Key result
Combo stent increases 1-year target lesion failure by ~99% vs Orsiro stent.
Why the study?
Target lesion failure after modern drug-eluting stents is significantly higher in patients with DM, leaving it unknown whether SORT OUT X study results apply to patients with and without DM.
Does the dual therapy CD34 antibody-covered sirolimus-eluting Combo stent reduce target lesion failure compared to the sirolimus-eluting Orsiro stent in patients with and without diabetes mellitus?
RCT (n=3,146)
randomized
Yes
Does the dual therapy CD34 antibody-covered sirolimus-eluting Combo stent reduce target lesion failure compared to the sirolimus-eluting Orsiro stent in patients with and without diabetes mellitus?
The dual therapy CD34 antibody-covered sirolimus-eluting Combo stent was associated with an increased risk of target lesion failure at 1 year compared to the sirolimus-eluting Orsiro stent in patients with and without diabetes mellitus, driven primarily by higher rates of target lesion revascularization.
Favors Orsiro over Combo stent to reduce target lesion failure; challenges dual-therapy coating superiority in patients with and without diabetes.
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.
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Jakobsen et al. (2022) conducted an RCT in Coronary artery disease requiring revascularization (n=3,146). Dual therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) vs. Sirolimus-eluting Orsiro stent (SES) was evaluated on Target lesion failure (TLF), a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 1 year (IRR 1.99, 95% CI 1.02-3.90). The Combo stent increased the 1-year risk of target lesion failure compared to the Orsiro stent in patients with diabetes (9.3% vs 4.8%; IRR 1.99, 95% CI 1.02-3.90) and without diabetes.
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