TY - JOUR
T1 - Impact of diabetes on clinical outcomes after revascularization with the dual therapy CD34 antibody-covered sirolimus-eluting Combo stent and the sirolimus-eluting Orsiro stent
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 - Kristensen, Steen D.
AU - Christensen, Martin K.
AU - Terkelsen, Christian J.
AU - Thim, Troels
AU - Eftekhari, Ashkan
AU - Jensen, Rebekka V.
AU - Støttrup, Nicolaj B.
AU - Junker, Anders
AU - Hansen, Henrik S.
AU - Jensen, Lisette O.
N1 - © 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.
PY - 2022/6/1
Y1 - 2022/6/1
N2 - Objectives: To compare the efficacy and safety of the dual therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) and the sirolimus-eluting Orsiro stent (SES) in patients with and without diabetes mellitus (DM) included in the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) X study. Background: The incidence of target lesion failure (TLF) after treatment with modern drug-eluting stents has been reported to be significantly higher in patients with DM when compared to patients without DM. Thus, whether the results from the SORT OUT X study apply to patients with and without DM remains unknown. Methods: In total 3146 patients were randomized to stent implantation with DTS (n = 1578; DM: n = 279) or SES (n = 1568; DM: n = 271). The primary end point, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 1 year. Results: At 1 year, the rate of TLF was increased in the DTS group compared to the SES group, both among patients with DM (9.3% vs. 4.8%; risk difference: 4.5%; incidence rate ratio: 1.99, 95% confidence interval [CI]: 1.02–3.90) and without DM (5.7% vs. 3.5%; incidence rate ratio: 1.67, 95% CI: 1.15–2.42). The differences were mainly explained by higher rates of TLR. Conclusion: Compared to the SES, the DTS was associated with an increased risk of TLF at 12 months in patients with and without DM. The differences were mainly explained by higher rates of TLR, whereas rates of cardiac death and target lesion MI did not differ significantly between the two stent groups in patients with or without DM.
AB - Objectives: To compare the efficacy and safety of the dual therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) and the sirolimus-eluting Orsiro stent (SES) in patients with and without diabetes mellitus (DM) included in the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) X study. Background: The incidence of target lesion failure (TLF) after treatment with modern drug-eluting stents has been reported to be significantly higher in patients with DM when compared to patients without DM. Thus, whether the results from the SORT OUT X study apply to patients with and without DM remains unknown. Methods: In total 3146 patients were randomized to stent implantation with DTS (n = 1578; DM: n = 279) or SES (n = 1568; DM: n = 271). The primary end point, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 1 year. Results: At 1 year, the rate of TLF was increased in the DTS group compared to the SES group, both among patients with DM (9.3% vs. 4.8%; risk difference: 4.5%; incidence rate ratio: 1.99, 95% confidence interval [CI]: 1.02–3.90) and without DM (5.7% vs. 3.5%; incidence rate ratio: 1.67, 95% CI: 1.15–2.42). The differences were mainly explained by higher rates of TLR. Conclusion: Compared to the SES, the DTS was associated with an increased risk of TLF at 12 months in patients with and without DM. The differences were mainly explained by higher rates of TLR, whereas rates of cardiac death and target lesion MI did not differ significantly between the two stent groups in patients with or without DM.
KW - diabetes
KW - randomized controlled trial
KW - stent comparison
KW - target lesion failure
UR - http://www.scopus.com/inward/record.url?scp=85128379923&partnerID=8YFLogxK
U2 - 10.1002/ccd.30175
DO - 10.1002/ccd.30175
M3 - Journal article
C2 - 35384254
AN - SCOPUS:85128379923
SN - 1522-1946
VL - 99
SP - 1965
EP - 1975
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
IS - 7
ER -