen, Anton B

AU - Kristensen, Steen D

AU - Christensen, Martin K

AU - Terkelsen, Christian J

AU - Aaroe, Jens

AU - Thim, Troels

AU - Lassen, Jens Flensted

AU - Hougaard, Mikkel

AU - Eftekhari, Ashkan

AU - Jensen, Rebekka V

AU - Støttrup, Nicolaj B

AU - Rasmussen, Jeppe G

AU - Junker, Anders

AU - Jensen, Svend E

AU - Hansen, Henrik S

AU - Jensen, Lisette O

PY - 2023/10

Y1 - 2023/10

N2 - BACKGROUND: Target lesion failure (TLF) remains an issue with contemporary drug-eluting stents. The dual-therapy sirolimus-eluting and CD34 antibody-coated COMBO stent (DTS) was designed to improve early healing.AIMS: We aimed to compare the 3-year outcomes of the DTS and the sirolimus-eluting Orsiro stent (SES) in all-comer patients treated with percutaneous coronary intervention.METHODS: The SORT OUT X trial is a prospective multicentre randomised clinical trial with a registry-based follow-up comparing DTS and SES. The primary endpoint, TLF, is a composite of cardiac death, myocardial infarction or target lesion revascularisation (TLR).RESULTS: A total of 3,146 patients were randomised to treatment with the DTS (1,578 patients) or the SES (1,568 patients). At 3 years, an intention-to-treat analysis showed that 155 patients (9.8%) who were assigned the DTS and 118 patients (7.5%) who were assigned the SES met the primary endpoint (incidence rate ratio for TLF=1.33, 95% confidence interval: 1.04-1.70; p=0.02). This difference was caused by a significantly higher TLF rate in the DTS group compared to the SES group within the first year, which was mainly explained by a higher incidence of TLR in the DTS group compared to the SES group. Of note, the TLF rates were almost identical from 1 year to 3 years in both stent groups.CONCLUSIONS: At 3 years, the SES was superior to the DTS, mainly because the DTS was associated with an increased risk of TLF within the first year but not from 1 to 3 years.CLINICALTRIALS: gov: NCT03216733.

AB - BACKGROUND: Target lesion failure (TLF) remains an issue with contemporary drug-eluting stents. The dual-therapy sirolimus-eluting and CD34 antibody-coated COMBO stent (DTS) was designed to improve early healing.AIMS: We aimed to compare the 3-year outcomes of the DTS and the sirolimus-eluting Orsiro stent (SES) in all-comer patients treated with percutaneous coronary intervention.METHODS: The SORT OUT X trial is a prospective multicentre randomised clinical trial with a registry-based follow-up comparing DTS and SES. The primary endpoint, TLF, is a composite of cardiac death, myocardial infarction or target lesion revascularisation (TLR).RESULTS: A total of 3,146 patients were randomised to treatment with the DTS (1,578 patients) or the SES (1,568 patients). At 3 years, an intention-to-treat analysis showed that 155 patients (9.8%) who were assigned the DTS and 118 patients (7.5%) who were assigned the SES met the primary endpoint (incidence rate ratio for TLF=1.33, 95% confidence interval: 1.04-1.70; p=0.02). This difference was caused by a significantly higher TLF rate in the DTS group compared to the SES group within the first year, which was mainly explained by a higher incidence of TLR in the DTS group compared to the SES group. Of note, the TLF rates were almost identical from 1 year to 3 years in both stent groups.CONCLUSIONS: At 3 years, the SES was superior to the DTS, mainly because the DTS was associated with an increased risk of TLF within the first year but not from 1 to 3 years.CLINICALTRIALS: gov: NCT03216733.

KW - •clinical trials

KW - •drug-eluting stent

KW - •no specific risk

UR - http://www.scopus.com/inward/record.url?scp=85177073333&partnerID=8YFLogxK

U2 - 10.4244/EIJ-D-23-00330

DO - 10.4244/EIJ-D-23-00330

M3 - Journal article

C2 - 37584207

SN - 1774-024X

VL - 19

SP - 676

EP - 683

JO - EuroIntervention

JF - EuroIntervention

IS - 8

ER -

Jakobsen L , Christiansen EH, Freeman P, Kahlert J, Veien K, Maeng M et al. Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial. EuroIntervention. 2023 okt.;19(8):676-683. Epub 2023 aug. 16. doi: 10.4244/EIJ-D-23-00330