Randomized comparison of the combined Sirolimus eluting and endothelial progenitor cell ComboTM stent vs. Biolimus eluting absorbable polymer coated BioMatrix AlphaTM stent in patients undergoing percutaneous coronary intervention. Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) XI trial: SORT-OUT XI Trial Design.

Abstract

Rationale: The biodegradable polymer BioMatrix Alpha™ stent contains biolimus A9 drug which is sirolimus derivative increase in lipophicity. The biodegradable polymer sirolimus eluting Combo™ stent is a dual-therapy sirolimus-eluting and CD34+ antobody coated stent capturing endothelial progenitor cells (EPCs).

Hypothesis: The main hypothesis of the SORT OUT XI trial was that the biodegradable polymer biolimus A9 BioMatrix Alpha ™ stent is noninferior to the biodegradable polymer sirolimus eluting Combo™ stent in an all-comers population with coronary artery disease undergoing percutaneous coronary intervention (PCI).

Methods: The SORT OUT XI study was a randomized, multicenter, single blinded, all-comer, 2-arm, noninferiority trial comparing the biodegradable polymer biolimus A9 BioMatrix Alpha™ stent to the biodegradable polymer sirolimus eluting Combo™ stent in three Danish University Hospitals in Western Denmark. The composite primary endpoint was target lesion failure (TLF) within 12 months. TLF was defined as composite of cardiac death, myocardial infarction not related to other than index lesion or target lesion revascularization. Clinically driven event detection was used and no planned follow up was performed. With a sample size of 1,564 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority with a predetermined noninferiority margin of 2.1%.

Results: The trial ran from August 14, 2019 to March 19, 2023. A total of 3141 patients were enrolled and randomized 1:1 to Combo™ stent (n=1,573) and BioMatrix Alpha™ stent (n=1,568). Conclusion The SORT OUT XI trial will assess if the biolimus A9 eluting BioMAtrix Alpha™ stent is noninferior to the dual-therapy Combo™ stent with respect to target lesion failure. (ClinicalTrials.gov NCT03952273).