Randomized Clinical Comparison of the Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Combo Stent With the
Lars Jakobsen1, Evald H Christiansen1, Phillip Freeman2
1Department of Cardiology (L.J., E.H.C., M.M., S.D.K., C.J.T., H.E.B., T.T., A.E., R.V.J., N.B.S.), Aarhus University Hospital, Denmark.
Circulation
|April 7, 2021
Summary
The dual-therapy sirolimus-eluting and CD34+ antibody-coated Combo stent (DTS) was not noninferior to the sirolimus-eluting Orsiro stent (SES) for target lesion failure. The SES demonstrated superiority, primarily due to a lower rate of target lesion revascularization with the DTS.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Target lesion failure remains a clinical challenge with current drug-eluting stents.
- The Combo stent (DTS) integrates sirolimus elution and CD34+ antibody coating to enhance early healing.
- This study evaluates the DTS against a contemporary sirolimus-eluting stent (SES) in a broad patient group.
Purpose of the Study:
- To assess the noninferiority of the dual-therapy sirolimus-eluting and CD34+ antibody-coated Combo stent (DTS) compared to the sirolimus-eluting Orsiro stent (SES).
- To evaluate target lesion failure as the primary endpoint in an all-comers patient population at 12 months.
Main Methods:
- A large-scale, randomized, multicenter, single-blind, noninferiority trial (SORT OUT X) with registry-based follow-up.
- 3146 patients were randomized to either DTS (1578) or SES (1568) groups.
- The primary endpoint was target lesion failure, a composite of cardiac death, myocardial infarction, or target lesion revascularization within 12 months.
Main Results:
- The DTS group experienced a primary endpoint event rate of 6.3% (100 patients) versus 3.7% (58 patients) in the SES group.
- The DTS failed to demonstrate noninferiority to the SES (absolute risk difference, 2.6%; upper 95% CI, 4.1%).
- The SES was superior to the DTS (incidence rate ratio, 1.74; P=0.00086), driven by a higher incidence of target lesion revascularization in the DTS group (3.4% vs. 1.5%).
Conclusions:
- The dual-therapy Combo stent (DTS) did not meet noninferiority criteria compared to the sirolimus-eluting Orsiro stent (SES) for target lesion failure at 12 months.
- The sirolimus-eluting Orsiro stent (SES) proved superior, primarily due to a significantly lower rate of target lesion revascularization in the DTS group.
- No significant differences were observed between the stent groups in the rates of death, cardiac death, or myocardial infarction at 12 months.
