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.
N1 - Publisher Copyright:
© 2023 Authors. All rights reserved.
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
U2 - 10.4244/EIJ-D-23-00330
DO - 10.4244/EIJ-D-23-00330
M3 - Journal article
C2 - 37584207
AN - SCOPUS:85177073333
SN - 1774-024X
VL - 19
SP - 676
EP - 683
JO - EuroIntervention
JF - EuroIntervention
IS - 8
ER -